The NH004-3 clinical trial is a double-blind, placebo-controlled, randomized, crossover, multicenter study comparing NH004 and placebo thin films in Parkinson's disease patient complaining of sialorrhea...Trevi Therapeutics Inc., of New Haven, Conn., started a Phase I, open-label study to characterize and compare the pharmacokinetics, safety and tolerability of escalating oral doses of nalbuphine hydrochloride extended-release tablets in end-stage renal disease patients on hemodialysis as compared

Chimerix Inc., of Durham, N.C., presented the first clinical outcomes data on lead candidate CMX001 in life-threatening infection with adenovirus (AdV), a disease with no approved therapy...The open-label study, which randomized 153 patients, evaluated two schedules of TG4040 in combination with PegIFNα2a (P) and ribavirin (R) vs. P/R alone (arm A

Cel-Sci Corp., of Vienna, Va., entered a co-development agreement with Ergomed, a clinical research organization (CRO), to expand its Phase III study of Multikine (leukocyte interleukin) as an injectable treatment for head and neck cancer...Under the agreement, Ergomed will contribute up to $10 million toward the study, for which it will perform clinical services in exchange for a single digit percentage of milestone and royalty payments, up to an undisclosed specified amount...Nymox Pharmaceutical

The open-label study under an investigational new drug application is designed to evaluate the safety and efficacy profile of repeated escalating doses of BL-8040 in adults with relapsed/refractory AML...Regentis raised $10 million last year in a Series C financing to support clinical studies and commercial launch of GelrinC in Europe. (See BioWorld Today, May 15, 2012

A preliminary open-label study of a precursor of the missing metabolite yielded promising results in 10 patients, Sedel said...The company's "exceptional team" and its potential to obtain rapid clinical efficacy data were two attractive attributes, Rafaèle Tordjman, managing partner at Sofinnova Partners, told BioWorld Today

The primary endpoint of the study is the induction of clinical remission at week 12...The study is being conducted by more than 60 clinical investigators worldwide, including about 11 sites in Brazil and 24 sites in India...The TRIG-05 study is expected to begin enrollment this month, with a primary clinical endpoint of demonstrating efficacy, tolerability and safety of TI-001

The open-label study will test the safety and efficacy of intra-articular injections of the autologous treatment in order to reduce inflammation and regenerate damaged joint tissue...Novavax Inc., of Rockville, Md., said top-line data from its Phase II dose-ranging study testing its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age hit its protocol-specified objectives, supporting progression to the next stage of advanced clinical testing

The open-label study assessed the safety and efficacy of CCH in Stage II unilateral idiopathic FSS in comparison to an exercise-only control group...dosage form of either tedizolid or linezolid with the option to switch to the respective oral dosage forms at the discretion of the clinical investigator on or after the second day of treatment

The Phase I/II trial showed a significantly slower decline in overall clinical and respiratory function, as measured by the ALS functional rating score (ALSFRS-R) and forced vital capacity (FVC) score, respectively, in the six patients who received an intrathecal injection of the cells in the six months following treatment, as compared to the three months preceding treatment...In the single-dose, open-label study, ISIS-SMNRx was well tolerated in children with SMA at all dose levels tested and

The company examined the triglycerides data from its open-label study in the course of planning its Phase III development of CaPre...The NX03-0040 prostate cancer clinical study of 150 men is testing low (2.5 mg) and high (15 mg) single doses of NX-1207 for the effect to eradicate or shrink low-grade localized prostate cancer tumors

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

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...Also, 93 percent of people in that dose group showed no clinical symptoms of influenza after three days of treatment, compared to 41 percent of people in the placebo group

Amicus Therapeutics Inc., of Cranbury, N.J., reported positive results from clinical and preclinical studies of the pharmacological chaperone AT2220 (duvoglustat HCl) in combination with ERT for Pompe disease at the Lysosomal Disease Network World Symposium...The open-label study followed 21 patients with unfavorable risk mRCC, with an expected survival of approximately 15 months

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 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

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

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

regulators are happy to see a clinical response, whereas European regulators seek the more stringent outcome of remission...Proceeds will be used to advance the clinical development of EPI-743...The drug previously demonstrated efficacy in prostate, breast and ovarian cancer models, as well as in endometriosis, and the recent fundraising is expected to move VAL201 through first-in-human clinical trials.