QUÉBEC CITY, June 18, 2012 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that data from two Phase 2 trials in renal cell carcinoma (RCC) for the Company's oral anticancer drug, perifosine, have been published in the June 2012 issue of Cancer, a publication of the American Cancer Society. The article is titled, "Two Phase 2 Trials of the Novel Akt Inhibitor Perifosine in Patients with Advanced Renal Cell Carcinoma After Progression on Vascular Endothelial Growth Factor-Targeted Therapy", D.C. Cho, T.E. Hutson, W. Samlowski, P. Sportelli, B. Somer, P. Richards, J.A. Sosman, I. Puzanov, M.D. Michaelson, K.T. Flaherty, R.A. Figlin and N.J. Vogelzang. It outlines perifosine's activity as monotherapy in patients with advanced RCC, which was comparable to current second-line agents. Both objective tumor responses and prolonged disease stability were observed, and perifosine was well tolerated at the 100mg daily dose used in this trial. Finally, the authors conclude that this compound may be worthy of further investigation in this indication in combination with available therapies.
Two single-arm, open-label Phase 2 trials (#228 and #231) were conducted to assess the efficacy and safety of perifosine as monotherapy in patients with advanced RCC who had failed on previous vascular endothelial growth factor (VEGF)-targeted therapy.
In the #228 trial, 24 patients with advanced RCC received oral perifosine (100 mg daily). The #231 trial enrolled 2 groups that received daily oral perifosine (100 mg daily): Group A comprised 32 patients who had received no prior mTOR inhibitor, and Group B comprised 18 patients who had received 1 prior mTOR inhibitor.
In the #228 trial, 1 patient achieved a partial response and 11 patients had stable disease as their best response. The median progression-free survival was 14.2 weeks.
In the #231 trial, 5 patients achieved a partial response and 16 patients had stable disease as their best response. The median progression-free survival was 14 weeks both in patient with and without prior mTOR inhibitor therapy.
Overall, perifosine was well tolerated, and there were very few grade 3 and 4 events. The most common toxicities included nausea, diarrhea, musculoskeletal pain, and fatigue.
Juergen Engel, PhD, President and CEO of Aeterna Zentaris stated, "These data demonstrate perifosine's anticancer activity in monotherapy as well as its good tolerability. The authors' conclusion that perifosine may be worthy of further studies in combination therapy is in line with the strategy behind our current Phase 3 trial in multiple myeloma in which perifosine is combined with bortezomib and dexamethasone."
Perifosine is a novel, oral anticancer drug that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. It is currently in a Phase 3 trial in multiple myeloma for which it has been granted orphan drug and Fast Track designations by the Food and Drug Administration, while also having received positive Scientific Advice and Orphan Medicinal Product designation from the European Medicines Agency. Furthermore, perifosine is in earlier-stage clinical development for other cancer indications. Rights for perifosine have been out licensed to Yakult Honsha Co. Ltd. for Japan, to Handok Pharmaceuticals Co. Ltd. for Korea and to Hikma Pharmaceuticals PLC for the Middle East and certain countries in North Africa. Aeterna Zentaris holds rights for the rest of the world.
About Aeterna Zentaris
Aeterna Zentaris is an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs. The Company's pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. For more information please visit 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 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.
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