• Accentia Biopharmaceuticals Inc., of Tampa, Fla., reported an interim analysis from blinded data on patients who have completed the 16-week Phase III placebo-controlled trial of SinuNase for the treatment of refractory chronic sinusitis. Based on analysis of more than 80 patients who have completed the trial at 16 weeks, the study has shown improvement in polyposis by endoscopy in about 50 percent of patients and improvement in sinus inflammation by CT scan in about 50 percent of patients. Moreover, the interim data showed almost 50 percent of patients with objective evidence of improvement achieved the primary endpoint of complete resolution of the two key cardinal symptoms. Accentia said it appears patients also are experiencing substantial symptom resolution and reduction in polyposis by two to four weeks. Accentia said it expects to have unblinded top-line results from the study around the end of the year. Its stock (NASDAQ:ABPI) gained 89 cents Wednesday, or 49.2 percent, to close at $2.70.

• Allos Therapeutics Inc., of Westminster, Colo., initiated patient enrollment in a Phase I, open-label, multicenter study of its antifolate PDX (pralatrexate) with vitamin B12 and folic acid supplementation in patients with relapsed or refractory cutaneous T-cell lymphoma. Up to 56 evaluable patients will be enrolled in the study, with the objective to determine the optimal dose and safety profile of PDX, a small-molecule agent designed to inhibit dihydrofolate reductase.

• CombinatoRx Inc., of Cambridge, Mass., said it dosed the first patient in a Phase IIa proof-of-concept trial of CRx-401 in Type II diabetes. The insulin sensitizer is designed to provide antidiabetic activity without promoting weight gain. It combines a sustained-released dose of bezafibrate, an anticholesterol agent, and a low dose of diflunisal, an analgesic salicylate derivative. The multicenter, randomized study will evaluate the safety and efficacy of CRx-401, as an add-on therapy, in comparison to bezafibrate alone in about 80 patients who are poorly controlled on metformin.

• Cytokinetics Inc., of South San Francisco, said GlaxoSmithKline plc, of London, initiated a first-time-in-humans Phase I trial of GSK-923295 in patients with solid tumors. The open-label, dose-finding trial is designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK-923295 in patients with advanced solid tumors. GSK-923295 is a small-molecule inhibitor of centromere-associated protein E. Initiation of the trial triggered a milestone payment of $1 million from GSK to Cytokinetics under their alliance established in June 2001.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., initiated a randomized, multicenter, Phase II trial to evaluate the efficacy of combining Velcade (bortezomib), lenalidomide/dexamethasone and cyclo-phosphamide in the front-line multiple myeloma setting. The EVOLUTION trial is expected to enroll about 100 patients. The primary endpoint of the trial is complete response and very good partial response rates. Secondary endpoints include duration of response, overall survival, safety and tolerability.

• Proteolix Inc., of South San Francisco, and the Multiple Myeloma Research Consortium enrolled the first patient in a multicenter Phase II trial to study Proteolix's selective proteasome inhibitor, carfilzomib (PR-171), in patients with relapsed and refractory multiple myeloma. The trial will evaluate the overall response rate for two cycles of carfilzomib in relapsed and refractory MM patients. Secondary objectives include safety and tolerability, clinical benefit response, time to progression, duration of response and progression-free survival.

• Romark Laboratories LC, of Tampa, Fla., initiated a Phase II trial of Alinia (nitazoxanide) for treating chronic hepatitis C. The STEALTH C-2 study is a randomized, double-blind, placebo-controlled trial in 60 patients in the U.S. It is designed to evaluate the effectiveness and safety of Alinia tablets administered in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in 60 patients with chronic hepatitis C genotype 1 who have failed to respond to standard therapy (peginterferon and ribavirin). Nitazoxanide is a small-molecule compound from the thiazolides class that targets cell-signaling pathways used in viral replication. Romark also said interim data from an international trial in patients with chronic hepatitis C will be communicated at the American Association for the Study of Liver Diseases meeting in November.

• Vion Pharmaceuticals Inc., of New Haven, Conn., said it has accrued 85 patients to the pivotal Phase II trial of its lead anticancer agent, Cloretazine (VNP40101M), in previously untreated elderly patients with de novo poor-risk acute myelogenous leukemia. The trial, initiated in May 2006, is evaluating Cloretazine as a single agent in AML patients older than 60. The primary endpoint is complete response rates and complete remissions with incomplete platelet recovery. Vion said it now would begin data analysis and, if warranted, prepare for a new drug application filing in 2008.

• YM BioSciences Inc., of Mississauga, Ontario, said European partner Oncoscience AG, of Wedel, Germany, recruited the 40th and final patient in a Phase III trial combining nimotuzumab with radiation for the treatment of children and adolescents suffering from diffuse intrinsic pontine glioma, an inoperable form of brain cancer. Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor. The primary endpoint of the trial is progression-free survival, with overall survival as a secondary endpoint.