KYNAMRO (mipomersen sodium) Data Presented at XVI International Symposium on Atherosclerosis

Phase 3 Extension Study Highlights Long-term Safety and Efficacy in Patients with Familial Hypercholesterolemia (FH)

CAMBRIDGE, Mass. & CARLSBAD, Calif.–(BUSINESS WIRE)–Mar 29, 2012 – Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), and Isis Pharmaceuticals Inc. (NASDAQ: ISIS), announced today that new two-year data from a phase 3 long-term extension study of KYNAMROTM (mipomersen sodium) were presented at the XVI International Symposium on Atherosclerosis in Sydney, Australia. In the study, patients treated with KYNAMROTM for two years maintained robust reductions in LDL-C and all other Apo B containing atherogenic lipoproteins measured with a safety profile consistent with the phase 3 studies of KYNAMROTM.

Data presented today included 141 patients who enrolled in the study after having completed one of the three phase 3 studies: homozygous FH, severe hypercholesterolemia, or the heterozygous FH. These studies were six months long and required patients to be on stable maximally tolerated lipid-lowering therapy throughout the study. To date, 63 patients remain on or have completed treatment with 40 patients consenting to participate for another two years of treatment – a total of four years of treatment.

In this study, sustained reductions in LDL-C with a mean reduction of 28 percent in LDL-C at six months and at two years were observed in patients treated with KYNAMROTM. Changes in liver fat were observed in some patients where the overall median change stabilized and then declined with continued treatment. The median change from baseline in percent liver fat increased from 5 percent at 26 weeks, to 13 percent at 52 weeks, and returned to 5 percent at 104 weeks. Results represent those patients in the extension study at each assessment period: 60 patients at 26 weeks, 31 patients at 52 weeks, and 39 patients at 104 weeks. The median change reflects both patients who continued at full dose as well as those with dose adjustments and dose interruptions. Upon treatment discontinuation, changes in liver fat returned towards normal.

“These data show that robust LDL-C reductions are seen in patients treated for 2 years and more. Liver fat may increase in some patients but in this long term study the median fat fraction is seen to stabilize and decline with time as measured by MRI,” said study investigator Raul D. Santos, M.D., Ph.D., Director of the Lipid Clinic of the Heart institute, Instituto do Coração, Hospital das Clínicas, São Paulo, Brazil. “These results are encouraging and support the potential for effective and safe long-term use in patients with the most aggressive forms of FH.”

Genzyme and Isis have completed the four phase 3 studies that are included in the European submission and will be included in the U.S. submission. In these studies, the most commonly observed adverse events were injection site reactions and flu-like symptoms. The long-term data demonstrate a safety and efficacy profile consistent with phase 3 findings.

“These positive and clinically meaningful results represent a significant addition to the KYNAMROTM clinical development program,” said Vice President and General Manager of Genzyme’s Cardiovascular Business, Paula Soteropoulos. “We look forward to continuing to work with regulatory authorities to bring this treatment to market for such a severe and life-threatening disease.”

KYNAMRO™ is the registered trade name submitted to health authorities for investigational agent mipomersen. Genzyme submitted for EU marketing approval of KYNAMROTM for the treatment of patients with homozygous FH (HoFH) and severe heterozygous FH (Severe HeFH) in July 2011. Genzyme also expects to submit an NDA for U.S. approval for the HoFH indication by the end of March 2012.

Webcast

At 4:00 p.m. Eastern Time today, Isis will host a live conference call webcast and slide presentation with Dr. Raul D. Santos to discuss KYNAMROTM data presented at the International Symposium on Atherosclerosis. Interested parties may listen to the call by dialing 866.761.0749 and refer to the passcode “ISIS 2012” or access the webcast with or without audio at http://www.isispharm.com. A webcast replay will be available for a limited time at the same address.

About KYNAMROTM (mipomersen sodium)

KYNAMROTM is a first-in-class Apo B synthesis inhibitor currently in late-stage development for patients with homozygous familial hypercholesterolemia (HoFH) and severe heterozygous familial hypercholesterolemia (Severe HeFH) to further reduce LDL cholesterol (LDL-C) in patients already maintaining a stable regimen of maximally tolerated lipid-lowering therapies. It is intended to reduce LDL-C by preventing the formation of atherogenic lipoproteins, the particles that carry cholesterol through the bloodstream. KYNAMROTM acts by blocking the production of, apolipoprotein B (Apo B), the protein that provides the structural core for these atherogenic particles, including LDL and lipoprotein-a (Lp(a)).

About Familial Hypercholesterolemia (FH)

FH is a genetic disease that results in elevated LDL-C levels and family patterns of increased risk of premature heart disease and heart disease-related death. FH patients have inherited abnormalities in liver cells that are responsible for clearing LDL particles from the blood. FH is autosomal dominant, which means that all first-degree relatives of FH patients have a 50 percent chance of having the disease as well, making early detection through family screening critically important.

The most severe FH patients have LDL-C levels that are two to four times higher than recommended levels, even when taking multiple cholesterol-lowering medications. These people, who are characterized as having severe FH, include: those who have inherited the disease from both parents (HoFH) and those who have inherited it from only one parent, and have a particularly severe form of the disease (Severe HeFH) defined as those people who are maximally treated and still have LDL-C greater than 200 mg/dL (5.1 mmol) with coronary heart disease or greater than 300 mg/dL (7.1 mmol) without coronary heart disease. People with HoFH may have aggressive heart disease beginning in childhood, and even with today’s therapies remain at significant risk of cardiovascular events. Learn more at http://www.FHJourneys.com.

About Genzyme, a Sanofi Company

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at http://www.genzyme.com.

Genzyme® and KYNAMROTM are registered trademarks of Genzyme Corporation. All rights reserved.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

About Isis Pharmaceuticals, Inc.

Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners. Isis’ broad pipeline consists of 25 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic and severe and rare/neurodegenerative diseases, and cancer. Isis’ partner, Genzyme, plans to commercialize Isis’ lead product, KYNAMRO, following regulatory approval, which is expected in 2012. Isis’ patents provide strong and extensive protection for its drugs and technology. Additional information about Isis is available at http://www.isispharm.com.

Isis Pharmaceuticals® is a registered trademark of Isis Pharmaceuticals, Inc.

Sanofi Forward Looking Statement

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Isis Forward Looking Statement

This press release includes forward-looking statements regarding Isis’ collaboration with Genzyme Corporation, its financial and business development activities, and the development, activity, therapeutic and commercial potential and safety of KYNAMRO in treating patients with high cholesterol. Any statement describing Isis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Isis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Isis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis’ programs are described in additional detail in Isis’ annual report on Form 10-K for the year ended December 31, 2011, which is on file with the SEC. Copies of this and other documents are available from the Company.

Contact: Media Contact Genzyme:
Ingrid Esser, 617-768-6699
Ingrid.esser@genzyme.com
or
Media Contact Isis:
Amy Blackley, Ph.D., 760-603-2772 (Media)
or
Kristina Lemonidis, 760-603-2490 (Investors)

Posted: March 2012

View the original article here

Lilly Targets Faulty c-MET Receptor in Cancer Research Studies Presented Today at AACR Meeting

Studies provided basis for ongoing Phase I, II studies in gastric, other cancers
CHICAGO, April 2, 2012 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced results of three preclinical studies focused on c-MET, a receptor tyrosine kinase that, when it functions normally, plays a key role in transmitting signals within a cell. Abnormalities in c-MET function and signaling have been found in many types of cancer including lung, breast, prostate, gastric, esophageal and renal cancers.

Two of the abstracts (#2734 and #2738) assess the anti-cancer activity of Lilly’s LY2875358, a humanized IgG4 monoclonal antibody directed against c-MET currently in Phase II clinical development, while the third (#1738) looks at a Lilly assay for detecting c-MET expression levels in circulating tumor cells (CTCs) that are shed into the bloodstream. The data were presented today during the American Association for Cancer Research (AACR) 103rd Annual Meeting in Chicago, Ill.

“Our c-MET program includes two different potential medicines in Phase I and II development—a monoclonal antibody and a small molecule inhibitor—that both target a receptor believed to play a critical role in the development of some cancers,” said Richard Gaynor, M.D., vice president of product development and medical affairs at Lilly Oncology. “Our job now is to discover if these potential medicines will inhibit the growth of certain cancers, and identify which patients would specifically benefit for treatments such as these.”

Identifying and Exploring c-MET
Normally, c-MET signaling is activated when its only known ligand—the hepatic growth factor (HGF)—binds to the c-MET receptor. c-MET signaling is necessary for normal embryonic development, particularly of the liver, as well as for liver regeneration and wound healing. Dysregulated c-MET signaling can cause cell proliferation, increased cell survival, angiogenesis, invasion, metastasis and drug resistance.

In cancer cells, c-MET signaling can become active in two ways: either by binding of its ligand HGF (i.e., ligand-dependent mechanisms) or by ligand-independent mechanisms, such as gene amplification or activating mutations. The c-MET antibody LY2875358 is capable of blocking both ligand-dependent and ligand-independent c-MET activations. LY2875358 binds to c-MET, which prevents the c-MET ligand HGF from binding, but also induces internalization and degradation of c-MET, thereby blocking ligand-independent c-MET signaling caused by overexpression, amplification or mutation of c-MET. Because LY2875358 affects both ligand-dependent and ligand-independent mechanisms, binding of this antibody to c-MET-expressing tumor cells has the potential to inhibit c-MET-driven tumor proliferation.

Abstract #2734: c-MET antibody LY2875358 (LA480) has enhanced efficacy with gastric cancer standard-of-care in vitro and in vivo
One of the ligand-independent causes of aberrant c-MET signaling—amplification of the c-MET gene—has been observed in 10 percent to 20 percent of gastric tumors. Gene overexpression due to these extra copies of the c-MET gene is associated with poor prognosis in gastric cancer patients.

In vitro, this study found that LY2875358 successfully reduced cell proliferation in gastric cancer cell lines in which c-MET activation was caused by c-MET overexpression. LY2875358 appeared to deplete the c-MET molecules from the surface of the cancer cells. In vivo, in an animal model to which human gastric tumors were grafted, LY2875358 alone showed marked antitumor activity.

The combination of LY2875358 therapy and standard chemotherapy was more effective than either treatment alone both in vitro and in vivo, suggesting that combining LY2875358 with standard chemotherapy may be a promising approach for treating gastric cancer.

Abstract #2738: c-MET antibody LY2875358 (LA480) shows differential antitumor effects in non-small cell lung cancer
Aberrant c-Met expression occurs in 41 percent to 72 percent of cases of non-small cell lung cancer (NSCLC); amplification of the c-MET gene is present in 5 percent to 10 percent of cases.

This study found that LY2875358, either alone or combined with standard chemotherapy, inhibits cell proliferation and migration, as well as signal transduction in NSCLC cells in which the c-MET gene was amplified, mutated or overexpressed.

In vitro, LY2875358 induces c-MET degradation in both wild type and mutant c-MET cells. In vivo, in an animal model bearing human NSCLC tumors produced by c-MET amplification, LY2875358 alone showed marked antitumor activity. The combination of LY2875358 with standard chemotherapy produced better efficacy than either treatment alone, both in vitro and in vivo.

Abstract #1738: Assay development for detecting c-MET expression in circulating tumor cells (CTC), a potential patient tailoring marker for evaluation of c-MET inhibitors
Patients with cancers in which the c-MET gene is amplified or overexpressed typically have a poor prognosis. Lilly scientists hypothesized that such patients would be especially likely to benefit from experimental therapies such as LY2875358, which target c-MET. What was needed was a noninvasive technique for monitoring the effectiveness of c-MET inhibitors over the course of treatment.

One noninvasive alternative to the standard biopsy is to count the CTCs present in a patient’s blood sample. These cells, which are shed by tumors, appear representative of cells migrating from primary tumors to form distant metastases. The greater the number of CTCs found in a blood sample, the worse the patient’s prognosis.

Lilly scientists evaluated the development of an assay that counts the number of CTCs in a blood sample and measures their c-MET expression to potentially determine which patients may respond better to agents such as LY2875358 that target c-MET. Scientists first collected cells from several cultured cell lines that were derived from solid epithelial tumors and had different c-MET expression levels. Initially, mouse blood was spiked with the cells from the various cell lines. Those results were later successfully reproduced using human whole blood from healthy subjects, to which tumor cells were added.

After the mouse and human blood was spiked with tumor cells, the CTCs were collected and counted. A Lilly proprietary c-MET antibody, optD11, was then used to determine the c-MET expression levels of the collected cells.

The optD11 antibody was used in this assay for several reasons. It could detect different c-MET expression levels among several cell lines in which c-MET was expressed at high levels, and it could successfully identify a different cell line as not having aberrant c-MET gene expression. Equally important, the optD11 antibody could function in the presence of the Lilly therapeutic antibody LY2875358. This means that the Lilly assay can monitor c-MET gene expression levels in patients being treated with LY2875358.

This Lilly assay for measuring c-MET expression levels in CTCs—and a different Lilly assay that measures c-MET gene amplification in CTCs—are now being used in early phase clinical studies evaluating additional c-MET inhibitors being developed in Lilly laboratories.

For more information on Lilly’s c-MET antibody, please visit http://www.lillyoncologynewsroom.com.

About Lilly Oncology
For more than four decades, Lilly Oncology, a division of Eli Lilly and Company, has been dedicated to delivering innovative solutions that improve the care of people living with cancer.  Because no two cancer patients are alike, Lilly Oncology is committed to developing novel treatment approaches.  To learn more about Lilly’s commitment to cancer, please visit http://www.LillyOncology.com.  

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs.

P-LLY

This press release contains forward-looking statements about the potential of LY2875358 and LY2801653 as treatments for various cancers and reflects Lilly’s current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that these products will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

SOURCE Eli Lilly and Company

Posted: April 2012

View the original article here

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

View the original article here

Promising Data Presented at AACR Further Support New Lung Cancer Treatment Combination as Well as Ongoing Studies of Peregrine’s Bavituximab

Data From Phase I Trial Evaluating Bavituximab Plus Carboplatin and Pemetrexed Indicate Encouraging Anti-Tumor Activity and a Positive Safety Profile; Data From Imaging Studies Show Potent Upregulation of Bavituximab’s PS Target Following Docetaxel Treatment Further Supporting Ongoing Bavituximab Plus Docetaxel Phase II NSCLC Trial

TUSTIN, CA — (Marketwire) — 04/02/12 — Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class monoclonal antibodies for the treatment of cancer and infectious diseases, today highlighted data(1) presented at the Annual Meeting of the American Association for Cancer Research (AACR) from a Phase Ib Investigator Sponsored Trial (IST) evaluating Peregrine’s lead PS-targeting antibody bavituximab in combination with carboplatin and pemetrexed in patients with previously untreated Stage IV non-small cell lung cancer (NSCLC). Data from the initial five patients including two dose levels of bavituximab indicate a promising safety profile comparable to that expected for the chemotherapy combination alone, with 3 patients achieving a partial tumor response and no signs of unexpected safety events. The study is currently ongoing and additional data is expected in 2012 as patient treatment and follow-up continues.

In another presentation scheduled for later today, data will be presented from a series of preclinical studies evaluating PS as an imaging target. Those studies have further validated the ability of docetaxel to strongly upregulate exposure of bavituximab’s PS target. These data further support an ongoing phase II randomized, double blinded trial evaluating bavituximab in combination with docetaxel in 121 second-line NSCLC patients with top-line data expected to be reported in the first half of 2012.

Based on bavituximab’s broad therapeutic potential, the product is currently being tested in a total of seven clinical oncology studies including three randomized Phase II trials in front-line and second-line non-small cell lung cancer (NSCLC), front-line pancreatic cancer and four ISTs in additional oncology indications with clinical data from each study expected in 2012.

“ISTs are an important part of our overall clinical development strategy with the potential to yield critical safety information for new drug combinations and early signs of potential anti-tumor activity that can help guide our overall clinical development. In that regard, we are very happy with the early results from this study which so far support the safety profile of bavituximab with this important chemotherapy combination and with some interesting early tumor responses in the study,” said Steven W. King, president and chief executive officer of Peregrine. “Bavituximab is now being clinically administered in conjunction with a growing number of different chemotherapies. We believe that data from studies like this IST and the imaging data to be presented later today will be the cornerstone of a successful bavituximab development program. We look forward to additional data from these studies as patient enrollment and follow-up continue and as we continue to explore more possible treatment combinations with bavituximab.”

About the Phase Ib NSCLC Study

In this Phase Ib single-arm, open-label investigator-sponsored clinical trial (IST), up to 25 patients with previously untreated locally advanced or metastatic non-squamous NSCLC will receive up to six 21-day cycles of the drugs pemetrexed and carboplatin with weekly bavituximab until progression or toxicity. The primary endpoint of the study is to determine the safety, dose-limiting toxicity (DLT) and recommended Phase II dose of bavituximab in combination with carboplatin and pemetrexed in non-squamous NSCLC. Secondary endpoints include assessment of overall response rate (ORR) measured by RECIST criteria, progression-free survival (PFS) and overall survival (OS) and exploratory biomarkers.

For further information about this trial, please visit http://www.peregrinetrials.com

or http://www.clinicaltrials.gov/ct2/results?term=bavituximab.

About Peregrine’s Investigator-Sponsored Trials (IST) Program

Peregrine’s IST program offers oncologists the opportunity to conduct clinical trials investigating bavituximab’s potential in additional indications and treatment combinations. To apply for Peregrine’s IST program, please visit http://www.peregrineinc.com/pipeline/investigator-sponsored-trials.html.

About Lung Cancer

Lung cancer is the leading cause of cancer death. According to the American Cancer Society, lung cancer is the second most commonly diagnosed cancer, with approximately 219,440 new cases and 159,000 deaths each year in the U.S. NSCLC is the most common type of lung cancer, accounting for approximately 85-90% of lung cancer cases.

About Bavituximab

Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody that represents a new approach to treating cancer. PS is a highly immunosuppressive molecule usually located inside the membrane of healthy cells, but “flips” and becomes exposed on the outside of cells that line tumor blood vessels, creating a specific target for anti-cancer treatments. PS-targeting antibodies target and bind to PS and block this immunosuppressive signal, thereby enabling the immune system to recognize and fight the tumor.

1. Presentation Title: A phase Ib study of bavituximab plus carboplatin and pemetrexed in chemotherapy naive stage IV non-squamous non-small cell lung cancer

Presentation Time: Monday, Apr 02, 2012, 8:00 AM – 12:00 PM

Location: McCormick Place West (Hall F), Poster Section 27

Poster Board Number: 4

Authors: Juneko Grilley-Olson(1), Jared Weiss(1), Thomas E. Stinchcombe(1), Anastasia Ivanova(1), Maureen Tynan(1), Joseph Shan(2), Mark A. Socinski(3). 1. Univ. of North Carolina, Chapel Hill, NC; 2. Peregrine Pharmaceuticals, Inc., Tustin, CA; 3. Univ. of Pittsburgh, Pittsburgh, PA

About Peregrine Pharmaceuticals

Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing multiple clinical programs in cancer and infectious diseases with its lead product candidate bavituximab and novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com.

Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals’ intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that data from future trials evaluating bavituximab in combination with carboplatin and pemetrexed will not be consistent with the data from the Phase I trial, and the risk that Peregrine may not have or raise adequate financial resources to complete the planned clinical programs. Factors that could cause actual results to differ materially or otherwise adversely impact the company’s ability to obtain regulatory approval for its product candidates include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the company’s SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2011 and the quarterly report on Form 10-Q for the quarter ended January 31, 2012. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.

Add to Digg Bookmark with del.icio.us Add to Newsvine

Contact:

Christopher Keenan or Jay Carlson

Peregrine Pharmaceuticals, Inc.

(800) 987-8256

info@peregrineinc.com

Posted: April 2012

View the original article here