The open-label trial will evaluate the efficacy, safety and tolerability of the drug in patients infected with HCV, of any genotype, who have previously failed or relapsed following standard-of-care treatment...The open-label trial consists of weekly doses of the Imprime PGG immunotherapeutic candidate, with Avastin administered once per cycle and the chemotherapies carboplatin and paclitaxel administered during week one of the first four to six cycles

Kythera Biopharmaceuticals Inc., of Calabasas, Calif., disclosed positive interim results from a Phase IIIb, multicenter, open-label study (ATX-101-11-26) to evaluate the safety and efficacy of ATX-101, an investigational injectable drug for the reduction of unwanted submental fat (SMF), commonly known as double chin...The ATX-101 global clinical development program has enrolled more than 2,500 total patients, of which more than 1,500 have been treated with ATX-101, the company said

The ADAPT study is a randomized, multicenter, open-label trial expected to enroll 450 patients in about 120 global sites, mostly in North America. (See BioWorld Today, April 25, 2012...Targeted Medical Pharma Inc., of Los Angeles, said results from an open-label study of oral amino acid-based erythrocyte stimulating system (ESS) for the treatment of chronic anemia showed that hemoglobin increased an average of 11.39 percent from baseline measurement to 45 days

Beyond ALX-0061, the cash infusion also will allow flexibility in the structure and timing of any licensing deals for other Phase II assets including an anti-TNF alpha Nanobody, ozoralizumab, which last year reported positive data from a 48-week open-label extension trial in a worldwide Phase II study in rheumatoid arthritis Another product, caplacizumab (ALX-0081) for treating acquired thrombocytopenic purpura (TTP), is on course to complete recruitment of 110 patients in the Phase II trial by

Oculus Innovative Sciences pulled off positive results in an open-label pilot study of Atrapro Antipruritic Hydrogel in combination with Neosalus Cream, demonstrating statistically significant 50 percent reduction in body surface area of atopic dermatitis from baseline to week four...The company is planning to begin clinical studies in the first half of 2014

The study also has exploratory endpoints for clinical efficacy and inflammation biomarkers...The open-label, multicenter study expects to enroll 20 patients with moderate-to-severe plaque psoriasis

The open-label trial will test the safety and effectiveness of ADXS-HPV when combined with standard chemotherapy and radiation treatment...The primary objectives include the evaluation of adverse events and the evaluation of six-month clinical response

The open-label study followed 21 patients with unfavorable risk mRCC, with an expected survival of approximately 15 months...The company is currently enrolling patients in an ADAPT Phase III study for AGS-003 – a randomized, multicenter, open-label clinical trial that is expected to enroll 450 patients in approximately 120 global sites, mostly in North America...The open-label, dose-escalation trial was conducted in 52 men with hormone-refractory prostate cancer that had progressed despite prior

Two posters feature clinical data of PROSTVAC evaluated as monotherapy or in combination with a radiopharmaceutical...A randomized Phase II, open-label study of Provenge with concurrent or sequential abiraterone acetate (AA) plus prednisone (P) in metastatic castrate-resistant prostate cancer demonstrated no significant differences in median cumulative CD54 upregulation (31.6 vs. 36.6) and CD54+ count (1.9 vs. 2.1 x 109) between the two arms, suggesting Provenge can be manufactured during treatment

Advanced Cell Technology Inc. (ACT), of Marlborough, Mass., said its clinical partner, the University of California, Los Angeles (UCLA), received FDA approval for its investigational new drug application...The prospective, open-label study is designed to determine the safety and tolerability of hESC-derived RPE cells following subretinal transplantation into patients with myopia at 12 months, the study's primary endpoint

The open-label, single-arm study will enroll about 37 patients after failure of second-line therapy, with a primary endpoint of overall response rate and secondary endpoints including progression-free survival, overall survival, median duration of response and safety...Portola Pharmaceuticals Inc., of South San Francisco, inked a clinical collaboration with Janssen Pharmaceuticals Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, and Bayer AG, of Leverkusen, Germany, to evaluate the

The study is an open-label trial of monthly Opaxio or Taxol for up to 12 consecutive months compared to surveillance in women with advanced ovarian cancer with no evidence of disease following platinum-taxane therapy...The goal of the trial will be first to find optimum dosing of the drug, and second to assess safety, pharmacokinetics, pharmacodynamics and clinical activity in disease-specific cohorts of at least 12 patients each

The open-label study is enrolling patients with Stage IIIb and Stage IV disease, and the primary objectives include evaluating the safety of a single dose and repeat doses...Repros Therapeutics Inc., of The Woodlands, Texas, provided a revised date for expected clinical results from the first pivotal trial, ZA-301, of Androxel (enclomiphene) in secondary hypogonadism, with data expected in the third quarter rather than the second quarter

Preob has already completed an open-label Phase IIa study in 30 patients...If the clinical data are good, it will be able to marshal strong pharmacoeconomic arguments

Ampio plans to start enrolling in a 450-patient clinical trial this quarter...Those data completed the pivotal pharmacokinetic and clinical program for BNX, which BDSI said will enable a new drug application submission in mid-2013...About 120 healthy adult volunteers will be enrolled in the open-label trial, which will evaluate the impact of the vaccine on ciprofloxacin as the primary objective

The VERTICAL study is a randomized, open-label study in pre-pubertal children with growth hormone deficiency not previously treated with rHGH...Proceeds will be used for general corporate purposes, ultimately focused on advancing the firm's clinical pipeline

Secondary endpoints also were met, including the clinical cure rate at end of treatment day 10 to day 14 (88.9 percent) and test of cure at day 21 to day 28 (100 percent...That allows Lorus to initiate a biomarker clinical investigation to further explore the effects of the drug at relevant doses determined in the trial...The complete clinical study report for the interim analysis would be supplied to the FDA during the review within 60 days of the resubmission

The registrational Phase II double-blind, placebo-controlled clinical study has completed the first of two interim analyses...The second Phase II open-label study should be completed by the end of the first quarter of 2013

Sarepta Therapeutics Inc., of Cambridge, Mass., said updated data from Study 202, its open-label, Phase IIb extension study of eteplirsen for the treatment of Duchenne's muscular dystrophy, showed that patients treated with eteplirsen for 62 weeks and evaluable on ambulatory measures (modified intent-to-treat population) maintained a statistically significant clinical benefit on the primary clinical outcome measure, the six-minute walk test, compared to patients who received placebo for 24 weeks