• Alvine Pharmaceuticals Inc., of San Carlos, Calif., dosed the first patient in its Phase I trial of ALV003, an orally administered drug that combines two proteases engineered to detoxify gluten. The drug is in development for celiac disease, an inherited autoimmune disease triggered by the ingestion of gluten, one of the most common food additives in the human diet. The study is expected to enroll about 36 subjects, including both healthy volunteers and celiac patients.

• Bioniche Life Sciences Inc., of Belleville, Ontario, said a data safety monitoring board has recommended continuation of a trial investigating Urocidin in patients with refractory bladder cancer. That indication was granted fast-track status by the FDA in April 2006, and the trial commenced the following year and has been progressing since that time, the company said. The independent monitoring board has recommended that the trial continue unmodified until the next "triggered" or scheduled meeting, which will be held in three months, the company said. Enrollment is ongoing, with a target of 105 patients.

• Cytheris SA, of Paris, presented follow-up data from a Phase I/II trial of Interleukin-7 (IL-7) in HIV. The data showed that IL-7 caused increases in CD4+ and CD8+ T-cell counts that were sustained for up to 48 weeks. Additional nonhuman primate studies confirmed the drug's ability to increase T-cell counts. The data were presented recently at the 2008 Conference on Retroviruses and Opportunistic Infections in Boston.

• DOR BioPharma Inc., of Ewing, N.J., presented data from Phase II and III trials of orBec (oral beclomethasone dipropionate) in gastrointestinal graft-vs.-host disease indicating the drug may help prevent the decline in pulmonary diffusing capacity that often occurs after allogeneic graft transplants. The initial data showed that 55 percent of orBec patients experienced a decline, compared to 79 percent of placebo patients, and that no patients on orBec developed a noninfectious pulmonary problem, compared to four placebo patients. The FDA delivered an approvable letter for orBec in GVHD last year, requiring a confirmatory Phase III trial. Shares of DOR (OTC BB:DORB) rose 3 cents, or 14.3 percent, to close at 20 cents Wednesday. (See BioWorld Today, Oct. 22, 2007.)

• Introgen Therapeutics Inc., of Austin, Texas, and the Moffitt Cancer Center in Tampa, Fla., said they have initiated a randomized, controlled Phase II study of INGN 225, the company's immunotherapy product for metastatic small-cell lung cancer. The trial, which is funded by the National Institutes of Health National Cancer Institute, will evaluate the efficacy and safety of INGN 225 in as many as 80 patients with this form of cancer. INGN 225 targets the p53 tumor suppressor molecular abnormality, using a patient's own cells to stimulate an antitumor immune response.

• Lipoxen plc, of London, said its partner Serum Institute of India initiated a Phase I trial of ErepoXen, a long-acting version of erythropoietin created using Lipoxen's polysialic acid polymer technology. The randomized, double-blind, placebo-controlled, 32-patient study is expected to deliver data in April.

• Mesoblast Ltd., of Melbourne, Australia, said 10 patients with nonhealing, long-bone leg fractures demonstrated new bone formation after treatment with the company's allogeneic adult stem cells. Seven patients achieved union of their fractures in a median time of 4.9 months, and no adverse events have been observed after six months. Mesoblast plans to use the data as part of an investigational new drug application.

• Progen Pharmaceuticals Ltd., of Brisbane, Australia, announced positive preliminary efficacy results from a Phase II investigator-initiated trial of PI-88 in combination with the chemotherapeutic agent Taxotere (docetaxel) administered to patients with prostate cancer. Data showed that 70 percent of the 55 patients recruited to the trial had a decrease in serum prostate-specific antigen of greater than 50 percent for three weeks or longer. These efficacy results compared favorably with the pivotal TAX327 Taxotere registration trial, where 45 percent of patients had at least a 50 percent decrease in serum PSA level.

• Raven Biotechnologies Inc., of South San Francisco, said it has completed enrollment of patients in the maximum tolerated dose cohort expansion segment of its Phase I/IIa trial of RAV12, the company's lead clinical monoclonal antibody drug candidate for cancer. The trial enrolled patients with cancers that express the RAAG12 antigen, particularly those of gastrointestinal origin, the privately held company said. An analysis of data from that trial is expected in the second or third quarter.

• YM BioSciences USA Inc., of Wayne, Pa., has enrolled the first patient in its Phase II trial of nimotuzumab in pediatric patients with recurrent diffuse intrinsic pontine glioma (DIPG), a form of inoperable, treatment-resistant brain cancer, parent company YM BioSciences Inc., of Mississauga, Ontario, said. Eight leading U.S. pediatric clinical centers and two Canadian centers will be participating in the single-arm trial, which is designed to enroll 44 patients with DIPG who will be treated with nimotuzumab as monotherapy. Recruitment is expected to be completed within approximately 18 months.