ArQule Inc., of Woburn, Mass., has expanded its clinical development program for ARQ 197, an orally administered small molecule inhibitor of the c-Met receptor tyrosine kinase, with a new target indication, hepatocellular carcinoma...The data showed CVT-3619 was safe and well tolerated in this study up to a single dose of the highest dose tested, 1,800 mg in healthy subjects and up to 1,500 mg in overweight or obese subjects, with no serious adverse events...The study involved 18 subjects with mild to

The aim of the trial is to reduce the relapse rate for those patients who have completed the standard combination therapy, consisting of high-dose injectable interferon alpha and oral ribavirin...XenoPort is conducting a multiple-dose trial with one of the formulations and expects to begin clinical testing in Parkinson's disease patients later this year

The study enrolled 20 patients to receive either placebo or low-dose or high-dose EVP-6124 for 21 days...The primary endpoint will be a clinical assessment of motor function at six months using the Unified Parkinson's Disease Rating Scale

The secondary endpoint of bone-specific alkaline phosphatase also showed a significant dose-dependent effect between the lowest and the two higher dose levels, as well as confirming the strong bone-targeting nature of Alpharadin, the company said...The study will examine the clinical pharmacology of the drug over a narrow dosing range...Those Data were presented at the American Society of Clinical Oncology's 2009 Gastrointestinal Cancers Symposium in San Francisco

Volunteers treated with increasing doses of CNS 7056 were successfully sedated at the higher dose cohorts as expected and recovered to full consciousness rapidly...The program involves two clinical trials, taking place in the U.S. (TG-MV-006 trial) and Europe and North America (TG-MV-007 trial

The interim results showed a clinical response rate of 50 percent compared to 25 percent with paclitaxel alone, as well as a robust immune response in clinically responsive patients...for the advanced development stages of IMP321, as we continue to collect data from this study at the highest dose," he said.

DTS-108 has been designed, based on Diatos' Vectocell technology platform, to deliver high doses of SN38 while avoiding the gastrointestinal toxicity observed with irinotecan...Forest will assume responsibility for the clinical development and commercialization of F2695 in the U.S

The study also met all key secondary endpoints, with the high dose demonstrating clinically and statistically significant superiority in the WOMAC OA score over the entire 21-day active treatment period and in the WOMAC subscales of pain, stiffness and physical function over the entire 35-day treatment and follow-up evaluation periods...Cytokinetics said it anticipates that in early 2009 it will complete the delivery of the clinical data relating to the compound to Amgen Inc

ML-10 in early assessment of response of metastatic brain tumors to high-dose, single-fraction radiotherapy (also known as stereotactic radiosurgery...Ortho-McNeil's planned clinical studies also will include the evaluation of patients with Type II diabetes...Pluristem plans to initiate the dose-ranging clinical trial during the second quarter 2009 at two sites in Berlin

Clinical trial results to date have demonstrated that it has lower toxicity than calcitriol, the natural active metabolite of vitamin D3, leading Hybrigenics to believe that inecalcitol could be administered at higher doses than calcitriol, making it a more effective therapy for prostate cancer

This study is testing higher doses of GFT505 than those administered in the earlier Phase IIa trial, whose results were announced last March...Even at the highest dose tested, the treatment did not show any effect on hematocrit, erythrocytes, hemoglobin, and creatinine," explained the company's vice president of product development Remy Hanf

The company's lead product, CPI-003, is an autologous adult stem cell product for myocardial infarction and is set to start clinical testing next year...CytRx Corp., of Los Angeles, said its orally available dual Bcr-Abl and Lyn-kinase inhibitor INNO-406 demonstrated clinical responses in patients with chronic myeloid leukemia...New studies will focus on finding the lowest dose of Oxycyte that reduces the platelet reduction (thrombocytopenia) and still provides clinical benefit in traumatic brain

Also, high dose DPS-101 showed statistically significant efficacy relative to placebo (p=0.002), statistically significant efficacy relative to nicotinamide monotherapy (p=0.02), and a trend towards statistical significance vs...This study confirms the results of a previous clinical trial in which Vyvanse showed ADHD symptom control throughout a 12-hour treatment day

The two clinical efficacy endpoints of most interest, gout flares and gout tophi, showed an increasing proportion of patients with favorable response over time...In the mITT analysis, high-dose Synavive provided treatment benefits compared to placebo and prednisolone, across a range of efficacy measures, including WOMAC pain, stiffness and physical function subscales

Lisa Dunkle, executive director of clinical research at Schering-Plough, told BioWorld Today that the vicriviroc study results represent the longest treatment duration for a CCR5 receptor antagonist...Other HIV clinical news from the ICAAC-IDSA meeting included...The company separately announced positive interim results (based on the first 20 of 44 patients treated) from the first clinical trial of subcutaneous PRO 140

The two clinical efficacy endpoints of most interest, gout flares and gout tophi, showed an increasing proportion of patients with favorable response over time...In the mITT analysis, high-dose Synavive provided treatment benefits compared to placebo and prednisolone, across a range of efficacy measures, including WOMAC pain, stiffness and physical function subscales

Gemin X Pharmaceuticals Inc., of Malvern, Pa., presented clinical and preclinical data from studies of two of the company's targeted cancer therapeutics - obatoclax (GX15-070), a pan-Bcl2 inhibitor...Data from a Phase I/II trial showed that obatoclax in combination with docetaxel was well tolerated at the highest dose evaluated

Mpex Pharmaceuticals Inc., of San Diego, presented clinical and preclinical data on MP-376, its aerosol formulation of levofloxacin for cystic fibrosis and chronic obstructive pulmonary disease...Opexa expects to conduct a Phase II close-out meeting with the FDA during the first half of 2009 to discuss next steps for the further clinical development of Tovaxin...The firm said the 438-patient, 12-week SKY2028-3-005 trial is the last Phase III clinical efficacy study the firm will conduct before seeking

Debiopharm Group, of Lausanne, Switzerland, said the first healthy elderly subjects were randomized in a clinical bioequivalence bridging study for an investigational new drug application in the U.S. The study will compare the tolerability, safety and pharmacokinetic profiles of a new Debio 9902 tablet formulation to the one used in the Phase IIb BRAINz trial (Better Recollection for Alzheimer's patients with the ImplaNt of ZT-1), which has now completed patient enrollment...In an earlier Russian