G&M: Positive results from prostate trial....
AEterna Zentaris reports positive Japanese prostate drug trial
Canadian Press
Thursday, March 22, 2007
QUEBEC — AEterna Zentaris Inc. said Wednesday its cetrorelix drug has shown a “good safety and tolerability profile” in a Japanese clinical trial for treatment of enlarged prostate glands.
In the Phase 2a trial on 50 men with benign prostate hyperplasia, “evaluation of efficacy was only exploratory,” Zentaris said Thursday, but the injected drug, a hormone-releasing hormone antagonist, “was safe and well tolerated at all dosage regimens.”
There also was “a transient reduction of testosterone concentration in blood, which did not reach or remain at the castration level.”
On the basis of this study, partner Shionogi has initiated a 300-patient Phase 2b study to assess the effectiveness of cetrorelix.
Meanwhile, the Canadian company's other Japanese partner, Nippon Kayaku, terminated its agreement to collaborate on the development of the drug.
In early trading Thursday on the TSX, AEterna stock gained 6.6 per cent to trade at $4.02 a share.
The latest trial results “further confirm the positive data observed in prior clinical trials in BPH with cetrorelix in non-Asian patients,” stated Gilles Gagnon, CEO of AEterna Zentaris.
Benign prostate hyperplasia — abnormal growth of prostate tissues caused by testosterone — causes urination problems and in some cases may develop into cancer.
Cetrorelix, unlike other common treatments, “is not associated with side-effects such as erectile dysfunction, loss of libido and chemical castration,” according to AEterna Zentaris, which is conducting a large Phase 3 program for prostate treatment while another partner, Solvay, is sponsoring a program for endometriosis.
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