QUEBEC CITY, June 29 /PRNewswire-FirstCall/ - Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company"), a late-stage drug development company specialized in oncology and endocrine therapy, today announced that abstract O-0017, entitled, "Subset Analysis of 5-FU Refractory Patients from a Randomized Phase 2 Study of Perifosine + Capecitabine (P-CAP) vs. Placebo + Capecitabine (CAP) in Patients with 2nd or 3rd Line Metastatic CRC", has been selected for oral presentation at the upcoming 12th World Congress on Gastrointestinal Cancer, to be held in Barcelona, Spain, from June 30-July 2, 2010. The oral presentation will be made by Paulo Hoff, M.D., Professor of Medicine and Chairman of Medical Oncology at the University of Sao Paulo, Brazil and former lead investigator for the capecitabine (Xeloda(R)) Phase 3 approval study in metastatic colorectal cancer.
Of the 38 patients enrolled in the Phase 2 study, 27 patients were previously refractory to a 5-FU based regimen. A Phase 3 randomized double-blind trial comparing perifosine + capecitabine vs. placebo + capecitabine in 5-FU refractory patients with advanced refractory colorectal cancer (X-PECT trial), under Special Protocol Assessment (SPA) from the Food and Drug Administration (FDA), is currently open and enrolling patients at multiple centers throughout the U.S. This Phase 3 trial is sponsored by Keryx Biopharmaceuticals, Inc. ("Keryx") (Nasdaq: KERX), Aeterna Zentaris' licensee for perifosine in the United States, Canada and Mexico.
About Perifosine
Perifosine, a novel, potentially first-in-class, oral Akt inhibitor, is currently in Phase 3 trials for advanced colorectal cancer and multiple myeloma, under SPA and Fast Track designation granted by the FDA for both indications. Perifosine has also been granted orphan-drug status by the FDA for multiple myeloma and has received a positive opinion for Orphan Medicinal Product designation from the European Medicines Agency (EMA) in this same indication. In addition, perifosine has received positive Scientific Advice from the EMA for both multiple myeloma and colorectal cancer programs.
Perifosine is also in a Phase 1 trial in pediatric patients, as well as in other Phase 1 and Phase 2 trials for several other tumor types.
Perifosine is licensed to Keryx, in the United States, Canada and Mexico. Aeterna Zentaris has also out-licensed perifosine to Handok in South Korea, while retaining rights for the rest of the world.
About Colorectal Cancer
According to the American Cancer Society, colorectal cancer is the third most common form of cancer diagnosed in the United States. It is estimated that in the U.S., over 146,000 people were diagnosed with some form of colorectal cancer with over 49,000 patients dying from colorectal cancer in 2009. Surgery is often the main treatment for early stage colorectal cancer. When colorectal cancer metastasizes (spreads to other parts of the body such as the liver) chemotherapy is commonly used. Treatment of patients with recurrent or advanced colorectal cancer depends on the location of the disease. Chemotherapy regimens (i.e. FOLFOX or FOLFIRI either with or without bevacizumab) have been shown to increase survival rates in patients with metastatic/advanced colorectal cancer. Currently, there are seven approved drugs for patients with metastatic colorectal cancer: 5-fluorouracil (5-FU), capecitabine (Xeloda(R)), irinotecan (Camptosar(R)), oxaliplatin (Eloxatin(R)), bevacizumab (Avastin(R)), cetuximab (Erbitux(R)), and panitumumab (Vectibix(R)). Depending on the stage of the cancer, two or more of these types of treatment may be combined at the same time or used after one another. For example, FOLFOX combines 5-FU, leucovorin and oxaliplatin and FOLFIRI combines 5-FU, leucovorin and irinotecan. Avastin(R), a VEGF monoclonal antibody inhibitor, is commonly administered together with FOLFIRI and FOLFOX. Typically, patients who fail FOLFIRI and/or FOLFOX (+ Avastin(R)) and who are considered EGFR-positive (non-mutated, wild-type KRAS status), receive the EGFR monoclonal antibody inhibitors Erbitux(R) or Vectibix(R). However, patients who continue to progress beyond these treatments have a poor prognosis.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a late-stage drug development company specialized in oncology and endocrine therapy. 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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Of the 38 patients enrolled in the Phase 2 study, 27 patients were previously refractory to a 5-FU based regimen. A Phase 3 randomized double-blind trial comparing perifosine + capecitabine vs. placebo + capecitabine in 5-FU refractory patients with advanced refractory colorectal cancer (X-PECT trial), under Special Protocol Assessment (SPA) from the Food and Drug Administration (FDA), is currently open and enrolling patients at multiple centers throughout the U.S. This Phase 3 trial is sponsored by Keryx Biopharmaceuticals, Inc. ("Keryx") (Nasdaq: KERX), Aeterna Zentaris' licensee for perifosine in the United States, Canada and Mexico.
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About Perifosine
Perifosine, a novel, potentially first-in-class, oral Akt inhibitor, is currently in Phase 3 trials for advanced colorectal cancer and multiple myeloma, under SPA and Fast Track designation granted by the FDA for both indications. Perifosine has also been granted orphan-drug status by the FDA for multiple myeloma and has received a positive opinion for Orphan Medicinal Product designation from the European Medicines Agency (EMA) in this same indication. In addition, perifosine has received positive Scientific Advice from the EMA for both multiple myeloma and colorectal cancer programs.
Perifosine is also in a Phase 1 trial in pediatric patients, as well as in other Phase 1 and Phase 2 trials for several other tumor types.
Perifosine is licensed to Keryx, in the United States, Canada and Mexico. Aeterna Zentaris has also out-licensed perifosine to Handok in South Korea, while retaining rights for the rest of the world.
About Colorectal Cancer
According to the American Cancer Society, colorectal cancer is the third most common form of cancer diagnosed in the United States. It is estimated that in the U.S., over 146,000 people were diagnosed with some form of colorectal cancer with over 49,000 patients dying from colorectal cancer in 2009. Surgery is often the main treatment for early stage colorectal cancer. When colorectal cancer metastasizes (spreads to other parts of the body such as the liver) chemotherapy is commonly used. Treatment of patients with recurrent or advanced colorectal cancer depends on the location of the disease. Chemotherapy regimens (i.e. FOLFOX or FOLFIRI either with or without bevacizumab) have been shown to increase survival rates in patients with metastatic/advanced colorectal cancer. Currently, there are seven approved drugs for patients with metastatic colorectal cancer: 5-fluorouracil (5-FU), capecitabine (Xeloda(R)), irinotecan (Camptosar(R)), oxaliplatin (Eloxatin(R)), bevacizumab (Avastin(R)), cetuximab (Erbitux(R)), and panitumumab (Vectibix(R)). Depending on the stage of the cancer, two or more of these types of treatment may be combined at the same time or used after one another. For example, FOLFOX combines 5-FU, leucovorin and oxaliplatin and FOLFIRI combines 5-FU, leucovorin and irinotecan. Avastin(R), a VEGF monoclonal antibody inhibitor, is commonly administered together with FOLFIRI and FOLFOX. Typically, patients who fail FOLFIRI and/or FOLFOX (+ Avastin(R)) and who are considered EGFR-positive (non-mutated, wild-type KRAS status), receive the EGFR monoclonal antibody inhibitors Erbitux(R) or Vectibix(R). However, patients who continue to progress beyond these treatments have a poor prognosis.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a late-stage drug development company specialized in oncology and endocrine therapy. 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.
