• Dynavax Technologies Corp., of Berkeley, Calif., started a Phase I dose-escalation trial with its TLR9 agonist in combination with a standard chemotherapeutic regimen for metastatic colorectal cancer. The enrollment target of the trial is 15 patients, all of whom will have been previously treated for colorectal cancer but had a recurrence of the disease. The trial, which will be conducted at three centers in the U.S., is designed to identify the optimum dose and to yield safety and tolerability data for escalating doses of a Dynavax TLR9 agonist administered with irinotecan and cetuximab. The company expects the trial to finish in the first half of next year, and will use the data to design a larger Phase II study.

• EPIX Pharmaceuticals Inc., of Lexington, Mass., began a Phase IIa trial to evaluate PRX-03140 as monotherapy and in combination with donepezil in Alzheimer's disease. The trial will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic of PRX-03140 administered orally once a day for 14 days to patients with mild Alzheimer's disease who are on a steady dose of donepezil (10 mg). Data from the trial are expected in the second half of 2007.

• Genmab A/S, of Copenhagen, Denmark, disclosed positive results from an interim analysis of the first 100 patients in the ongoing Phase II rheumatoid arthritis study with HuMax-CD20 (ofatumumab), a fully human antibody targeted at the CD20 molecule found in the cell membrane of B cells. A statistically significant proportion of patients on active treatment obtained a 20 percent improvement of the American College of Rheumatology response compared to patients treated with placebo. Also, in all groups treated with the drug, a greater proportion of patients benefited from moderate or good EULAR responses compared to placebo. The study enrolled 226 patients and completed accrual in September. Genmab expects to present results for the full Phase II study during the first half of 2007.

• Inovio Biomedical Corp., of San Diego, said its partner, Huddinge, Sweden-based Tripep AB, filed an application for a Phase I study with the Swedish Medical Products Agency for testing its DNA vaccine, ChronVac-C, administered using Inovio's MedPulse DNA Delivery System. That combination is designed to activate a T-cell response capable of clearing hepatitis C virus. The planned Phase I study in healthy volunteers is expected to begin in early 2007.

• Inspire Pharmaceuticals Inc., of Durham, N.C., initiated a Phase II trial to evaluate epinastine nasal spray for the treatment of seasonal allergic rhinitis. The trial is a 14-day randomized, double-blind comparison of two doses of nasal spray to placebo in about 580 subjects who have a history of seasonal allergic rhinitis to mountain cedar pollen. Nasal and non-nasal symptoms, quality-of-life scores and standard safety assessments will be measured. Trial results should be available by mid-year 2007.

• Isotechnika Inc., of Edmonton, Alberta, enrolled its first patient in a European/Canadian Phase III trial for moderate to severe psoriasis with its lead immunosuppressive drug, ISA247. The 24-week trial will be performed at 36 clinical centers in Canada, Germany and Poland with 500 patients. The following parameters will be used to measure the success of the trials: static physician's global assessment scores, psoriasis area and severity index scores and kidney function.

• Lexicon Genetics Inc., of The Woodlands, Texas, submitted an investigational new drug application to the FDA for LX1031, an internally developed small-molecule compound for gastrointestinal disorders such as irritable bowel syndrome. Following FDA review, Lexicon intends to initiate a Phase I trial of LX1031 in healthy volunteers to assess the compound's safety, tolerability and pharmacokinetics.

• Somaxon Pharmaceuticals Inc., of San Diego, said oral nalmefene, its impulse-control disorder drug, missed its primary endpoint in a Phase II/III trial in patients diagnosed with pathological gambling. The drug, an opiate antagonist, did not demonstrate a statistically significant difference compared to placebo, as measured by the PG-YBOCS Yale Brown Obsessive Compulsive Scale modified for Pathological Gambling at week 12 of the treatment period for either of the doses (20 mg and 40 mg). In addition, neither dose achieved statistical significance on the secondary endpoints. Somaxon said it will further assess those results, along with previously reported results from a Phase II trial evaluating nalmefene in smoking cessation, before deciding the future development of the nalmefene program.

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