Aeterna Zentaris Receives Positive Opinion for Orphan Medicinal Product Designation for AEZS-108 for Treatment of Ovarian Cancer

20-May-2010 - Canada

Aeterna Zentaris Inc. announced that it has received a positive opinion for orphan medicinal product designation from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency, for its compound AEZS-108 for the treatment of ovarian cancer. AEZS-108, the Company's doxorubicin targeted conjugate compound, is currently in a Phase 2 trial in advanced ovarian and advanced endometrial cancer in Europe.

Juergen Engel, Ph. D., President and CEO of Aeterna Zentaris stated, "We are very pleased with AEZS-108 gaining orphan medicinal product designation for ovarian cancer from European authorities, especially after having been recently granted orphan-drug designation by the FDA. This means that with both these orphan designations, AEZS-108 would be provided with extra market exclusivity protection in Europe as well as in the United States for the treatment of ovarian cancer. We now look forward to reporting the final results from our ongoing European Phase 2 study in ovarian and endometrial cancer, later this year."

AEZS-108 represents a new targeting concept in oncology using a cytotoxic peptide conjugate which is a hybrid molecule composed of a synthetic peptide carrier and a well-known cytotoxic agent, doxorubicin. The design of this product allows for the specific binding and selective uptake of the cytotoxic conjugate by LHRH-receptor-positive tumors. The binding of AEZS-108 to cancerous cells that express these receptors results in its accumulation and preferential uptake in the malignant tissue.

https://www.bionity.com/en/news/117765/aeterna-zentaris-receives-positive-opinion-for-orphan-medicinal-product-designation-for-aezs-108-for-treatment-of-ovarian-cancer.html