Phase 3 X-PECT Trial (Xeloda(R)) + Perifosine Evaluation in
Colorectal Cancer Treatment) being conducted by partner Keryx
Biopharmaceuticals pursuant to Special Protocol Assessment with the
Food and Drug Administration
QUEBEC CITY, April 8
/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 the
initiation of a Phase 3 registration clinical trial with perifosine
(KRX-0401) ), the Company's novel, potentially first-in-class, oral
anti-cancer agent that inhibits Akt activation in the
phosphoinositide 3-kinase (PI3K) pathway, for the treatment of
refractory advanced colorectal cancer. The trial is sponsored and
conducted by Keryx Biopharmaceuticals ("Keryx") (Nasdaq: KERX),
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 Phase 3 trial, entitled "X-PECT (Xeloda(R) + Perifosine
Evaluation in Colorectal cancer Treatment) trial", is being
conducted pursuant to a Special Protocol Assessment ("SPA") with
the Food and Drug Administration. Perifosine has also been granted
Fast Track designation for the treatment of refractory advanced
colorectal cancer. Approximately 40 to 50 U.S. sites will
participate in the study. Keryx expects enrollment to take
approximately 12 - 14 months, with study completion expected in the
second half of 2011.
Dr. Johanna Bendell, Director of
GI Oncology Research for the Sarah Cannon Research Institute,
Nashville, Tennessee, will lead
the Phase 3 investigational team that includes Dr. Cathy Eng, Associate Medical Director for the
Colorectal Center at MD Anderson Cancer Center in Houston, Texas.
Juergen Engel, Ph.D., President
and Chief Executive Officer of Æterna Zentaris, commented, "We are
very pleased with the initiation and sponsorship of this key
registration Phase 3 trial in refractory advanced colorectal cancer
in North America which our partner
Keryx expects to complete in the second half of 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, where in some countries, we expect they
will be sufficient to do so without any additional studies."
Phase 3 Trial Design
The Phase 3 X-PECT (Xeloda(R) + Perifosine Evaluation in
Colorectal cancer Treatment) trial is a randomized (1:1),
double-blind trial comparing the efficacy and safety of perifosine
+ capecitabine (capecitabine is a chemotherapy marketed by Roche as
Xeloda(R)) vs. placebo + capecitabine in approximately 430 patients
with refractory advanced colorectal cancer. Patients must have
failed available therapy including 5-fluorouracil (5-FU),
oxaliplatin (Eloxatin(R)), irinotecan (Camptosar(R)), bevacizumab
(Avastin(R)) and, if KRAS wild-type, failed therapy with prior
cetuximab (Erbitux(R)) or panitumumab (Vectibix(R)). For
oxaliplatin-based therapy, failure of therapy will also include
patients who discontinued due to toxicity. The primary endpoint is
overall survival, with secondary endpoints including overall
response rate (complete + partial responses), progression-free
survival and safety. The median overall survival for the X-PECT
study's targeted patient population, that has failed prior
therapies as described above, is approximately 5 months. The X-PECT
study will be powered at 90% to detect a statistically significant
difference in overall survival, with an assumed median overall
survival for the control arm of 5-6 months and 7-8 months for the
perifosine arm. Approximately 360 events of death will trigger the
unblinding of the study.
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.