QUEBEC CITY, June 10 /CNW Telbec/ - AEterna Zentaris Inc. (NASDAQ: AEZS;
TSX: AEZ), a global biopharmaceutical company focused on endocrine therapy and
oncology, today announced the opening of an extended study in the Phase 3
program with cetrorelix pamoate for the treatment of benign prostatic
hyperplasia (BPH), a benign enlargement of the prostate, affecting more than
20 million men in the U.S. alone. Sanofi-aventis U.S. LLC entered into a
previously announced agreement with AEterna Zentaris for the development,
registration and marketing of cetrorelix in BPH for the U.S. market.
As a result of this collaboration between sanofi-aventis U.S. and AEterna
Zentaris, patients completing two years of therapy in the North American trial
of cetrorelix, NCT00449150, will be eligible to continue with cetrorelix
treatment, according to treatment regimen of the ongoing Phase 3 study, until
the end of 2011. Patients entering this extension study will be followed-up
for safety, International Prostate Symptom Score (IPSS) and quality of life
during the extended treatment, providing follow-up data on cetrorelix for up
to 5 years.
Juergen Engel, Ph.D., President and CEO of AEterna Zentaris commented,
"We have been pleased with the decision of patients and their physicians to
continue into this extended period of open-label treatment follow-up,
sponsored by our partner sanofi-aventis U.S. We are confident that patients
and their physicians will continue into this extension, as the continuation
rate of patients into the open-label part of the study remains at over 90% of
those eligible to continue at week 52 and compares favorably with those
reported by others.(1) We look forward to presenting the data from the
double-blind portion of the study in the next quarter."
About the Phase 3 Program with Cetrorelix in BPH
Cetrorelix pamoate is currently in three Phase 3 trials involving more
than 1,600 patients with symptomatic BPH in Canada, the United States and
The first multi-center efficacy study for which patient recruitment was
completed in April 2008, is currently being conducted primarily in the United
States and Canada, with additional sites in Europe and involves 667 patients
under the supervision of lead investigator, Herbert Lepor, MD, Professor at
NYU School of Medicine, New York. Patients enter a 4-week run-in no-treatment
observation period to confirm severity and stability of voiding symptoms based
on the International Prostate Symptom Score (IPSS). Patients are then randomly
allocated to cetrorelix or placebo in a double-blind fashion. Patients are
administered cetrorelix by intra-muscular (IM) injection at Week 0, 2, 26 and
28 and are followed up to Week 52. Then, in an open-label extension, patients
receive cetrorelix by IM injection at Week 52, 54, 78 and 80 and are followed
up to Week 90.
The second multi-center Phase 3 efficacy study for which patient
recruitment was completed in October 2008, involves 420 patients, mainly in
Europe. Patients in this randomized placebo-controlled study with open-label
extension conducted under the supervision of lead investigator, Prof. Frans
M.J. Debruyne, MD, of the Andros Mannenkliniek, Arnhem, The Netherlands,
receive cetrorelix according to similar dosing regimens used in the first
The primary endpoint for both North American and European efficacy
studies is absolute change in IPSS between baseline and Week 52. Other
efficacy endpoints include additional measures of BPH symptom progression and
the need for BPH-related surgery. Safety endpoints include changes in sexual
function. Other important endpoints include plasma changes in levels of
testosterone, and assessment of other adverse events.
The third study in the Phase 3 program, a multi-center safety study, for
which patient recruitment was completed in December 2008, is an ongoing
open-label, single-armed study involving 528 patients in North America. The
lead investigator is Joel Kaufman, M.D., Associate Clinical Professor in
Urology at University of Colorado School of Medicine in Denver, Colorado and
at Urology Research Options in Aurora, Colorado.
First efficacy results are expected during the third quarter of 2009 with
an NDA filing targeted in 2010.
Cetrorelix pamoate is an investigational agent that has shown in Phase 2
studies to provide fast and long lasting relief of BPH symptoms and was well
tolerated, with a low incidence of sexual side effects. Cetrorelix is part of
AEterna Zentaris' luteinizing hormone-releasing hormone (LHRH) antagonist
therapeutic approach. This peptide-based active substance was developed by the
Company in cooperation with Nobel Prize winner Prof. Andrew Schally, currently
of the U.S. Veterans Administration in Miami.
Cetrorelix acetate is marketed under the brand name Cetrotide(R), the
first LHRH antagonist approved for therapeutic use as part of in vitro
fertilization programs (controlled ovulation stimulation/assisted reproductive
technologies) in Europe, the USA and Japan. It was launched on the market
through Serono (now Merck Serono) in the U.S., Europe and in several other
countries, as well as in Japan through Shionogi.
About Benign Prostatic Hyperplasia
Benign prostatic hyperplasia (BPH) is one of the most common diseases of
aging men - affecting more than 20 million men in the United States - but its
etiology is far from being completely understood. Data from ongoing research
suggest BPH and lower urinary tract symptoms (LUTS) are more complex
conditions than once thought. While previous research on BPH etiology tended
to focus on testosterone and other hormones, more recent research suggests
other factors - including inflammation, various growth factors, and
adrenoreceptors - actually may play a greater role in the development of BPH
BPH is associated with LUTS, including: frequent urination, a sudden,
uncontrollable urge to urinate, waking at night to urinate (nocturia),
difficulty starting a urine stream (hesitancy and straining), decreased
strength of the urine stream (weak flow), feeling that the bladder is not
completely empty, an urge to urinate again soon after urinating and pain
during urination (dysuria). Currently available therapies may improve symptoms
to some degree, but often come with sexual and other side effects.
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.
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.
(1) Reference: Verhamme KMC et al, Eur Urol 2003;44:539 and Nichol MB et
al, J Urol 2009;181:2214.
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