• Diatos SA, of Paris, said the doxorubicin prodrug DTS-201 was well tolerated and resulted in clinical benefit for 40 percent of the 25 cancer patients in a Phase I trial. Nine patients with chemo-resistant tumors showed disease stabilization for at least four treatment cycles, and one patient showed a partial response. Results were presented at the AACR-NCI-EORTC International Conference.
• Kamada Ltd., of Ness Ziona, Israel, submitted a proposal to the FDA for a clinical development program with its inhaled formulation of Alpha-1 Antitrypsin (AAT) for congenital emphysema. Kamada markets an intravenous formulation of AAT in several countries and is conducting Phase III trials in the U.S. Trials of the inhaled formulation are ongoing in Europe.
• Living Cell Technologies Ltd., of Melbourne, Australia, released additional data from its Phase I/IIa trial of DiabeCell porcine islet cell implant for Type I diabetes. Two of six patients have been treated without adverse effects and have shown control of blood glucose levels, the company said.
• Orexigen Therapeutics Inc., of San Diego, presented data from a double-blind, placebo-controlled, 419-patient Phase IIb trial of Contrave. The company previously announced weight loss in all three Contrave dosage groups in the trial. The new data concern secondary endpoints such as serum lipids, glycemic indices and other measures, for some of which the Contrave 32/400-mg dose group demonstrated significantly greater improvement than the placebo or monotherapy groups. The data were presented at the annual meeting of the North American Association for the Study of Obesity.
• Peregrine Pharmaceuticals Inc., of Tustin, Calif., submitted a Phase II protocol with the Ministry of Health of the Republic of Georgia to study bavituximab in combination with docetaxel chemotherapy in patients with metastatic breast cancer and expects to start enrolling patients upon regulatory and ethics committee approvals. The trial will involve up to 15 patients initially, with plans to expand to as many as 46 patients if promising results are observed in the first cohort, with a primary objective of assessing the overall response rate to the combination of bavituximab with docetaxel. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters.
• TorreyPines Therapeutics Inc., of La Jolla, Calif., reported mixed results from a 306-patient Phase IIb trial of its AMPA/kainate antagonist tezampanel (NGX424) in acute migraine. While the 40-mg dose resulted in a statistically significant improvement in the primary endpoint of headache pain, the 70-mg and 100-mg doses did not achieve statistical significance. All three doses were well-tolerated with no serious adverse events. The company said it intends to submit the findings to the FDA and seek permission to begin a Phase III trial in the second half of 2008. Shares of TorreyPines (NASDAQ:TPTX) fell 93 cents or 16.2 percent, to close at $4.80 on Monday.