Aeterna Zentaris: Partner Yakult Initiates Phase 1 Trial in Multiple Myeloma with Perifosine in Japan
QUEBEC CITY, June 28, 2012 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that its Japanese partner Yakult Honsha ("Yakult") (Tokyo: 2267) has initiated a Phase 1 trial in multiple myeloma, a form of blood cancer, with perifosine, the Company's oral Akt/PI3K inhibitor drug. Yakult, who are sponsoring and conducting this trial in Japan, reported that a first patient has been treated with perifosine.
This is an open-label, two step Phase 1 trial in which perifosine is combined with bortezomib (Velcade®) and dexamethasone in patients with refractory multiple myeloma who had previously been treated with bortezomib. The trial is expected to include a total of 18 patients (6 in step 1 and 12 in step 2). Patients will receive perifosine daily (50 mg, Days 1-21) in combination with bortezomib (1.3 mg/m2, Days 1, 4, 8 and 11) and dexamethasone (20 mg, Days 1, 2, 4, 5, 8, 9, 11 and 12) according to a three-week cycle (21 days ± 3 days). The primary endpoint is safety while secondary endpoints include response rate, progression-free survival, and time to tumor progression.
Juergen Engel, PhD, President and CEO at Aeterna Zentaris stated, "We would like to thank our partner Yakult for their close collaboration in initiating this important Phase 1 trial in multiple myeloma which is necessary at this time in order to comply with Japan's specific registration requirements. Perifosine, also currently in a Phase 3 trial in other parts of the world in multiple myeloma for which we expect to reach an interim analysis in the first quarter of next year, remains a key component of our deep pipeline focused on providing novel, targeted treatment options for cancer patients facing unmet medical needs".
Perifosine is a novel, oral anticancer treatment that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. It has been granted orphan drug and orphan medicinal product designations from both the FDA and EMA for multiple myeloma. Perifosine has also received Fast Track designation from the FDA and positive Scientific Advice from the EMA with results from the Phase 3 trial in multiple myeloma expected to be sufficient for registration in Europe, as well as in North America. Perifosine is also being explored in combination therapy and in monotherapy in other cancer indications. Aeterna Zentaris holds rights to perifosine for North America and Europe, while rights have been licensed to Yakult Honsha for Japan, to Handok for Korea, and to Hikma Pharmaceuticals for the MENA (Middle East and North Africa) region.
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.
SOURCE AETERNA ZENTARIS INC.