• Advaxis Inc., of Princeton, N.J., said ADXS-HPV gave positive results in an ongoing Phase II trial in cervical cancer. The study has enrolled 87 subjects in India out of a planned total of 110. Qualifying participants had been previously treated with radiation and/or chemotherapy, with subsequent relapse; 62 percent of patients were alive at six months and 41 percent at nine months. One year survival was 40 percent. Data were presented at the World Cancer Immunotherapy Conference in San Diego.

• Auxilium Pharmaceuticals Inc., of Malvern, Pa., initiated a Phase Ib trial of Xiaflex (collagenase clostridium histolyticum) for edematous fibrosclerotic panniculopathy, or cellulite. Xiaflex, a collagenase mixture that breaks down collagen, is approved for Dupuytren's contracture and would work similarly in cellulite to release the collagen tethers that cause skin dimpling.

• Biogen Idec Inc., of Weston, Mass., and Elan Corp. plc, of Dublin, Ireland, initiated a global Phase IIIb trial, dubbed ASCEND, to evaluate Tysabri (natalizumab) in secondary-progressive multiple sclerosis (SPMS). Tysabri already is approved for the relapsing forms of MS; SPMS is more serious. The randomized, double-blind, placebo-controlled study will enroll 850 patients with a primary endpoint of slowing the accumulation of disability not related to relapses.

• Boehringer Ingelheim GmbH, of Ingelheim, Germany, began two Phase III trials (LUX-Head and Neck 1 and LUX-Head and Neck 2) of afatinib for head and neck cancer. Afatinib is designed to irreversibly block ErbB, which is thought to play a role in the growth of many cancers. In a Phase II study, afatinib was comparable to Erbitux (cetuximab, Eli Lilly and Co.) in patients with recurrent metastatic head and neck cancer following chemotherapy. LUX-Head and Neck 1 will evaluate progression-free survival and overall survival in patients who have progressed following platinum-based chemotherapy. LUX-Head and Neck 2 will study recurrence of disease and overall survival in patients with locally advanced disease following chemoradiotherapy.

• The Drug Development Office of Cancer Research UK, of London, began the first trial of aurora kinase inhibitor AT9283 in childhood leukemia. The goal of the trial will be to establish a correct drug dosage and evaluate treatment potential in children and adolescents with leukemia. Great North Children's Hospital, of Newcastle upon Tyne, UK, is leading the trial, with participation by four other clinical centers.

• Vanda Pharmaceuticals Inc., of Rockville, Md., said initial data on the first four patients in the Phase III RESET study of tasimelteon for non-24-hour sleep-wake disorder showed the drug can reset the body clock and align it to a 24-hour day. RESET is being conducted in blind patients with no light perception; 20 tasimelteon responders will be enrolled, and data are expected from this study and another Phase III trial by the end of the year. Tasimelteon is an MT1 and MT2 receptor agonist thought to be able to regulate circadian rhythms. It also has completed Phase III trials in insomnia. (See BioWorld Today June 27, 2008.)