• Cobalis Corp., of Irvine, Calif., reported top-line results from two Phase III clinical trials with its drug PreHistin (cyanocobalamin) in patients with moderate to moderately severe seasonal allergic rhinitis, or hay fever. The trials showed very low symptom levels in both placebo and PreHistin-treated patient groups, thereby leaving no room to demonstrate a meaningful drug effect. In the randomized, six week, placebo-controlled trials involving a total of 1,551 subjects, PreHistin did not achieve statistically significant differences from placebo in the primary measure of efficacy, the reduction in total nasal symptom score (TNSS). The TNSS data for placebo-treated patients was far lower than would be expected for the moderate to moderately severe patient population called for in the protocol, the company said, and low pollen counts in many of the regions during the time PreHistin was being tested may have resulted in low mean placebo symptom scores for the overall study population.

• Enzon Pharmaceuticals Inc., of Bridgewater, N.J., said several patients have been enrolled in two Phase I studies of PEG-SN38 (EZN-2208), its PEGylated form of SN38, the active metabolite of the cancer drug Camptosar (irinotecan HCl injection). The studies will evaluate the safety, tolerability and pharmacokinetics of PEG-SN38 in different dosing schedules for patients with advanced solid tumors or lymphoma. Enzon previously reported that preclinical data showed that treatment with the SN38 resulted in significant tumor growth inhibition in mice resistant to Camptosar and outperformed Camptosar in mice when given as a second-round therapy. Additionally, it demonstrated long-lasting antitumor activity in mouse models of human breast, colorectal and pancreatic cancers.

• Kosan Biosciences Inc., of Hayward, Calif., initiated its TIME-2 trial, a Phase II/III study of Hsp90 inhibitor tanespimycin (KOS-953) in relapsed/refractory multiple myeloma. The 130-patient trial will evaluate three doses of tanespimycin in combination with Velcade (bortezomib, Millennium Pharmaceuticals Inc.). The primary endpoint is dose response based on objective response rate as measured by M protein levels, with secondary endpoints including comparison of response rates between doses, progression-free survival, time to treatment failure and overall survival. As part of its pivotal program, Kosan also will begin the TIME-1 Phase III trial later this year or early next year in first-relapse patients.

• Kuros Biosugery AG, of Zurich, Switzerland, treated the first patient in a trial to test its combination product for severe burns. The trial is enrolling patients with partial and full thickness burns that require grafting. Kuros' product consists of a variant of platelet-derived growth factor incorporated into a fibrin sealant from Baxter Healthcare Corp., of Deerfield, Ill.

• MacroGenics Inc., of Rockville, Md., initiated a pivotal Phase II/III trial of the CD3 monoclonal antibody teplizumab in Type I diabetes. The trial, called Protégé, will evaluate three dosing regimens to assess the ability of teplizumab to inhibit the autoimmune response in recently diagnosed Type I diabetes patients. Teplizumab also is being studied in three investigator-initiated trials: AbATE, a Phase II trial of a longer period between dosing in recent-onset Type I diabetics; Delay, a Phase II study in less-recently diagnosed patients; and a Phase II trial using teplizumab as an induction therapy in pancreatic islet cell transplantation.

• Oxford BioMedica Ltd., of Oxford, UK, said data from a Phase II trial with Trovax, a vaccine for colorectal cancer, shrank tumors in six of 17 patients with metastatic disease. The study, reported in the Aug. 1 issue of Clinical Cancer Research, was designed to demonstrate the safety and immunogenicity of the vaccine, also called modified vaccinia Ankara-encoding 5T4, when used alongside standard chemotherapy. The research was funded by Oxford BioMedica, which is developing the vaccine in partnership with Sanofi-Aventis Group, of Paris.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., initiated a 40-patient, open-label, Phase II trial of Cotara in glioblastoma multiforme patients in India. The primary objective is to confirm the maximum tolerated dose; secondary objectives include survival, progression-free survival and the proportion of patients alive at six months. Trials of Cotara, which links a monoclonal antibody to a radioactive isotope, are ongoing in the U.S.

• Pharmasset Inc., of Princeton, N.J., completed patient enrollment in its multiple ascending dose study of R7128 for the treatment of hepatitis C virus. R7128, a nucleoside polymerase inhibitor of HCV, is being evaluated in a Phase I clinical trial as part of Pharmasset's collaboration with F. Hoffmann-La Roche Ltd., of Basel, Switzerland. The primary objective of the study is to assess the safety, tolerability and pharmacokinetics of R7128 after once-daily or twice-daily dosing for 14 days in up to 40 patients chronically infected with HCV genotype 1 who have previously failed interferon therapy. The secondary objective is to assess antiviral efficacy by measuring the change in HCV RNA in those patients.

• Unigene Laboratories Inc., of Fairfield, N.J., started a study in the U.S. with its proprietary formulation of oral calcitonin for the treatment of osteoporosis, using an improved solid dosage form of the firm's Enteripep oral delivery technology. The novel dosage form is the subject of a recently filed patent application and has been shown in animal studies to deliver a more consistent dose of calcitonin while maintaining therapeutic blood levels of this peptide, the company said. An earlier version of the Enteripep technology previously has been used to successfully deliver calcitonin, parathyroid hormone and several other therapeutically important peptides, according to Unigene, which previously licensed its Secrapep manufacturing technology to Basel, Switzerland-based Novartis AG for a formulation of oral calcitonin that entered Phase III clinical studies earlier this year for osteoporosis and osteoarthritis.