Seattle Genetics Announces Updates to Adcetris Prescribing Information

BOTHELL, Wash.–(BUSINESS WIRE)–Jan 13, 2012 – Seattle Genetics, Inc. today announced updates to the U.S. Prescribing Information (PI) for Adcetris (brentuximab vedotin). The revised PI will include the following updated information:

A boxed warning related to the risk that JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in patients receiving Adcetris.A discussion in the PML warning and precaution provision regarding other possible contributing factors to PML such as other prior therapies and underlying disease, symptoms to be aware of and suggested methodologies for diagnosis of PML.A contraindication warning of the concomitant use of Adcetris and bleomycin due to pulmonary toxicity.

Adcetris is an antibody-drug conjugate (ADC) directed to CD30 that was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2011 for two indications: (1) the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The indications for Adcetris are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with Adcetris.

“Our first priority is patient safety. By developing these agreed upon label updates with the FDA regarding PML and the contraindication with bleomycin, we aim to heighten awareness among healthcare professionals in order to most safely treat their patients with Adcetris. Although PML in lymphoma patients can be caused by factors such as underlying disease and prior therapies that affect the immune system, a contributory role of Adcetris cannot be excluded,” said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. “The contraindication for the concomitant use of Adcetris and bleomycin is based on data suggesting an increased risk of pulmonary toxicity relative to ABVD alone that was identified in our phase I clinical trial in patients with newly diagnosed advanced Hodgkin lymphoma. We are confident that these label changes will help guide appropriate patient care while on treatment with Adcetris.”

PML is associated with a weakened immune system that can occur in patients with diseases such as lymphoma, leukemia and other hematologic malignancies. According to published literature, the risk of PML in persons with hematologic malignancies is estimated to be 0.07%, or approximately one in 1,400 (1). More than 2,000 patients worldwide have received treatment with Adcetris to date.

PML was described in the original PI for Adcetris based on a single case reported in a patient who had received four chemotherapy regimens prior to receiving Adcetris. Following the occurrence of a second case of PML, Seattle Genetics began working in conjunction with the FDA to add a boxed warning in order to heighten awareness of the potential risk of PML. There has also been a third suspected, but unconfirmed, case of PML reported in a heavily-pretreated patient receiving Adcetris.

In addition, based on data from a phase I clinical trial of Adcetris in combination with ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) for the treatment of newly diagnosed Hodgkin lymphoma patients, a contraindication for concomitant use of bleomycin and Adcetris will be added to the PI. This is based on data demonstrating that 40 percent of patients (10 out of 25) in the Adcetris plus ABVD cohorts of the trial had an event of pulmonary toxicity, compared to an overall rate of pulmonary toxicity with bleomycin-based regimens reported in published literature of 10 to 25 percent (2,3). To date, no pulmonary toxicity events have been observed in the Adcetris plus AVD cohorts of the trial. Adcetris is not approved for the front-line treatment of Hodgkin lymphoma.

When finalized, the updated PI will be posted at http://www.seattlegenetics.com.

PML is a rare, progressive, demyelinating disease of the central nervous system that often leads to death or severe disability. PML is caused by reactivation of the John Cunningham (JC) virus. JC virus resides in latent form in 40-80 percent of healthy adults. Reactivation of the latent infection is associated with immunocompromised conditions and may occur months following discontinuation of immunosuppressive therapy. PML has been reported in patients with Hodgkin lymphoma, HIV-positive patients, immunosuppressed cancer patients, transplantation patients and patients with autoimmune disease. There are no known interventions that can reliably prevent or adequately treat PML.

Adcetris (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

Seattle Genetics and Millennium: The Takeda Oncology Company are jointly developing Adcetris. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize Adcetris in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for Adcetris on a 50:50 basis, except in Japan where the Takeda Group is solely responsible for development costs.

Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. The FDA granted accelerated approval of Adcetris in August 2011 for two indications. Adcetris is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC programs: SGN-75, ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at http://www.seattlegenetics.com.

Important Safety Information

Warnings and Precautions:

Adverse Reactions:

Adcetris was studied as monotherapy in 160 patients in two phase 2 trials. Across both trials, the most common adverse reactions (‰¥20%), regardless of causality, were neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough and vomiting.

Drug Interactions:

Patients who are receiving strong CYP3A4 inhibitors concomitantly with Adcetris should be closely monitored for adverse reactions.

For additional important safety information, please see the full U.S. prescribing information for Adcetris at http://www.seattlegenetics.com or http://www.Adcetris.com.

Certain of the statements made in this press release are forward looking, such as those, among others, relating to continued patient treatment with Adcetris. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks related to Seattle Genetics’ ability to demonstrate to the medical community the safety and efficacy of Adcetris and its potential advantages over any side effects compared to existing therapeutics and products currently in clinical development, and risks related to the FDA’s post-approval requirements for Adcetris, including the risk that results from Seattle Genetics’ required post-approval studies may fail to verify the clinical benefit of Adcetris in its approved indications. More information about the risks and uncertainties faced by Seattle Genetics is contained in Seattle Genetics’ quarterly report on Form 10-Q for the quarter ended September 30, 2011, filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact: Seattle Genetics, Inc.
Peggy Pinkston, 425-527-4160
ppinkston@seagen.com

Posted: January 2012

Adcetris (brentuximab vedotin) FDA Approval History

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Aeterna Zentaris Announces Top-Line Data from the Perifosine Phase 3 Trial in Refractory Advanced Colorectal Cancer

QUÉBEC CITY, April 2, 2012 /CNW Telbec/ – Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX:?AEZ) (the “Company”) today announced that the Phase 3 “X-PECT” (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment) clinical trial evaluating perifosine + capecitabine (Xeloda®) in patients with refractory advanced colorectal cancer did not meet the primary endpoint of improving overall survival versus capecitabine + placebo. The trial involving 468 patients in 65 sites in the U.S was conducted by the Company’s North American licensee partner, Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX).

Juergen Engel, Ph.D., Aeterna Zentaris President and Chief Executive Officer, commented, “Although we are obviously very disappointed that the trial did not meet its primary endpoint, I would like to thank all those involved in this trial for their dedicated work. We are currently conducting further data analyses in collaboration with our licensee partners, in order to determine the future development strategy for perifosine. Our other ongoing late-stage programs with AEZS-108 and AEZS-130, as well as earlier-stage programs from our deep pipeline will continue as planned, with a sufficient cash position to pursue these programs for more than the next 12 months.”

The Company will host a conference call and webcast later today, Monday, April 2, 2012 at 10:00 a.m. (Eastern). Participants may access the live webcast through the Company’s website at http://www.aezsinc.com in the “Newsroom” section, or by telephone: in Canada, (514) 807-9895 or (647) 427-7450, outside Canada, (888) 231-8191. A replay of the webcast will also be available on the Company’s website for a period of 15 days.

About Aeterna Zentaris Inc.

Aeterna Zentaris is a late-stage oncology drug development company currently investigating potential treatments for various cancers. The Company’s innovative approach of “personalized medicine” means tailoring treatments to a patient’s specific condition and to unmet medical needs. Aeterna Zentaris’ deep pipeline is drawn from its proprietary discovery unit providing the Company with constant and long-term access to state-of-the-art therapeutic options. For more information please visit http://www.aezsinc.com.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbour provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.

For further information:

Investor Relations
Ginette Beaudet Vallières
Investor Relations Coordinator
(418) 652-8525 ext. 265
gvallieres@aezsinc.com

Media Relations
Paul Burroughs
Director of Communications
(418) 652-8525 ext. 406
pburroughs@aezsinc.com

Posted: April 2012

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Keryx Biopharmaceuticals Announces Top-Line Data from the Perifosine (KRX-0401) X-PECT Phase 3 Clinical Trial

NEW YORK, April 2, 2012 /PRNewswire/ — Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) reported today that the Phase 3 “X-PECT” (Xeloda® + Perifosine Evaluation in Colorectal cancer Treatment) clinical trial evaluating perifosine (KRX-0401) + capecitabine (Xeloda) in patients with refractory advanced colorectal cancer did not meet the primary endpoint of improving overall survival versus capecitabine + placebo.

This Phase 3 trial was conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA.  468 patients at sixty-five U.S. sites participated in this study.

Ron Bentsur, Chief Executive Officer of Keryx, stated, “We are all extremely disappointed with the results of the study.  We thank the investigators who participated in what we believe was a well-run study, despite the outcome.  We will evaluate whether our Phase 3 study of Perifosine in relapsed/refractory multiple myeloma will continue as planned.”

Mr. Bentsur commented further, “With approximately $31 million in cash as of March 31, 2012, and a well-controlled burn rate, we plan to focus our resources on the pending completion of the Zerenex (ferric citrate) long-term Phase 3 study for end stage renal disease (ESRD) patients with hyperphosphatemia, expected in the fourth quarter of 2012, and the New Drug Application (NDA) filing for Zerenex which will hopefully follow shortly thereafter.”

KRX-0401 (perifosine) is in-licensed by Keryx from AeternaZentaris Inc. in the United States, Canada and Mexico.

Keryx will host a conference call today, April 2, 2012, at 8:00am EDT. In order to participate in the conference call, please call 1-877-869-3847 (U.S.), 1-201-689-8261 (outside the U.S.), call-in ID: KERYX. The audio recording of the conference call will be available for replay at http://www.keryx.com, for a period of 15 days after the call.

ABOUT KERYX BIOPHARMACEUTICALS, INC.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease and cancer. Keryx is developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA.  Keryx is also developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and potentially also affects a number of other key signal transduction pathways.  KRX-0401 is currently in Phase 3 clinical development for multiple myeloma, being conducted pursuant to an SPA agreement with the FDA, and in Phase 1 and 2 clinical development for several other tumor types. Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for Zerenex (ferric citrate) and KRX-0401 (perifosine) may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: if, upon final analysis, it is determined that all trials of KRX-0401 should be terminated, our ability to successfully adjust our strategy and reduce our operating expenses relating to KRX-0401 clinical trials in order to properly support the trials of Zerenex; our ability to successfully and cost-effectively complete clinical trials for Zerenex and KRX-0401; the risk that the data (both safety and efficacy) from the ongoing Phase 3 trials will not coincide with the data analyses from previous clinical trials reported by the Company; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

KERYX CONTACT:
Lauren Fischer
Director – Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com

SOURCE Keryx Biopharmaceuticals, Inc.

Posted: April 2012

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Transgenomic, Inc. Announces Presentation of Results from 448-Gene NuclearMitome Test in 78 Patients at the 2012 Annual Meeting of the American College of Medical Genetics

OMAHA, Neb.–(BUSINESS WIRE)–Mar 30, 2012 – Transgenomic, Inc. (OTCBB: TBIO) today announced that Jeana DaRe, Ph.D., Assistant CLIA Laboratory Director at Transgenomic, presented clinical findings from patients tested for nuclear mitochondrial disorders using Transgenomic’s NuclearMitome Test on Thursday, March 29, at the 2012 Annual Meeting of the American College of Medical Genetics (ACMG) in Charlotte, North Carolina. The discussion, titled “Clinical re-sequencing of over 410 genes to diagnose mitochondrial disorders” included details of both the technical performance of the NuclearMitome Test as well as the wide variety of clinically revealing results discovered through its use. The NuclearMitome Test employs next-generation sequencing technology to identify mutations in 448 genes, and represents the most comprehensive genetic test available for mitochondrial disorders.

In her presentation, Dr. DaRe highlighted two case studies. In both cases, patients achieved a definitive diagnosis through the identification of genetic mutations far outside the normal spectrum of genetic testing. These results concluded the patients’ diagnostic odysseys, which had encompassed wide-ranging genetic and non-genetic tests as well as consultation with various medical specialties, all of which had failed to pinpoint the underlying disease. These results are a typical occurrence in patients sent for NuclearMitome testing.

“The NuclearMitome Test is a cutting-edge technology that is reshaping the process for accurately diagnosing and effectively treating patients with mitochondrial disorders,” said Craig Tuttle, CEO of Transgenomic. “Since its launch in June 2011, clinicians have embraced this test as a way to simultaneously assay the hundreds of genes relevant to mitochondrial-based developmental disorders and achieve otherwise impossible diagnoses. The NuclearMitome test is rapidly becoming an important asset for the medical and patient communities and for Transgenomic.”

About Mitochondrial Diseases

Mitochondrial diseases are the most common metabolic diseases of childhood with an estimated frequency of 1 in 2000 births. They are characterized by multi-organ involvement, particularly neuromuscular symptoms, and often follow a rapidly progressive course. The variability in clinical presentation makes diagnosis tremendously challenging, as it traditionally relies on often-inconclusive enzymatic analyses that do not pinpoint the underlying molecular defect. Knowledge of the specific cause of disease can be important for developing personalized treatment strategies.

About Transgenomic, Inc.

Transgenomic, Inc. (www.transgenomic.com) is a global biotechnology company advancing personalized medicine in cancer and inherited diseases through its proprietary molecular technologies and world-class clinical and research services. The company has three complementary business divisions: Transgenomic Pharmacogenomic Services is a contract research laboratory that specializes in supporting all phases of pre-clinical and clinical trials for oncology drugs in development. Transgenomic Clinical Laboratories specializes in molecular diagnostics for cardiology, neurology, mitochondrial disorders, and oncology. Transgenomic Diagnostic Tools produces equipment, reagents, and other consumables that empower clinical and research applications in molecular testing and cytogenetics. Transgenomic believes there is significant opportunity for continued growth across all three businesses by leveraging their synergistic capabilities, technologies, and expertise. The company actively develops and acquires new technology and other intellectual property that strengthen its leadership in personalized medicine.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” of Transgenomic within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to management’s current views and estimates of future economic circumstances, industry conditions, company performance and financial results, including the ability of the Company to grow its involvement in the diagnostic products and services markets. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in Transgenomic’s filings with the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Accordingly, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release. All information in this press release is as of the date of the release and Transgenomic does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

Contact: Investor Contact:
Argot Partners
David Pitts, 212-600-1902
david@argotpartners.com
or
Company Contact:
Transgenomic, Inc.
Investor Relations, 402-452-5416
investorrelations@transgenomic.com

Posted: March 2012

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Transgenomic, Inc. Announces Presentation of Results from 448-Gene NuclearMitome Test in 78 Patients at the 2012 Annual Meeting of the American College of Medical Genetics

OMAHA, Neb.–(BUSINESS WIRE)–Mar 30, 2012 – Transgenomic, Inc. (OTCBB: TBIO) today announced that Jeana DaRe, Ph.D., Assistant CLIA Laboratory Director at Transgenomic, presented clinical findings from patients tested for nuclear mitochondrial disorders using Transgenomic’s NuclearMitome Test on Thursday, March 29, at the 2012 Annual Meeting of the American College of Medical Genetics (ACMG) in Charlotte, North Carolina. The discussion, titled “Clinical re-sequencing of over 410 genes to diagnose mitochondrial disorders” included details of both the technical performance of the NuclearMitome Test as well as the wide variety of clinically revealing results discovered through its use. The NuclearMitome Test employs next-generation sequencing technology to identify mutations in 448 genes, and represents the most comprehensive genetic test available for mitochondrial disorders.

In her presentation, Dr. DaRe highlighted two case studies. In both cases, patients achieved a definitive diagnosis through the identification of genetic mutations far outside the normal spectrum of genetic testing. These results concluded the patients’ diagnostic odysseys, which had encompassed wide-ranging genetic and non-genetic tests as well as consultation with various medical specialties, all of which had failed to pinpoint the underlying disease. These results are a typical occurrence in patients sent for NuclearMitome testing.

“The NuclearMitome Test is a cutting-edge technology that is reshaping the process for accurately diagnosing and effectively treating patients with mitochondrial disorders,” said Craig Tuttle, CEO of Transgenomic. “Since its launch in June 2011, clinicians have embraced this test as a way to simultaneously assay the hundreds of genes relevant to mitochondrial-based developmental disorders and achieve otherwise impossible diagnoses. The NuclearMitome test is rapidly becoming an important asset for the medical and patient communities and for Transgenomic.”

About Mitochondrial Diseases

Mitochondrial diseases are the most common metabolic diseases of childhood with an estimated frequency of 1 in 2000 births. They are characterized by multi-organ involvement, particularly neuromuscular symptoms, and often follow a rapidly progressive course. The variability in clinical presentation makes diagnosis tremendously challenging, as it traditionally relies on often-inconclusive enzymatic analyses that do not pinpoint the underlying molecular defect. Knowledge of the specific cause of disease can be important for developing personalized treatment strategies.

About Transgenomic, Inc.

Transgenomic, Inc. (www.transgenomic.com) is a global biotechnology company advancing personalized medicine in cancer and inherited diseases through its proprietary molecular technologies and world-class clinical and research services. The company has three complementary business divisions: Transgenomic Pharmacogenomic Services is a contract research laboratory that specializes in supporting all phases of pre-clinical and clinical trials for oncology drugs in development. Transgenomic Clinical Laboratories specializes in molecular diagnostics for cardiology, neurology, mitochondrial disorders, and oncology. Transgenomic Diagnostic Tools produces equipment, reagents, and other consumables that empower clinical and research applications in molecular testing and cytogenetics. Transgenomic believes there is significant opportunity for continued growth across all three businesses by leveraging their synergistic capabilities, technologies, and expertise. The company actively develops and acquires new technology and other intellectual property that strengthen its leadership in personalized medicine.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” of Transgenomic within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to management’s current views and estimates of future economic circumstances, industry conditions, company performance and financial results, including the ability of the Company to grow its involvement in the diagnostic products and services markets. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in Transgenomic’s filings with the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Accordingly, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release. All information in this press release is as of the date of the release and Transgenomic does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

Contact: Investor Contact:
Argot Partners
David Pitts, 212-600-1902
david@argotpartners.com
or
Company Contact:
Transgenomic, Inc.
Investor Relations, 402-452-5416
investorrelations@transgenomic.com

Posted: March 2012

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Oncolytics Biotech Inc. Announces Reovirus Research to be Presented at AACR Annual Meeting

CALGARY, March 29, 2012 /PRNewswire/ – Oncolytics Biotech Inc. (“Oncolytics”) (TSX:ONC) (NASDAQ:ONCY) announced today that abstracts of preclinical research on reovirus (REOLYSIN®) are available on the American Association for Cancer Research (AACR) website at http://www.aacr.org. The research is scheduled to be presented at the 2012 AACR Annual Meeting in Chicago, IL, which takes place from March 31 to April 4, 2012.

“We are delighted to see that the research community has been embracing preclinical research utilizing reovirus,” said Dr. Matt Coffey, Chief Operating Officer of Oncolytics.  “This research helps us to continue to refine our understanding of REOLYSIN’s mechanism of action, its suitability for combination with other treatment modalities and its potential for application to a growing range of potential cancer indications.”

The first abstract, entitled “Reovirus (REOLYSIN) as a potential therapy for malignant peripheral nerve sheath tumors,” covers preclinical work malignant in peripheral nerve sheath tumors (MPNST), a rare form of soft tissue sarcoma. The results show that MPNST-derived cell lines including sporadic MPNST without active Ras were efficiently transduced, promoted virus replication and were killed by the oncolytic reovirus. The poster is scheduled to be presented on Monday, April 2, 2012.

The second abstract, entitled “REOLYSIN: A novel reovirus-based agent that induces endoplasmic reticular stress in RAS-activated pancreatic cancer,” covers preclinical work done to better understand the mechanisms associated with the synergies in this co-treatment approach. The results demonstrate that the abnormal protein accumulation induced by REOLYSIN and bortezomib promotes heightened ER stress and apoptosis in pancreatic cancer cells.  The poster is scheduled to be presented on Monday, April 2, 2012.

The third abstract, entitled “Oncolytic reovirus synergizes with bortezomib and dexamethasone in overcoming therapy resistance of multiple myeloma,” covers preclinical work done in therapy resistant multiple myeloma (MM) cell lines. The investigators noted that highly synergistic cytotoxicity was observed with reovirus and bortezomib in both reovirus and drug resistant cell lines OPM2 and KMS-11 at all drug combination ratios. Dexamethasone and reovirus treatment induced synergy in OPM2 cells. The poster is scheduled to be presented on Tuesday, April 3, 2012.

The fourth abstract, entitled “Serum regulates reovirus-mediated cytopathy in K-Ras activated colorectal cancer and intestinal epithelial cell lines,” covers the use of isogenic human-derived colorectal cancer cell lines that differ only by the presence of mutant Kras and normal rat intestinal epithelial cells (IEC) with inducible Kras to evaluate whether the presence of oncogenic Kras alters the sensitivity of colon cancer cells to reovirus.  The investigators demonstrated that the activity of reovirus was observed in all cell lines studied. Reduction in cell variability was greater in Kras-mutant HCT116 compared to WT Hke3 cells. Consistently, induction of Kras in IEC cells increased the potency of reovirus. The poster is scheduled to be presented on Tuesday, April 3, 2012.

The fifth abstract, entitled “Mammalian orthoreovirus downregulates HIF-1a in hypoxic prostate tumor cells via RACK1-mediated proteasomal degradation and translational inhibition,” was added as a late-breaking abstract. The poster is scheduled to be presented on Tuesday April 3, 2012.

About Oncolytics Biotech Inc.

Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics’ clinical program includes a variety of human trials including a Phase III trial in head and neck cancers using REOLYSIN, its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: http://www.oncolyticsbiotech.com.

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the implication of the abstracts and materials presented on the AACR website and at this meeting with respect to REOLYSIN, and the Company’s belief as to the potential of REOLYSIN as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN as a cancer treatment, the tolerability of REOLYSIN outside a controlled test, the success and timely completion of clinical studies and trials, the Company’s ability to successfully commercialize REOLYSIN, uncertainties related to the research and development of pharmaceuticals and uncertainties related to the regulatory process. Investors should consult the Company’s quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.

SOURCE Oncolytics Biotech Inc.

CONTACT:

The Equicom Group
Nick Hurst
300 5th Ave. SW, 10th Floor
Calgary, Alberta, T2P 3C4
Tel: 403.218.2835
Fax: 403.218.2830
nhurst@equicomgroup.com 

IRG, LLC
Erika Moran
20th Floor, 1251 Avenue of the Americas
New York, NY  10020
Tel:  212.825.3210
Fax:  212.825.3229
emoran@investorrelationsgroup.com

Posted: March 2012

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ImmunoGen, Inc. Announces Positive Results in Trastuzumab Emtansine (T-DM1) EMILIA Phase III Trial

• Roche has announced lead Phase III trial with trastuzumab emtansine has met progression-free survival endpoint

• Plans to apply for marketing approval of trastuzumab emtansine in US and Europe

• Study data being submitted for presentation at major medical meeting

WALTHAM, MA, March 30, 2012 – ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops anticancer products using its Targeted Antibody Payload (TAP) technology, today announced that Roche has announced positive topline results from its trastuzumab emtansine (T-DM1) EMILIA Phase III trial. Trastuzumab emtansine consists of ImmunoGen’s potent cancer-killing agent, DM1, attached to the HER2-targeting antibody, trastuzumab, and is in global development by Roche under an agreement between ImmunoGen and Genentech, a member of the Roche Group.

Roche announced today that the EMILIA patients who were randomized to treatment with trastuzumab emtansine had a significantly longer duration of progression-free survival (PFS) than those randomized to treatment with the control therapy, lapatinib (Tykerb®) plus capecitabine (Xeloda®). EMILIA is the most advanced trastuzumab emtansine Phase III study, and evaluates the compound for the treatment of HER2-positive metastatic breast cancer (mBC) in patients who have previously received treatment with trastuzumab (Herceptin®) and a taxane.

Roche said that, based on these findings, it plans to apply for marketing approval of trastuzumab emtansine for HER2-positive mBC in the US (through Genentech) and in Europe. Roche also noted that the safety profile of trastuzumab emtansine in the EMILIA trial was consistent with previous studies and that final results for overall survival (OS) are not yet mature. PFS and overall survival are co-primary efficacy endpoints of EMILIA.

“The topline results reported today underscore the significance of trastuzumab emtansine and its potential to help patients,” commented Daniel Junius, President and CEO. “We’re delighted with these results and with Roche’s plans to submit trastuzumab emtansine for marketing approval. We look forward to seeing the detailed study data at an upcoming medical meeting.”

Trastuzumab emtansine is in Phase III testing for treatment of HER2-positive mBC in multiple clinical settings in the EMILIA, MARIANNE, and TH3RESA trials, and in Phase II testing for adjuvant/neoadjuvant use for earlier-stage disease.

Conference Call Information

ImmunoGen is holding a conference call today at 8:00 am ET to discuss this release and also the Company’s advancement of its wholly owned IMGN901 product candidate into Phase II testing. To access the live call by phone, dial 913-312-0982. Passcode is 8250254. The call also may be accessed through the Investor Information section of the Company’s website, http://www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through April 6, 2012.

About ImmunoGen’s TAP Technology

ImmunoGen developed its TAP technology to achieve more effective, better tolerated anticancer drugs. A TAP compound consists of a manufactured antibody that binds specifically to a target found on tumor cells with one of the Company’s highly potent cancer-killing agents attached as a payload. The antibody serves to target the payload specifically to the cancer cells, and the payload serves to kill the cancer cells. In the case of some compounds that use ImmunoGen’s TAP technology (trastuzumab emtansine and ImmunoGen’s IMGN529 compound), the antibody component also has meaningful anticancer activity.

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics using the Company’s expertise in tumor biology, monoclonal antibodies, potent cancer-cell killing agents and engineered linkers. The Company’s TAP technology uses monoclonal antibodies to deliver one of ImmunoGen’s proprietary cancer-killing agents specifically to tumor cells. There are now numerous TAP compounds in clinical development with a wealth of clinical data reported. ImmunoGen’s collaborative partners include Amgen, Bayer HealthCare, Biotest, Lilly, Novartis, Roche, and Sanofi. The most advanced compound using ImmunoGen’s TAP technology, trastuzumab emtansine (T-DM1), is in Phase III testing through the Company’s collaboration with Genentech, a member of the Roche Group. More information about ImmunoGen can be found at http://www.immunogen.com.

This press release includes forward-looking statements. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. It should be noted that there are risks and uncertainties related to the development of novel anticancer products, including trastuzumab emtansine (T-DM1), including risks related to clinical studies and regulatory submissions, their timings and results. A review of these risks can be found in ImmunoGen’s Annual Report on Form 10-K for the fiscal year ended June 30, 2011 and other reports filed with the Securities and Exchange Commission.

Tykerb® is a registered trademark of GlaxoSmithKline plc.

Xeloda® is a registered trademark of Roche.

Herceptin® is a registered trademark of Genentech, a member of the Roche Group.

# # #

Posted: March 2012

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Shire Announces Top-line Results of the PREVENT2 Trial

PHILADELPHIA, Pennsylvania, March 30, 2012/PRNewswire-FirstCall/ —

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced top-line results of the PREVENT2 trial, a phase 3 investigational study of once-daily SPD476, MMX(R) mesalamine in patients with a history of diverticulitis.[1] The study, conducted in 10 countries worldwide including the United States, did not meet the primary endpoint in reducing the rate of recurrence of diverticulitis over a 2-year treatment period. In addition, SPD476, MMX mesalamine did not show a significant difference compared to placebo on the key secondary endpoint of the study.[1]

“PREVENT2, a large, well-controlled trial, provided us with important information regarding diverticulitis.” said Dr Jeffrey Jonas, Senior Vice President of Research and Development for Shire’s Specialty Pharmaceuticals and Regenerative Medicine businesses. “We will continue to analyze these data and those of the second study, PREVENT1, which was similar in design to PREVENT2 and will report later in the year. Although the results of the second trial are pending, it is our current intention not to pursue a regulatory filing for this indication for MMX(R) mesalamine.”

The objective of the PREVENT2 investigational study was to evaluate the safety and efficacy of SPD476, MMX mesalamine versus placebo in reducing the incidence of recurrent attacks of diverticulitis in patients with a history of at least one prior attack.[1]

The primary efficacy measure was the proportion of patients without a recurrence of diverticulitis between three doses of SPD476, MMX mesalamine and placebo at week 104. Recurrence of diverticulitis was defined as: 1) the presence of each and all of the following three items: abdominal pain, a 15% increase in white blood cell count from baseline, and bowel wall thickening (>5mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan, or 2) surgical intervention for diverticular disease. The key secondary endpoint evaluated recurrence based on CT scan only.[1] There were no new safety observations identified in the PREVENT2 trial.

About the PREVENT program

The PREVENT investigational program consists of two trials, PREVENT1 and PREVENT2. These are phase 3, randomized, double-blind, dose-response, stratified, placebo-controlled studies with an identical design. PREVENT2 randomized 592 subjects to receive once-daily SPD476, MMX mesalamine 1.2g, 2.4g or 4.8g, or placebo, over a period of 104 weeks.[1] The PREVENT1 trial results are expected later this year.

About SPD476, MMX mesalamine[2,3]

SPD476, MMX mesalamine is an anti-inflammatory drug, with each delayed-release tablet containing 1.2g of 5-aminosalicylic acid (5-ASA; mesalamine). In the U.S., SPD476, MMX mesalamine is registered as Lialda(R) (mesalamine) and is approved for the induction of remission in patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. In Europe, it is registered as Mezavant(R)/Mezavant XL(R) and is approved for the induction of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis and for maintenance of remission. SPD476, MMX mesalamine should be taken once daily with food.[2,3]

MMX is a registered trademark of Cosmo Technologies, Ltd., Ireland.

IMPORTANT SAFETY INFORMATION

You should not take Lialda if you are allergic to salicylates (including mesalamine, aspirin, or aspirin-containing products) or to any of the ingredients of Lialda.

Reports of problems with kidney function have been associated with mesalamine-containing products like Lialda. Tell your doctor if you have or have had problems with your kidneys. It is recommended that all patients have their kidney function checked before starting Lialda and periodically while on therapy.

Products that contain mesalamine, like Lialda, have been associated with a condition that may be difficult to distinguish from an ulcerative colitis flare-up. Symptoms include cramping, stomach ache, bloody diarrhea, fever, headache, and rash. If you experience any of these symptoms, talk to your doctor immediately. Your doctor may decide to discontinue your medication.

Tell your doctor if you are allergic to sulfasalazine, as you may also be allergic to Lialda or drugs that contain or are converted to mesalamine. Some patients taking Lialda or mesalamine-containing products have reported heart-related allergic reactions, such as inflammation of the heart muscle and inflammation of the lining of the heart. Tell your doctor if you have or have had a history of myocarditis or pericarditis as this may increase your likelihood of having these types of reactions.

Reports of liver failure have been associated with mesalamine-containing products like Lialda in patients that have or have had liver disease. Tell your doctor if you have a problem with your liver.

Tell your doctor if you have a stomach blockage, as this may delay the release of medication.

In clinical trials, common side effects reported with Lialda included ulcerative colitis, headache, gas, abnormal liver function test results, and stomach ache. Inflammation of the pancreas was reported which led to discontinuation of Lialda therapy. Other side effects may occur.

Before starting Lialda, tell your doctor about all medications you are taking. Mesalamine may increase the risk of kidney problems when used with non-steroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen). Mesalamine may increase the risk of blood disorders when used with azathioprine and 6-mercaptopurine.

Please see Full Prescribing Information [http://pi.shirecontent.com/PI/PDFs/Lialda_USA_ENG.pdf ].

References

1. DoF corresponding to PREVENT2 topline data presentation.

2. Lialda (mesalamine delayed release tablets) Prescribing Information. Wayne, PA: Shire US, Inc; 2011.

3. Mezavant XL, 1200mg, gastro-resistant, prolonged release tablets. Summary of Product Characteristics. Shire Pharmaceuticals Limited, 2010.

Notes to editors

SHIRE PLC

Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company’s website: http://www.shire.com.

“SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company’s Specialty Pharmaceuticals, Human Genetic Therapies and Regenerative Medicine products, as well as the ability to secure new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company’s products; the Company’s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company’s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission.

For further information please contact:

Investor Relations Eric Rojas, erojas@shire.com, +1-781-482-0999 Sarah Elton-Farr, seltonfarr@shire.com, +44-1256-894157 Media Jessica Mann (Corporate), jmann@shire.com, +44-1256-894-280 Gwen Fisher (Specialty Pharma), gfisher@shire.com, +1-484-595-9836

Source: Shire plc  

Posted: March 2012

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ArQule Announces Presentations at AACR 102nd Annual Meeting

WOBURN, Mass.–(BUSINESS WIRE)–Mar 29, 2012 – ArQule, Inc. (Nasdaq: ARQL) today announced eight presentations of clinical and pre-clinical data for tivantinib (ARQ 197) at the Annual Meeting of the American Association for Cancer Research (AACR), held from March 31 – April 4 in Chicago, Illinois. Tivantinib is an oral inhibitor of c-MET, a receptor tyrosine kinase, which is currently in Phase 3 clinical trials for non-squamous non-small cell lung cancer (NSCLC). Several other studies related to the Company’s earlier-stage product candidates and discovery platform will also be presented at AACR.

Tivantinib highlights

An exploratory biomarker analysis evaluating the effect of the c-MET inhibitor tivantinib (ARQ 197) and erlotinib in NSCLC patients in a randomized, double-blinded phase 2 study: Abstract number 1729.

An exploratory immunohistochemistry (IHC) analysis was conducted of archival tissue from a concluded Phase 2 clinical trial with tivantinib and erlotinib in NSCLC. Findings confirmed that in this trial non-squamous NSCLC tumors were more often positive for c-MET expression than squamous NSCLC tumors. In this study, 76 percent of evaluable patients with non-squamous tumors were c-MET positive, and 12 percent of evaluable patients with squamous tumors were c-MET-positive, a percentage that is consistent with existing literature.

Data analysis showed that treatment with the combination of tivantinib and erlotinib improved progression-free survival (HR = 0.58, p = 0.28) and overall survival (HR = 0.46, p = 0.21) in patients with non-squamous histology and c-MET-positive tumors, as measured by IHC, compared with patients who received with erlotinib plus placebo.

Targeted inhibition of c-MET receptor by a selective c-MET inhibitor, Tivantinib, and a specific shRNA reduces breast cancer-derived bone metastases: Abstract number 846.

A pre-clinical study with tivantinib explored dual c-MET inhibition with both tivantinib and RNA interference in an experimental bone metastatic model of human breast cancer. C-MET inhibition with the combined therapeutic interventions induced pronounced tumor growth suppression with marked decreases in tumor size and an improvement in survival.

Findings highlighted the efficacy of c-MET inhibition in delaying the onset and progression of bone metastases and suggest that targeting the c-MET receptor may have promise in the prevention and treatment of bone metastases from breast cancer.

The titles and times of ArQule’s and alliance partner Daiichi Sankyo’s data presentations for tivantinib at AACR are as follows:

An exploratory biomarker analysis evaluating the effect of the c-MET inhibitor tivantinib (ARQ 197) and erlotinib in NSCLC patients in a randomized, double-blinded phase 2 study
Abstract Number 1729
Poster Section 26
Poster Board 19
Monday, April 2, 2012, 8:00 AM – 12:00 PMTargeted inhibition of c-MET receptor by a selective c-MET inhibitor, Tivantinib, and a specific shRNA reduces breast cancer-derived bone metastases
Abstract Number 846
Poster Section 32
Poster Board 3
Sunday, April 1, 2012, 1:00 PM – 5:00 PMTargeting the pro-survival protein c-MET with ARQ 197 inhibits growth of multiple myeloma cells
Abstract Number 844
Poster Section 32
Poster Board 1
Sunday, April 1, 2012, 1:00 PM – 5:00 PMPreclinical assessment of MET modulation by a VEGFR inhibitor/MET inhibitor combination that shows additive antitumor efficacy
Abstract Number 3672
Poster Section 25
Poster Board 14
Tuesday, April 3, 2012, 8:00 AM – 12:00 PMP53 is potential predictive biomarker for combination therapy of epidermal growth factor receptor (EGFR) and MET inhibitors in non-small cell lung cancer (NSCLC) with wild-type EGFR
Abstract Number 2476
Poster Section 18
Poster Board 1
Monday, April 2, 2012, 1:00 PM – 5:00 PMA randomized, crossover, phase 1 study to evaluate the effect of a strong CYP3A4 inhibitor on tivantinib (ARQ 197) pharmacokinetics in healthy subjects
Abstract Number 760
Poster Section 28
Poster Board 14
Sunday, April 1, 2012, 1:00 PM – 5:00 PMA randomized, open-label, phase 1 study to evaluate the effect of food on tivantinib (ARQ 197) pharmacokinetics
Abstract Number 755
Poster Section 28
Poster Board 9
Sunday, April 1, 2012, 1:00 PM – 5:00 PMAbsorption, distribution, metabolism and excretion of 14C-Labeled tivantinib (ARQ 197) in healthy male subjects
Abstract Number 747
Poster Section 28
Poster Board 1
Sunday, April 1, 2012, 1:00 PM – 5:00 PM

Additional ArQule data presentations include:

Discovery and optimization of orally bioavailable, selective and potent ATP-independent Akt inhibitors
Abstract Number LB-1
Sunday, April 1, 2012, 1:00 PM – 5:00 PM
Poster Section 40Synthesis and structure activity relationship of substituted N,6-diphenyl-5,6-dihydrobenzo(h)quinazolin-2-amine as inhibitors of fibroblast growth factor receptors (FGFR)
Abstract Number 3905
Tuesday, April 3, 2012, 8:00 AM – 12:00 PM
Poster Section 35
Poster Board 18Creation of a novel biochemical and biophysical assay suite to enable the identification of inhibitors targeting inactive kinases
Abstract Number 2914
Monday, April 2, 2012, 3:50 PM – 4:05 PM
Location: McCormick Place West (Level1), Room W187

About ArQule

ArQule is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics. The Company’s targeted, broad-spectrum products and research programs are focused on key biological processes that are central to human cancers. ArQule’s lead product, in Phase 2 and Phase 3 clinical development, is tivantinib, an oral, selective inhibitor of the c-MET receptor tyrosine kinase. The Company’s pipeline consists of ARQ 621, designed to inhibit the Eg5 kinesin motor protein, and ARQ 736, designed to inhibit the RAF kinases. ArQule’s current discovery efforts, which are based on the ArQule Kinase Inhibitor Platform (AKIP™), are focused on the identification of novel kinase inhibitors that are potent, selective and do not compete with ATP (adenosine triphosphate) for binding to the kinase.

This press release contains statements regarding the Company’s pre-clinical and clinical development of tivantinib (ARQ 197), as well as pre-clinical activities related to its Akt inhibitor program, its fibroblast growth factor inhibitor program, and its discovery platform. These statements are based on the Company’s current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. Positive information about pre-clinical and early stage clinical trial results does not ensure that later stage or larger scale clinical trials will be successful. For example, these products and programs may not demonstrate promising therapeutic effect; in addition, they may not demonstrate an appropriate safety profile in current or later stage or larger scale clinical trials as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards. Problems or delays may arise during clinical trials or in the course of developing, testing or manufacturing these compounds that could lead the Company or its partners to discontinue development. Even if later stage clinical trials are successful, the risk exists that unexpected concerns may arise from analysis of data or from additional data. Obstacles may arise or issues may be identified in connection with review of clinical data with regulatory authorities, or regulatory authorities may disagree with the Company’s view of the data or require additional data or information or additional studies. In addition, the planned timing of initiation and completion of clinical trials for tivantinib is subject to the ability of the Company or Daiichi Sankyo, Inc., its partner, and Kyowa Hakko Kirin, a licensee of tivantinib, to enroll patients, enter into agreements with clinical trial sites and investigators, and overcome other technical hurdles and issues related to the conduct of the trials that may not be resolved. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Positive pre-clinical data may not be supported in later stages of development. Furthermore, ArQule may not have the financial or human resources to successfully pursue drug discovery in the future. Moreover, Daiichi Sankyo has certain rights to unilaterally terminate its tivantinib license, co-development and co-commercialization agreement with the Company. If it were to do so, the Company might not be able to complete development and commercialization of tivantinib on its own. For more detailed information on the risks and uncertainties associated with the Company’s drug development and other activities, see the Company’s periodic reports filed with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements.

Contact: ArQule, Inc.
William B. Boni, 781-994-0300
VP, Investor Relations/
Corp. Communications
http://www.ArQule.com

Posted: March 2012

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Shionogi-ViiV Healthcare Announces Initial Data from Pivotal Phase III Study of Dolutegravir in HIV

SPRING-2 study meets primary endpoint of non-inferiority of dolutegravir compared to raltegravir over 48 weeks in treatment-naive HIV patients
LONDON, April 2, 2012 /PRNewswire/ — ViiV Healthcare and Shionogi & Co., Ltd. today announced that initial results have been received from the SPRING-2 (ING113086) Phase III study of the investigational integrase inhibitor dolutegravir in treatment-naive adults with HIV-1. The study met its primary objective, demonstrating non-inferiority of dolutegravir to raltegravir. Through 48 weeks, 88% of study participants on dolutegravir were virologically suppressed (<50 copies/mL) vs. 85% of participants on raltegravir [with a 95% confidence interval (CI) for the difference, -2.2% to + 7.1%; the lower end of the CI (-2.2%) was above the prespecified -10% non-inferiority limit].

SPRING-2 is an ongoing non-inferiority study designed to compare the efficacy and safety of dolutegravir 50mg administered once-daily versus raltegravir 400mg administered twice daily, both with two nucleoside reverse transcriptase inhibitors (NRTIs); 411 treatment-naive study participants were randomized in each arm. The primary endpoint of the study was the proportion of study participants with undetectable HIV-1 RNA (<50c/mL) through 48 weeks.  The tolerability of dolutegravir was similar to that of raltegravir, with rates of adverse events leading to withdrawal at 2% in both arms. Drug-related nausea was reported by 10% of patients in each arm; no other adverse events related to study medication were reported by more than 5% of participants in either arm.

“The SPRING-2 findings indicate that once daily unboosted dolutegravir may offer people living with HIV an additional treatment option in the future. These are the first large-scale safety and efficacy data in naive patients, and we look forward to seeing further data in 2012 to build a more comprehensive picture of the role of dolutegravir,” said Dr John Pottage, Chief Medical Officer, ViiV Healthcare.

“At ViiV Healthcare we have a total focus on the needs of people living with HIV, and as a result we see the continued need for new, effective and convenient therapies.  We are committed to building connections and collaborations, like the Shionogi-ViiV Healthcare dolutegravir program, to meet these needs,” said Dr. Dominique Limet, Chief Executive Officer, ViiV Healthcare.

“The SPRING-2 study has met its primary endpoint for dolutegravir in treatment-naive patients.  This marks an important milestone for the development of dolutegravir and the Shionogi-ViiV Healthcare joint venture. We look forward to completing further Phase III studies in a variety of clinical settings in order to fully understand the potential clinical benefit for a range of HIV patient populations,” said Dr. Tsutae “Den” Nagata, Chief Medical Officer, Shionogi & Co., Ltd.

Full results of this study, including the full results of the secondary endpoints, will be presented at an upcoming scientific meeting.  SPRING-2 is the first of four Phase III studies that are due to be reported in 2012. Data from the clinical trials SINGLE (ING114467), VIKING-3 (ING112574) and SAILING (ING111762), will be received throughout the year and will allow further determination of the profile of dolutegravir.  These studies are designed to support a future regulatory file for dolutegravir.

About SPRING-2
SPRING-2 (ING113086) is a Phase III, randomized, double-blind, multicentre, parallel group, non-inferiority study. The study included 822 HIV-1 infected treatment-naive participants. The study compares the efficacy and safety of dolutegravir and raltegravir as part of an overall treatment regimen; both treatment arms are administered with investigator-selected dual nucleoside reverse transcriptase inhibitor therapy (either abacavir + lamivudine or tenofovir + emtricitabine).

The primary objective for SPRING-2 is to demonstrate the antiviral activity of dolutegravir 50mg administered once-daily compared to raltegravir 400mg administered twice daily over 48-weeks. Secondary objectives include the assessment of antiviral activity of dolutegravir compared to raltegravir at 96-weeks, to compare the tolerability, long-term safety and antiviral and immunologic activity of dolutegravir to raltegravir and to evaluate viral resistance in study participants experiencing virological failure.

About Dolutegravir
S/GSK1349572 (dolutegravir) is an investigational integrase inhibitor (INI) currently in development by Shionogi-ViiV Healthcare LLC for the treatment of HIV. It is currently the only once-daily, unboosted INI in Phase III clinical development. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Given the stage of development of this investigational HIV therapy, the full picture of the efficacy and safety of dolutegravir has not been conclusively determined.

About Shionogi-ViiV Healthcare LLC
The Shionogi-ViiV Healthcare LLC is a joint venture between Shionogi & Co., Ltd. and ViiV Healthcare Ltd., a global company with a sole focus on HIV established in 2009 by GlaxoSmithKline and Pfizer, Inc.  Dolutegravir is the lead compound in the Shionogi-ViiV Healthcare LLC partnership. Shionogi-ViiV Healthcare LLC is also developing another integrase inhibitor which is at an earlier stage of development.

About Shionogi & Co., Ltd
Headquartered in Osaka, Japan, Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to placing the highest value on patients. Shionogi’s Research and Development currently targets three therapeutic areas: Infectious Diseases, Pain, and Metabolic Syndrome. The Company is the originator of innovative medicines which have been successfully delivered to millions of patients worldwide. In addition, Shionogi is engaged in new research areas such as allergy and cancer. Contributing to the health of patients around the world through development in these therapeutic areas is Shionogi’s primary goal. For more details, please visit http://www.shionogi.co.jp. For more information on Shionogi Inc. headquartered in Florham Park, NJ, please visit http://www.shionogi.com.

About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. The company’s aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline and commitment, please visit http://www.viivhealthcare.com.

GlaxoSmithKline Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’ s operations are described under ‘Risk factors’ in the ‘Financial review & risk’ section in the company’s Annual Report 2011 included as exhibit 15.2 to the company’s Annual Report on Form 20-F for 2011.

Pfizer disclosure notice: Pfizer assumes no obligation to update any forward-looking statements contained in this release as a result of new information or future events or developments.  This release contains forward-looking information about Pfizer, GlaxoSmithKline and ViiV Healthcare and about the prospects of the companies, including revenues from in-line products and the potential benefits of product candidates that will be contributed to that company, as well as the potential financial impact of the transaction. Such information involves substantial risks and uncertainties including, among other things, decisions by regulatory authorities regarding whether and when to approve any drug applications that have been or may be filed for such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates; and competitive developments.

A further list and description of risks and uncertainties can be found in Pfizer’s Annual Report of Form 10-K for the fiscal year ended December 31, 2011 and in its reports on Form 10-Q and Form 8-K.

Shionogi forward-looking statement: This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. This announcement contains information on pharmaceuticals (including compounds under development), but this information is not intended to make any representations or advertisements regarding the efficacy or effectiveness of these preparations nor provide medical advice of any kinds.

SOURCE Shionogi-ViiV Healthcare LLC

Posted: April 2012

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Sangamo BioSciences Announces Publication in Nature Medicine Demonstrating Use of ZFN Technology to Engineer Safer and More Effective Cancer Treatments

Award-Winning Study Demonstrates Use of ZFN Technology to Develop Novel Therapeutics Designed to Kill Cancer Cells
RICHMOND, Calif., April 2, 2012 /PRNewswire/ — Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced today the publication of a preclinical study demonstrating the use of zinc finger nucleases (ZFNs) to engineer safer and more potent cancer immunotherapies. The study, published in Nature Medicine, advances the development of novel, cell-based therapies for the treatment of a broad range of cancers. 

The studies were performed in the laboratory of Chiara Bonini, M.D., Head of the Experimental Hematology Unit, San Raffaele Hospital, Milan, in collaboration with Luigi Naldini, Head of TIGET, San Raffaele Hospital, and Sangamo scientists. Dr. Bonini also presented the data at the opening session of the 2012 Annual Meeting of the European Group for Blood and Marrow Transplantation (EBMT). The importance of the work has been recognized with the Van Bekkum Award, the most prestigious EBMT award for the best abstract submitted to the physician’s program and is selected by the EBMT Board. The meeting is being held from April 1- 4, 2012, in Geneva, Switzerland.

“These data represent a significant advance in maximizing the potential safety and efficacy of adoptive T-cell therapies for cancer,” said Dr. Bonini. “While we can reprogram cells of the immune system to preferentially recognize and kill tumors, several hurdles remain that limit the potential of this approach. ZFN-based genome editing enables us to specifically modify these redirected cells and disrupt genes that interfere with their potency and specificity, thus generating a safer, more efficacious therapeutic product.”

Cancer immunotherapy uses the immune system, specifically CD8+ T-cells, that have been “redirected” to seek out and destroy tumors.  These redirected T-cells are genetically engineered to express new cell surface receptors that specifically recognize tumor cells. However, CD8+ T-cells have a natural specificity for different (non-tumor) targets and the resulting competition between the natural and the tumor-targeting gene products limits the potency of this cell therapy. More importantly, it can also make the cells “self-reactive,” leading to graft versus host disease (GvHD).

In this study, ZFNs were used to specifically disrupt the native T-cell receptor (TCR) genes in these tumor-directed CD8+ T-cells resulting in an enhanced immunotherapeutic product with potent anti-cancer activity coupled with the elimination of GvHD in a mouse model. The data are described in a Nature Medicine paper entitled “Editing T-cell Specificity Towards Leukemia by Zinc Finger Nucleases and Lentiviral Gene Transfer” which appears as an Advance Online Publication on the Nature Medicine website http://dx.doi.org/10.1038/nm.2700 .

“We congratulate our scientists and collaborators on this potentially significant medical advance in the treatment of cancer, and are gratified by the continued recognition of our ZFN-genome editing technology to generate both novel therapeutic approaches and expand the utility of existing therapies,” stated Edward Lanphier, Sangamo’s president and chief executive officer. “Our clinical and preclinical programs are currently focused on developing ZFP Therapeutics for HIV/AIDS and monogenic and rare diseases. However, as these data in oncology applications demonstrate, our ZFP technology platform enables the development of novel and innovative therapeutics to address a broad range of indications.”

About Sangamo

Sangamo BioSciences, Inc. is focused on research and development of novel DNA-binding proteins for therapeutic gene regulation and genome editing. It has ongoing Phase 2 and Phase 1/2 clinical trials to evaluate the safety and efficacy of a novel ZFP Therapeutic® for the treatment of HIV/AIDS. Sangamo’s other therapeutic programs are focused on monogenic diseases, including hemophilia and hemoglobinopathies such as sickle cell anemia and beta-thalassemia, and a program in Parkinson’s disease. Sangamo’s core competencies enable the engineering of a class of DNA-binding proteins known as zinc finger DNA-binding proteins (ZFPs). Engineering of ZFPs that recognize a specific DNA sequence enables the creation of sequence-specific ZFP Nucleases (ZFNs) for gene modification and ZFP transcription factors (ZFP TFs) that can control gene expression and, consequently, cell function. Sangamo has entered into a strategic collaboration with Shire to develop therapeutics for hemophilia and other monogenic diseases and has established strategic partnerships with companies in non-therapeutic applications of its technology including Dow AgroSciences and Sigma-Aldrich Corporation. For more information about Sangamo, visit the company’s website at http://www.sangamo.com

ZFP Therapeutic® is a registered trademark of Sangamo BioSciences, Inc.

This press release may contain forward-looking statements based on Sangamo’s current expectations. These forward-looking statements include, without limitation, the potential of ZFNs to advance cancer immunotherapy and treat other human diseases, research and development of novel ZFP TFs and ZFNs and therapeutic applications of Sangamo’s ZFP technology platform. Actual results may differ materially from these forward-looking statements due to a number of factors, including uncertainties relating to the initiation and completion of stages of our clinical trials, whether the clinical trials will validate and support the tolerability and efficacy of ZFNs, technological challenges, Sangamo’s ability to develop commercially viable products and technological developments by our competitors. For a more detailed discussion of these and other risks, please see Sangamo’s SEC filings, including the risk factors described in its Annual Report on Form 10-K and its most recent Quarterly Report on Form 10-Q. Sangamo assumes no obligation to update the forward-looking information contained in this press release.

SOURCE Sangamo BioSciences, Inc.

Posted: April 2012

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Futures for Children announces President & CEO Jim West’s…

Albuquerque, New Mexico (PRWEB) March 30, 2012

Futures for Children announces President & CEO Jim West’s retirement effective no later than January 2, 2013.

“I am grateful for the opportunity to have led Futures for Children and to have been a spokesman for its unique and meaningful mission. I have been inspired daily by the indomitable spirit of the American Indian children and young people we serve,” said Jim West.

From early childhood in Oklahoma in a challenging and supportive environment, with a successful Cheyenne artist/father, Dick West and a musically talented mother, Jim West embarked upon a diverse educational path, studying music and humanities while playing college football. He received his B.A. in 1968, from the University of Redlands, and his Masters of Divinity in 1971 from Andover Newton Theological School, augmented by studies in science, medicine and business.

Former President of Jim West Financial Group, Inc. and Okom Enterprises, Inc., Jim has also been an executive with the American Indian National Bank of Albuquerque. He has vast experience in management, financial services and laws related to Native American issues, as well as twenty-nine years experience in political and economic development and crisis resolution with 130 Indian tribes and many Third World nations.

Jim was appointed President of Futures for Children in 1997 after eight and a half years as a member of the FFC Board of Directors. During his tenure, Futures for Children has grown in size, audience and services provided.

Futures for Children’s three-pronged approach (Youth Leadership, Friendship/Mentorship and Families in Action) to self-sufficiency in Hopi, Navajo, Pueblo and Mescalero Apache communities in Arizona and New Mexico as well as the Cheyenne-Arapaho Tribes of Oklahoma is effective and efficient. Futures for Children’s founder Dr. Richard P. Saunders’ vision lives on today – “to build communities empowered by self-reliance.”

Please visit http://www.futuresforchildren.org/about/details/president_ceo/ to review the job description.
If you meet the qualifications, and are interested in applying for the position of President & CEO of Futures for Children, please send a cover letter, resume and references to CEOsearch@futuresforchildren.org.

If you wish to support/mentor an American Indian child, please contact Inky Kim, Vice President of Development, at kimi@futuresforchildren.org.

Press Contact:
Inky Kim at kimi@futuresforchildren.org
Futures for Children
9600 Tennyson Street NE
Albuquerque, NM 87122-2282
505-821-2828 x 109
http://www.futuresforchildren.org

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Walleye™ Technologies Announces Appointment of John W. Wood, Jr. to…

Somerville, MA (PRWEB) April 02, 2012

Walleye™ Technologies, Inc., the leading developer of hand-held and portable microwave imaging systems, announced today the appointment of John W. Wood, Jr. to its Board of Directors.

Mr. Wood’s leadership experience spans start-ups, turn-arounds, and global corporations, and includes eighteen years as chief executive officer of public companies. From 2003 to 2006 he was Chief Executive Officer of Analogic Corporation, a leading designer and manufacturer of medical imaging and security systems. Prior to joining Analogic, he held senior executive positions over a 22-year career at Thermo Electron Corporation, now Thermo Fisher Scientific, Inc.

From 1984 to 1998 John was CEO of Thermedics Inc., a publicly-held subsidiary of Thermo Electron. Under John’s guidance Thermedics grew to a broad-based company in medical devices, security equipment, analytical and process instruments. During his tenure he gained wide experience in acquisition search, deal negotiation, closure and post-deal integration.

Mr. Wood currently serves on the Boards of Directors of ESCO Corporation, a privately-held company, and American Semiconductor Corporation, AMSC and FLIR Systems, public companies. FLIR Systems is a world leader in the design, manufacture and marketing of thermal imaging and stabilized camera systems for a wide range of applications.

“Mr. Wood’s knowledge and expertise will be an invaluable asset to Walleye Technologies as we move into the next phase of growth,” says Chris Adams, CEO of Walleye Technologies. “We are delighted that he will be serving on our Board.”

About Walleye Technologies
Walleye Technologies develops next generation hand-held portable imaging systems capable of “seeing” into and through solid objects. The company’s patented imaging technology platform, the Walleye Imaging System, generates high quality images and has a diversity of applications from consumer to security imaging markets.. To learn more about Walleye Technologies, please visit http://www.walleyetechnologies.com.

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