AEterna Zentaris Partner, Keryx, Initiates Phase 3 Registration Trial with Perifosine (KRX-0401) for the Treatment of Patients w
16 Diciembre 2009 - 7:35AM
PR Newswire (US)
Trial conducted pursuant to Special Protocol Assessment with the
Food and Drug Administration QUEBEC CITY, Dec. 16
/PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (NASDAQ: AEZS; TSX:
AEZ) (the "Company"), a global biopharmaceutical company focused on
oncology and endocrine therapy, today announced the initiation, by
its partner Keryx Biopharmaceuticals Inc. ("Keryx") (NASDAQ:KERX),
of a Phase 3 registration clinical trial for perifosine (KRX-0401),
the Company's PI3K/Akt pathway inhibitor, in relapsed/refractory
multiple myeloma patients. Keryx 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
trial, entitled, "A Phase 3 Randomized Study to Assess the Efficacy
and Safety of Perifosine Added to the Combination of Bortezomib
(Velcade(R)) and Dexamethasone in Multiple Myeloma Patients
Previously Treated with Bortezomib", is a double-blind,
placebo-controlled trial comparing the efficacy and safety of
perifosine vs. placebo when combined with bortezomib (Velcade(R))
and dexamethasone. The trial 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. This
trial is being conducted pursuant to a Special Protocol Assessment
(SPA) with the Food and Drug Administration (FDA). Additionally,
the FDA has granted perifosine Orphan Drug and Fast Track
designations in this indication. An estimated 40 to 50 centers
throughout the United States and select centers outside of the
United States will be participating in this Phase 3 trial. The
Phase 3 trial is being led by the Principal Investigator, Dr. Paul
Richardson, Clinical Director of the Jerome Lipper Multiple Myeloma
Center, at Dana-Farber Cancer Institute (DFCI) in Boston, MA and
Dr. Kenneth C, Anderson, Chief, Division of Hematologic Neoplasia
at DFCI. Dr. Richardson's clinical research focuses on studying
novel therapies for multiple myeloma. He was the lead investigator
of the SUMMIT and APEX clinical trials that led to the FDA approval
of bortezomib (Velcade(R)) for the treatment of multiple myeloma.
More recently, he served as clinical trials core chair of the
Multiple Myeloma Research Consortium, completing 5 years of service
in the role this year. Dr. Anderson serves as Chair of the NCCN
Multiple Myeloma Clinical Practice Guidelines Committee and chairs
the scientific advisory board for the Multiple Myeloma Research
Foundation. In addition to playing an integral role in the
development and approval of bortezomib (Velcade(R)), Drs.
Richardson and Anderson led both preclinical and early phase
clinical trials for the immunomodulatory drug lenalidomide
(Revlimid(R)), leading to its FDA approval in 2007. Juergen Engel,
Ph.D., President and CEO at AEterna Zentaris stated, "We are very
excited with Keryx's initiation of this Phase 3 trial with
perifosine, our lead oncology compound. Based on prior positive
results, we believe that perifosine could become a novel oral
combination treatment of great benefit to patients suffering from
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
(Velcade(R)) and dexamethasone in approximately 400 patients with
relapsed or relapsed/refractory multiple myeloma. Patients will be
randomized to bortezomib (Velcade(R)) at 1.3 mg/m2 days 1, 4, 8 and
11 every 21 days in combination with dexamethasone 20 mg on the day
of and day after bortezomib (Velcade(R)) treatment, and either
perifosine 50 mg daily or placebo. The Phase 3 trial design is
based on positive data reported from the Phase 1/2 trial which was
recently reported at the 51st American Society of Hematology
meeting. Patients eligible for the Phase 3 trial must have been
previously treated with both bortezomib (Velcade(R)) and an
immunomodulatory agent (Revlimid(R) and/or Thalidomid(R)), and been
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. Patients can be relapsed from and refractory to all
non-bortezomib based therapies, however, patients can only be
relapsed (progressed more than 60 days after discontinuing therapy)
from prior bortezomib-based therapies. The study is powered at 90%
to demonstrate the required difference in progression-free survival
between the two arms. Approximately 265 events (defined as disease
progression or death) will trigger the un-blinding of the data. The
Company expects a patient recruitment period of approximately 16-18
months, with study completion expected within approximately 20-22
months from today. 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 a Phase 3 trial, under
Special Protocol Assessment (SPA), in multiple myeloma for which it
has received Orphan Drug and Fast Track designations from the FDA
in this indication. Perifosine is also in Phase 2 clinical trials
for several other tumor types. 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 oncology and endocrine therapy, 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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