• BioMS Medical Corp., of Edmonton, Alberta, said the first patients have been enrolled in MAESTRO-03, its U.S. pivotal Phase III trial of MBP8298, a synthetic peptide for the treatment of multiple sclerosis. The randomized, double-blind study is enrolling about 510 secondary progressive MS patients at about 60 sites. The primary endpoint of the two-year study is time to disease progression in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Already ongoing is the MAESTRO-01 pivotal Phase III trial of MBP8298 being conducted in Canada and Western Europe. BioMS also is running the MINDSET-01 Phase II trial in relapsing-remitting MS.

• Clinuvel Pharmaceuticals Ltd., of Melbourne, Australia, dosed the first patients in a Phase III trial of CUV1647 in erythropoietic protoporphyria (EPP), a genetic condition involving absolute intolerance to the sun. The randomized, double-blind, placebo-controlled study will evaluate whether CUV1647 can reduce the number and severity of phototoxic reactions and increase the tolerable duration of exposure to sunlight. Interim data are expected in mid-2008. Last month, Clinuvel initiated a Phase III study of CUV1647 in polymorphic light eruption, or sun poisoning.

• Immunomedics Inc., of Morris Plains, N.J., reported initial results from a Phase I trial of its humanized anti-MUC1 monoclonal antibody hPAM4, labeled with yttrium-90, in patients with unresectable and metastatic pancreatic cancer. Of 11 patients, two had tumor shrinkage, although all showed disease progression at or after eight weeks. Data were reported at the Society of Nuclear Medicine meeting in Washington.

• Javelin Pharmaceuticals Inc., of Cambridge, Mass., said results from a Phase II multidose study of Rylomine (intranasal morphine) were published in Pain Medicine, the official journal of The American Academy of Pain Medicine. Top-line data from the first of two pivotal, post-surgical Phase III trials of Javelin's Rylomine is anticipated this summer.

• NovaDel Pharma Inc., of Flemington, N.J., said data from two clinical studies comparing zolpidem oral spray with zolpidem tablets (Ambien, Sanofi-aventis Group) support a new drug application filing this year under the 505(b)(2) regulatory process. The studies were conducted in healthy volunteers and established bioequivalence and a faster achievement of therapeutic levels.

• Novelos Therapeutics Inc., of Newton, Mass., said the Medical University of South Carolina Hollings Cancer Center has enrolled the first patient in a Phase II trial of neoadjuvant treatment with NOV-002 in combination with chemotherapy in patients with early stage breast cancer. The primary objective of this open-label single-arm trial is to define the rate of pathologic complete response in the affected breast after the preoperative administration of NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel in patients with Stage IIb-IIIc breast cancer. Up to 46 women may be enrolled in the trial, and may receive up to eight cycles of NOV-002 in combination with chemo. Interim results are expected mid-2008.

• NPS Pharmaceuticals Inc., of Parsippany, N.J., said partner GlaxoSmithKline plc, of London, initiated a Phase II trial with the small-molecule calcilytic 751689 in post-menopausal osteoporosis. The double-blind, placebo-controlled, dose-ranging study will evaluate bone mineral density, vertebral and hip strength parameters, biomarkers of bone turnover, and safety in 520 patients over a 12-month period. NPS has other programs on the market and in Phase III trials.

• Oncolytics Biotech Inc., of Calgary, Alberta, disclosed positive data from its U.S. Phase I clinical trial examining the systemic administration of Reolysin, a formulation of the human reovirus, in patients with advanced cancers. The results from 18 patients treated indicated the drug can be delivered systemically to patients with advanced and metastatic cancers and cause antitumor activity. Of the 18 patients treated, eight demonstrated stable disease as measured by Response Evaluation Criteria in Solid Tumors criteria, including a patient with progressive breast cancer who experienced a 28.5 percent shrinkage in tumor volume. Toxicities were generally mild and included chills, fever and fatigue.

• Repros Therapeutics Inc., of The Woodlands, Texas, said top-line Phase III data indicated that oral Androxal is not inferior to Androgel (testosterone gel, Solvay SA) in secondary hypogonadism. After six months of treatment, 70.5 percent of patients on 12.5 mg Androxal and 84 percent of patients on 25 mg Androxal achieved testosterone levels greater than 300 ng/dl, compared to 53.2 percent for the Androgel group and 31.9 percent for the placebo group. Androxal treatment also increased luteinizing hormone and follicle stimulating hormone levels into the normal range, while Androgel decreased them and placebo did not affect them. Repros plans to discuss the findings with the FDA this summer.