• Clavis Pharma ASA, of Oslo, Norway, said Deerfield, Ill.-based Baxter International Inc. has released its first batch of elacytarabine for clinical use. Regulatory agencies have granted first approvals for the material from Baxter as the new contract manufacturer. At the same time, Ben Venue Laboratories, the previous manufacturer, has released its last batch of the drug, and it is being used in the CLAVELA study. Consequently, recruitment restrictions which had been in place for clinical trials have been lifted. Clavis expects to complete recruitment in the second half of 2012, and to report top-line results in the first quarter of 2013.

• Clovis Oncology Inc., of Boulder, Colo., reached its target for enrollment in its pivotal LEAP trial of CO0101 in metastatic pancreatic cancer. The 360-patient trial will evaluate overall survival of patients receiving CO-101 vs. gemcitabine in patients with pancreatic cancer. Top-line data are expected in the fourth quarter, with expected filing for approval in mid-2013.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., reported results from the 52 to 56-month follow-up study of patients who participated in the U.S. NX02-0016 study of NX-1207 in benign prostatic hyperplasia (BPH), completed in 2007. Results showed no significant drug safety problems and found that, of patients who received NX-1207 2.5 mg, 52 percent currently were not taking BPH medication and had not received surgical treatments for their BPH, while 36 percent had required no medical or surgical treatments for their BPH since receiving their initial doses of NX-1207 2.5 mg. Two Phase III studies are under way in the U.S. and are nearing full enrollment. Nymox and European partner Recordati SpA, of Milan, Italy, recently started a Phase III trial in Europe.

• Optimer Pharmaceuticals Inc., of San Diego, Calif., published results from a Phase III trial of Dificid (fidaxomicin) for Clostridium difficile infection (CDI) that showed similar cure rates as oral vancomycin. Secondary endpoint analysis showed superior rates of sustained clinical response 25 days after the end of treatment, and lower recurrence rates within four weeks of treatment. Adult subjects with CDI received 200 mg Dificid orally twice daily or 125 mg vancoymicin orally four times daily for 10 days. Among patients treated with Dificid, 87.7 percent achieved the primary endpoint of clinical cure, compared to 86.8 percent of patients treated with vancomycin. Data were published in The Lancet.