• Akesis Pharmaceuticals Inc., of San Diego, said the FDA accepted its investigational new drug application for AKP-020, a vanadium compound, in Type II diabetes. Screening already has begun for patients in a Phase IIa trial measuring the drug's efficacy using the euglycemic-hyperinsulinemic clamping procedure. The company expects to dose the first patient before the end of the year.

• AtheroGenics Inc., of Atlanta, said it stopped testing the highest dose of AGI-1067 (300 mg) in its ongoing ANDES trial based on further review of the overall risk/benefit profile. The trial will continue with the 75-mg and 150-mg doses. ANDES is a dose-ranging study designed to confirm pre-specified diabetes findings announced in May from the company's previous Phase III trial, which missed its endpoint in a composite of cardiovascular measurements but showed promise in a subset of diabetes patients. AtheroGenics anticipates to complete enrollment in the ANDES trial before the end of the year, with an interim analysis to be reported in the second quarter of 2008. Shares of AtheroGenics (NASDAQ:AGIX) fell 40 cents, or 29 percent, Monday to close at $1. (See BioWorld Today, June 1, 2007.)

• BioMS Medical Corp., of Edmonton, Alberta, said more than 133 patients have enrolled in its pivotal Phase III study of MBP8298 in secondary progressive multiple sclerosis, and an interim safety and efficacy analysis will follow after those patients complete 24 months of the clinical trial. The study is expected to involve a total of 510 patients to receive either MBP8298 or placebo intravenously every six months for a period of two years. The primary endpoint is defined as a statistically and clinically significant increase in the time to disease progression. BioMS said it is on track to complete enrollment in the first half of 2008.

• Chelsea Therapeutics International Ltd., of Charlotte, N.C., said the FDA accepted its investigational new drug application for Droxidopa, an oral, synthetic precursor of norepinephrine that is marketed in Japan for orthostatic hypotension. Chelsea now plans to move forward with pivotal Phase III trials in neurogenic orthostatic hypotension (NOH), and will conduct two trials in a total of 236 patients. The primary endpoint for both trials will be a statistically significant improvement in symptomatic benefit between active and placebo, as defined by the dizziness or light-headedness assessment of the Orthostatic Hypotension Symptom Assessment scale. Chelsea anticipates completing both trials by the end of 2008, and pending positive results, would file a new drug application in early 2009.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., reported results from its two Phase III trials of Xibrom (bromfenac sodium ophthalmic solution) QD (once-daily formulation) showing that the drug was statistically significantly superior to placebo in more than 500 patients who underwent cataract surgery. The studies met their primary endpoints of showing Xibrom's superiority in achieving the absence of ocular inflammation within 15 days following surgery, as well as secondary endpoints of elimination of ocular pain at day one. Data were presented at the ophthalmology meeting in New Orleans.

• Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, submitted an investigational new drug application for LX2931, an oral drug candidate for rheumatoid arthritis and other autoimmune conditions. Following the FDA's review, the company will initiate a Phase I trial in healthy volunteers.

• NicOx SA, of Sophia Antipolis, France, said additional results from the first pivotal Phase III trial of naproxcinod in patients with osteoarthritis of the knee showing that each of the active treatment groups in the trial - naproxcinod dosed at either 750 mg or 375 mg and naproxen dosed at 500 mg - were statistically significantly superior to placebo at two, six and 13 weeks. At week 13, both doses of naproxcinod showed a slight decrease in systolic blood pressure in terms of the mean change from baseline compared to placebo, while a 2 mmHg increase was observed for naproxen compared to placebo. Top-line results reported in 2006 showed that naproxcinod met all three co-primary endpoints of the trial. Data were presented at the American College of Rheumatology meeting in Boston.

• Ondine Biopharma Corp., of Vancouver, British Columbia, said it plans to accelerate its methicillin-resistant Staphylococcus aureus (MRSA) nasal decolonization program, part of its photodisinfection platform, and will begin a trial in the first quarter of 2008 to test its next-generation products. The company's decision is based on reports from five case studies showing full eradication of MRSA in the anterior nares without the use of antibiotics. All those patients continue to remain MRSA-negative at one month post-treatment.

• Synvista Therapeutics Inc., of Montvale, N.J., dosed the first patient in its 100-patient Phase II trial of alagebrium (ALT-711), a compound designed to act as an advanced glycation end-product (AGE)-cross-link breaker in patients with chronic heart failure. The BENEFICIAL study is designed to measure the effect of alagebrium on exercise tolerance in CHF patients, and results are expected to guide development of a Phase III program.

• Targeted Genetics Corp., of Seattle, said final molecular test results from a fatal serious adverse event, which led to the clinical hold of the company's tgAAC94 trial in July, underscored initial observations that no amplification of viral vector occurred in the patient's body as a result of the investigational therapy and that only trace amounts of vector DNA were detected in tissues outside the treated joint. Those data were presented at the American College of Rheumatology meeting in Boston. The company also reported interim data from its Phase I/II trial of tgAAC94 in inflammatory arthritis suggested that the therapy showed improvement in patient reported outcome measures. Data from 66 subjects enrolled in the Phase II portion reported in a self-administered patient questionnaire that those receiving tgAAC94 experienced greater improvements in joint symptoms and pain management compared to those in the placebo group, with 40 percent of tgAAC94-treated patients reporting a 30 percent decrease in injected joint global symptoms on a visual-analogue scale vs. 19 percent of placebo-injected patients. (See BioWorld Today, July 30, 2007.)