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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