• Akela Pharma Inc., of Montreal, Quebec, has started a Phase I trial for EDACS, its platform technology to prevent abuse of controlled substances. The technology uses extrusion technology to prepare an insoluble matrix containing dispersed drug, which can be shaped into tablets. The open-label, randomized, single-dose, crossover study will investigate the pharmacokinetics and safety of three different extended-release formulations of a well-known opioid product compared to an immediate-release formulation of the same opioid drug. The study will be carried out in 12 healthy subjects, and results are expected in the third quarter.

• Cell Therapeutics Inc., of Seattle, said its investigational drug pixantrone, a DNA major groove binder, will be studied in a Phase I/II trial initiated by the Fondation Charcot Stichting, in Brussels, Belgium. The study will enroll 20 patients with aggressive, relapsing remitting or secondary progressive multiple sclerosis. Patients who failed to respond to approved immunomodulatory agents (interferons, glatiramer acetate) will be included. The trial is an open-label, multicenter, noncomparative study of pixantrone administered at a dose of 120 mg/m2 once every 21 days. The objectives of the study are to determine the efficacy of pixantrone as an immunosuppressive agent based on its ability to decrease the lymphocyte count and to evaluate efficacy in MS based on gadolinium-enhanced magnetic resonance imaging.

• EpiCept Corp., of Tarrytown, NY, said it has earned a milestone payment from Myriad Genetics Inc., of Salt Lake City, for progress due to patient dosing in a Phase II trial being conducted by Myriad for Azixa (MPC-6827) in melanoma that has spread to the brain. Azixa is an apoptosis inducer with vascular disrupting activity licensed as part of a series of compounds by EpiCept to Myriad. In addition to the milestone payment, EpiCept will earn a separate milestone upon the initiation of a Phase III trial.

• GammaCan International Inc., of Kiryat Ono, Israel, said it completed a series of animal experiments confirming the effectiveness of IgG preparations derived from vitiligo donors against melanoma cells, which is the basis for the company's lead product, VitiGam. In human melanoma models using SCID mice and the A375 human melanoma cell line, the company demonstrated that vitiligo-derived IgG preparations can prevent, in a statistically significant manner, the growth of subcutaneous melanomas. Results also showed that those preparations reduced the size of small tumors.

• Manhattan Pharmaceuticals Inc., of New York, has concluded successful pre-investigational new drug meetings with the FDA and may file IND applications for both Altoderm and Altolyn. The company intends to develop Altoderm (topical cromolyn sodium) to treat pruritus (itching) associated with atopic dermatitis, and Altolyn (oral tablet cromolyn sodium) to treat mastocytosis. The FDA determined that following completion of certain nonclinical studies and the acceptance of an IND, Phase II studies can be initiated in the U.S., and that the proposed indication of pruritus associated with dermatologic conditions including atopic dermatitis can be pursued.

• ProMetic Life Sciences Inc., of Montreal, reported favorable top-line findings from the third cohort in its Phase II trial of PBI-1402 in patients with chemotherapy-induced anemia, with analysis of compiled data from 18 patients showing an overall statistically significant increase of the mean hematocrit values at weeks four, six and eight, and an increase in hemoglobin values at week eight. The company extended enrollment in the trial to include an additional 12 patients receiving the lowest trial dose, and data from those patients are expected by June. In addition, another Phase II study is planned to test PBI-1402 in patients with anemia resulting from chronic kidney disease.