Perifosine: Development discontinued
Aeterna Zentaris discontinued development of perifosine to treat MM after a pre-planned interim analysis of a double-blind, international Phase III trial by an independent DSMB showed that once-daily 50 mg oral perifosine plus Velcade bortezomib and dexamethasone was unlikely to meet the primary endpoint of improving PFS vs. placebo plus Velcade and dexamethasone. No safety concerns were identified. The trial had planned to enroll about 450 patients with MM who relapsed on a prior Velcade treatment regimen. The company had an SPA from FDA for the trial. Last year, Aeterna reported that perifosine plus Xeloda capecitabine missed the primary and secondary endpoints in the Phase III X-PECT trial in refractory metastatic colorectal cancer (mCRC) patients (see BioCentury, April 9, 2012 & June 18, 2012). Perifosine is in Phase II testing to treat renal cell carcinoma (RCC), breast cancer and sarcoma.
Aeterna said it remains focused on its other products including Zoptarelin doxorubicin acetate ( AEZS-108), a doxorubicin chemotherapeutic conjugated to a luteinizing hormone-releasing hormone (LHRH) receptor agonist slated to start Phase III testing for endometrial cancer "shortly"; and Solorel macimorelin ( AEZS-130), an oral ghrelin-mimetic growth hormone secretagogue. AEZS-108 is also in Phase II testing to treat ovarian, prostate, breast and bladder cancer. This quarter, the company plans to submit an NDA to FDA for Solorel to diagnose adult growth hormone deficiency (GHD). Aeterna has 1 marketed product - Cetrotide cetrorelix, an LHRH antagonist for in vitro fertilization (IVF). ...