Data demonstrated that patients with established atrial fibrillation (AF) receiving Gencaro in the trial had improvements in heart failure clinical endpoints, and those receiving Gencaro were more likely to achieve ventricular rate control

The company plans to use proceeds to expand clinical development of its dismutase mimetics, small-molecule mimics of critical enzymes in the oxygen metabolic pathways designed to overcome limitations of prior approaches to controlling superoxide and its harmful roles in human disease

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

The study is being conducted at 76 clinical sites in the USA, Canada, Europe and Australia...with experience and expertise in stem cell clinical trials studying treatments for cardiovascular heart diseases...Dompe Group, of Milan, Italy, said it presented the status of a clinical trial to evaluate the safety and pharmacokinetic profile of Reparixin, administered orally in combination with paclitaxel in women with metastatic breast cancer at the San Antonio Breast Cancer Symposium

RedHill Biopharma Ltd., of Tel Aviv, Israel, said it completed a private placement of approximately $6.5 million, which will be used to advance the company's late clinical-stage programs...It also plans to start a Phase IIa trial with RHB-104 for the treatment of multiple sclerosis in January 2013.

BCI-838 showed a favorable safety profile, with no treatment-related trends in clinical laboratory results, vital sign measurements, 12 lead ECG results or physical examination findings, and the drug was well tolerated up to the dose levels predicted for efficacy

NeuroVive Pharmaceutical AB, of Lund, Sweden, said Phase I data published in Clinical Drug Investigation showed that its CicloMulsion, a Cremophor-free intravenous cyclosporine formula, was bioequivalent to Sandimmune injection and was safe and well tolerated...CicloMulsion is a cyclophilin inhibitor in clinical development to treat cardiac reperfusion injury and, under the name NeuroSTAT, in development for traumatic brain injury

The Series D enables Zafgen to move clinical and regulatory activities forward without the distraction of additional fundraising, Hurwitz added...Proceeds will support a Phase III trial of Multikine (leukocyte interleukin, injection).

Because of the nature of the registry and vision testing variability, the company said, a clear comparison could not be drawn between registry data and clinical trial results

Net proceeds are expected to total about $44.7 million – or $51.5 million if underwriters exercise in full their overallotment option for 900,000 additional shares – and will be used for commercial launch activities and continued clinical development of the firm's pipeline of extended-release drugs

FDA Seeks Comments on Cellular, Gene Therapy The FDA made available a draft document relating to preclinical assessment of cellular and gene therapy products providing guidance on the substance and scope of information needed to support clinical trials...The brief was filed in connection with an antitrust action against Warner Chilcott, alleging that Warner Chilcott maintained a monopoly for its antibacterial drug Doryx by reformulating the drug three times.

delafloxacin showed an 88 percent clinical response rate dosed at 300 mg twice daily, compared to 82 percent for Tygacil (tigecyline, Pfizer Inc...A separate Phase II trial in community-acquired pneumonia showed an 87 percent clinical response rate at 200-mg and 400-mg doses of oral delafloxacin...Shares of Rexahn (NYSE:RNN) fell 14 cents, or 30.3 percent, to close Thursday at 33 cents.

Top-line data from the PEARL-SC trial, presented in June, showed the drug missed its primary endpoint, defined as clinical improvement at 24 weeks in the SLE responder index, but further data showed that the BAFF inhibitor produced sustained and greater treatment effects vs

AiCuris GmbH, of Wuppertal, Germany, said it started the second clinical efficacy trial testing pritelivir (AIC316), its herpes simplex virus (HSV) drug, after data from the first study showed a high degree of efficacy against genital herpes...A Phase Ib study of ProHema achieved its primary objective of demonstrating safety and tolerability and established early clinical proof of concept, including trends of accelerated neutrophil recovery, improved 100-day survival and low rates of graft-vs.-host

Accera Inc., of Broomfield, Colo., started a clinical efficacy trial examining the effects of AC-1204 in patients with mild-to-moderate Alzheimer's disease (AD

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.

Subcutaneous administration achieved efficient conversion to decitabine, resulting in an improved pharmacokinetic profile over the intravenous Dacogen (decitabine) formulation, and clinical responses were observed in the heavily pretreated population of patients with relapsed/refractory intermediate- or high-risk myelodysplastic syndromes or acute myelogenous leukemia

Using Electronic Data in Clinical Trials The FDA also is requesting comments on a revised draft guidance on the use of electronic source data in clinical trials...The document is designed to help sponsors, contract research organizations, data management centers, clinical investigators and others involved in capturing, reviewing and archiving electronic source data in FDA-regulated clinical trials to ensure the reliability, quality, integrity and traceability of the data

The Patient-Centered Outcomes Research Institute (PCORI) will award $12 million in funding through 14 contracts for studies addressing knowledge gaps in comparative clinical effectiveness research