•Akela Pharma Inc.(formerly LAB International Inc.), of Montreal, initiated a Phase IIb asthma trial of CGRP, a 37 amino acid, natural neuropeptide produced in the lung in response to allergic stimuli. The double-blind study will randomize 16 patients to receive inhaled CGRP or placebo in two one-week treatment periods with a goal of demonstrating efficacy in clinical and inflammatory parameters.

• Ascenta Therapeutics Inc., of San Diego, said that preliminary data from a Phase I/II trial of AT-101 indicate that the compound has biological activity in combination with docetaxel and prednisone in men with hormone-refractory-prostate cancer (HRPC). Eight of nine chemotherapy-naive patients treated in the Phase I portion of the trial achieved a 50 percent partial response of the tumor marker prostate specific antigen, and all nine achieved a 30 percent drop in PSA levels. No dose-limiting toxicities were observed for any patient in the study.

• Diamyd Medical AB, of Stockholm, Sweden, said it has a pre-investigational new drug meeting with the FDA scheduled later this week to discuss NP2, a pain drug that uses the nerve targeting drug delivery system gene therapy platform. Pending a favorable outcome, Diamyd plans to begin a 12-patient, Phase I trial in cancer pain later this year. The company also plans to begin a Phase III trial with its diabetes vaccine later this year.

• Hemispherx Biopharma Inc., of Philadelphia, announced that enrollment in its nationwide Alferon N Phase IIb trial to treat West Nile Virus has nearly reached its 50-percent mark. The ongoing Alferon N West Nile Virus study is the only well-controlled clinical study being conducted in the United States at this time, Hemispherx Biopharma said. The firm also reported early results from its April 23 strategic agreement with Armada Health Care to launch Alferon N sales for refractory human papillomavirus. The Armada agreement contributes about 40 percent to overall Alferon N sales, the company said.

• Implicit Bioscience Pty. Ltd., of Brisbane, Australia, announced that a Phase IIa clinical trial of intranasal oglufanide disodium to treat chronic hepatitis C viral infection is underway. The product, which regulates the body's innate immune response to defeat invading germs and cancer cells, has also been studied in other forms to treat severe infectious disease. The drug is also under development by Implicit as a biodefense therapy and for ovarian cancer.

• Marshall Edwards Inc., of Washington, began European enrollment in its Phase III OVATURE trial, which started U.S. enrollment in June. The 470-patient, double-blind trial will compare phenoxodiol plus carboplatin to placebo plus carboplatin in recurrent ovarian cancer. Interim results are expected within 12 to 18 months. Marshall Edwards is a majority-owned subsidiary of Sydney, Australia-based Novogen Ltd.

• MedImmune Inc., a Gaithersburg, Md., unit of AstraZeneca plc, said a Phase III trial of motavizumab (formerly known as Numax) showed the product reduce hospitalizations due to respiratory syncytial virus by 83 percent vs. placebo (8.3 percent in placebo arm vs. 1.4 percent for motavizumab; p<0.001), the trial's primary endpoint. In addition, the trial showed the monoclonal antibody resulted in a 71 percent reduction in the incidence of RSV-specific lower respiratory infections requiring outpatient management (p<0.001), a secondary endpoint. The Phase III trial involved 1,410 full-term infants less than 6 months of age in two Native American populations. Data support positive results seen in a Phase III pivotal trial comparing motavizumab and its approved product Synagis (palivizumab).

• Onyx Pharmaceuticals Inc., of Emeryville, Calif., and partner Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., said an independent data monitoring committee (DMC) recommended the Asia-Pacific regional Phase III trial of Nexavar (sorafenib) in advanced liver cancer be halted so that all patients can receive treatment. In its planned review, the DMC found that Nexavar significantly improved overall survival, progression free survival, and time to progression. Nexavar is a multi-kinase inhibitor approved in more than 50 countries for kidney cancer, and regulatory applications seeking approval in liver cancer are under review in the U.S., Europe, China and other countries based on a previous pivotal Phase III trial. Shares of Onyx (NASDAQ:ONXX) rose $3.42, or 10 percent, to close at $37.04 on Monday.

• Protalix BioTherapeutics Inc., of Carmiel, Israel, treated the first patient in its Phase III trial of prGCD, a plant cell-expressed recombinant form of human glucocerebrosidase for Gaucher's disease, a lysosomal storage disorder. The trial design consists of 30 patients, and is being conducted under a special protocol assessment with the FDA.

• TorreyPines Therapeutics Inc., of La Jolla, Calif., has initiated a Phase I multiple dose clinical trial to evaluate the safety, tolerability and pharmacokinetics of tezampanel, an AMPA/kainate (AK) receptor antagonist that selectively binds to certain AK receptors to potentially block the transmission of pain signals. Data from the double-blind, placebo-controlled, multiple-dose trial will support the continued development of tezampanel for the treatment of migraine headaches and potentially for other chronic pain conditions.