• AEterna Zentaris Inc., of Quebec City, said that dosing of AEZS-108, a luteinizing hormone-releasing hormone (LHRH) agonist linked to doxorubicin, has begun a Phase II trial in gynecological cancers. The open-label, noncomparative multicenter trial will treat up to 82 women with LHRH-receptor positive ovarian and endometrial cancerous tumors. The primary endpoint for the trial will be the partial or complete tumor response rate according to Response Evaluation Criteria in Solid Tumors and/or Gynecologic Cancer Intergroup guidelines. The trial is being conducted in 15 centers in Europe.

• Debiopharm Group SA, of Lausanne, Switzerland, presented Phase III data showing that its six-month formulation of Decapeptyl (triptorelin pamoate) showed similar safety and efficacy in treating advanced prostate cancer as the marketed one-month and three-month versions. The data were presented at the 9th International Symposium on GnRH, in Berlin.

• Depomed Inc., of Menlo Park, Calif., announced positive efficacy results from a Phase II double-blind, placebo-controlled, multicenter trial evaluating Gabapentin GR for the treatment of women with moderate to severe menopausal hot flashes. The 124-patient study showed that Gabapentin GR, an extended-release formulation of gabapentin, significantly reduced the frequency and severity of hot flashes from baseline to the end of treatment compared to placebo. A decrease of at least 80 percent in the frequency of moderate to severe hot flashes was observed in 63 percent of patients in the 1,800-mg treatment arm, compared to 20 percent of placebo patients, which decrease was statistically significant (p > 0.001). Gabapentin GR was well tolerated in the study.

• Diamyd Medical, of Stockholm, Sweden, said it has received one FDA question relating to the Phase III investigational new drug application for Diamyd in treatment of Type I diabetes. The question has been answered with additional documentation, and the FDA now has 30 days to respond. The trial is a double-blind study including approximately 300 new onset Type I diabetes patients. A similar Phase III trial is planned for Europe, which has been initiated with a clinical trial application in Sweden.

• Hana Biosciences, of South San Francisco, has completed patient enrollment in its Phase I dose-escalation clinical trial of Alocrest (vinorelbine liposomes injection, Optisome). The trial was designed to assess the safety, tolerability and preliminary efficacy of Optisomal encapsulated vinorelbine, or Alocrest. Preliminary results showed that Alocrest was generally well tolerated with acceptable and predictable toxicities and had a maximum tolerated dose comparable to that of unencapsulated vinorelbine. Hana said it anticipates submitting those data for presentation at a major medical conference in Europe this summer.

• Iomai Corp., of Gaithersburg, Md., said interim results of a study showed that the second dose of the two-dose regimen for its patch-based travelers' diarrhea vaccine yields a robust immune response when self-applied by subjects outside of a clinical setting. The 160-subject study, part of a Phase II program for the vaccine, measured the immune response to the vaccine patch. All groups had robust responses to the vaccine, and a statistical analysis of immune parameters following vaccination showed no significant differences between treatment groups at any time point.

• MorphoSys AG, of Martinsried, Germany, said regulatory authorities in the Netherlands have approved the clinical trial application to initiate a Phase I study of the HuCAL-derived antibody MOR103. MorphoSys had submitted the clinical trial application in December. In parallel, MorphoSys has received a manufacturing license from the Bavarian government allowing MorphoSys to release clinical trial material for MOR103 clinical studies as a sponsor. MOR103 is a fully human HuCAL antibody directed against GM-CSF (granulocyte macrophage-colony stimulating factor), being developed in the area of inflammatory diseases.

• Ophthotech Corp., of Princeton, N.J., enrolled the first patient in its Phase I trial of E10030, an anti-PDGF aptamer, in combination with an anti-VEGF agent in patients with wet age-related macular degeneration. The trial will enroll up to 36 patients. In preclinical studies, E10030 demonstrated the potential to regress neovascularization when used in combination with a VEGF-A inhibitor.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said patient dosing has begun in its clinical trial to evaluate the safety and efficacy of bavituximab in combination with chemotherapy in patients with advanced breast cancer. The primary objective of the study is to assess the overall response rate to the combination of bavituximab with docetaxel, a chemotherapy drug commonly used in breast cancer. The multicenter clinical trial is being conducted in the Republic of Georgia.

• Thallion Pharmaceuticals Inc., of Montreal, said it reached an agreement with the FDA on a plan to advance its dual monoclonal antibody, Shigamabs, in Shigatoxin-mediated E. coli infections. The company and the agency had previously disagreed about endpoints, with Thallion proposing earlier-stage composite endpoints as an alternative to the late-stage complication of Hemolytic Uremic Syndrome. Last fall, Thallion said it would go ahead with a pivotal Phase II/III trial outside of the U.S., but the new agreement means U.S. sites will also be included. Shares of Thallion (TSX:TLN) rose C10 cents, or 19.2 percent, to close at C59 cents on Tuesday. (See BioWorld Today, Oct. 30, 2007.)