QUEBEC CITY, Dec. 2 /PRNewswire-FirstCall/ - Æterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the "Company"), a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company's PI3K/Akt pathway inhibitor compound, perifosine (KRX-0401), for the treatment of relapsed/refractory multiple myeloma. Keryx Biopharmaceuticals, Inc. ("Keryx") (Nasdaq: KERX), is Æterna Zentaris' partner and licensee for perifosine in the United States, Canada and Mexico. Perifosine is also out-licensed to Handok in South Korea while Æterna Zentaris retains rights for the rest of the world.
The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
"We are very pleased with the FDA's Fast Track designation and we look forward to the emergence of the data from the forthcoming Phase 3 clinical trial in multiple myeloma to be conducted by our partner Keryx, which we hope will establish perifosine as a novel treatment of this serious condition", stated Juergen Engel, Ph.D., President and CEO at Æterna Zentaris. "We further believe that this North American clinical development program will also be very useful to support the development and registration of perifosine for the benefit of patients in the rest of the world."
A Phase 3 trial investigating perifosine in combination with bortezomib (VELCADE(R)) and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma is expected to commence by year-end under a Special Protocol Assessment (SPA) with the FDA. In addition, in September, perifosine had received Orphan-Drug designation in the United States for the treatment of multiple myeloma.
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 Phase 2 clinical development for multiple tumor types, with a Phase 3 in multiple myeloma, under Special Protocol Assessment (SPA), pending commencement by year-end. Perifosine has also received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma.
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 Æterna Zentaris Inc.
Æterna Zentaris Inc. is a global biopharmaceutical company focused on endocrine therapy and oncology, with proven expertise in drug discovery, development and commercialization. News releases and additional information are available at www.aezsinc.com.
Forward-Looking Statements
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.
SOURCE AETERNA ZENTARIS INC.
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The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
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"We are very pleased with the FDA's Fast Track designation and we look forward to the emergence of the data from the forthcoming Phase 3 clinical trial in multiple myeloma to be conducted by our partner Keryx, which we hope will establish perifosine as a novel treatment of this serious condition", stated Juergen Engel, Ph.D., President and CEO at Æterna Zentaris. "We further believe that this North American clinical development program will also be very useful to support the development and registration of perifosine for the benefit of patients in the rest of the world."
A Phase 3 trial investigating perifosine in combination with bortezomib (VELCADE(R)) and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma is expected to commence by year-end under a Special Protocol Assessment (SPA) with the FDA. In addition, in September, perifosine had received Orphan-Drug designation in the United States for the treatment of multiple myeloma.
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 Phase 2 clinical development for multiple tumor types, with a Phase 3 in multiple myeloma, under Special Protocol Assessment (SPA), pending commencement by year-end. Perifosine has also received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma.
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 Æterna Zentaris Inc.
Æterna Zentaris Inc. is a global biopharmaceutical company focused on endocrine therapy and oncology, with proven expertise in drug discovery, development and commercialization. News releases and additional information are available at www.aezsinc.com.
Forward-Looking Statements
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.
SOURCE AETERNA ZENTARIS INC.
