• Depomed Inc., of Menlo Park, Calif., completed enrollment of Breeze 2, the second of two pivotal Phase III trials of Serada (formerly called DM-5689) for the treatment of menopausal hot flashes. The Phase III registration program for Serada in menopausal hot flashes includes two randomized, double-blind, placebo-controlled studies of approximately 540 patients per study. The treatment duration of the Breeze 1 study is six months, with primary efficacy endpoints assessed after four and 12 weeks of stable treatment.

• DePuy Spine Inc., of Raynham, Mass., in collaboration with Advanced Technologies and Regenerative Medicine LLC, also of Raynham, said it began testing a genetically engineered human protein in patients with moderate to severe low back pain in a Phase I/II trial. The first of a series of studies will test the safety and efficacy of the protein, intradiscal rhGDF-5 (recombinant human growth and differentiation factor-5), to see if injections of the protein into the lower spine can relieve pain and slow or even reverse early stage degenerative disc disease. Clinical outcomes will be measured using standard validated tools, and lumbar disc changes will be measured using magnetic resonance imaging data.

• Elan Corp. plc, of Dublin, Ireland, and partner Wyeth, of Madison, N.J., discontinued the highest dose in two ongoing Phase III trials of Alzheimer's disease drug bapineuzumab. The companies said the decision affects only patients who do not carry the Apolipoprotein E4 (ApoE4) allele and has no impact on two separate Phase III studies in ApoE4 carriers. The decision was based on the trials' safety monitoring committee's review of vasogenic edema data.

• Osiris Therapeutics Inc., of Columbia, Md., treated the first patient in a Phase II trial evaluating Prochymal for the treatment of heart attacks. Prochymal is a formulation of adult stem cells designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration and preventing scar formation. The double-blind, placebo-controlled study is designed to enroll approximately 220 patients following their first heart attack.

• Pfizer Inc., of New York, said it discontinued one of its Phase III studies of Sutent (sunitinib malate), its oral multikinase inhibitor, in advanced breast cancer based on statistical assessment for futility. An independent data monitoring committee found that even if the trial, designated SUN 1107, had been allowed to continue, treatment with single-agent Sutent would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared to single-agent capecitabine in a broad range of patients with advanced breast cancer following failure of standard treatment. The company continues to test Sutent as a single agent and in combination with standard-of-care chemotherapy in specific patient populations with advanced breast cancer through three additional Phase III and two Phase II trials.