Oncolytics Biotech Inc., of Calgary, Alberta, said that it entered an agreement with the NCIC Clinical Trials Group at Queen's University, Kingston, Ontario, which will sponsor and conduct a randomized Phase II study of Reolysin in patients with advanced or metastatic breast cancer...Medigene AG, of Martinsried, Germany, said that a clinical formulation trial with RhuDex achieved positive results and that the further clinical development of the drug for the treatment of autoimmune diseases will

The open-label, dose-escalation trial also showed that eight of 10 patients with secondary progressive disease who were treated for 12 weeks showed some improvement in their signs and symptoms...Spectrum Pharmaceuticals Inc., of Henderson, Nev., reported updated clinical data for Zevalin (ibritumomab tiuxetan) injection for intravenous use in an oral presentation at the 17th Congress of the European Hematology Association

Astex also is eligible to receive further milestones during clinical development and royalties on commercialization of products derived from the collaboration. (See BioWorld Today, June 10, 2008...The open-label trial involved administration of Reolysin to 10 patients

The open-label study will treat 30 patients with uncomplicated gonorrhea with a single 1,200-mg oral dose of solithromycin...Primary efficacy was measured using the Clinical Dyskinesia Rating Scale and the Unified Parkinson's Disease Rating Scale

In the clinical analysis, more than 1,700 patients were stratified in quartiles by baseline body weight, and results showed that A1C reduction and weight loss were comparable across all quartiles...Those data came from a Phase IIb open-label extension study

Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., said its clinical research organization completed the analysis of the primary endpoint in the Optina trial for diabetic macular edema, with results confirming a significant interaction between the patient's body mass index (BMI) and efficacy at the different doses of Optima...The open-label, adaptive, randomized study will enroll up to 548 chemotherapy-naïve patients with extensive-stage small-cell lung cancer, randomizing them to

ChemoCentryx Inc., of Mountain View, Calif., reported Phase II data showing that CCX354, a selective, oral inhibitor of chemokine receptor CCR1, was generally well tolerated by patients with rheumatoid arthritis and showed evidence of clinical activity using the ACR20 response criteria at week 12...Immunomedics Inc., of Morris Plains, N.J., reported data from the ALLEVIATE trials testing epratuzumab, including results from the open-label extension study showing clinically meaningful improvements in

The open-label, study's primary objectives were to evaluate trabedersen's maximum tolerated dose and dose-limiting toxicities...CytRx Corp., of Los Angeles, reported Phase Ib/II data showing that tumor-targeting doxorubicin conjugate INNO-206 produced a clinical benefit at the maximum tolerated dose in 10 of 13 (76.9 percent) evaluable patients with relapsed or refractory soft-tissue sarcoma

The trial is one of three prospective, open-label trials being carried out in the U.S...In clinical trials, 14 percent of the prior null responders with cirrhosis who received Incivek combination therapy achieved SVR vs. 10 percent in the placebo group, OPDP pointed out

Preliminary data from the study will be presented at the upcoming American Society of Clinical Oncology meeting in Chicago...Ocera Therapeutics Inc., of San Diego, reported preliminary data from an open-label Phase II study evaluating the effectiveness and safety of OCR-002 (ornithine phenylacetate) for the treatment of cirrhosis of the liver and upper gastrointestinal bleeding

The Phase II study design is based on the successful completion of a Phase I study of EP-100 in advanced solid tumors that will be presented at the American Society of Clinical Oncology annual meeting...The multicenter, open-label, Phase II is designed to evaluate the safety and efficacy of the combination therapy, randomizing 100 patients in North America to Zevalin plus rituximab, with and without MGd

Sunovion Pharmaceuticals Inc., of Marlborough, Mass., reported results from an open-label study that switched clinically stable, but symptomatic adult outpatients with schizophrenia from other antipsychotic agents to Latuda (lurasidone HCl...The six-week open-label study included 244 patients who were clinically stable for at least eight weeks prior to the start of the study and had been on stable doses of other antipsychotic agents for at least four weeks

GTx Inc., of Memphis, Tenn., said the FDA removed its full clinical hold on the company's investigational new drug application for prostate cancer drug Capesaris following review of the firm's complete response and its new Phase II protocol...GTx plans to start the open-label Phase II trial in the third quarter

clinical trial in June testing allergy immunotherapy JRC-LAMP-Vax in subjects sensitive to Japanese red cedar pollen...Results were presented at the European Summit for Clinical Nanomedicine in Basel, Switzerland...Oncolytics Biotech Inc., of Calgary, Alberta, said it entered an agreement for the NCIC Clinical Trials Group at Queen's University in Kingston, Ontario, to sponsor and conduct a Phase II study of Reolysin in patients with advanced or metastatic colorectal cancer

Fourteen clinical trials support Supernus' application for SPN-538...Nine clinical trials support Supernus' application for SPN-804...In an open-label, dose-ranging trial in 78 children between 6 and 12 years of age, SPN-810 was well tolerated and produced improvements in outcome measures such as conduct problems and ADHD scales

Pharmanest AB, of Stockholm, Sweden, said the first patient was dosed in a 15-patient, open-label Phase I study testing SHACT, a product developed for pain relief in connection with intrauterine device (IUD) insertion...Syndax Pharmaceuticals Inc., of Waltham, Mass., said Phase II data published in the Journal of Clinical Oncology confirmed preclinical findings and demonstrated an improved overall survival in a subset of non-small-cell lung cancer (NSCLC) patients with tumors expressing elevated

TOP is an ongoing open-label, multicenter, observational study designed to assess long-term outcomes in patients with relapsing-remitting MS (RRMS) in Europe, Australia and Canada...Baseline anti-JCV antibody testing results from more than 35,000 MS patients who were either receiving or considering treatment with Tysabri showed that the overall prevalence of anti-JCV antibodies was 53.5 percent, which is consistent with the prevalence of anti-JCV antibodies observed in MS patients in other clinical

The company said the data supported the progression of CK-2017357 into later-stage clinical development...The open-label trial will enroll up to 27 patients to receive IV INNO-206 once every three weeks for eight cycles

Assuming that we succeed, of course, at that point we plan to sit down with the FDA to determine what they're going to want in the balance of the clinical program," Oclassen said...We got good results in open-label studies, and those gave us the courage to move forward with this trial