• Chelsea Therapeutics International Ltd., of Charlotte, N.C., said it received approval from the UK's Medicines and Healthcare Products Regulatory Agency to begin a Phase II trial of droxidopa, alone and in combination with carbidopa, for the treatment of fibromyalgia. The multicenter, randomized, double-blind, placebo-controlled, dose-response trial is planned to begin in September. The company plans to enroll 120 patients, who will be divided into 12 treatment arms. The primary endpoint will be the average reduction in pain as measured by the short-form McGill Pain Questionnaire.

• CombinatoRx Inc., of Cambridge, Mass., said it has discontinued the CRx-102 Phase IIb rheumatoid arthritis clinical trial (MARS-1). The company said it faced challenges with finding patients who are not already on glucocorticoids and issues with both its third-party supplier of clinical trial material and clinical contract research organization. As a result, the company decided to discontinue the trial to preserve money. It expects to save approximately $20 million through 2009. Specifically, it provides resources to secure a partner for Synavive, which is in a Phase IIb safety and efficacy trial in symptomatic knee osteoarthritis.

• Dendreon Corp., of Seattle, said it expected the independent data monitoring committee to review the interim analysis of overall survival relating to its Phase III trial of Provenge (sipuleucel-T) for treatment of prostate adenocarcinoma in October. The primary endpoint is overall survival. The company said it would amend its biologics license application based on positive interim results. If the prespecified criterion for statistical significance is not met, then the company anticipates continuing the trial with the expectation of reporting final results in the second half of 2009.

• Duska Therapeutics Inc., of La Jolla, Calif., announced the submission of its proposed Phase III study for ATPace (adenosine triphosphate injection) to the FDA division of cardiovascular and renal products. The proposed single, prospective, placebo-controlled, randomized study is designed to evaluate the safety and efficacy of ATPace in patients presenting to the emergency room with paroxysmal supraventricular tachycardia. The FDA has agreed to review the proposed study under the special protocol assessment procedure. Upon successful completion of the Phase III study, Duska plan to file a new drug application for ATPace.

• Introgen Therapeutics Inc., of Austin, Texas, presented additional supportive statistical analyses from a pivotal Phase III trial of Advexin in patients with recurrent, refractory head and neck cancer. The data showed that patients with p53 tumor profiles positive for Advexin efficacy demonstrated statistically significant increased survival benefit at both six months (p < 0.0051) and overall (p = 0.0265) following treatment with Advexin. The analyses also showed that for patients with tumor p53 profiles negative for Advexin efficacy there is a statistically significant increased survival benefit associated with methotrexate treatment.

• Nabi Biopharmaceuticals, of Rockville, Md., announced positive interim results from its Phase II NicVAX (nicotine conjugate vaccine) schedule optimization immunogenicity study to assess the antibody response and safety of a 400-mcg, six-dose immunization schedule. Interim results indicated that significantly higher antinicotine antibody levels can be generated three months earlier and in a much higher percentage of subjects than observed in previous Phase IIb proof-of-concept studies. The revised schedule was well tolerated with an adverse event profile comparable to previous NicVAX clinical studies.

• Optimer Pharmaceuticals Inc., of San Diego, said it completed enrollment in the first two Phase III trials evaluating the safety and efficacy of OPT-80 for the treatment of Clostridium difficile infection (CDI), compared to oral vancomycin, the only FDA-approved antibiotic for CDI treatment. The study was designed to evaluate safety and compare the response to treatment by subjects during and after a 10-day course of therapy for cure, which is the primary endpoint. If cured, subjects are followed for a subsequent four-week period to evaluate recurrence, which is the secondary endpoint.

• Sound Pharmaceuticals Inc., of Seattle, filed an investigational new drug application to begin testing its formulation of ebselen for the prevention of chemotherapy-induced hearing loss or ototoxicity. The oral capsule containing ebselen, SPI-3005, will be tested in advanced-stage lung cancer and head and neck cancer patients receiving platinum-based chemotherapy.

• Topigen Pharmaceuticals, of Montreal, said it completed enrollment for its Phase II trial of TPI ASM8, evaluating the drug's safety and efficacy in asthma. The multicenter, randomized, placebo-controlled, crossover study will evaluate once-daily inhalation doses of TPI ASM8 over 14 days. Topigen said it expects to complete the study and report the data by the end of the year.

• Ziopharm Oncology Inc., of New York, said it released data from two Phase I trials of indibulin, a synthetic, tubulin-targeted, antimitotic, orally administered drug. Out of 34 patients participating - with various forms of sarcomas and carcinomas, including pancreatic thyroid, ovarian, prostate and lung cancer - 24 have completed at least two cycles of therapy and are evaluable using RECIST criteria. Of those patients, 11 have experienced more than four months of stable disease, with three reaching eight or more months, so far. Data were presented recently at the American Association for Cancer Research conference in Monterey, Calif.