AEterna Zentaris Announces Positive Phase 2 Results for Ozarelix in Benign Prostatic Hyperplasia
October 03 2006 - 8:35AM
PR Newswire (US)
- Highly statistically significant (p less than 0.0001) results
seen for primary endpoint in favor of ozarelix - Clinical
improvement lasts for six months following two doses of ozarelix -
Ozarelix was safe and well tolerated - Company plans to advance
development to a pivotal program in this indication QUEBEC CITY,
Oct. 3 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ;
NASDAQ: AEZS) today disclosed highly statistically significant
positive data from its Phase 2 trial with ozarelix for patients
suffering from benign prostatic hyperplasia (BPH). The study
achieved its primary efficacy end-point of improving clinical
symptoms of BPH, at week 12, as measured by significant changes in
the International Prostate Symptom Score (I-PSS), the standard
method of assessing BPH symptoms. This multi-center double-blind,
randomized, placebo-controlled, dose-ranging Phase 2 trial included
a total of 144 patients who received either different intramuscular
dosage regimens of the luteinizing hormone-releasing hormone (LHRH)
antagonist, ozarelix, or a placebo, to assess its safety and
efficacy. The trial was conducted in Europe in collaboration with
AEterna Zentaris' partner, Spectrum Pharmaceuticals Inc.
(NASDAQ:SPPI). In this study, ozarelix 5 mg, 10 mg, 15 mg or 20 mg
was administered intramuscularly according to different dosing
schedules at day 1 and 15. While the primary efficacy end-point was
achieved at all dosage regimens, the best results, in terms of the
most important decrease of the I-PSS score, were obtained with a
dose of 15 mg administered on day 1 and 15. More specifically, the
observed mean decrease of the I-PSS score at week 12 was minus 8.6;
it peaked at minus 9.4 at week 20 and was still at minus 8.7 as of
week 28. This 47% mean improvement of the I-PSS represents a highly
statistically significant difference versus baseline (p less than
.001) as well as versus placebo (p less than 0.0001). Furthermore,
this long lasting effect, which was still present at the end of the
28-week observation period, was seen at all dosage regimens,
whereas testosterone suppression levels were maintained above
castration levels at all times. These observations support a
chronic intermittent therapy approach. Secondary efficacy
parameters such as uroflow, residual urinary volume, quality of
life, and circulating testosterone levels were also measured and
showed very good results especially with the day 1 and 15
administration of the 15 mg dose. The results of the trial
demonstrated an excellent safety profile with ozarelix where
patients had no serious side effects. In particular, the erectile
function, as measured by the International Index of Erectile
Function, was not affected at any dose regimen. Full details on the
trial results will be presented at an international conference in
2007. "We are very excited with these results which confirm the
mechanism of action of our LHRH antagonist approach and the
potential effectiveness of ozarelix to achieve suppression of
sexual hormones in a dose-dependent manner, enabling for the
treatment of hormone-dependent conditions from benign conditions
such as benign prostatic hyperplasia up to malignant conditions
such as prostate cancer, for which we recently disclosed positive
results as well. Now that we have a suitable dosage regimen of
ozarelix for BPH, we are confident that we can further advance the
clinical development of ozarelix in this indication as part of a
pivotal program," commented Dr. Jurgen Engel, Executive Vice
President, Global R&D and Chief Operating Officer at AEterna
Zentaris. "These positive results further validate the potential of
our LHRH antagonist approach to treat hormone-dependent diseases.
The studies conducted so far with ozarelix with such a
dose-response profile are "state of the art pharmacology" and
strengthen ozarelix's position as a lead compound in our
portfolio," stated Gilles Gagnon, President and Chief Executive
Officer at AEterna Zentaris. "We are now in an even better position
to become recognized as a late-stage company and execute our
strategy in building solid endocrinology and oncology franchises."
About Ozarelix and Partnerships Ozarelix is a fourth generation
luteinizing hormone-releasing hormone (LHRH) antagonist
administered as a depot formulation for the treatment of benign and
malign hormone-dependent diseases. It is currently in
advanced-stage clinical trials for benign prostatic hyperplasia and
prostate cancer. In August 2004, AEterna Zentaris granted Spectrum
Pharmaceuticals an exclusive license to develop and market ozarelix
for all potential indications in North America and India, while
AEterna Zentaris retains exclusive rights to the rest of the world.
Spectrum will also receive 50% of any upfront and milestone
payments, royalties and/or profits from sales of the product in
Japan. Furthermore, AEterna Zentaris recently granted Japanese
rights for all potential oncology indications to Nippon Kayaku, a
key player in the Japanese oncology market. About Benign Prostate
Hyperplasia Benign prostatic hyperplasia (BPH) is a non-cancerous
enlargement of the prostate frequently occurring in men over the
age of 50. The enlargement can result in the gradual squeezing of
the urethra, resulting in increased frequency or difficulty in
urinating. Enlargement of the prostate is controlled by
testosterone. According to the National Institutes of Health, BPH
affects more than 50% of men over the age of 60 and as many as 90%
of men over the age of 70. Treatment options for BPH include
surgery and medications to reduce the amount of tissue and increase
the flow of urine. Current treatment options are inconvenient,
leading to ineffective compliance and are only effective in roughly
half of the patients treated. According to Decision Resource, in
2004, the total prevalence cases of BPH in the major pharmaceutical
markets was estimated at 56 million men and is expected to increase
to 65 million cases by 2014. The BPH market is a significant
market, with current annual sales of more than $4 billion. About
AEterna Zentaris Inc. AEterna Zentaris Inc. is a growing global
biopharmaceutical company focused on oncology and endocrine therapy
with proven expertise in drug discovery, development and
commercialization. AEterna Zentaris also owns 48.3% of the equity
of Atrium Biotechnologies Inc. (TSX: ATB) and 64.7% of its voting
rights. Atrium is a developer, manufacturer and marketer of
science-based products for the cosmetics, pharmaceutical, chemical
and nutritional industries. News releases and additional
information are available at http://www.aeternazentaris.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. DATASOURCE: AETERNA
ZENTARIS INC. (FORMERLY/ANCIENNEMENT - LES LABORATOIRES AETERNA
LABORATORIES INC.) CONTACT: Media Relations: Paul Burroughs, (418)
652-8525 ext. 406, ; Investor Relations: Jenene Thomas, (418)
655-6420 or (908) 996-3154,
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