QUEBEC CITY, April 5 /PRNewswire-FirstCall/ - Æterna Zentaris
Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company"), a late-stage drug
development company specialized in oncology and endocrine therapy,
today announced that its partner, Keryx Biopharmaceuticals (Nasdaq:
KERX), was granted Fast Track designation by the U.S. Food and Drug
Administration ("FDA") for perifosine (KRX-0401), the Company's
novel, potentially first-in-class, oral anti-cancer agent that
inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the
treatment of refractory advanced colorectal cancer. Keryx is Æterna
Zentaris' partner and licensee for perifosine in the United States, Canada and Mexico. Æterna Zentaris has also out-licensed
perifosine to Handok in South
Korea while retaining 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.
A randomized, double-blind Phase 3 trial investigating
perifosine in combination with capecitabine (Xeloda(R)) versus
placebo in combination with capecitabine (Xeloda(R)) in patients
with refractory metastatic colorectal cancer is expected to
commence this quarter under a Special Protocol Assessment (SPA)
with the FDA.
Juergen Engel, Ph.D., President
and Chief Executive Officer of Æterna Zentaris, commented, "We now
look forward to the initiation and sponsorship by our partner,
Keryx, of this key registration Phase 3 trial in refractory
metastatic colorectal cancer in North
America which they expect to complete in 2011, with product
launch, in the USA, in 2012. These
data will be very supportive of our efforts to register perifosine
in the rest of the world, and in some countries, we expect they
will be sufficient to do so without any additional studies."
In addition to colorectal cancer, perifosine is currently in a
Phase 3 trial, under a SPA, for the treatment of
relapsed/refractory multiple myeloma, with Orphan Drug Status and
Fast Track Designation granted. This trial is also sponsored by our
partner, Keryx.
Furthermore, the Company received a positive opinion for Orphan
Medicinal Product Designation for perifosine from the Committee for
Orphan Medicinal Products (COMP) of the European Medicines Agency
for the treatment of multiple myeloma.
About Perifosine
Perifosine is a novel, potentially first-in-class, oral
anti-cancer agent that modulates Akt, and a number of other key
signal transduction pathways, including the JNK and MAPK pathways,
all of which are pathways associated with programmed cell death,
cell growth, cell differentiation and cell survival. The effects of
perifosine on Akt are of particular interest because of the
importance of this pathway in the development of most cancers, with
evidence that it is often activated in tumors that are resistant to
other forms of anticancer therapy, and the difficulty encountered
thus far in the discovery of drugs that will inhibit this pathway
without causing excessive toxicity. High levels of activated Akt
(pAkt) are seen frequently in many types of cancer and have been
correlated with poor prognosis.
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 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. Bevacizumab, a VEGF monoclonal antibody, is commonly
administered with chemotherapy. Typically, patients who fail 5-FU,
oxaliplatin, irinotecan, and bevacizumab-containing therapies, and
who have wild-type KRAS status receive EGFR monoclonal antibody
therapy with either cetuximab or panitumumab. Once patients
progress on these agents, there are no further standard treatment
options.
About Æterna Zentaris Inc.
Æterna 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.