Bayer Inc., of Deerfield, Ill., and the Population Health Research Institute said they started the COMPASS trial, the largest clinical study to date of oral anticoagulant rivaroxaban

The data, compared to month three, showed a further improvement in clinical symptoms linked to RA for patients in whom the Kinoid induced antibody (Abs) to TNF, compared to those without such antibody

The primary endpoint of the study is clinical benefit of AEZS-108...The study, conducted in 20 Asian patients at seven clinical trial sites, compared the outcome of a single intravenous dose of Zybrestat (15, 25, 35 or 45 mg/kg) with placebo...Based on outcomes for safety and tolerability, and measures of absorption, distribution, metabolism and excretion, Path will proceed to the next Phase of clinical trials in 2013

The data were presented during a late-breaking clinical trials session at the 9th International Congress of the Society for Melanoma Research in Hollywood, Calif

The Phase III study met its primary endpoint and demonstrated statistically significant protection against clinical and severe malaria in infants...In the trial, infants (ages 6-12 weeks at first vaccination) receiving the RTS,S vaccine candidate experienced one-third fewer episodes of both clinical and severe malaria and experienced similar reactions to the injection when compared to those who received the control meningococcal C conjugate vaccine

Although the trial was not designed to demonstrate efficacy, evidence of clinical activity was observed in some patients...Response evaluation to date among 30 evaluable patients showed 27 patients had stable disease or better for a 90 percent clinical benefit rate (nine partial response [30 percent] and 18 stable disease [60 percent...In the clinical trial (n = 39 patients), OMP-59R5 was generally well tolerated, with diarrhea as the main treatment-related and dose-related adverse event

The three clinical trials involve four of the top-ranked eye hospitals in the U.S., and two of the leading eye hospitals in the UK...Across the various clinical trial sites, with regular patient follow-up, no adverse safety issues relating to the transplanted cells have been observed...The clinical trial, called Transplantation In Myocardial Infarction Evaluation (TIME), was designed to see if heart function would improve by administering stem cells derived from the patient's own bone marrow either

Going into the NRAS population isn't surprising, given the promising Phase II data reported at the American Society of Clinical Oncology (ASCO) meeting earlier this year...Over the summer, it hit its primary endpoint of reducing pain more effectively than placebo in a Phase II trial in osteoarthritis. (See BioWorld Today, Aug. 2, 2012.) Proceeds from the public offering – funds could increase by about $9.9 million if underwriters exercise their 2.7 million-share overallotment option in full – are

Sanofi Pasteur, of Swiftwater, Pa., the vaccines division of Sanofi SA, said Pediatric Infectious Disease Journal published pivotal clinical trial data used by the FDA to support the license expansion for its meningococcal conjugate vaccine, Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), to include a two-dose schedule for infants and toddlers 9 months through 23 months of age

clinical centers...Novartis also plans to pursue clinical development in combination with a Raf inhibitor in BRAF mutant melanoma, with regulatory submissions projected on or after 2016

Moberg Derma AB, of Stockholm, Sweden, said it received the final results from a Phase II study of MOB-015 in patients with onychomycosis and, because the clinical efficacy was unsatisfactory, said it decided to initiate a new study with an improved formulation...Senesco Technologies Inc., of Bridgewater, N.J., said it expanded its clinical trial of SNS01-T to include diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL) patients

Proceeds will be used to begin investigational new drug application-enabling studies and clinical trials through Phase IIa with its cyclophilin inhibitor, EDP-546, as well as to begin preclinical development of a nucleotide polymerase inhibitor and to support other research and development activities...Novartis snapped up exclusive, worldwide rights to another pipeline program, EDP-239, in February for $34.4 million up front, and up to $406 million in clinical, regulatory and commercial milestones

Chelsea Therapeutics International Ltd., of Charlotte, N.C., reported results from a clinical study designed to determine the blood pressure effect of escalating doses (100 mg, 200 mg and 400 mg) of Northera (droxidopa) in hypotensive individuals with chronic spinal cord injuries ranging from cervical to low thoracic lesions...A completed Phase I trial in end-stage cancer showed a desirable safety profile, plus stable disease or clinical response in about 25 percent of patients

Funds will be used for working capital and general corporate purposes, including the funding of its ongoing clinical trials...The net proceeds will be used for working capital and general corporate purposes, including the continued conduct of the Abili-T clinical study, Opexa's recently initiated Phase IIb trial of personalized T-cell therapy Tcelna in patients with secondary progressive multiple sclerosis.

In clinical trials, Infasurf was compared to Exosurf Neonatal, which is no longer marketed, and Survanta, over which Infasurf did not demonstrate clinical superiority

The clinical significance of those analyses is unknown. (See BioWorld Today, March 28, 2012

The company laid groundwork for clinical trials in advance of the financing and plans to begin a "very substantial" randomized Phase II study in the U.S...Results from a positive Phase I of ME-143 were presented at the American Society of Clinical Oncology meeting in June...Novelos plans to use the proceeds to complete an in-house clinical-stage manufacturing facility for its small-molecule, broad-spectrum, cancer-targeted imaging agent I-124-CLR1404 (LIGHT

The clinical significance of those analyses is unknown. (See BioWorld Today, March 28, 2012

Isconova AB, of Uppsala, Sweden, carried out a fully subscribed rights issue of about SEK50 million (US$7.4 million) to finance clinical trials in-house, increase production capacity and continue research in new indications for the adjuvant Matrix M. Shareholders representing 46.3 percent committed to subscribe for their respective pro rata share of the issue, with the remainder guaranteed by a consortium