President and Managing Director of Almac Diagnostics, Professor Paul Harkin , said "We are very pleased to collaborate with Aeterna Zentaris on this exciting project. The plan to develop a companion diagnostic for AEZS-108 shows Aeterna Zentaris's clear commitment to personalized medicine, which will provide this compound with the best opportunity for success "
AEZS-108, a doxorubicin LHRH receptor targeted conjugate, is currently in a Phase 2 trial in advanced ovarian and endometrial cancer. Positive final results in ovarian cancer were disclosed at this year's American Society of Clinical Oncology (ASCO) meeting*, while final results in endometrial cancer are expected by year-end. AEZS-108 has been granted orphan-drug designation by the U.S. Food and Drug Administration and has received a positive opinion for Orphan Medicinal Product designation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency, for the treatment of ovarian cancer.
An Investigational New Drug (IND) in the U.S. is in place for the treatment of bladder cancer.
Additional clinical studies in hormone-resistant prostate cancer and other cancer types are being planned. There may be benefits during the regulatory review process from the medical and scientific logic of this personalized treatment approach to patient selection and possibly have value in reimbursement considerations.
* Asco poster presentation: abstract #5035 entitled, "Phase 2 study of AEZS-108, a targeted cytotoxic LHRH analog, in patients with LHRH receptor positive platinum resistant ovarian cancer.
|SOURCE AETERNA ZENTARIS INC.|
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