• Avicena Group Inc., of Palo Alto, Calif., initiated a Phase I study of the neuroprotective agent AL-02 in subjects with amyotrophic lateral sclerosis. The open-label study in six patients with sporadic ALS is designed to establish the optimal dose for further studies, and to evaluate brain concentration levels of AL-02.

• BioDelivery Sciences International Inc., of Morrisville, N.C., announced additional statistically significant results from its Phase III trial of BEMA Fentanyl in cancer patients with breakthrough pain. Data showed the product demonstrated statistical significance vs. placebo on a summary of pain at 15 minutes, a secondary endpoint. Last month, BDSI disclosed statistically significant results of its primary efficacy endpoint, a summary of pain intensity at 30 minutes. BEMA Fentanyl consists of a small, dissolvable polymer disc, formulated with the opioid narcotic fentanyl, for application to the buccal membranes.

• Dyax Corp., of Cambridge, Mass., began patient treatment in the Phase II trial of DX-88 (ecallantide) for the prevention of blood loss during on-pump cardiothoracic surgery, which includes coronary artery bypass graft surgery and heart valve replacement or repair procedures. The randomized, placebo-controlled, 160-patient trial will compare two doses of DX-88 to placebo on endpoints that include chest tube drainage, transfusion requirements and pharmacodynamics. DX-88 is a recombinant small protein that has been shown to inhibit human plasma kallikrein.

• Ichor Medical Systems, of San Diego, received FDA approval to conduct a Phase I trial of a melanoma vaccine to be administered to patients using an Ichor delivery technology. The vaccine, developed at the Memorial Sloan-Kettering Cancer Center, consists of DNA encoding a form of the tyrosinase protein, an immunotherapy target. The vaccine will be administered to malignant melanoma patients with the Ichor TriGrid Delivery System, which uses electroporation to increase the intracellular delivery of the DNA vaccine to the cells at the site.

• Momenta Pharmaceuticals Inc., of Cambridge, Mass., initiated dosing in a Phase I study to evaluate safety, tolerability, bioavailability and pharmacokinetics of a subcutaneous formulation of M118, a next-generation anticoagulant designed specifically for use in treating acute coronary syndromes. The trial will be conducted in healthy adult volunteers. M118 is designed to interact at multiple points in the coagulation cascade by selectively binding to anti-thrombin III and thrombin.

• Nautilus Biotech, of Paris, received clearance from the FDA for a Phase I trial of oral Belerofon, a variant of human interferon-alpha being developed for hepatitis C and other indications. A Phase I study of injectable, subcutaneous Belerofon began last month. The oral study expected to begin later this year will evaluate safety, tolerability and pharmacokinetics in healthy adult subjects.

• Oncolytics Biotech Inc., of Calgary, Alberta, said the U.S. National Cancer Institute filed a protocol with the FDA for a Phase II trial of Reolysin in up to 47 patients with metastatic melanoma. The NCI is sponsoring the study under a clinical trials agreement with Oncolytics, which will provide clinical supplies of Reolysin, its formulation of the human reovirus.

• Pro-Pharmaceuticals Inc., of Newton, Mass., said stabilized disease was seen in seven of eight patients in a Phase II trial of Davanat, which was used with a chemotherapy regimen in first-line treatment of chemotherapy-sensitive colorectal cancer patients. The trial will enroll up to 50 patients. In a Phase II study for first-line treatment of biliary cancer, four of five patients have shown stabilized disease. That open-label study with 5-FU is designed to enroll up to 42 patients.

• SkyePharma plc, of London, and Sciele Pharma Inc., of Atlanta, completed a clinical trial program for a new formulation of Sular, a calcium channel blocker for treating high blood pressure. The study showed that the new Sular formulation, which uses SkyePharma's Geomatrix technology, is bioequivalent to Sciele's currently marketed Sular. Sciele said it plans a supplemental new drug application filing this quarter.

• Vical Inc., of San Diego, presented data showing that antigen-specific memory T-cell responses to cytomegalovirus, which may be important in protecting against CMV disease, were detected six months after DNA vaccination in a majority of CMV-seronegative subjects in a previously completed Phase I study. The cultured interferon-gamma Elispot assay detected memory T-cell immune responses in 15 of 22 CMV-seronegative subjects using archived samples from the company's completed Phase I trial of its bivalent DNA vaccine encoding CMV phosphoprotein 65 and glycoprotein B.