Cetrorelix peptide-based drugs were developed by the Company in cooperation with Nobel Prize winner Prof. Andrew Schally, currently of the U.S. Veterans Administration in Miami.
Cetrorelix acetate is marketed under the brand name Cetrotide(R), the first LHRH antagonist approved for therapeutic use as part of in vitro fertilization programs (controlled ovarian stimulation/assisted reproductive technologies) in Europe, the U.S. and Japan. It was launched on the market through Serono (now Merck Serono) in the United States, Europe and in several other countries, as well as in Japan through Shionogi.
About the Cetrorelix Phase 3 Program in BPH
Cetrorelix pamoate is being studied in three Phase 3 trials which will
include approximately 1,500 men with symptomatic BPH in the United States,
Canada and Europe. One Phase 3 efficacy trial, primarily in the United
States and Canada and with additional sites in Europe, involves
approximately 600 patients (which are fully enrolled) and is being led by
Herbert Lepor, M.D., Professor and Martin Spatz Chairman of Urology, New
York University School of Medicine, New York. In the trial, patients enter
a no-treatment run-in observation period to confirm severity and stability
of voiding symptoms based on the International Prostate Symptom Score
(I-PSS). Patients are then randomly allocated to cetrorelix or placebo in a
double-blind fashion. Patients are administered cetrorelix by
intra-muscular (IM) injection at Week 0, 2, 26 and 28 and are followed up
to Week 52. Then, in an open-label extension, patients will receive
cetrorelix by IM injection at W
|SOURCE AETERNA ZENTARIS INC.|
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