• Alkermes Inc., of Cambridge, Mass., completed patient enrollment for the registration study of Vivitrol (naltrexone for extended-release injectable suspension) for the treatment of opioid dependence. Alkermes expects to report topline results in late calendar 2009 and anticipates a sNDA submission in calendar 2010. The firm also announced it will initiate a Phase IIIb study in health care professionals to assess its safety and tolerability in health care professionals with a history of opioid dependence who are enrolled in an extended outpatient treatment program that includes psychosocial support.

• Ardea Biosciences Inc., of San Diego, announced positive results from a Phase I study in normal, healthy volunteers of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, and a pilot Phase IIa proof-of-concept study in gout patients of RDEA594's prodrug, RDEA806. Statistically significant reductions in uric acid were dose-dependent and seen in all dose groups, ranging from 5 mg to 600 mg. A reduction of 45 percent from baseline (corrected for placebo) was observed after 10 days at the highest dose evaluated. The compound was well-tolerated with no serious adverse events or drug-related discontinuations due to adverse events.

• Circassia Ltd., of Oxford, UK, has initiated a Phase II study of its ToleroMune technology in allergy patients with asthma. The trial builds on positive Phase II results and extends clinical investigations to those with allergy-associated asthma. The latest study, in Canada, will enroll 48 patients with confirmed cat allergies and cat allergen-induced asthma.

• Cytos Biotechnology Ltd., of Zurich, Switzerland, has initiated a Phase IIa study with CYT003-QbG10, an immunotherapeutic product candidate for the allergen-independent treatment of allergy and asthma. The study is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability and exploratory efficacy in 60 patients with persistent allergic asthma bronchiale. First results are expected to be available in the first half of 2010.

• Dendreon Corp., of Seattle, has enrolled the first patient in a Phase I trial of D3263 in patients with advanced cancer. D3263 is Dendreon's lead small-molecule drug candidate designed to target TRPM8, a transmembrane cation channel protein, in cancer cells to induce cell death. The trial is an open-label, dose-escalation study evaluating the safety and pharmacokinetics of orally-administered D3263 in patients with solid tumors that are refractory to standard therapies. The trial will enroll three to six patients per cohort during the dose escalation phase of the study. An expansion cohort may be enrolled following determination of the maximum-tolerated dose.

• InterMune Inc., of Brisbane, Calif., has amended the clinical study of protease inhibitor ITMN-191 (R7227) in combination with nucleoside polymerase inhibitor R7128 (Roche/Pharmasset) to include additional cohorts to explore the combination in treatment-experienced and null responder HCV patients. In addition, the protocol now includes the administration of twice-daily and higher-dose regimens of ITMN-191 in combination with R7128 in treatment-naive patients.

• International Stem Cell Corp., of Oceanside, Calif., said it received excellent preliminary results for a new retail skin rejuvenation product developed as a result of its research into parthenogenic stem cells. Scientists and clinicians discovered that a combination of the special growth media for human skin tissue created by the company, coupled with the by-products of the production of parthenogenic stem cells, appeared to have a dramatic impact on the restoration and retention of skin moisture.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said a Phase III trial for that for NX-1207, the company's investigational drug for benign prostatic hypertrophy, has been given investigational review board approval to begin. Screening and enrollment of patients will begin in the next two weeks. The firm will undertake two pivotal Phase III U.S. trials with a total of 1,000 patients. The trials will test the safety and efficacy of the drug compared to placebo. Efficacy will be determined by symptomatic improvement.

• Poniard Pharmaceuticals Inc., of South San Francisco, presented final data from a Phase I dose-escalation study of picoplatin in patients with metastatic colorectal cancer. Results demonstrated that picoplatin can be safely administered in combination with 5-fluorouracil and leucovorin as a first-line option for CRC. Based on the safety data, Poniard initiated a randomized, controlled, proof-of-concept Phase II trial to evaluate picoplatin as a neuropathy-sparing alternative to oxaliplatin for the first-line treatment of metastatic CRC.

• Transave Inc., of Monmouth Junction, N.J., completed patient enrollment in a Phase II study evaluating the safety and efficacy of Arikace (liposomal amikacin for inhalation) in noncystic fibrosis bronchiectasis patients. The results are expected by midyear. The double-blind, placebo-controlled study is designed to evaluate Arikace in non-CF patients who have bronchiectasis with Pseudomonas lung infections.