• Advanced Magnetics Inc., of Cambridge, Mass., said a data monitoring committee overseeing the ferumoxytol Phase III intravenous iron replacement therapy program met for the final time and identified no safety concerns. The DMC recommended continuation of the ferumoxytol Phase III studies with no modifications. At the meeting, the DMC reviewed safety data from 1,610 subjects enrolled in the Phase III program. The therapy is being tested in chronic kidney disease patients.

• AlphaRx Inc., of Markham, Ontario, completed the treatment phase of its double-blind, controlled, multicenter Phase II clinical trial evaluating the efficacy and safety of Indaflex for treating osteoarthritis of the knee. Results are expected to be reported by the end of the month. In April, AlphaRx licensed Indaflex - a topical nonsteroidal anti-inflammatory drug - to Proprius Pharmaceuticals Inc., of San Diego. (See BioWorld Today, April 12, 2006.)

• Arena Pharmaceuticals Inc., of San Diego, said it initiated dosing in a 100-patient Phase II trial of APD125 in chronic insomnia. The randomized, double-blind, placebo-controlled study is evaluating the safety and efficacy of nighttime dosing. The trial will evaluate standard measurements of sleep, such as wake after sleep onset, number of awakenings, total sleep time and latency to persistent sleep. The trial employs a crossover design, meaning every patient will receive each of the two active doses of APD125 and placebo over the course of the study.

• Ciphergen Biosystems Inc., of Fremont, Calif., presented data from a prospective trial demonstrating its ovarian triage test correctly identified 84 percent of the ovarian cancer cases, compared to only 33 percent identified using standard diagnosis methods without the test. The poster presentation was made Sunday at the Society of Gynecologic Oncologists meeting on women's cancer in San Diego.

• Collegium Pharmaceutical Inc., of Cumberland, R.I., said a proof-of-concept study showed benefit for its once-a-day combination product on nasal symptoms in patients with seasonal allergic rhinitis. The 76-patient trial compared the combination product against one of its individual components and placebo. Collegium said that following completion of an end-of-Phase II meeting with the FDA, it expects to finalize its Phase III protocol and begin pivotal trials with its modified-release formulation (CP-118).

• Iomai Corp., of Gaithersburg, Md., announced publication of results from the double-blind challenge study of its vaccine patch for travelers' diarrhea. The study found that volunteers who received the vaccine before being exposed to high levels of enterotoxigenic E. coli bacteria had less severe diarrhea and were significantly less likely to require intravenous fluids than patients who were not vaccinated. The study enrolled 27 subjects who received three doses of the Iomai ETEC vaccine and 20 patients who received placebo. Results were published online in advance of print publication in the journal Vaccine.

• Kamada Ltd., of Ness Ziona, Israel, said it is beginning Phase III trials of its alpha-1 antitrypsin product, also known as alpha-1 proteinase inhibitor. The trial, which follows an FDA-approved protocol, will include 50 patients from the U.S. The injectable drug already is marketed in certain countries for treating congenital emphysema. Kamada also has an aerosolized formulation of the product in Phase I trials.

• LAB International Inc., of Montreal, reported positive results from the open-label arm of its Fentanyl Taifun Phase IIb trial. The results from 24 patients demonstrated successful dose titration resulting in effective control of breakthrough pain episodes, it said. Fentanyl Taifun is a fast-acting fentanyl formulation delivered using the company's Taifun dry-powder inhaler platform. The double-blind, placebo-controlled extension arm of the study, which is under way, is expected to be completed by the end of the second quarter.

• Myriad Genetics Inc., of Salt Lake City, presented additional data from a completed Phase II follow-on study of Flurizan in patients with mild Alzheimer's disease. Previously reported 24-month data demonstrated a statistically significant benefit. The new data showed that overall, 42 percent of patients on Flurizan showed improvement or no decline in one or more of the three primary endpoints of cognition, global function and activities of daily living, compared to 10 percent for the placebo group, indicating the drug may not only slow disease progression but also either halt that decline or even improve symptoms. Flurizan is in Phase III trials. Myriad's stock (NASDAQ:MYGN) gained $1.40 Monday to close at $32.63.

• Neoprobe Corp., of Dublin, Ohio, said results from the first stage of a multicenter Phase II trial of Lymphoseek support commencement of enrollment in the second stage of the Phase II study. Lymphoseek is a radioactive tracing agent being developed for use in connection with gamma detection devices in a surgical procedure known as intraoperative lymphatic mapping. Lymphoseek identified lymphatic tissue in more than 97 percent of treated patients. It began the second stage, which will involve an additional 40 patients with either melanoma or breast cancer. Neoprobe also is preparing to submit its Phase III protocol and related materials to the FDA.

• Phenomix Corp., of San Diego, completed a Phase IIa trial of PHX1149, an orally administered inhibitor of the serine protease DPP4, in 174 Type II diabetes patients. The trial met its primary endpoint of improved postprandial glucose as well as secondary endpoints related to HbA1c and GLP-1 levels. The trial also demonstrated favorable tolerability data. Phenomix expects to begin a 12-week Phase IIb study in the first half of this year and Phase III trials in 2008.

• Transition Therapeutics Inc., of Toronto, reported interim data from exploratory Phase IIa trials in diabetes. A study in Type II diabetics demonstrated that E1-I.N.T. significantly lowered blood glucose levels for patients using metformin with or without thiazolidinediones. In Type I diabetics, six of 11 patients responded to E1-I.N.T. therapy, either by decreasing their average daily insulin usage by more than 20 percent or reducing their HbA1c levels. There were no responders among the placebo group. The I.N.T. technology platform entails a series of gastrin-based combination therapies for treating diabetes.