Full Press Release Details
a2194277zex-99_1.txt
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AETERNA ZENTARIS INC. 1405 du Parc-Technologique Blvd.
Quebec (Quebec) Canada G1P 4P5 T 418 652-8525 F 418 652-0881
AETERNA ZENTARIS ANNOUNCES RESULTS FROM TWO PHASE 3 STUDIES WITH CETRORELIX IN
BENIGN PROSTATIC HYPERPLASIA
QUEBEC CITY, CANADA, AUGUST 17, 2009 - AEterna Zentaris Inc. (NASDAQ: AEZS; TSX:
AEZ) (the "Company"), a global biopharmaceutical company focused on endocrine
therapy and oncology, today reported Phase 3 results for its North American
efficacy trial Z-033 and the safety trial Z-041 in benign prostatic hyperplasia
(BPH), with its lead endocrinology compound for urology, cetrorelix pamoate. As
announced on March 6, 2009, sanofi-aventis U.S. LLC entered into an agreement
with AEterna Zentaris for the development, registration and marketing of
cetrorelix in BPH for the U.S. market.
The first multi-center efficacy trial Z-033 was conducted in 53 sites in the
United States and Canada, with 8 additional sites in Europe. The study involved
667 patients under the supervision of lead investigator, Herbert Lepor, M.D.,
Professor and Chairman, Department of Urology, at NYU School of Medicine, New
York. Patients entered a 1- to 4-week screening period to confirm severity and
stability of voiding symptoms based on the International Prostate Symptom Score
(IPSS). Patients were then randomly allocated to cetrorelix or placebo in a
double-blind fashion. Patients were administered cetrorelix by intra-muscular
(IM) injection at Week 0, 2, 26 and 28 (for treatment Arm A, those in Arm B
received IM injection at week 0, 2 and 26 followed by placebo at Week 28).
Patients in treatment Arm C received placebo injections at Week 0, 2, 26 and 28.
All patients were followed up to Week 52.
The study Z-033 demonstrated no clear differences in overall efficacy with all 3
groups showing an improvement in IPSS of approximately 4 points that was
maintained throughout the 52 weeks. There was a slight advantage in favor of the
main active treatment arm (Arm A) up to Week 46 of the follow-up, which was no
longer demonstrated at Week 52. These differences did not achieve statistical
significance. Furthermore, a favorable trend on the IPSS, as compared to
placebo, was seen in a sub-group of patients with large prostate glands [greater
than 50 cm3] on entry to the study.
Tolerability of cetrorelix in study Z-033 was very good, as evidenced by the
absence of major differences to placebo with regard to both clinical adverse
events or changes in laboratory parameters. The most frequently reported adverse
experiences included hot flushes,
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nasopharyngitis, injection site pain, and headache, which is what was seen in
the safety study Z-041. In particular, the incidence of hot flushes was lower
than was seen in study Z-041 (see below), and they were also reported by
patients randomized to placebo.
In the safety study Z-041, all patients received cetrorelix by intra-muscular
(IM) injection at Weeks 0 and 2, and were followed up to Week 26. The primary
endpoint was the incidence of possibly drug-related adverse events; efficacy
parameters were evaluated as secondary endpoints. The study was conducted in 68
sites in the United States and Canada.
Cetrorelix was generally well tolerated. Adverse events were mostly mild and
transient in intensity. Serious adverse events occurred in 12 patients, but none
of these was assessed as possibly drug-related. The most frequently reported
adverse experiences included hot flushes, nasopharyngitis, injections site pain,
and headache. Hot flushes were reported by 49 patients and were mild and of
short duration in the majority of patients. Only one patient experienced a
severe episode. A questionnaire was used to assess the local tolerance of the IM
injection and affirmed the acceptability of this route of administration.
Efficacy was assessed using the IPSS which showed an improvement from a mean
score of 21.2 at baseline to 15.6 at Week 26. In 63% of the patients, the
improvement was by at least 3 points. Notably, the 46% of patients who had
received previous treatment for BPH showed an important mean improvement of 5
points, which is only slightly less than the 6 point improvement seen in
treatment-naive patients. Maximum uroflow improved by 25%, from 10.3 to 12.5
ml/sec, and also the mean uroflow showed similar improvement.
Juergen Engel, Ph.D., AEterna Zentaris President and CEO stated, "Although the
data received for the open-label safety study Z-041 with a nearly 6 point
reduction in IPSS are in line with what we had observed in our Phase 2 program,
we are disappointed by the failure to achieve the primary endpoint in the
efficacy study Z-033. We remain committed to the ongoing Phase 3 program with
cetrorelix in BPH and are working towards receiving the results of the second
pivotal efficacy study Z-036 in November."
Herbert Lepor, M.D., Professor and Chairman, Department of Urology, at NYU
School of Medicine, New York and Lead Investigator of the Z-033 trial added,
"These findings are unexpected in light of the previous Phase 2 experience.
Those data and the strength of the safety data available to date had given us
confidence in this potential new treatment for BPH. It is now important to await
results of the other placebo-controlled efficacy study Z-036."
The Company will host a conference call and webcast to discuss these results
later today, Monday, August 17, 2009 at 10:00 a.m., Eastern Time.
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Participants may access the live webcast via the Company's website at
www.aezsinc.com in the "Investors" section, or by telephone using the following
numbers: (outside Canada): 800-588-4942. (Canada): 416-644-3426 or 514-807-8791.
A replay of the webcast will also be available on the Company's website for a
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 Europe.
The first Phase 3 efficacy trial Z-033, titled, "CETRORELIX PAMOATE INTERMITTENT
IM DOSAGE REGIMENS IN PATIENTS WITH SYMPTOMATIC BPH: A 1-YEAR PLACEBO-CONTROLLED
EFFICACY STUDY AND LONG-TERM SAFETY ASSESSMENT", involved 667 patients mostly in
North America and assessed an intermittent dosage regimen of cetrorelix as
treatment for BPH-related signs and symptoms.
As announced recently, patients completing the 52 week double-blind study are
then allowed to continue into an open-label extension of this study, sponsored
by sanofi-aventis, where patients receive the same dosing regimen of cetrorelix
by IM injection at Week 52, 54, 78 and 80, and are followed up to Week 90.
Patients entering this extension study will be followed-up for safety, IPSS and
quality of life, thus providing follow-up data on cetrorelix for up to 5 years.
The second multi-center Phase 3 efficacy study Z-036 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