• Bradmer Pharmaceuticals Inc., of Toronto, met with the FDA regarding a proposed Phase III trial of Neuradiab, a monoclonal antibody conjugated to radioactive iodine for treating glioblastoma multiforme. Specific guidance received from the agency included simplifying and strengthening the study design to use an exploratory genomic marker to better understand how patients respond or fail to respond to conventional chemotherapy. The primary endpoint in the trial will be the median overall survival in the Neuradiab plus standard-of-care arm compared to patients receiving standard of care alone.

• Critical Therapeutics Inc., of Lexington, Mass., said the National Institutes of Health will sponsor and fund a clinical trial to evaluate whether using Zyflo (zileuton tablets) to treat patients admitted to the hospital with acute exacerbations of chronic obstructive pulmonary disease will shorten their hospital stay. The trial is set to begin in the first quarter of 2007 and will enroll 520 patients.

• Genentech Inc., of South San Francisco, said results from the second interim analysis from the BCIRG 006 Phase III breast cancer study confirmed that, at a three-year median follow-up, Herceptin combined with Taxotere-based regimens significantly improved disease-free survival for women with early HER2-positive breast cancer. In terms of a reduction in the risk of death, 41 percent and 34 percent of patients in the AC-TH (one year of Herceptin to the doxorubicin/cyclophosphamide/Taxotere regimen) and TCH (Taxotere and carboplatin with one year of Herceptin) arms, respectively. Results were reported at the San Antonio Breast Cancer Symposium.

• GenVec Inc., of Gaithersburg, Md., said results from a Phase I trial showed that its HIV vaccine was safe and well tolerated in healthy adult volunteers at multiple doses. The vaccine is based on GenVec's adenovirus vector technology. Results were published in Journal of Infectious Disease.

• ImmunoGen Inc., of Cambridge, Mass., said findings from a Phase I study of South San Francisco-based Genentech Inc.'s trastuzumab-MCC-DM1 for the treatment of HER2-positive metastatic breast cancer show that the patient receiving the 2.4 mg/kg dose level had an objective response by RECIST criteria. The trial is designed to assess the safety, tolerability and pharmacokinetics of trastuzumab (Herceptin)-MCC-DM1 given every three weeks. Results were presented at the San Antonio Breast Cancer Symposium.