QUEBEC CITY, March 26 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS;
TSX: AEZ), a global biopharmaceutical company focused on endocrine therapy and
oncology, today reported dosing has commenced with its flagship product
candidate, cetrorelix, the Company's lead luteinizing hormone-releasing
hormone (LHRH) antagonist, in the second efficacy study of its Phase 3 program
in benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the
"We are very pleased to be on track with our Phase 3 clinical program for
cetrorelix in BPH," said David J. Mazzo, Ph.D., President and CEO, Aeterna
Zentaris. "Based on our new understanding of the multiple processes involved
in the development of BPH and its symptoms, cetrorelix may offer a novel
therapeutic approach to doctors and patients currently making trade-offs in
care. We look forward to continuing our investigation of cetrorelix in this
comprehensive clinical program."
The study, titled, "Cetrorelix pamoate in patients with symptomatic BPH:
a double-blind, placebo-controlled efficacy study", will involve approximately
400 patients, and will assess an intermittent dosage regimen of cetrorelix as
a potential safe and tolerable treatment providing prolonged improvement in
BPH-related signs and symptoms. This Phase 3 trial, conducted in Europe under
the supervision of lead investigator, Prof. Dr. Frans M.J. Debruyne, MD, of
the Andros Mannenkliniek, Arnhem, The Netherlands, is part of the Company's
Phase 3 program with cetrorelix being studied in approximately 1,500 patients
in North America and Europe in men with symptomatic BPH.
About the Phase 3 Program with Cetrorelix in BPH
The first multi-center efficacy study for which first patient
randomization commenced in April 2007, is currently being conducted primarily
in the United States and Canada, with additional sites in Europe and involves
approximately 600 patients under the supervision of lead investigator,
Herbert Lepor, MD, Professor at NY University 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 will receive cetrorelix by
IM injection at Week 52, 54, 78 and 80 will be followed up to Week 90.
The second multi-center Phase 3 efficacy study for which first patient
dosing was announced today, will enroll approximately 400 patients in Europe.
Patients in this randomized placebo-controlled study with open-label
extension, will receive cetrorelix according to similar dosing regimens used
in the first study.
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,
expected to commence shortly, is an open-label, single-armed study involving
approximately 500 patients in both North America and Europe.
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.
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' 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
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.
In addition to the Phase 3 program in BPH, cetrorelix is also being
studied in a Phase 2b program in this same indication in Japan, sponsored by
the Company's partner, Shionogi.
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.
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