• Allos Therapeutics Inc., of Westminster, Colo., completed patient enrollment in its pivotal Phase III ENRICH study of Efaproxyn (efaproxiral) in women with brain metastases originating from breast cancer. ENRICH (Enhancing Whole-Brain Radiation Therapy In Patients with Breast Cancer and Hypoxic Brain Metastases) is designed to evaluate whole-brain radiation therapy with supplemental oxygen with or without Efaproxyn. A total of 360 patients were enrolled at 126 participating centers in the U.S., Canada, Europe and South America. The primary endpoint is survival, and secondary endpoints include response rate in the brain.

• Cellegy Pharmaceuticals Inc., of Huntingdon Valley, Penn., said an independent data safety monitoring board recommended discontinuing a Phase III trial of Savvy (C31G vaginal gel) in Nigeria after concluding that the study was not likely to provide convincing evidence that the product protects against HIV in women. The board observed a lower-than-expected rate of HIV seroconversion in the study, which was less than half the expected rate and possibly due to procedures designed to ensure ethical trial design, such as HIV counseling and the distribution of condoms. Last fall, Cellegy halted a similar study of Savvy in Ghana based on low seroconversion rates. (See BioWorld Today, Nov. 9, 2005.)

• Connetics Corp., of Palo Alto, Calif., reported results from a Phase III trial of Extina (ketoconazole) Foam, 2 percent, formulated in VersaFoam-HF, for the treatment of seborrheic dermatitis. The four-week, double-blind, active- and placebo-controlled trial included 1,162 patients at 24 centers in the U.S. Based on the Investigator's Static Global Assessment, Extina demonstrated a 56 percent response, compared with a 42 percent response for placebo (p=0.0001). The trial also demonstrated noninferiority vs. an active comparator arm of ketoconazole cream.

• Genentech Inc., of South San Francisco, and Biogen Idec Inc., of Cambridge, Mass., said Rituxan (rituximab) met its endpoint in a Phase II study relapsing-remitting multiple sclerosis. Results from the 104-patient trial showed a statistically significant reduction in the total number of gadolinium-enhancing T1 lesions observed on serial MRI scans of the brain at weeks 12, 16, 20 and 24 in the Rituxan-treated group compared to placebo. Patients will continue to be followed for 48 weeks.

• InSite Vision Inc., of Alameda, Calif., said the FDA accepted for filing the new drug application for AzaSite (azithromycin 1 percent ophthalmic solution) indicated to treat bacterial conjunctivitis. AzaSite is formulated with DuraSite, InSite's drug delivery vehicle, which enhances the retention time of the antibiotic on the surface of the target tissue. The NDA contains data from two Phase III trials in which 698 patients were treated with AzaSite, demonstrating the drug provided clinically and statistically significant improvements in clinical resolution of symptoms, and bacterial eradication compared to placebo.

• Oncolys BioPharma Inc., of Tokyo, obtained the FDA's approval to begin a Phase I trial of Telomelysin, an adenovirus therapy, in patients with solid cancers. The study will enroll patients who have been resistant to existing treatment and who have no alternatives. Telomelysin is a conditional-restricted, replication-competent adenovirus designed to replace a transcriptional element of the E1A adenovirus gene with a human telomerase reverser transcriptase (hTERT) gene promoter sequence. Oncolys expects to complete the Phase I study by the end of 2007.

• Pharmaxis Ltd., of Sydney, Australia, said the U.S. Aridol Phase III trial in subjects with suspected asthma has finished recruitment. The trial was conducted in more than 400 subjects in 30 hospitals. It compared Aridol with certain methods for diagnosing airway responsiveness.

• Sinovac Biotech Ltd., of Beijing, said Phase I data on its pandemic influenza vaccine showed that the vaccine with different dosages can induce an immune response. There were no serious adverse events reported with the 120 volunteers. The vaccine is co-developed with the Chinese Centers for Disease Control and Prevention.

• Synthetic Blood International Inc., of Costa Mesa, Calif., completed treatment in its Phase IIa study of Oxycyte in traumatic brain injury, and Oxycyte administration appeared to increase oxygen tension over baseline in all eight evaluable trial patients. The study's primary endpoint is to demonstrate Oxycyte's ability to increase brain oxygen tension and favorably affect other brain chemistries that impact clinical outcome in head injury patients. Preliminary data are expected in the fourth quarter.