AEterna Zentaris Partner, Keryx, Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial with Perifosine (KRX-0401) for the Treatment of Multiple Myeloma



    QUEBEC CITY, Aug. 3 /CNW Telbec/ - AEterna Zentaris Inc. (NASDAQ:   AEZS,
TSX: AEZ), ("the Company") a global biopharmaceutical company focused on
endocrine therapy and oncology, today announced that Keryx Biopharmaceuticals,
Inc. (Nasdaq:   KERX), its partner and licensee for perifosine in the North
American market, has reached an agreement with the U.S. Food and Drug
Administration (FDA) regarding a Special Protocol Assessment (SPA) on the
design of a Phase 3 trial for the Company's PI3K/Akt pathway inhibitor
compound, perifosine (KRX-0401), in relapsed or relapsed/refractory multiple
myeloma patients previously treated with bortezomib (VELCADE(R)). The SPA
provides agreement that the Phase 3 study design adequately addresses
objectives in support of a regulatory submission. The study, entitled, "A
Phase 3 Randomized Study to Assess the Efficacy and Safety of Perifosine Added
to the Combination of Bortezomib and Dexamethasone in Multiple Myeloma
Patients Previously Treated with Bortezomib", will be a double-blind,
placebo-controlled study comparing the efficacy and safety of perifosine vs.
placebo when combined with bortezomib and dexamethasone. The trial, powered at
90%, will enroll approximately 400 patients with relapsed or
relapsed/refractory multiple myeloma. The primary endpoint is progression-free
survival and secondary endpoints include overall response rate, overall
survival and safety.
    Juergen Engel, Ph. D., President and Chief Executive Officer of AEterna
Zentaris commented, "We are very pleased and excited about perifosine moving
forward into a Phase 3 trial. This represents a major milestone in our
oncology drug development strategy which could hold great promise for patients
with multiple myeloma."

    About the Phase 3 Trial Design

    The Phase 3 trial is a randomized (1:1), double-blind trial comparing the
efficacy and safety of perifosine to placebo when combined with bortezomib and
dexamethasone in approximately 400 patients with relapsed or
relapsed/refractory multiple myeloma. Patients must have been previously
treated with both bortezomib (VELCADE(R)) and an immunomodulatory agent
(REVLIMID(R) or THALIDOMID(R)) and previously treated with one to four prior
lines of therapy. The primary endpoint is progression-free survival and
secondary endpoints include overall response rate, overall survival and
safety.

    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 Perifosine

    Perifosine is a novel, first-in-class, oral anti-cancer 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 single agent anti-tumor activity in Phase 1 and
Phase 2 studies and is currently being studied as a single agent and in
combination with several forms of anti-cancer treatments for various forms of
cancer. Most recently, positive results were reported for the single agent use
of perifosine in patients with advanced metastatic renal cancer and in
combination with capecitabine for advanced metastatic colon cancer
(placebo-controlled), as well as for perifosine in combination with bortezomib
+/- dexamethasone in relapsed and refractory myeloma.

    About Special Protocol Assessments

    The Special Protocol Assessment (SPA) process is a procedure by which the
FDA provides official evaluation and written guidance on the design and size
of proposed protocols that are intended to form the basis for a new drug
application.
    Final marketing approval depends on the results of efficacy, the adverse
event profile and an evaluation of the benefit/risk of treatment demonstrated
in the Phase 3 trial. The SPA agreement may only be changed through a written
agreement between the sponsor and the FDA, or if the FDA becomes aware of a
substantial scientific issue essential to product efficacy or safety. For more
information on the Special Protocol Assessment process, please visit:
<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf">http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Gui</a>
<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf">dances/ucm080571.pdf</a>

    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 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 requested by a
governmental authority or applicable law.




For further information:

For further information: Investor Relations: Ginette Vallières, Investor
Relations Coordinator, (418) 652-8525 ext. 265, gvallieres@aezsinc.com; Media
Relations: Paul Burroughs, Director of Communications, (418) 652-8525 ext.
406, pburroughs@aezsinc.com

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Aeterna Zentaris Inc.

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