• Avila Therapeutics Inc., of Waltham, Mass., started a Phase I trial of AVL-292, an oral, covalent drug aimed at Bruton's tyrosine kinase, in healthy volunteers. The drug, which the company said performed well in a variety of animal models, could have potential against B-cell cancers and autoimmune diseases such as rheumatoid arthritis.

• Celsion Corp., of Columbia, Md., said that a data monitoring committee has unanimously recommended the continuation of a pivotal Phase III trial of ThermoDox (the HEAT study) for primary liver cancer. The trial currently has 401 patients enrolled, with a goal of reaching the 600 required to complete the study. With nearly 75 percent of patients enrolled in the trial, Celsion plans to complete patient enrollment over the next four months. The independent committee will continue to assess safety in patients randomized at Japanese sites. The goal is to provide data from this cohort sufficient to support immediate registration in Japan following a successful study.

• Circassia Ltd., of Oxford, UK, which started Phase II testing with its grass allergy therapy, began the final stage of Phase II testing with its ragweed allergy treatment and progressed Phase III development plans for its cat allergy therapy. All three programs emerged from the company's ToleroMune technology, which uses the T-cell vaccine approach to combat allergies.

• Duke University Medical Center, in Durham, N.C., will begin enrolling patients for a Phase I trial of Neogenix Oncology Inc.'s therapeutic antibody for advanced pancreatic or colorectal cancer, NPC-1C. Duke joins Johns Hopkins Hospital and North Shore Long Island Jewish Health System in the multicenter trial. Preclinical studies by the Great Neck, N.Y.-based company demonstrated that NPC-1C targets pancreatic and colorectal cancer sparing healthy tissue.

• Repligen Corp., of Waltham, Mass. completed enrollment of patients in a Phase IIb trial of its investigational drug RG2417 for bipolar depression. RG2417 is an oral formulation of uridine. Secondary objectives of the safety and efficacy study include evaluation of changes on the Montgomery-Asberg Depression Rating Scale, improvements in the Clinical Global Impression Scale, and a lack of increase of mania according to Young's Mania Rating Scale. The study includes 175 patients at 29 clinical sites within the U.S. Top-line results are expected in the first quarter of 2011 .

• Repros Therapeutics Inc., of The Woodlands, Texas, said it was granted a Type B meeting, scheduled for Nov. 8, for the Division of Reproductive and Urologic Products to review its Phase III efficacy protocols for Androxal in secondary hypogonadism. The proposed protocol calls for two trials, with 80 patients enrolled in each and randomized into four arms: two testing different doses of Androxal, one placebo and one open-label approved topical testosterone. The proposed primary endpoint is responder analysis. Repros anticipates starting the studies in 2011 and is exploring partnering and financing options to support the program.

• Santarus Inc., of San Diego, and Cosmo Pharmaceuticals SpA, of Lainate, Italy, reported top-line results from a Phase III trial of budesonide MMX for the induction of remission of mild or moderate active ulcerative colitis, which showed that the drug, taken once daily, met the primary endpoint of superiority to placebo (p = 0.0143) in achieving clinical remission as measured by the ulcerative colitis disease activity index score after eight weeks of treatment. A European Phase III is ongoing and, pending positive data from that trial, Santarus anticipates submitting a new drug application in the second half of 2011. Budesonide MMX is a locally acting corticosteroid developed in a tablet formulation using Cosmo's MMX multi-matrix system technology. Shares of Santarus (NASDAQ:SNTS) gained 21 cents, to close Thursday at $3.01.

• SciClone Pharmaceuticals Inc., of Foster City, Calif., reported at the American Association for Cancer Research's Molecular Diagnostics in Cancer Therapeutics Development Conference that researchers have identified two unique gene clusters that differentiated subjects who responded to treatment in the company's Phase IIa proof-of-concept study of SCV-07 for the prevention of severe oral mucositis in patients with advanced head and neck cancer. The company believes that the discovery of these gene clusters may assist in providing the framework for effectively identifying those patients most likely to respond to SCV-07 in future clinical trials based on their individual genomic profile or gene signature. SciClone is planning to initiate a Phase IIb study in late 2010 or early 2011.

• Teva Pharmaceuticals Industries Ltd., of Jerusalem, and OncoGenex Pharmaceuticals Inc., of Bothell, Wash., began a Phase III trial of custirsen for castrate-resistant prostate cancer (CRPC). The study will enroll about 800 men with metastatic CRPC and will compare treatment with docetaxel/prednisone plus custirsen to docetaxel/prednisone alone, evaluating overall survival as the endpoint. Phase II trials showed clinical benefits of custirsen with an overall survival of 23.8 months compared to 16.9 months. Custirsen has been given fast-track status by the FDA.

• Zealand Pharma A/S, of Copenhagen, Denmark, said partner Sanofi-Aventis SA, of Paris, disclosed top-line results from the Phase III GETGOAL-L-ASIA trial testing lixisenatide, a once-daily GLP-1 receptor agonist, in combination with basal insulin. Results showed that the drug, when dosed once daily, significantly improved glycemic control with no specific safety concerns in patients with Type II diabetes. The 24-week, 311-patient study met its primary endpoint, with the addition of lixisenatide to basal insulin reducing A1C levels by 0.88 percent vs. placebo (p < 0.0001). Zealand and Sanofi reported positive top-line data from the first GETGOAL study in April. (See BioWorld Today, April 16, 2010.)