• Active Biotech AB, of Lund, Sweden, and Teva Pharmaceutical Industries Ltd., of Jerusalem, presented data from their Phase III BRAVO trial showing multiple sclerosis drug laquinimod significantly reduced annualized relapse rates by 21.3 percent (p = 0.026) when imbalances in baseline characteristics were corrected. Without those corrections, the trial missed its primary endpoint, as previously reported. Additional data from the Phase III ALLEGRO trial and preclinical data also were presented at the Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis in Amsterdam, the Netherlands. (See BioWorld Today, Aug. 2, 2011.)

• Allozyne Inc., of Seattle, said a double-blind, placebo-controlled Phase Ib trial of AZ01 showed the drug was well tolerated and has a half-life two to three times longer than other pegylated interferon beta therapeutics in clinical development. AZ01 is a pegylated interferon beta 1-b drug for relapsing/remitting multiple sclerosis. Pivotal trials are expected to begin in 2012.

• Amicus Therapeutics Inc., of Cranbury, N.J., and partner GlaxoSmithKline plc, of London, closed patient recruitment in the first Phase III trial of Amigal (migalastat HCl) for Fabry disease. Enrollment is expected to be completed this quarter.

• Biogen Idec Inc., of Weston, Mass., and Elan Corp. plc, of Dublin, Ireland, presented data showing multiple sclerosis patients on Tysabri (natalizumab) experienced reduced annualized relapse rates, particularly when treated early. Additional data showed Tysabri patients who responded early had long-term benefits, and that anti-JC virus antibody status can be used to stratify patients at risk for developing progressive multifocal leukoencephalopathy. The data were presented at the Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis in Amsterdam, the Netherlands.

• Cleveland BioLabs Inc., of Buffalo, N.Y., reported that an investigational new drug application for testing CBLB502 in a variety of cancers has been opened with the FDA and the Roswell Park Cancer Institute's investigational review board has approved a protocol for the first trial in advanced cancer patients. Up to 48 patients are expected to enroll in multiple trial cohorts to determine the safety, tolerability and maximum tolerated dose of repeated administrations of the drug. CBLB502, which is being developed to reduce the risk of death following exposure to radiation, demonstrated anticancer properties in a number of preclinical tumor models. (See BioWorld Today, Sept. 8, 2011.)

• Genfit SA, of Lille, France, reported partial results from a pharmaco-clinical study demonstrating a hepatic mechanism of action for GFT505 in insulin-resistant patients. Results for 19 of 22 patients showed that the drug significantly increased the response of the liver to insulin action. At the end of the treatment period, the decrease in hepatic glucose production induced by insulin was -51 ± 5 percent after GFT505 vs. -34 ± 4 percent after placebo (p = 0.0014).

• Genticel SA, of Toulouse, France, said it completed patient recruitment for its Phase I trial testing a liquid formulation of ProCervix, a therapeutic human papillomavirus vaccine designed for adult women already infected with HPV genotype 16 or 18. The key objectives of the trial are to evaluate safety and immunogenicity. Genticel also reported that Belgian regulators approved the firm's request to extend the Phase I trial to confirm the safety of a lyophilized formulation of the vaccine.

• Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass., presented Phase I data at the Congress of the European Association of Nuclear Medicine in Birmingham, UK, showing that 99mTc-MIP-1404 and 99mTc-MIP-1405 rapidly detected both bone and lymph node lesions in six metastatic prostate cancer patients and, in some cases, demonstrated a greater number of lesions in bone than standard-of-care imaging such as bone scans. Neither compound localized in the normal prostate gland. 99mTc-MIP-1404 and 99mTc-MIP-1405 are small-molecule inhibitors of prostate-specific membrane antigen.