• Biodel Inc., of Danbury, Conn., completed enrollment in two pivotal Phase III trials of VIAject, its fast-acting injectable human insulin. The open-label trials will compare VIAject to Humulin (recombinant human insulin, Eli Lilly & Co.) in about 400 Type I diabetes patients and 400 Type II diabetes patients. Biodel expects to complete the trials and potentially submit a new drug application by the end of the year. The company also is building a manufacturing facility to prepare for VIAject commercialization.

The International Myeloma Foundation, of North Hollywood, Calif., said updated data from a Phase II study, known as BiRD, showed that patients with multiple myeloma taking Revlimid (lenalidomide), marketed by Celgene Corp., of Summit, N.J., plus a low dose of dexamethasone and Biaxin (clarithromycin), sold by Abbott, of Abbott Park, Ill., had an overall response rate of 90.3 percent. About 39 percent of patients achieved a complete response and 73.6 percent achieved a 90 percent or greater decrease in m-protein levels, according to IMF. The BiRD treatment did not impede stem cell transplantation, and demonstrated a two-year event-free survival rate of 85.2 percent for patients who underwent stem cell transplant and 75.2 percent for those who continued on therapy without transplant, the foundation said. Median event-free survival time was not reached.

• Kosan Biosciences Inc., of Hayward, Calif., said it has opened enrollment for the Tanespimycin in Myeloma Evaluation, or TIME-1, Phase III trial for tanespimycin in multiple myeloma. The pivotal trial is comparing tanespimycin in combination with Velcade (bortezomib) or Velcade alone in patients following a single prior course of treatment after first-relapse. TIME-1 is being conducted under an FDA special protocol assessment and a scientific advice process with the Committee for Medicinal Products for Human Use of the centralized European Medicines Agency. The TIME-2 trial, which recently was opened for patients who have failed at least three prior myeloma therapies and designed to support TIME-1, will be closed and replaced with an alternative supportive trial, the firm said.

• Metabasis Therapeutics Inc., of San Diego, said preliminary Phase Ib data indicated MB07811 is well tolerated and reduces both fasting low-density lipoprotein cholesterol levels and fasting triglyceride levels. The Phase Ib trial is ongoing, and Metabasis plans to explore higher doses prior to initiating a Phase II trial this year. MB07811 is an oral, liver-targeted, beta-subtype-selective, thyroid hormone receptor agonist for hyperlipidemia.

• MethylGene Inc., of Montreal, said it filed an investigational new drug application with the FDA for MGCD265, the firm's multitargeted (c-MET) kinase inhibitor. MGCD265 targets the c-MET, vascular endothelial growth factor receptor (VEGFR) 1, VEGFR2, VEGFR3, Tie-2 and Ron receptor tyrosine kinases, which appear to play key roles in tumor development and survival, blood vessel formation and cancer cell metastasis.

• Rib-X Pharmaceuticals Inc., of New Haven, Conn., initiated two Phase II trials of the oxazolidinone antibiotic RX-1741. One trial is a randomized, double-blind, 160-patient study of multiple doses of RX-1741 in community-acquired pneumonia. The other trial is a randomized, open-label, 150-patient study comparing RX-1741 to Zyvox (linezolid, Pfizer Inc.) in uncomplicated skin and skin structure infections. Data from both trials are expected in the first half of 2008.

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