• BioGeneriX AG, of Mannheim, Germany, announced positive data from two Phase I clinical studies of GlycoPEG-GCSF for the treatment of neutropenia associated with myelosuppressive chemotherapy. Results showed single doses of GlycoPEG-GCSF demonstrated potent stimulation of neutrophils and mobilization of peripheral blood progenitor cells. The compound demonstrated an approximately 30 percent greater absolute neutrophil count response vs. Neulasta (pegfilgrastim), and a 60 percent increased bioavailability vs. Neulasta. It also was generally well tolerated with no serious adverse events.

• BioMS Medical Corp., of Edmonton, Alberta, said the independent data safety monitoring board for its Phase II MINDSET-01 trial of MBP8298 in patients with relapsing-remitting multiple sclerosis completed a safety analysis and recommended that the trial continue. The double-blind, placebo-controlled trial is to evaluate the safety and efficacy of MBP8298 in patients with relapsing-remitting MS. The 15-month trial is fully enrolled with 218 patients at 24 sites in six countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 vs. placebo as measured by relapse rate, MRI activity and disease progression.

• Epiphany Biosciences, of San Francisco, has enrolled the first patient in a Phase IIb trial with valomaciclovir (EPB-348) for the treatment of herpes zoster. The trial will examine the safety and efficacy of once-daily valomaciclovir against an active comparator, three-times-daily valacyclovir. Valomaciclovir is a highly potent antiviral with enhanced delivery and bioavailability.

• LifeCycle Pharma A/S, of Horsholm, Denmark, said results from a Phase I head-to-head clinical trial comparing LCP-Tacro, its lead product candidate being developed as a once-daily tablet version of tacrolimus, showed that LCP-Tacro proved superior to Advagraf (tacrolimus prolonged release, Astellas Pharma Inc.). The multidose trial enrolled 19 healthy volunteers, and clinical data confirmed that LCP-Tacro, when compared to Advagraf, demonstrated approximately 50 percent higher bioavailability, and a lower Cmax/Cmin ratio.

• Meditor Pharmaceuticals Ltd., of Rehovot, Israel, said the primary endpoint and safety evaluation in the Phase II, randomized double-blind, placebo-controlled dose-escalating study of MTR106 in migraine patients was successful. MTR106 was found to be safe and well tolerated; no serious adverse events occurred in the four studied doses; and no symptoms related to chest pain or changes in heart rate or blood pressure were observed. The results demonstrated that at two hours and at the third and fourth hours post-treatment more patients treated with MTR106 had pain relief compared to those treated with placebo.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, and Active Biotech AB, of Lund, Sweden, have begun enrolling patients in a Phase III study of the safety, efficacy and tolerability of laquinimod, an oral liquid to prevent the progression of relapsing-remitting multiple sclerosis. The trial will last 24 to 30 months and aims to enroll about 1,000 patients. Another Phase III trial of laquinimod is set to begin enrollment in the first quarter 2004, the companies said. That study will enroll 1,200 patients and follow them for two years.