Decision follows recent failure of cetrorelix in Phase III BPH trial.
Sanofi-aventis and AEterna Zentaris ended their agreement to develop and commercialize the latter’s LHRH antagonist, cetrorelix. The decision follows the drug’s recent failure in a European Phase III trial in patients with benign prostatic hyperplasia. AEterna and sanofi-aventis originally signed their cetrorelix collaboration and licensing deal in March.
AEterna Zentaris is now focusing its clinical development efforts on the late-stage oral PI3K/Akt inhibitor oncology candidate, perifosine. Keryx Biopharmaceuticals, AEterna’s partner and licensee for perifosine in the U.S., Canada, and Mexico, recently confirmed the start of a Phase III registrational trial with the drug in patients with relapsed/refractory multiple myeloma. AEterna Zentaris retains rights to perifosine in the rest of the world, except for South Korea where the candidate has been licensed to Handok.
Juergen Engel, Ph.D., AEterna Zentaris’ president and CEO, reports that his firm is also evaluating further development plans for the targeted doxorubicin–peptide conjugate AEZS-108. Positive results from Phase II ovarian and endometrial cancer trials with the drug were reported in November. AEZS-108 is designed to specifically target LHRH-receptor positive tumors.
The company is separately “in the process of reactivating” a Phase III trial with the oral ghrelin agonist, macimorelin (AEZS-130), as a diagnostic for adult growth hormone deficiency. The original Phase III study had been initiated in the U.S. by AEterna Zentaris’ former licensee, Ardana, but was suspended before completion because of Ardana’s insolvency.
AEterna Zentaris has since assumed sponsorship of the IND application for AEZS-130 and is discussing with the FDA the best way to complete the ongoing Phase III program and subsequently file an NDA.