• BioMS Medical Corp., of Edmonton, Alberta, said a independent data safety monitoring board has reviewed data from the on-going MAESTRO-03 U.S. pivotal Phase III clinical trial of MBP8298 for the treatment of secondary progressive MS and recommended that the trial continue. More than 133 patients have been enrolled in the trial and an interim safety and efficacy analysis will be performed on data when they have completed 24 months of the trial

• Ceregene Inc., of San Diego, said long-term follow-up data from a Phase I study of CERE-120 in 12 Parkinson's disease patients suggest sustained reduction in symptoms at 18 months and 24 months post-treatment. The company previously reported an average of 36 percent reduction in Parkinson's symptoms at 12 months following CERE-120 administration, and, with nine of the 12 subjects treated showing a clinically meaningful reduction of symptoms, averaging a 46 percent reduction rate. The latest data show that the eight evaluable responders exhibited a persistent mean improvement in symptoms of 52 percent at their longest time of follow-up (24 months for the low-dose cohort and 18 months for the high-dose cohort). There also was a statistically significant improvement in the primary endpoint compared to baseline, defined as the reduction in Parkinson's symptoms as measured by the Unified Parkinson's Disease Rating.

• EntreMed Inc., of Rockville, Md., said the FDA has accepted its investigational new drug application for Panzem (2-Methoxyestradiol or 2ME2) in rheumatoid arthritis. In three preclinical treatment models oral administration demonstrated antiarthritic activity in which arthritic activity was attenuated and joint damage stopped.

• Genmab AS, of Copenhagen, Denmark, said an investigational new drug application has been filed with the FDA for a Genmab antibody developed under a collaboration with F. Hoffmann-LaRoche, of Basel, Switzerland. Roche and Genentech Inc., of South San Francisco, are collaborating on development of the antibody which selectively blocks the interaction of the OX40 ligand and its receptor. The companies are evaluating the antibody for the treatment of asthma. Genmab will receive an unspecified milestone payment from Roche.

• Orexigen Therapeutics Inc., of San Diego, has initiated the fourth trial in its Phase III clinical trial program for its lead product candidate Contrave as a treatment for obesity. This trial is a 56-week study to assess the safety, tolerability and efficacy of Contrave in generally healthy, nondiabetic, obese patients. A unique aspect of this trial design is the blinded re-randomization of any Contrave patients who have not responded at week 28 to receive either a higher dose of Contrave or continue on the patient's original dose. The trial will take place at approximately 50 centers nationwide and is expected to enroll approximately 1,500 individuals.

• Peplin Inc., of Emeryville, Calif., announced positive preliminary results of PEP005-007, its Phase IIa actinic (solar) keratosis clinical trial. The trial evaluated various formulation strengths at two and three consecutive day dosing regimes. The trial established the maximum tolerated dose at 0.025 percent applied daily for two consecutive days to the face or face and scalp sites. The drug suggested a favorable safety profile and was well tolerated. Side effects were primarily transient local skin responses at the treatment site. No drug-related serious adverse events were reported.

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