QUEBEC CITY, Oct. 3 - AEterna Zentaris Inc. 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.
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.
WHAT DOES THIS MEAN?
This is exciting to me. I once worked on a project using prostate cells in culture. As prostate cancer progresses, the tumor becomes androgen independent (it doesn't need testosterone or other hormones) in order to continue to grow. So this drug is essentially blocking the early phase of the cancer ( and hyperplastic [swollen] prostate that's not cancer) by not allowing hormones to bind to the cells [which they need when becoming cancerous]. The I-PSS asks questions on a 1-5 scale meant to answer the severity of prostate related issues (such as frequency, how much etc).
AEterna Zentaris Inc. (TSX: AEZ : NASDAQ: AEZS) trades on both the Toronto Stock Exchange and the NASDAQ Index. On the NASDAQ, AEZS finished up 4 cents to $5.16. More than likely, they knew that the data was good, and it's figured into the stock price, noting the unimpressive rise in stock price. SPPI, it's partner company was up 6.6% at close today.
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment