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news.Aeterna Zentaris, a late-stage drug development company specialised in oncology and endocrinology, has received FDA orphan-drug designation for AEZS-108.
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AEZS-108 is doxorubicin targeted conjugate compound, for the treatment of ovarian cancer. AEZS-108 is currently in a Phase 2 trial in advanced ovarian and advanced endometrial cancer in Europe.
Aeterna Zentaris said that 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.
Juergen Engel, president and CEO of Aeterna Zentaris, said: “We are very pleased with AEZS-108 gaining orphan-drug designation for ovarian cancer from the FDA as it would provide it with extra market exclusivity protection. We look forward to reporting the final results from our ongoing European Phase 2 study in ovarian and endometrial cancer, later this year.”