• Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., announced positive initial top-line results from an investigator-initiated Phase II double-blind, placebo-controlled trial, demonstrating that vigabatrin is effective for the treatment of cocaine addiction. Catalyst's lead compound, CPP-109, is bioequivalent to vigabatrin. The 103-subject trial is the first randomized, double-blind, placebo-controlled clinical trial studying vigabatrin's effectiveness in treating cocaine addiction. Those data showed that a statistically significantly greater number of subjects treated with vigabatrin were able to abstain from cocaine usage during the last three weeks of the dosing period compared to those receiving placebo. Achievement of abstinence for an extended period during treatment is the critical first step for cocaine addicted patients to potentially achieve abstinence for much longer time periods. The data confirmed positive results from two previous open-label trials.

• Epiphany Biosciences, of San Francisco, has begun a Phase II clinical trial with valomaciclovir (EPB-348) for the treatment and management of acute infectious mononucleosis. Currently, there are no approved therapeutics for this debilitating condition or any other disease caused by the Epstein-Barr virus (EBV). The double-blind, placebo-controlled trial will examine fluctuations in viral load as influenced by valomaciclovir as well as assess symptom scores.

• Genmab A/S, of Copenhagen, Denmark, initiated a Phase I/II study of HuMax-CD38 in multiple myeloma. The trial will include up to 122 patients who are relapsed or refractory to at least two different prior treatments and are without further established treatment options. It will consist of two parts: in the first part, to involve 26 to 62 patients depending on the number of dose levels reached during escalation, HuMax-CD38 will be given in seven infusions, and the second part of the study will enroll 60 patients, divided into three groups, to receive six infusions of the drug at weekly intervals.

• Seattle Genetics Inc., of Bothell, Wash., has initiated a Phase IIb trial of SGN-40 in combination with Rituxan (rituximab) plus chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Under the terms of the company's collaboration agreement with Genentech Inc., of South San Francisco, Seattle Genetics will receive a $12 million milestone payment for initiating the study. The randomized, double-blind, placebo-controlled trial, named SeaGen MARINER, is expected to enroll approximately 200 relapsed or refractory DLBCL patients at more than 60 medical centers worldwide. Patients will receive either Rituxan, ifosfamide, carboplatin and etoposide (R-ICE) plus SGN-40 or R-ICE plus placebo. The primary endpoint is complete response rate. Additional endpoints include safety, tolerability, failure-free and overall survival.

• Sequoia Pharmaceuticals Inc., of Gaithersburg, Md., submitted an investigational new drug application to start testing with SPI-452, a pharmacokinetic enhancer designed to improve the exposure of co-administered HIV medications. The firm previously submitted an IND for its first program in February, SPI-256, an HIV protease inhibitor.

• SymBio Pharmaceuticals, of Tokyo, has begun a Phase II study of bendamustine HCl in patients with previously treated low-grade non-Hodgkin's lymphoma at 17 medical institutions nationwide. That follows promising safety and efficacy results of the preceding Phase I study completed in September. Bendamustine HCl is an anticancer drug licensed from Astellas Deutschland GmbH, of Munich, Germany. SymBio holds the development and marketing rights for bendamustine HCl in Japan. In Germany, the drug has been approved and marketed as Ribomustin for the treatment of patients with indolent non-Hodgkin's lymphoma. In the U.S., a new drug application for the drug in the treatment of chronic lymphocytic leukemia has been submitted to the FDA under the brand name of Treanda.

• TargeGen Inc., of San Diego, has submitted an investigational new drug application for TG101348, and the company plans to initiate a multicenter clinical trial in January. TG101348 is an internally discovered, oral and highly selective JAK2 inhibitor. In preclinical models of myeloproliferative diseases, TG101348, administered orally, was shown to reduce V617F expressing cell populations in a dose-dependant manner without adversely impacting normal hematopoeisis.