• Antares Pharma Inc., of Exton, Pa., said Phase II data of Anturol, a gel-based transdermal treatment for overactive bladder, showed the therapy was well tolerated at all doses with a reduced adverse event profile in comparison to those reported in both oral and adhesive patch formulations. It is expected to begin pivotal Phase III trials in the second half of this year. The Phase II study involves 48 healthy subjects.

• Antisoma plc, of London, said its aptamer drug AS1411 has been granted orphan drug status in the European Union for the treatment of renal and pancreatic cancers. The drug already has orphan drug status in the U.S. for both cancers.

• Biovest International Inc., of Worcester, Mass., a subsidiary of Accentia Biopharmaceuticals Inc., said it made a formal amendment request to the FDA to use pivotal Phase III data on molecular remissions, combined with physical examination and CT scan evidence of gross tumor remission, to gain conditional approval of BiovaxID to treat follicular non-Hodgkin’s lymphoma. If granted, the approval would require the company to complete the ongoing Phase III study as a condition to continue marketing of BiovaxID.

• DiObex Inc., of San Francisco, began treating patients with Type II diabetes in a randomized, placebo-controlled clinical trial. Patients will be treated for two weeks to evaluate the safety and pharmacokinetics of three dose levels of the cortisol synthesis inhibitor, DIO-902.

• Inotek Pharmaceuticals Corp., of Beverly, Mass., began enrolling patients in a Phase I trial of IMS, a therapeutic designed to interrupt signal transduction for inflammation. The company is developing IMS as an oral compound for the treatment of inflammatory bowel disease, with initial efficacy trials planned in ulcerative colitis. Phase II studies are expected to begin toward the end of the year.

• Northwest Biotherapeutics Inc., of Bothell, Wash., said a Phase I trial of its personalized cancer vaccine, DCVax-Brain, showed that patients taking the vaccine are surviving more than twice as long as those taking either of the two therapeutics currently approved by the FDA for glioblastoma multiforme. Northwest has entered into an agreement with the University of California at Los Angeles to begin providing booster shots to clinical trial participants. Current treatments have extended survival by only two to three months.

• Norwood Abbey Ltd., of Melbourne, Australia, said its subsidiary, Norwood Immunology Ltd., began a Phase II trial in cancer patients undergoing autologous bone marrow transplant. A total of 80 patients will be randomized to receive either Lupron Depot (leuprolide acetate for depot suspension) or placebo to determine whether there is an enhanced immune recovery with the company’s technology.

• PediaMed Pharmaceuticals Inc., of Florence, Ky., completed enrollment in a Phase II study evaluating an investigational medication to treat persistent gastrointestinal dysfunction in children with autism. The 22-site trial is evaluating efficacy, as well as whether the treatment has an impact on the unique emotional and behavioral manifestations of autism.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., said PRO 140 has been designated a fast-track product by the FDA to treat human immunodeficiency virus infection. The Phase Ib product is a humanized monoclonal antibody directed against CCR5.

• Rigel Pharmaceuticals Inc., of South San Francisco, said preliminary Phase I data from a double-blind, placebo-controlled trial of R788, an oral syk kinase inhibitor, in combination with methotrexate in rheumatoid arthritis patients showed the combined treatment was well tolerated and had no significant adverse pharmacokinetic interactions. The company plans to start separate clinical efficacy studies in rheumatoid arthritis and in immune thrombocytopenic purpura in the second half of 2006.

• SkinMedica Inc., of Carlsbad, Calif., said Phase III trials of Desonate (desonide) HydroGel 0.05 percent to treat atopic dermatitis demonstrated a consistently robust and highly statistically significant treatment effect compared to placebo. The randomized, double-blind, placebo controlled studies included 582 pediatric patients that received either Desonate HydroGel or placebo twice daily for four weeks.

• Telik Inc., of Palo Alto, Calif., started a multicenter Phase I/IIa study to evaluate the tolerability and pharmacokinetics of Telintra tablets in patients with myelodysplastic syndrome. The oral formulation may support the evaluation of Telintra in additional hematologic disorders characterized by low levels of one or more of the three blood cell lineages. Telintra, a small molecule shown to have myelorestorative activity, was discovered using Telik’s TRAP small molecule drug discovery technology.

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