Cytovax Biotechnologies Inc., of Edmonton, Alberta, enrolled the last subject in the Phase I trial of its lead product, Cytovaxine, a peptide vaccine designed to prevent infections caused by Pseudomonas aeruginosa. In the randomized, double-blinded study, designed to investigate the product's safety, 35 individuals were enrolled and will receive one of three escalating dose levels of Cytovaxine or a control vaccine. A study-entry, six-week and five-month injection schedule will be employed. A six-week safety evaluation prior to dose escalation also was included.
MGI Pharma Inc., of Minneapolis, and Helsinn Healthcare SA, of Lugano, Switzerland, submitted to the FDA a new drug application for palonosetron, their agent for the prevention of chemotherapy-induced nausea and vomiting. Subject to FDA approval, MGI said it plans to be ready for U.S. launch of the differentiated 5-HT3 receptor antagonist in the second half of next year. Studies in nearly 2,800 patients have demonstrated that palonosetron was well tolerated and adverse events were similar to currently marketed 5-HT3 antagonists, with the most common being mild to moderate headache and constipation. Helsinn, which owns the worldwide rights to palonosetron, said it is negotiating with European and Far Eastern pharmaceutical companies to finalize distribution and licensing agreements. MGI is the exclusive U.S. and Canadian licensing and distribution partner.
Morphotek Inc., of Exton, Pa., received from Wyeth Pharmaceuticals, a unit of Wyeth, of Madison, N.J., an undisclosed milestone payment based on delivery of an evolved cancer cell line from the companies' research collaboration. The line comes from a program using Morphotek's Direct-Line technology, which has been used to develop cell lines useful for understanding the molecular mechanism of a small molecule that is in clinical development.
Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., reported at the Interscience Conference on Antimicrobial Agents and Chemotherapy in San Diego positive findings from a completed Phase II trial of its investigational HIV entry inhibitor, PRO 542. Single doses of PRO 542 reduced HIV concentrations in blood by 60 percent to 80 percent in a target population of highly treatment-experienced patients with PRO 542-sensitive virus. The viral load reductions were sustained throughout the six-week follow-up period, and no serious side effects were observed. Progenics added that it began multidose Phase II studies of PRO 542 as salvage therapy of HIV-infected individuals who no longer are responding to currently available antiretroviral medications.
The Lasker Award for Basic Medical Research was presented Friday in New York to James E. Rothman of the Sloan-Kettering Institute and Randy W. Schekman at the University of California at Berkeley. They shared discovery of the universal molecular machinery that orchestrates the budding and fusion of membrane vesicles. "This advance," the citation said, "has transformed the study of molecular trafficking from a descriptive field into one of detailed molecular clarity." A separate Lasker Award for Basic Medical Research was given to Willem J. Kolff of the Utah University School of Medicine and Belding H. Scribner at the University of Washington School of Medicine, "for the development of renal hemodialysis, a technological advance that has revolutionized the treatment of acute and chronic kidney failure."
Transition Therapeutics Inc., of Toronto, said studies of its Islet Neogenesis Therapy (INT) show the treatment increases the survival of diabetic mice through the regeneration of insulin-producing islet cells. After the onset of diabetes, the mice were treated with either INT or placebo. Data demonstrated that INT treatment for 14 days increased the survival rate of non-obese diabetic mice from 23 percent to 100 percent, increased pancreatic insulin levels and resulted in normal blood glucose levels for most of the mice. The improvement was maintained for at least 14 days after treatment ended.
Sequenom Inc., of San Diego, released its Allelotyping and MassArray 20K system products, designed to increase speed and efficiency in large-scale genetics studies. The Allelotyping product was developed to rapidly analyze genetic variations across large DNA pools that combine up to 500 individual samples. The MassArray 20K system is designed to automate the preparation of up to 20,000 analytical reactions over 12 hours.