• BioCurex Inc., of Richmond, British Columbia, said study results showed a rapid test for ambulatory cancer detection based on its RECAF cancer marker was able to detect 80.4 percent of ovarian cancers with 88 percent specificity. The device used in the research was similar to the common pregnancy test kit. The study was conducted in conjunction with the Blokhin Cancer Research Centre in Moscow.

• Biodel Inc., of Danbury, Conn., said additional data from its VIAject Phase II meal study demonstrated statistically significant and clinically relevant improved glycemic control compared to regular human insulin and lispro (Humalog, Eli Lilly & Co.) in Type I diabetes patients. Subjects in the study received either VIAject, Humulin (regular recombinant human insulin, Lilly) or Humalog (rapid-acting insulin analogue) in conjunction with a standardized meal, with patients' plasma insulin and blood glucose levels being monitored throughout the trial. Findings showed administration of VIAject resulted in statistically significantly faster insulin absorption than Humulin and Humalog and lower plasma insulin levels than both after three hours. Results also showed VIAject provides better postprandial blood glucose control with less hyperglycemia in the first three hours after the meal and less risk of hypoglycemia in the next five hours. Those data were presented at the European diabetes meeting in Amsterdam, the Netherlands.

• Cytokinetics Inc., of South San Francisco, said two poster presentations related to CK-1827452, a small-molecule activator of cardiac myosin, were presented at a meeting on heart failure in Washington. The product is partnered with Amgen Inc., of Thousand Oaks, Calif. One presentation concluded that the absolute bioavailability of CK-1827452 approached 100 percent for all formulations administered in a clinical trial. The other presentation was titled, "Systolic ejection time is a sensitive indicator of left ventricular systolic function during treatment with the selective cardiac myosin activator CK-1827452." The product is in Phase II development in patients with stable heart failure.

• LipoNova AG, of Hanover, Germany, said the FDA in a pre-investigational new drug application meeting gave it the go-ahead for its overall development program. The company is developing Reniale, an autologous vaccine for renal cell carcinoma. The pre-IND meeting involved plans for an international Phase III trial, which the company expects to start in the first half of 2008. Reniale previously produced encouraging results in a Phase III trial of the product in Germany.

• Pfizer Inc., of New York, said new data supported the long-term efficacy and safety of Exubera in patients who used the diabetes product for eight years. An eight-year extension study showed the insulin inhalation powder was well tolerated and effective at maintaining blood sugar control. The product was developed in collaboration with Nektar Therapeutics Inc., of San Carlos, Calif.

• Pharmacopeia Inc., of Princeton, N.J., said Bristol-Myers Squibb Co., of New York, initiated a Phase II trial with a p38 kinase inhibitor (BMS-582949) that resulted from a collaboration between the companies. BMS 582949 is being evaluated for the oral treatment of moderate to severe psoriasis. The multicenter, randomized, double-blind, placebo-controlled trial will examine safety and efficacy of the compound at three doses in about 100 patients. BMS also is conducting a Phase I trial in Canada with a second p38 kinase inhibitor resulting from their collaboration.

• Provectus Pharmaceuticals Inc., of Knoxville, Tenn., said preliminary results of a Phase I trial of Provecta in metastatic melanoma demonstrated minimal side effects, significant efficacy and "bystander effect" on melanoma tumors in Stage III patients. The study evaluated safety and efficacy of Provecta in 20 subjects at two sites in Australia. Provecta was injected once into one to 20 tumors in each subject. An additional one to three tumors were left untreated in each subject to allow assessment of a potential bystander effect resulting from immune system response to tumor treatment. A total of 114 tumors were injected and 39 bystander tumors were observed in the study. Subjects were followed for four to 27 weeks. Study treatment was well tolerated and elicited minimal side effects, Provectus said.

• Samaritan Pharmaceuticals Inc., of Las Vegas, said the FDA cleared it to proceed with a Phase II study of SP-6300 in patients experiencing hypercortisolism, or Cushing's syndrome. The product acts by reducing the levels of the rate-limiting enzyme HMGCoA reductase mRNA, leading to reduced activity and decreased cholesterol and corticosteroid biosynthesis, Samaritan said. Details on the proposed study were not disclosed.

• Sinobiomed Inc., of Shanghai, China, updated data on a Phase IIa trial of recombinant batroxobin made by its 82 percent-owned subsidiary, Shanghai Wanxing Bio-pharmaceuticals Co. Ltd. The trial in China showed rBat was both safe and efficacious in reducing both the amount of bleeding and bleeding time during surgery. It said rBat is the first batroxobin to be synthesized through gene recombination in a yeast expression system. An ongoing Phase IIb trial designed to observe the anti-bleeding effect of different routes of administration on surgical and nonsurgical bleeding is expected to be completed in December.

• The Multiple Myeloma Research Consortium, of Norwalk, Conn., began a Phase I/II trial to explore the combination of Torisel (temsirolimus), an mTOR inhibitor from Wyeth, of Madison, N.J., and Velcade (bortezomib), a proteasome inhibitor from Millennium Pharmaceuticals Inc., of Cambridge, Mass., for treating relapsed or refractory multiple myeloma. The Phase I component of the trial will evaluate safety and the maximum tolerated dose of the combination, as well as determining doses for Phase II study.

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