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.