• Anthera Pharmaceuticals Inc., of San Mateo, Calif., said the FDA approved its investigational new drug application for its lead cardiovascular compound, A-002. Anthera will initiate a multicenter Phase II trial called PLASMA (Phospholipase Levels And Serological Markers of Atherosclerosis) that will examine the effect of A-002 on secretory phospholipase A2 levels and other well established markers of inflammation and cardiovascular risk in patients with stable coronary artery disease due to underlying atherosclerosis. PLASMA is expected to complete enrollment by the fourth quarter of 2007.

• BiPar Sciences Inc., of Brisbane, Calif., began enrolling its Phase Ib study of BSI-201 to assess the effects of BSI-201 in combination with four different cytotoxic regimens, in patients with qualifying solid tumors. BSI-201 is BiPar's lead compound in a new class of cancer therapies known as poly-ADP-ribose polymerase inhibitors.

• BN ImmunoTherapeutics Inc., of Mountain View, Calif., said the FDA accepted its investigational new drug application for MVA-BN-HER2, a breast cancer vaccine. The company expects to begin clinical testing early this year in the U.S., and anticipates a European trial to begin shortly thereafter. The Phase I/II studies are designed to test the vaccine's safety and tolerability, as well as the biological activity as measured by HER-2 specific immune responses in treated patients.

• Innovive Pharmaceuticals Inc., of New York, said the FDA granted orphan drug designation to INNO-406, an oral dual Bcr-Abl and Lyn-kinase inhibitor for Gleevec-resistant or intolerant chronic myelogenous leukemia. That designation would provide the product seven years of marketing exclusivity upon approval. INNO-406 is in a dose-escalating Phase I study, with final data expected in the second quarter.

• Medarex Inc., of Princeton, N.J., said enrollment has been completed in a pivotal, registrational clinical trial evaluating ipilimumab (MDX-010) as monotherapy for the second-line treatment of metastatic melanoma. Ipilimumab is a fully human antibody against human CTLA-4, a molecule on T cells that suppresses the immune response. Medarex and Bristol-Myers Squibb Co., of New York, are developing the drug.

• Nuvelo Inc., of San Carlos, Calif., began patient enrollment in a Phase II trial of recombinant nematode anticoagulant protein c2 for the treatment of metastatic colorectal carcinoma. The primary objectives of the multicenter, two-stage trial are to determine the safety and efficacy of twice-weekly, subcutaneous rNAPc2 for the second-line treatment of mCRC in combination with 5-fluorouracil-based chemotherapy regimens. The first stage will evaluate the safety and activity of rNAPc2 in a three-tier dose escalation format (2.5, 5 and 10 micrograms/kg). The second will randomize patients to doses determined safe during the first stage by an independent data monitoring committee and placebo in conjunction with standard chemotherapy regimens. Nuvelo plans to enroll up to 100 patients in the study.