• Arena Pharmaceuticals Inc., of San Diego, said Ortho-McNeil Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, initiated a Phase I trial of APD668 for the treatment of Type II diabetes. This trial triggers a $5 million milestone payment to Arena under its collaboration with Ortho-McNeil to develop compounds targeting the glucose-dependent insulinotropic receptor.

• Avalon Pharmaceuticals Inc., of Germantown, Md., completed the three-week dosing regimen on the first patient in Cohort II, and initiated Cohort I of its Phase I trial of AVN944 in patients with advanced hematological malignancies. The trial is designed to evaluate the safety and tolerability of AVN944, as well as to determine the optimal dose for a Phase II study. AVN944 is an oral, small-molecule inhibitor of the enzyme inosine monophosphate dehydrogenase that appears to inhibit cell proliferation.

• BioMS Medical Corp., of Edmonton, Alberta, said it received recommendation to continue its pivotal Phase II/III trial for MBP8298 in secondary progressive multiple sclerosis following the third meeting of the data safety monitoring board. The safety data included MRI scans conducted on the first 100 patients dosed in the study.

• DOV Pharmaceutical Inc., of Hackensack, N.J., initiated dosing in a Phase II trial of bicifadine, an analgesic, in patients with painful osteoarthritis of the hip or knee. The study is designed to evaluate bicifadine alone and in combination with ibuprofen. DOV expects to complete dosing in the third quarter.

• GenVec Inc., of Gaithersburg, Md., said data from a Phase I study of its AdPEDF gene therapy in 28 patients with advanced neovascular age-related macular degeneration showed evidence of a halt in disease progression lasting six to 12 months after patients received a single intravitreous injection. No serious adverse events, severe ocular inflammation or dose-limiting toxicities were reported. Results were published in the February issue of Human Gene Therapy.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., completed a Phase I study of an oral formulation of ISIS 301012, demonstrating oral bioavailability and pharmacological activity. The drug is a second-generation antisense drug designed to target apoB-100, a protein critical to the synthesis and transport of low density lipoprotein cholesterol. Study data showed that one month of dosing resulted in an average of 6 percent bioavailability, and a statistically significant reduction of about 13 percent in apoB-100.

• Nabi Biopharmaceuticals, of Rockville, Md., reported positive data from Phase I studies of its S. epidermis PS-1 vaccine and its S. aureus Type 336 vaccine, showing that escalating doses were well tolerated, and resulted in significant dose-related increases in antibody levels. The company said these data support moving the vaccines into Phase II development.

• New River Pharmaceuticals Inc., of Radford, Va., presented positive data from a Phase I/II study comparing the bioavailability of two formulations of its hydrocodone derivative, NRP290, relative to Vicodin tablet in fasted state adult volunteers. Results were presented at the Merrill Lynch Global Pharmaceutical, Biotechnology and Medical Device conference in New York. In separate news, New River reported that it received a $50 million milestone payment from Basingstoke, UK-based Shire plc, stemming from the companies collaboration signed a year ago to develop and commercialize NRP104 in attention deficit hyperactivity disorder. The FDA accepted the new drug application for NRP104 for review last month. (See BioWorld Today, Feb. 1, 2005.)

• Optimer Pharmaceuticals Inc., of San Diego, said Phase IIa studies indicated that its lead antibiotic candidate, OPT-80/PAR-101, appears to be efficacious in Clostridium difficile-associated diarrhea. The drug was well tolerated, with an overall cure rate of 91 percent (41 of 45 patients). The company, along with partner Par Pharmaceutical Companies Inc., of Spring Valley, N.Y., recently received FDA approval for a Phase IIb/III trial, expected to begin in April.

• Palatin Technologies Inc., of Cranbury, N.J., and King Pharmaceuticals Inc., of Bristol, Tenn., initiated enrollment in a Phase IIb trial of PT-141, a melanocortin receptor agonist, in patients with female sexual arousal disorder. The trial is designed to evaluate the drug's safety and efficacy in about 60 FSAD patients over a two-month treatment period.

• Prana Biotechnology Ltd., of Melbourne, Australia, completed a second Phase I trial with its lead compound, PBT2, in Alzheimer's disease, with initial analysis indicating that the drug has a safety and pharmacokinetic profile suitable for further development. Full Phase I analysis is expected in March. The company is conducting chronic toxicology studies and the GMP manufacturing developing that's required before beginning Phase II trials.

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