• CV Therapeutics Inc., of Palo Alto, Calif., said a study of ranolazine in patients with a hereditary form of long QT syndrome called LQT3 syndrome was published in the Journal of Cardiovascular Electrophysiology. In the study, ranolazine significantly shortened the QT interval by 26 milliseconds in a concentration-dependent manner. Additionally, ranolazine improved diastolic function, as measured by a 13 percent improvement in left ventricular relaxation time. No adverse effects of ranolazine were observed in the study patients.

• Neurologix Inc., of Fort Lee, N.J., said it received institutional review board approvals to start recruiting patients for its Phase II trial of a gene transfer approach in advanced Parkinson's disease, which seeks to restore gamma-aminobutyric acid by inserting the GAD (glutamic acid decarboxylase) gene back into the subthalamic nucleus to improve motor control. A total of 40 participants are expected to be enrolled, with 20 to receive an infusion of the gene-based treatment bilaterally via a catheter temporarily placed in each subthalamic nucleus by stereotactic surgery and the remaining 20 patients to receive sterile saline solution into a partial thickness burr hole made into the skull, with no brain infusion. The primary endpoint will be a clinical assessment of motor function at six months using the Unified Parkinson's Disease Rating Scale. All patients also will be monitored for safety for 12 months following the procedure.

• Pain Therapeutics Inc., of San Mateo, Calif., and King Pharmaceuticals Inc., of Bristol, Tenn., said final data from their pivotal Phase III study of Remoxy in chronic pain confirmed that the drug provides effective around-the-clock analgesia in a formulation that is designed to resist common methods of misuse and abuse. It showed the analgesic efficacy of a twice-daily oxycodone formulation over 12 weeks. A new drug application for Remoxy is under priority review at the FDA. Pain Therapeutics and King also presented results of an alcohol interaction study, in which human volunteers consumed Remoxy 40 mg with up to 8 ounces of 80-proof alcohol. Results showed that Remoxy's formulation resisted dissolution in alcohol. Data were presented at the World Congress of the International Association for the Study of Pain in Glasgow, Scotland.

• PregLem SA, of Geneva, announced the start of an international Phase III trial for PGL4001 (ulipristal) in symptomatic uterine myoma, a common benign solid tumor of the genital tract in women of reproductive age. The trial is composed of two parts and being carried out in parallel in 14 countries, with results expected in 2010. PGL4001 is an orally active, selective progesterone receptor modulator, and was shown in a previous Phase II study to be well tolerated and effective in immediately stopping uterine bleeding.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., and Bayer HealthCare AG, of Leverkusen, Germany, said patients with wet age-related macular degeneration receiving VEGF Trap-Eye, a fully human, soluble VEGF receptor fusion protein, in a Phase II extension study continued to show highly significant improvements at 52 weeks in the primary and key secondary endpoints of retinal thickness (an anatomic measure of treatment effect) and vision gain. VEGF Trap-Eye was generally well tolerated, and there were no drug-related serious adverse events. The most common adverse events were those typically associated with intravitreal injections.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., will proceed with its REALIZE trial, a pivotal Phase III study with the oral inhibitor of hepatitis C virus (HCV) protease, telaprevir, in combination therapy for patients with chronic HCV infection who failed to achieve a sustained viral response (SVR) with prior therapy. The trial will enroll approximately 650 genotype 1 HCV patients who failed prior treatment with PEGylated-interferon and ribavirin. It is designed to evaluate two 48-week telaprevir-based regimens in comparison with a 48-week control arm, with primary endpoint as SVR, defined as undetectable HCV RNA (< 10 IU/mL) 24 weeks after the completion of treatment.

• Vion Pharmaceuticals Inc., of New Haven, Conn., said it entered into an agreement with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology to conduct a two-part Phase III trial of Cloretazine (laromustine or VNP40101M) with standard remission-induction therapy in patients ages 18-65 with previously untreated acute myelogenous leukemia and high-risk myelodysplasia. Part A of the trial will evaluate the pharmacokinetics, efficacy and dosing feasibility of laromustine with cytarabine and idarubicin. Part B will evaluate the efficacy of the laromustine combination vs. two cycles of cytarabine and idarubicin without laromustine.