QUÉBEC CITY, Dec. 14 /PRNewswire-FirstCall/ - Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company") today presented a Comprehensive R&D review and its strategic outlook for 2011, at the InterContinental New York Barclay Hotel in New York City.
Key Announcements
- Perifosine
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- On track for completion of the Phase 3 X-PECT trial in metastatic colorectal cancer expected in the second half of 2011;
- Additional centers opened outside the U.S. for ongoing Phase 3 trial in multiple myeloma - patients under screening;
- Decision to come on the development in new indications such as Chronic Lymphocytic Leukemia (CLL).
- AEZS-108
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- First pivotal study in endometrial cancer to be initiated;
- Phase 1/2 trial initiated in castration refractory prostate cancer at Norris Comprehensive Cancer Center - first patients treated;
- Phase 1/2 trial initiated in refractory bladder cancer at Sylvester Comprehensive Cancer Center - patients under screening;
- Further proof-of-concept studies to be initiated in pancreatic and breast cancer.
- AEZS-130 (Solorel®)
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- NDA to be filed as an oral diagnostic test for growth hormone deficiency (GHD) in adults;
- Trial to be initiated as an oral diagnostic test for GHD in children;
- Proof-of-concept study to be initiated in cancer induced cachexia.
- AEZS-112, AEZS-120 and PI3K/Erk inhibitors
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- Preclinical and early-stage clinical development to be pursued in oncology.
Review of ongoing late-stage clinical programs by distinguished Key Opinion Leaders
- Perifosine
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- Phase 3 registration trial in metastatic colorectal cancer presented by Johanna Bendell, S.B., M.D., Director, GI Cancer Research - Associate Director, Drug Development Unit, Sarah Cannon Research Institute, Nashville;
- Phase 3 registration trial in multiple myeloma presented by Paul G. Richardson, M.D., Clinical Director, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Associate Professor of Medicine, Harvard Medical School, Boston.
- AEZS-108
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- Phase 2 program in advanced endometrial and advanced ovarian cancer presented by David S. Miller, M.D., F.A.C.O.G., F.A.C.S., Director of Gynecologic Oncology, Dallas Foundation chair in Gynecologic Oncology, Professor of Obstetrics & Gynecology, University of Texas Southwestern Medical Center, Dallas.
- Solorel®:
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- Phase 3 program as an oral diagnostic test for adult GHD presented by Beverly M.K. Biller, M.D., F.A.C.P., Professor of Medicine, Harvard Medical School, Faculty member - Neuroendocrine Unit, Massachusetts General Hospital, Boston.
"2011 should be an exciting year for the Company as we will continue the late-stage development of our lead novel compounds," stated Juergen Engel, Ph.D., President and CEO at Aeterna Zentaris. "We look forward to the disclosure of Phase 3 results for perifosine in metastatic colorectal cancer, the initiation of a first pivotal trial in endometrial cancer with AEZS-108, as well as the completion of the Phase 3 trial with Solorel® in adult GHD and the NDA filing for the use as an oral diasnostic test in this indication. We will continue the preclinical and early clinical development of AEZS-112, AEZS-120 and PI3K/Erk inhibitors which could represent the way of the future in targeted cancer treatment. We feel confident that with the human and financial resources at hand, we will achieve our goals in the upcoming year for the benefit of both patients and shareholders."
A replay of the meeting is available on the Company's website in the "Newsroom" section under "Events and Webcasts" at: www.aezsinc.com
About Aeterna Zentaris Inc.
Aeterna Zentaris is a late-stage oncology drug development company currently investigating potential treatments for various cancers including colorectal, ovarian, endometrial cancer and multiple myeloma. 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 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 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.
SOURCE AETERNA ZENTARIS INC.