• Addex Pharmaceuticals, of Geneva, announced the completion of the first of a two-part Phase I trial to evaluate ADX48621, a metabotropic glutamate receptor 5 negative allosteric modulator. The first part was a randomized two-way crossover comparison study in 12 healthy subjects to test the pharmacokinetics, safety and tolerability of the original active pharmaceutical ingredient in capsule with the modified-release capsule. The modified-release formulation achieved the predefined pharmacokinetic criteria required to continue into part two. ADX48621 is scheduled to start a Phase IIa proof-of-concept study for the treatment of levodopa-associated dyskinesia in Parkinson's disease during the first half of 2009.

• Avigen Inc., of Alameda, Calif., said it launched an exploratory study of AV411 (ibudilast) in opioid withdrawal symptoms, which will be largely funded by the National Institute on Drug Abuse. The study will test AV411, administered twice daily to heroin addicts who are maintained on morphine over a 14-day period, to determine its preliminary efficacy in reducing withdrawal symptoms. AV411 is a small-molecule glial attenuator designed to suppress pro-inflammatory cytokines interleukin (IL)-1 beta, tumor necrosis factor-alpha and IL-6, while possibly up-regulating cytokine IL-10.

• Biothera, of Eagan, Minn., said it started dosing patients in the second arm of its metastatic colorectal cancer trial to test the combination therapy of its lead drug, Imprime PGG, and Erbitux (cetuximab, ImClone Systems Inc). Imprime PGG is an immunotherapy designed to work in concert with antitumor monoclonal antibodies to activate a large population of neutrophils. The first arm of the trial tested Imprime PGG in combination with both Erbitux and the chemotherapeutic agent irinotecan.

• ChemoCentryx Inc., of Mountain View, Calif., has initiated a Phase I trial of CCX025, its fourth investigational new drug and second orally administered compound that inhibits the chemokine receptor known as CCR9. The Phase I double-blind, placebo-controlled trial is being conducted in healthy male and female volunteers to evaluate the safety, tolerability and pharmacokinetics of CCX025 over a range of dose levels. In preclinical studies, the compound has been shown to be well-tolerated and highly selective.

• Genzyme Corp., of Cambridge, Mass., said it began enrollment in a worldwide postmarketing trial evaluating the efficacy and safety of treating male patients ages 5-18 with mild Fabry disease symptoms with lower-dose regimens of Fabrazyme (agalsidase beta) over the course of five years. Patients will receive either half the recommended dose of Fabrazyme every two weeks (0.5mg/kg of body weight) or a dose of 1mg/kg every four weeks.

• Insmed Inc., of Richmond, Va., said it received approval from the UK's Medicines and Healthcare products Regulatory Agency to initiate a Phase I study for the its second follow-on biologic product candidate, INS-20. The study will compare the safety and establish the bioequivalence of INS-20 to FDA-approved Neulasta (pegfilgrastim, Amgen Inc.), a pegylated recombinant form of human G-CSF (granulocyte colony-stimulating factor) used to boost white blood cell count. Results from the trial are anticipated in 2009, and are expected to be used as part of a submission to the FDA to establish a protocol with the agency for a Phase III trial.

• Jennerex Inc., of San Francisco, said it completed treatment for the first patient cohort in its Phase I trial of targeted poxvirus JX-594, delivered by intravenous infusion. No significant toxicities were reported and treatment was well tolerated. The Phase I trial involves patients with advanced, metastatic solid tumors refractory to standard therapy. Once the maximum tolerated dose (MTD) is defined, an additional three to six patients will be enrolled at that dose level. In addition to determining MTD, the trial will evaluate I.V. delivery of JX-594 in solid tumors.

• MethylGene Inc., of Montreal, announced the administration of MGCD290 as a single agent to the first cohort of healthy adult volunteers in a Phase I study. MGCD290 is an orally available fungal Hos2 inhibitor designed to be used in combination with azoles for the treatment of fungal infections. The purpose of this trial is to evaluate MGCD290's safety, pharmacokinetics and tolerability.

• Seattle Genetics Inc., of Bothell, Wash., has achieved a milestone under its antibody-drug conjugate agreement with Progenics Pharmaceuticals, of Tarrytown, N.Y. The milestone was triggered by Progenics' initiation of a Phase I trial with its prostate-specific membrane antigen-targeted ADC for patients with hormone-refractory prostate cancer. Under the ADC collaboration agreement, Progenics has exclusive rights to use Seattle Genetics' ADC technology with monoclonal antibodies that target PSMA. The amount of the milestone was not disclosed.

• The Medicines Co., of Parsippany, N.J., said one-year follow-up data from the HORIZONS-AMI trial demonstrated that Angiomax (bivalirudin) significantly reduced cardiac-related death by 43 percent, improved overall survival by 31 percent and reduced major bleeding complications by 39 percent compared to heparin plus a platelet glycoprotein IIb/IIIa inhibitor in patients undergoing angioplasty. Angiomax showed an absolute reduction of 1.7 percent in cardiac-related death and 1.4 percent in all-cause death at one year. Those findings were presented at the Transcatheter Cardiovascular Therapeutics meeting in Washington. The HORIZONS-AMI trial involved 3,602 patients presenting with the most severe form of heart attack, ST-elevation myocardial infarction, undergoing a primary PCI strategy. Of patients in the Angiomax arm, the majority (93 percent) received monotherapy treatment. Angiomax is a direct thrombin inhibitor that is approved as a blood thinner in patients undergoing coronary angioplasty procedures.