QUÉBEC CITY, May 21 /PRNewswire-FirstCall/ - Aeterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS), (the "Company") a late-stage drug development company specialized in oncology and endocrine therapy, today announced that data on two of its lead anticancer compounds, perifosine and AEZS-108, will be presented at the upcoming Annual Meeting of the American Society of Clinical Oncology (ASCO), which will be held June 4 through 8, 2010 at McCormick Place in Chicago. Two posters on perifosine, Aeterna Zentaris' novel, potentially first-in-class, oral anticancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, will be presented in pediatric solid tumors and colorectal cancer. A poster will also be presented on the Company's doxorubicin targeted conjugate compound, AEZS-108, in ovarian cancer.
Abstracts selected for presentation are as follows:
Perifosine ---------- Abstract # 9540: "Phase I Study of Single Agent Perifosine for Recurrent Pediatric Solid Tumors" Lead Author: Oren J. Becher, MD, Memorial Sloan-Kettering Cancer Center Presenter: Mark Kieran, MD, PhD, Dana-Farber Cancer Institute Date and Time: Sunday, June 6, 2010, 2 pm-6 pm (poster discussion 5:40pm-6pm) Poster Board #: 42b Location: S Hall A2 (poster discussion in S504) Abstract # 3531: "Final results of a randomized Phase II study of perifosine in combination with capecitabine (P-CAP) vs. placebo plus capecitabine (CAP) in patients (pts) with second or third line metastatic colorectal cancer (mCRC)" Lead Author: Donald A. Richards, MD, PhD, Texas Oncology Presenter: Wells Messersmith, MD, University of Colorado Date and Time: Tuesday, June 8, 2010, 8 am-12 noon (poster discussion 11:45 am-12 noon) Poster Board #: 22 Location: S403 (poster discussion in S406) AEZS-108 -------- Abstract # 5035: "Phase 2 study of AEZS-108, a targeted cytotoxic LHRH analog, in patients with LHRH receptor positive platinum resistant ovarian cancer" Lead Author: Prof. Günter Emons, Chairman, Department of Obstetrics & Gynaecology Georg-August University Gottingen, Germany Presenter: Prof. Günter Emons Date and Time: Saturday, June 5, 2010 2pm- 6pm Poster Board #: 45B Location: S Hall A2
Copies of these abstracts are currently available and can be viewed on-line through the ASCO website: www.asco.org.
Perifosine, a novel, potentially first-in-class, oral Akt inhibitor, is currently in Phase 3 trials for multiple myeloma and advanced colorectal cancer, under Special Protocol Assessment and Fast Track designation granted by the Food and Drug Administration (FDA) for both indications. FDA has also granted perifosine orphan-drug status for multiple myeloma. Furthermore, the European Medicines Agency (EMA) has issued a positive Scientific Advice as well as a positive opinion for Orphan Medicinal Product designation for perifosine for multiple myeloma.
Perifosine is also in a Phase 1 trial in pediatric patients, as well as in other Phase 1 and Phase 2 trials for several other tumor types.
Keryx Biopharmaceuticals, Inc. (Keryx) (Nasdaq: KERX) is Aeterna Zentaris' partner and licensee for perifosine in the United States, Canada and Mexico. Perifosine is also out-licensed to Handok for South Korea, while Aeterna Zentaris retains rights for the rest of the world.
AEZS-108, a doxorubicin LHRH receptor targeted conjugate, is currently in a Phase 2 trial in advanced ovarian and endometrial cancer for which final results are expected before year-end. AEZS-108 has been granted orphan-drug designation by the FDA and has received a positive opinion for Orphan Medicinal Product designation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency, for the treatment of ovarian cancer. An IND in the U.S. is in place for the treatment of bladder cancer.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a late-stage drug development company specialized in oncology and endocrine therapy. News releases and additional information are available at www.aezsinc.com.
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, 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 R&D projects, the successful and timely completion of clinical studies, 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 the 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 except if we are required by a governmental authority or applicable law.
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