Access Pharmaceutials Inc., of Dallas, has begun a new clinical study of ProLindac in France...Later this month, an Access management and clinical development team is meeting with Access' Chinese partner, Aosaikang Medicinal Group, and several key oncology opinion leaders to finalize plans for ProLindac development in China...The hold was imposed in late March after the FDA's review of preclinical high-dose toxicity studies resulted in some abnormal movements

Cytos has a third trial (Study 03) ongoing, evaluating the vaccine in the same treatment regimen but at higher doses...The trial started in Russia with a low dose of Diabecell, with preliminary data showing sustained long-term clinical benefit, with no remarkable adverse events

These data show that short-course oral treatment with Cladribine Tablets resulted in rapid and sustained improvements in clinical and magnetic resonance imaging outcomes, which were accompanied by rapid and sustained effects on blood-cell subtypes implicated in the pathogenesis of multiple sclerosis...An amended protocol for the trial will allow inclusion of younger LCA patients in the trial and the treatment of patients with higher doses of an adeno-associated virus vector containing the RPE65

Staff Writer The American Society of Clinical Oncology's annual meeting kicked off Friday afternoon, and a session on leukemia, myelodysplasia and transplantation generated plenty of attention...Patients on a seven-day dosing schedule achieved two responses at the higher dose and four at the lower dose

Evening administration of the highest dose of PF03187207 showed a numerical improvement over Xalatan of 12 percent in reducing diurnal intraocular pressure after 28 days, compared to baseline...Two preclinical posters and one on a meta-analysis of clinical data for PF03187207 and several currently used glaucoma treatments also were scheduled to be presented

Additionally, significant sustained levels of POT-4 were consistently measured via serum analysis in subjects receiving the highest dose studied, the company said...Pulmatrix said it expects to advance PUR003 into multiple clinical studies to demonstrate its use in the treatment, prevention and control of infectious and progressive respiratory diseases this year, including influenza...SuperGen Inc., of Dublin, Calif., said Phase Ib data demonstrated an overall clinical benefit rate of 54 percent when

Principal investigator Ed Gane of Auckland Clinical Studies said the INFORM-1 trial was "based on the rationale from the HIV treatment paradigm...Subsequent cohorts looking at higher doses of R7227 in treatment-experienced HCV patients are under way

Amarillo Biosciences Inc., of Amarillo, Texas, said its partner CytoPharm Inc., of Taipei, Taiwan, will be conducting a study aimed at reducing the virologic relapse rate in patients with chronic hepatitis C virus infection who have completed the standard combination therapy of high-dose injectable interferon alpha and ribavirin...Those data were published in the May 2009 issue of the Journal of Clinical Immunology

Geron Corp., of Menlo Park, Calif., said imetelstat (GRN163L), now in six clinical trials examining the safety, pharmacokinetics and pharmacodynamics of the drug, alone or in combination with standard therapies, in solid tumors, chronic lymphoproliferative diseases, multiple myeloma, lung and breast cancers, continued to show telomerase inhibition not only in the bulk tumor fraction of patients' bone marrow, but also in the stem cell-containing fraction...Lorus Therapeutics Inc., of Toronto

The trial builds on positive Phase II results and extends clinical investigations to those with allergy-associated asthma...InterMune Inc., of Brisbane, Calif., has amended the clinical study of protease inhibitor ITMN-191 (R7227) in combination with nucleoside polymerase inhibitor R7128 (Roche/Pharmasset) to include additional cohorts to explore the combination in treatment-experienced and null responder HCV patients...In addition, the protocol now includes the administration of twice-daily and

Five of seven patients with advanced solid tumors and brain metastases who received higher doses of ANG1005 experienced an objective response, including one partial response...Array BioPharma Inc., of Boulder, Colo., presented two abstracts showing both the clinical benefit of ARRY-543 in tumors that signal through multiple ErbB family members, and its efficacy in preclinical models when compared to, and combined with, Herceptin (trastuzumab), Xeloda (capecitabine) and Taxotere (docetaxel...Clinical

The drug recently was placed on partial clinical hold in epilepsy due to findings of certain high-dose preclinical studies, and the firm is in the process of conduction additional preclinical trials to address concerns raised by the FDA

Two patients - one with breast cancer and one with lung cancer - achieved stable disease at the maximum tolerated dose level, while a patient with colorectal cancer had stable disease at a higher dose level...It is the first Btk selective inhibitor to be tested in humans, and is Pharmacyclics' fourth product in clinical development

However, the carcinomas were only apparent in females and only at the highest dose, he said...He vowed that the Senate would act quickly to pass the companion bill.

Clinical outcomes will be measured using standard validated tools, and lumbar disc changes will be measured using magnetic resonance imaging data...plc, of Dublin, Ireland, and partner Wyeth, of Madison, N.J., discontinued the highest dose in two ongoing Phase III trials of Alzheimer's disease drug bapineuzumab

In this trial, the combination of Zemiva imaging with initial clinical information resulted in improved sensitivity (85 percent) compared to the sensitivity of the initial clinical diagnosis alone (52.2 percent) (p < 0.0001), while maintaining specificity (p=NS...In the study, the high dose of NT-501 stabilized best corrected visual acuity at 12-months, with 96.3 percent (p=0.078) of treated-patients losing fewer than three lines of vision, or 15 letters, versus 75 percent of the patients in the

Clinically and statistically significant reductions in fasting plasma glucose also were observed at the two highest doses...Transition Therapeutics Inc., of Toronto, said the first patient has been dosed in a clinical study of gastrin analogue TT-223 in combination with an Indianapolis-based Eli Lilly and Co

Data also showed that 27.3 percent of high-dose patients had improved best corrected visual acuity (BCVA) of 15 letters or greater over baseline, and 23.1 percent of the low-dose patients had an improvement in BCVA of 15 letters or greater over baseline...The data were published in the Journal of Clinical Investigation

Clinical Data Inc., of Newton, Mass., said that the complete results from its first pivotal Phase III study of vilazodone in major depressive disorder were published online in the Journal of Clinical Psychiatry...INT131-007 is a 24-week, high-dose active comparator (45 mg Actos) and placebo-controlled study of INT131 at four doses in poorly controlled Type II diabetics