• Active Biotech AB, of Lund, Sweden, plans to launch a Phase I combination trial to study tasquinimod (TASQ) in prostate cancer. The primary objective for the CATCH (Cabazitaxel [Jevtana] And Tasquinimod in Men with Castration-Resistant Heavily pre-treated Prostate Cancer) trial is to determine the recommended dose of TASQ in combination with cabazitaxel, based on safety and tolerability in men with chemo-refractory metastatic castration-resistant prostate cancer (CRPC). Secondary objectives include efficacy, measured by progression-free survival (PFS), and overall survival (OS). The study will include about 30 CRPC patients. A pivotal global, randomized, double-blind, placebo-controlled Phase III study of TASQ in metastatic CRPC continues, with the goal of confirming the compound's effect on the disease, with radiological PFS as the primary endpoint and OS as secondary endpoint. Active is partnered with Ipsen SA, of Paris, in a TASQ deal potentially valued at $235 million. (See BioWorld Today, April 19, 2011.)

• BioAlliance Pharma SA, of Paris, said results of a Phase I trial showed a satisfactory safety and a signal of efficacy via local administration of its AMEP biotherapy, so the firm is moving into a European Phase I/II trial testing an intramuscular route of delivery of patients with metastatic melanoma. AMEP is designed to target integrins overexpressed by melanoma cells involved in tumor growth and tumor angiogenesis.

• Enlivex Therapeutics Ltd., of Jerusalem, said it completed patient enrollment in the Phase I/II trial of its drug under development for autoimmune diseases. The trial was conducted on bone marrow transplant patients, who often acquire graft-vs.-host disease (GVHD), but the company said results are relevant to other immune system diseases. The company said initial results showed that safety measures were achieved, and the drug appeared to reduce the chance that patients would develop more severe grades of GVHD. Study data also suggested the treatment may have a beneficial effect on liver protection. The company expects to complete data collection in July.

• EpiCept Corp., of Tarrytown, N.Y., said it received additional guidance from the FDA for the Phase III development and subsequent new drug application filing of AmiKet (amitriptyline 4 percent, ketamine 2 percent) in chemotherapy-induced peripheral neuropathy (CIPN). In the final minutes from the company's December 2011 meeting with the FDA, the agency acknowledged that pain due to CIPN represents a significant unmet medical need and encouraged EpiCept to apply for fast-track designation. EpiCept said the agency waived several nonclinical toxicology studies and indicated that a single four-arm factorial trial might suffice for regulatory approval if combined with pivotal data in another neuropathy, such as diabetic peripheral neuropathy. The key element of the proposed Phase III program is a 12-week, four-arm, factorial-designed trial in CIPN that would seek to demonstrate AmiKet's superiority compared with placebo and with the component drugs of AmiKet. EpiCept said it plans to request a special protocol assessment for the trial.

• ImmunoCellular Therapeutics Ltd., of Los Angeles, said it enrolled patients at 23 sites in its Phase II trial of ICT-107, the company's dendritic cell-based cancer vaccine candidate targeting multiple tumor antigens in glioblastoma multiforme. The company has received institutional review board approval from 24 trial sites. The trial is expected to enroll 160 to 200 patients to treat 102 patients with HLA-A1/A2 immunological subtypes. The trial has enrolled 115 patients, and the company expects to complete enrollment by the second quarter. An interim analysis is expected when 50 percent of events (32 deaths) have been observed.

• Medicure Inc., of Winnipeg, Manitoba, added a new trial site in India for its ongoing Phase II study of Tardoxal in tardive dyskinesia (TD) and expects to begin enrolling patients at that site next month. The addition of a new trial site is expected to increase the rate of enrollment. To date, 29 patients have been recruited, and 40 are needed for a planned interim analysis. The 12-week study is assessing the effect of Tardoxal on the reduction of expressed symptoms of TD compared to placebo as the primary endpoint. Medicure also reported that it received fast-track designation for the small-molecule drug for treating moderate to severe TD.

• Spectrum Pharmaceuticals Inc., of Henderson, Nev., said a randomized study, published online in Cancer, concluded that standard-dose Zevalin (ibritumomab tiuxetan) injection combined with beam high-dose chemotherapy is safe and possibly more effective than beam alone as a conditioning regimen for autologous stem-cell transplantation (ASCT). Based on the study's findings, Spectrum plans to expand its clinical development program for Zevalin to include support for a larger study using Z-beam for ASCT. The existing clinical program includes a Phase III study in diffuse large B-cell lymphoma and a trial to evaluate Zevalin in previously untreated follicular non-Hodgkin's lymphoma. (See BioWorld Today, Jan. 6, 2011.)