Healthcare Industry News: benign prostatic hyperplasia
News Release - October 3, 2006
AEterna Zentaris Announces Positive Phase 2 Results for Ozarelix in Benign Prostatic HyperplasiaHighly 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 (HSMN NewsFeed) - 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 www.aeternazentaris.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.
Source: AETERNA ZENTARIS
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