The company previously reported on the safety aspects of the trial, which demonstrated that OX1 is safe and well tolerated at all dose levels tested...The primary endpoint of "clinical benefit response" is a composite measurement of pain, performance status and lean body mass

The trial showed that the vaccine was generally safe and well tolerated, and immunologic and virologic responses were achieved at all dose levels...The NSCLC trial started in June after the FDA partially lifted a clinical hold on the vaccine to investigate a case of encephalitis in a multiple myeloma patient. (See BioWorld Today, June 18, 2010

The randomized, double-blind trial in 160 patients worldwide will have two dose levels plus placebo...Ohr Pharmaceutical Inc., of New York, enrolled the first patients at a new clinical site, the Ottawa Hospital Cancer Centre, in an ongoing Phase IIb trial of OHR/AVR118 for cancer cachexia

Clinical Data Inc., of Newton, Mass., reported results of two Phase I studies demonstrating that vilazodone, a dual-acting modulator of serotonin neurotransmission in development for the treatment of major depressive disorder, did not prolong the QT interval and that alteration of gastric pH does not adversely affect its pharmacokinetics...The results were presented in Anaheim, Calif., at the 2010 Midyear Clinical & Exhibition Meeting of the American Society of Health-System Pharmacists...The results

The firm said administration of the third-dose level in patients recruited since September was completed as expected...The company received the credit for its lead clinical candidate amdoxovir for the treatment of HIV-1 infections and said it will be used to support an upcoming Phase II study of amdoxovir which is expected to begin during the first quarter of 2011

Astex Therapeutics, of Cambridge, UK, will report clinical data on three anticancer candidates at the 22nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics Nov. 16-19 in Berlin...AT7519 was safe and well tolerated in nine out of 29 patients at four dose levels over 2.5 to 11.1 months and will progress to Phase II studies...It was statistically noninferior to Zyvox (linezolid, Pfizer Inc.) for all clinical test-of-cure and short-term follow-up endpoints

Results were published in the Journal of Clinical Oncology...The trial will be carried out at the Wilmer Eye Institute at Johns Hopkins in Baltimore and will enroll 18 patients with wet AMD to evaluate three dose levels of the drug

About 50 percent of patients receiving Traficet-EN in the maintenance period were in clinical remission by the end of 36 weeks compared to 31 percent of patients on placebo...Intellect Neurosciences Inc., of New York, obtained an initial draft report of its Phase Ib trial for lead Alzheimer's candidate Oxigon (OX1), with data showing that the drug was safe and well tolerated at all dose levels tested in healthy elderly volunteers, ages 60 and older, during 14 days of repeated dosing...Verona Pharma

The 12-week trial will test two dose levels of DCCR against placebo and active control arms, and half of the study patients will be statin-treated...NovaBay Pharmaceuticals Inc., of Emeryville, Calif., reported that clinical and bacteriological response rates of children with impetigo treated with three concentrations of the firm's Aganocide compound, NVC-422, ranged from 84 percent to 95 percent at end of treatment and at follow-up

Idera Pharmaceuticals Inc., of Cambridge, Mass., reported that IMO-3100 was well tolerated at all dose levels evaluated in the 30 healthy subjects that received IMO-3100 in a single-dose, dose-escalation Phase I clinical trial, and that target engagement of TLR7 and TLR9 was observed through inhibition of TLR7- and TLR9-mediated immune responses...The company said the next step in the clinical development of IMO-3100 will be a Phase II clinical trial in a selected autoimmune disease indication

Neovacs SA, of Paris, said its data safety monitoring board authorized the firm to proceed to the next higher dose of INFalpha-Kinoid in its ongoing Phase I/II trial in lupus after reviewing the data for patients administered the second dose level...The study will enroll up to 200 patients who will be randomized to receive one of three dosing regimens of PMX-30063 or daptomycin active control and will have an early treatment assessment at 48 hours and 72 hours for clinical and microbiologic

At the highest dose level, AP214 markedly reduced the development of AKI by 70 percent and reduced the IL-6 response by 40 percent, compared to placebo...The initial clinical indication for Bendavia is the treatment of ischemia reperfusion injury, a common complication of interventional procedures for acute myocardial infarction

MAP Pharmaceuticals Inc., of Mountain View, Calif., said all four clinical trials required to support a new drug application filing for Levadex (inhaled dihydroergotamine mesylate) in acute migraine have completed enrollment...That trial examined the safety and activity of different dose levels of a tablet formulation of oral methylnaltrexone in subjects with chronic, noncancer pain with a history of OIC receiving various opioid treatment regimens

Secondary objectives include assessing the pharmacokinetics and antitumor activity of AGS-16M8F and identifying a recommended dose and regimen for future clinical trials...Preliminary data showed that the drug was well tolerated at all dose levels, with no drug-related serious adverse events or dose-related trends in frequency or type of adverse events

Cerulean Pharma Inc., of Cambridge, Mass., reported results of a Phase I clinical study of CRLX101 (formerly IT-101), Cerulean's lead clinical development candidate, and preclinical data on Cerulean's development candidate, CRLX288, at the American Chemical Society National Meeting & Exposition, ongoing in Boston...FibroGen Inc., of San Francisco, reported results of a two-year clinical study demonstrating that surgical implantation of biosynthetic corneas formulated with the company's recombinant

The primary endpoint is clinical improvement in the SLE responder index, while secondary endpoints will include safety, improvement in other clinical assessment scores, patient responses vs...Treatment with ITI-007 also yielded clinical signs consistent with antipsychotic and antidepressant efficacy, including a reduction in the total Positive and Negative Syndrome Scale and the Calgary Depression Scale for Schizophrenia

Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, presented clinical data and analysis from its Phase IIa trial of LX4211 for patients with Type II diabetes at the Endocrine Society meeting...After initial dose ranging in 14 patients, two dose levels were selected for further study

The following data were revealed at the American Society of Clinical Oncology meeting in Chicago...Ariad Pharmaceuticals Inc., of Cambridge, Mass., said updated data from an ongoing Phase I study confirmed strong clinical evidence of hematologic, cytogenetic and molecular anti-leukemia activity of AP24534, a multitargeted kinase inhibitor, in heavily pretreated patients with chronic myeloid leukemia, including those with the T315I mutation of the target protein Bcr-Abl...BioTheranostics, of San Diego

Ltd., of Jiangsu, China, said data from a clinical trial testing umbilical cord mesenchymal stem transplants in 16 patients with severe refractory systemic lupus erythematosus showed that disease activity was improved during the first three months of follow-up, and after nearly two years, most patients showed clinical remission with no adverse events detected to date or treatment-related mortality...The planned study is designed to compare two dose levels of drug to placebo in 300 patients over 24