• Adventrx Pharmaceuticals Inc., of San Diego, completed patient enrollment in its bioequivalence study of ANX-514 (docetaxel emulsion for injection). The company is on track to announce results from this study in the second quarter. ANX-514 is a reformulation of the blockbuster chemotherapeutic agent, Taxotere, an anti-cancer agent that is approved to treat breast, non-small-cell lung, prostate, head and neck and gastric cancers. In 2007, the aggregate worldwide market for Taxotere was in excess of $3 billion.

• BioDelivery Sciences International Inc., of Raleigh, N.C., reported initial results of a Phase I study assessing the tolerability, safety, and pharmacokinetics of Bioral amphotericin B, BDSI's lead product candidate from the company's Bioral drug delivery technology. Bioral encapsulates a drug (in this case, the antifungal agent amphotericin B) in a lipid crystal to help the oral administration of drugs otherwise given by injection. Encapsulation of amphotericin B with the Bioral technology provides a potential opportunity to administer the drug orally.

• Cytopia Ltd., of Melbourne, Australia, successfully concluded dose escalation in its oral Phase I study for CYT997, its anticancer vascular-disrupting agent (VDA). The primary objectives of safety and tolerability were achieved. Those were to determine the maximum tolerated dose and the dose-limiting toxicities for the agent when administered orally in capsule form every two weeks to patients with a diverse range of solid tumors. Safety and tolerability data from the study augmented data obtained in the company's first Phase I study where CYT997 was administered intravenously. Together, those studies suggested that the CYT997 is a potent and selective VDA, which is well tolerated at biologically efficacious doses and is worthy of further investigation as a novel anticancer agent, the company said.

• ImClone Systems, of New York, a wholly owned subsidiary of Indianapolis-based Eli Lilly and Co., and Genentech Inc., of South San Francisco, were the subject of a study published in the New England Journal of Medicine concerning the addition of ImClone's Erbitux (cetuximab) to Genentech's Avastin (bevacizumab) and the chemotherapy drugs capecitabine and oxaliplatin in the first-line treatment of metastatic colorectal cancer. The 755-patient randomized Phase III study, known as CAIRO2, found that the addition of Erbitux decreased progression-free survival and quality of life while increasing adverse events. Data were first presented at the 2008 annual meeting of the American Society of Clinical Oncology.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., initiated a Phase I study of SGLT2Rx, its first kidney-targeted antisense drug for Type II diabetes. It is an antisense drug that inhibits the production of sodium dependent glucose co-transporter Type 2. SGLT2 is the major transporter responsible for glucose reabsorption in the kidney. The study is designed to assess the safety and pharmacokinetic profile of SGLT2Rx as well as to measure its activity by evaluating its effect on glucose excretion in urine.

• Raptor Pharmaceuticals Corp., of Novato, Calif., completed patient enrollment in its Phase IIa open-label trial to evaluate cysteamine bitartrate (cysteamine) in patients diagnosed with nonalcoholic steatohepatitis (NASH), a form of liver disease that accounts for about 10 percent of newly diagnosed cases of chronic liver disease and a leading cause of cirrhosis in the U.S. NASH patients currently are limited to managing their disease through weight control, diet and exercise.

• Transition Therapeutics Inc., of Toronto, completed patient enrollment for a Phase II study of gastrin analogue TT-223 in patients with Type II diabetes. The dose-ranging study was designed to evaluate the safety, tolerability and efficacy of daily TT-223 treatments for 12 weeks with a six-month follow-up. Approximately 80 patients with Type II diabetes have been enrolled. Patients receive a daily treatment of TT-223 in addition to their current regimen of oral glucose-lowering agents (metformin and/or thiazolidinediones).