Trial conducted pursuant to Special Protocol Assessment with the Food and Drug Administration
QUEBEC CITY, Dec. 16 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the "Company"), a global biopharmaceutical company focused on oncology and endocrine therapy, today announced the initiation, by its partner Keryx Biopharmaceuticals Inc. ("Keryx") ( KERX), of a Phase 3 registration clinical trial for perifosine (KRX-0401), the Company's PI3K/Akt pathway inhibitor, in relapsed/refractory multiple myeloma patients. Keryx is AEterna Zentaris' partner and licensee for perifosine in the United States, Canada and Mexico. Perifosine is also out-licensed to Handok in South Korea while AEterna Zentaris retains rights for the rest of the world.
The trial, entitled, "A Phase 3 Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib (Velcade(R)) and Dexamethasone in Multiple Myeloma Patients Previously Treated with Bortezomib", is a double-blind, placebo-controlled trial comparing the efficacy and safety of perifosine vs. placebo when combined with bortezomib (Velcade(R)) and dexamethasone. The trial will enroll approximately 400 patients with relapsed or relapsed/refractory multiple myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. This trial is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA). Additionally, the FDA has granted perifosine Orphan Drug and Fast Track designations in this indication. An estimated 40 to 50 centers throughout the United States and select centers outside of the United States will be participating in this Phase 3 trial.
The Phase 3 trial is being led by the Principal Investigator, Dr. Paul Richardson, Clinical Director of the Jerome Lipper Multiple Myeloma Center, at Dana-Farber Cancer Institute (DFCI) in Boston, MA and Dr. Kenneth C, Anderson, Chief, Division of Hematologic Neoplasia at DFCI.
Dr. Richardson's clinical research focuses on studying novel therapies for multiple myeloma. He was the lead investigator of the SUMMIT and APEX clinical trials that led to the FDA approval of bortezomib (Velcade(R)) for the treatment of multiple myeloma. More recently, he served as clinical trials core chair of the Multiple Myeloma Research Consortium, completing 5 years of service in the role this year. Dr. Anderson serves as Chair of the NCCN Multiple Myeloma Clinical Practice Guidelines Committee and chairs the scientific advisory board for the Multiple Myeloma Research Foundation. In addition to playing an integral role in the development and approval of bortezomib (Velcade(R)), Drs. Richardson and Anderson led both preclinical and early phase clinical trials for the immunomodulatory drug lenalidomide (Revlimid(R)), leading to its FDA approval in 2007.
Juergen Engel, Ph.D., President and CEO at AEterna Zentaris stated, "We are very excited with Keryx's initiation of this Phase 3 trial with perifosine, our lead oncology compound. Based on prior positive results, we believe that perifosine could become a novel oral combination treatment of great benefit to patients suffering from multiple myeloma."
About the Phase 3 Trial Design
The Phase 3 trial is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine to placebo when combined with bortezomib (Velcade(R)) and dexamethasone in approximately 400 patients with relapsed or relapsed/refractory multiple myeloma. Patients will be randomized to bortezomib (Velcade(R)) at 1.3 mg/m2 days 1, 4, 8 and 11 every 21 days in combination with dexamethasone 20 mg on the day of and day after bortezomib (Velcade(R)) treatment, and either perifosine 50 mg daily or placebo. The Phase 3 trial design is based on positive data reported from the Phase 1/2 trial which was recently reported at the 51st American Society of Hematology meeting.
Patients eligible for the Phase 3 trial must have been previously treated with both bortezomib (Velcade(R)) and an immunomodulatory agent (Revlimid(R) and/or Thalidomid(R)), and been previously treated with one to four prior lines of therapy. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. Patients can be relapsed from and refractory to all non-bortezomib based therapies, however, patients can only be relapsed (progressed more than 60 days after discontinuing therapy) from prior bortezomib-based therapies. The study is powered at 90% to demonstrate the required difference in progression-free survival between the two arms. Approximately 265 events (defined as disease progression or death) will trigger the un-blinding of the data.
The Company expects a patient recruitment period of approximately 16-18 months, with study completion expected within approximately 20-22 months from today.
About Perifosine (KRX-0401)
Perifosine is a novel oral anticancer agent that modulates several key signal transduction pathways, including Akt, MAPK, and JNK that have been shown to be critical for the survival of cancer cells. Perifosine has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. Perifosine is currently in a Phase 3 trial, under Special Protocol Assessment (SPA), in multiple myeloma for which it has received Orphan Drug and Fast Track designations from the FDA in this indication. Perifosine is also in Phase 2 clinical trials for several other tumor types.
About Multiple Myeloma
Multiple myeloma, a cancer of the plasma cell, is an incurable but treatable disease. Multiple myeloma is the second most-common hematologic cancer, representing 1% of all cancer diagnoses and 2% of all cancer deaths. According to the American Cancer Society, in 2009 there will be an estimated 20,580 new cases of multiple myeloma and an estimated 10,500 deaths from multiple myeloma in the United States. To date, several FDA approved therapies exist for the treatment of multiple myeloma. Despite this progress, patients continue to relapse, become refractory to prior treatments and eventually die from their disease. Thus, new therapies are needed to treat these patients and extend their survival.
About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a global biopharmaceutical company focused on oncology and endocrine therapy, with proven expertise in drug discovery, development and commercialization. News releases and additional information are available at www.aezsinc.com.
This press release contains forward-looking statements made pursuant to the safe harbor 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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