• Auxilium Pharmaceuticals Inc., of Malvern, Pa., received clearance from the FDA to resume its phase III clinical trials for Xiaflex (clostridial collagenase for injection) in the treatment of Dupuytren's contracture, a condition that involves contracture of joints in the hand that impairs patients' ability to straighten and move their fingers due to a thickening and shortening of the normal ligaments of the palm and fingers. The company plans to begin enrolling patients within a month.

• Bioniche Life Sciences Inc., of Belleville, Ontario, said a full complement of 25 sites have been qualified to enroll patients in its clinical trial with Mycobacterial Cell Wall-DNA Complex (MCC) - trademarked Urocidin - in patients with non muscle-invasive bladder cancer that is refractory to the current standard therapy. This indication was given fast track designation by the FDA in April 2006. The targeted enrollment of 105 patients is expected by the end of the year.

• Immunomedics Inc., of Morris Plains, N.J., reported results from a study showing epratuzumab inhibits the activation of B-cells from patients with systemic lupus erythematosus (SLE) but not normal subjects. Epratuzumab is a humanized monoclonal antibody that targets the CD22 antigen found on B-cells. In an earlier Phase I/II study, epratuzumab was found to show activity and good safety in the treatment of patients with lupus. A study aimed at understanding the mechanism of action of epratuzumab showed it preferentially targets naive and transitional B-cells, which the company said may be a unique difference to other therapeutic antibodies. In the second part of the study with 11 patients and seven normal subjects, epratuzumab stopped the over-activation of B-cells from SLE patients but not normal B-cells, when activated by certain immune stimulating agents.

• Inovio Biomedical Corp., of San Diego, and Tripep AB, of Huddinge, Sweden, received approvals from the Swedish Medical Products Agency and local ethics committees to initiate a Phase I/II clinical trial of a novel DNA vaccine designed to treat chronically infected hepatitis C virus patients. The trial will test Tripep's proprietary DNA vaccine, ChronVac-C, administered using Inovio's MedPulser DNA Delivery System, in 12 subjects already infected with HCV. The trial, beginning in October, will be conducted in Sweden at two Karolinska University Hospitals, the Center for Gastroenterology in Solana and the Infections Clinic in Huddinge.

• Myriad Genetics Inc., of Salt Lake City, has initiated a third Phase II human clinical trial of Azixa (MPC-6827), in patients with non-small-cell lung cancer that has spread to the brain. The primary endpoint of the trial is a comparison of the overall survival of patients treated with Azixa alone to those treated with temozolomide or the combination of Azixa plus temozolomide. Secondary endpoints include progression-free survival and a quality of life assessment of patients.

• Pro-Pharmaceuticals Inc., of Newton, Mass., said the FDA has granted a "compassionate use" investigational new drug application for use of Davanat in combination with 5-Fluorouricil (5-FU) to treat a patient with unresectable cholangiocarcinoma (cancer of the bile duct) that progressed after initial chemotherapy. The patient is being treated at Tampa General Hospital which is a clinical site for the company's Phase II trial for first line treatment of patients with advanced biliary cancer. In a Phase II study underway, eight patients have been dosed with Davanat in combination with 5-FU. One patient has tumor shrinkage of greater than 30 percent, which is considered a partial response. Five patients are currently on study with stable disease of up to six months.