• Allon Therapeutics Inc., of Vancouver, British Columbia, said AL-208 advanced into the randomized portion of its Phase II trial for treating the mild cognitive impairment that can occur following coronary artery bypass graft surgery. The initial portion of the study assessed safety in patients. Now the product's effect on cognitive function will be tested against placebo. The company selected the 300-mg dose, the highest dose studied, for further testing.

• BioMS Medical Corp., of Edmonton, Alberta, received FDA clearance for a pivotal Phase III trial of MBP8298 in multiple sclerosis. The MAESTRO-03 (A Double-blind, Placebo-Controlled Multi-center Study to Evaluate the Efficacy and Safety of MBP8298 in subjects with Secondary Progressive Multiple Sclerosis) study will enroll about 510 patents with HLA-DR2 and/or HLA-DR4 immune response genes to be randomized to receive either the drug or placebo intravenously every six months for two years. The primary endpoint is defined as a statistically and clinically significant increase in the time to disease progression as measured by the Expanded Disability Status Scale. BioMS also has an ongoing pivotal Phase III trial in Canada and Europe, which started in 2004 and is enrolling 550 patients. To date, that trial has passed six safety reviews by its independent data safety monitoring board. (See BioWorld Today, Dec. 9, 2004.) In separate news, BioMS completed patient recruitment in its Phase II/III trial and remains on track to receive interim data in mid-2008 from the first 200 patients enrolled.

• Cell Genesys Inc., of South San Francisco, said follow-up data from a 60-patient Phase II trial of GVAX immunotherapy in pancreatic cancer showed a median survival of 26.8 months. That compares favorably to median survival of 17 to 22 months seen among historical data. Fifty-two of the 60 patients in the study were considered high risk, based on their cancer having spread to regional lymph nodes. Treatment was well tolerated. Data were presented at the American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium held in Orlando, Fla.

• Chelsea Therapeutics International Ltd., of Charlotte, N.C., said the FDA granted orphan drug designation to its drug candidate Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure, a group of diseases that includes Parkinson's disease, pure autonomic failure and multiple systems atrophy. Chelsea plans to initiate a pivotal Phase III trial in that patient population during the second half of 2007. It will evaluate improvements in orthostatic blood pressure. Droxidopa, on the market since 1989 in Japan, was licensed from Dainippon Sumitomo Pharma Co. Ltd., of Osaka, Japan.

• Halozyme Therapeutics Inc., of San Diego, reported positive data from a pharmacokinetics and safety study of its Enhanze technology applied to delivery of an approved protein drug in 15 patients. Improved absorption and bioavailability were seen vs. injection of the large molecule without Enhanze, an enzyme-based delivery platform based on recombinant human PH20 hyaluronidase.

• iCo Therapeutics Inc., of Vancouver, British Columbia, said the FDA accepted its investigational new drug application for a Phase I trial of iCo-007 for treating diabetic macular edema. The product, a second-generation antisense drug that targets c-Raf kinase messenger RNA, was licensed from Isis Pharmaceuticals Inc.

• Infinity Pharmaceuticals Inc., of Cambridge, Mass., and MedImmune Inc., of Gaithersburg, Md., presented updated preliminary data from an open-label Phase I study of IPI-504, showing further evidence of biological activity. The small-molecule inhibitor of heat shock protein 90 is being tested in patients with Gleevec-resistant metastatic gastrointestinal stromal tumors. Data were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in Orlando, Fla. Also, the companies said they began dosing on a second schedule in the Phase I trial.

• Innocoll Inc., of Ashburn, Va., said the FDA approved its investigational new drug application for a Phase II study of CollaRx Gentamicin as a topical antibiotic treatment for mildly infected diabetic foot ulcers. The product is a biodegradable and fully resorbable gentamicin-collagen sponge formulated with Innocoll's CollaRx technology. Upon application to a wound, the product releases gentamicin, an aminoglycoside antibiotic. The product already is marketed in Europe and certain other areas.

• Introgen Therapeutics Inc., of Austin, Texas, said expanded p53 biomarker study data show a highly significant correlation of abnormal p53 protein levels with increase survival of patients treated with Advexin. Median survival of patients with tumors abnormally expressing p53 was 11.6 months compared to only 3.5 months in patients whose tumors did not have the p53 biomarker, and tumor disease control was observed in 75 percent of patients with the biomarker compared to 18 percent without. Those results were presented at the Phacilitate Cell and Gene Therapy Forum in Baltimore.

• Migenix Inc., of Vancouver, British Columbia, said its partner, Cutanea Life Sciences Inc., of San Diego, initiated a Phase II study of CLS001 (topical omiganan) in rosacea. The trial will involve 240 subjects with papulopustular rosacea, and the primary endpoint is to determine the product's efficacy in reducing the number of inflammatory lesions. The study is expected to be completed by the end of 2007. Migenix licensed CLS001 to Cutanea in 2005, in exchange for an up-front fee and up to $21 million in potential milestones and royalties on any product sales.

• Sequella Inc., of Rockville, Md., received fast-track status for SQ109, its lead drug candidate for pulmonary tuberculosis. That designation calls for expedited development and review of a new drug application. SQ109 has demonstrated in preclinical studies in vitro activity against drug-susceptible and drug-resistant TB bacteria, including XDR-TB, as well as in vivo activity against pulmonary TB alone and with other TB drugs.

• Sirion Therapeutics Inc., of Tampa, Fla., started enrolling patients in two Phase III trial of ST-601 (difluprednate) in inflammation following ocular surgery. Sirion acquired the product last year through an exclusive licensing agreement with Japan-based Senju Pharmaceutical Co. Ltd., gaining U.S. rights to develop and market a topical ophthalmic emulsion containing the steroid compound for inflammatory eye diseases.