AEterna Zentaris' Anti-Cancer Compound, Perifosine (KRX-0401), Receives FDA Fast Track Designation for the Treatment of Relapsed
02 Dezembro 2009 - 11:35AM
PR Newswire (US)
QUEBEC CITY, Dec. 2 /PRNewswire-FirstCall/ -- AEterna 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
AEterna Zentaris' partner and licensee for perifosine in the United
States, Canada and Mexico. Perifosine is also out-licensed to
Handok in South Korea while AEterna 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
AEterna 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 AEterna Zentaris Inc. AEterna 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 http://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.
DATASOURCE: AETERNA ZENTARIS INC. CONTACT: Investor Relations:
Dennis Turpin, SVP and CFO, (418) 652-8525 ext. 242, ; Media
Relations: Paul Burroughs, Director of Communications, (418)
652-8525 ext. 406,
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