Specifically, OS showed somewhat greater in the control arm than in the tivozanib arm. (See BioWorld Today, Jan. 4, 2012, and Aug. 6, 2012.) The OS glitch is "something that we have addressed with the FDA," Johnston said, and AVEO will be presenting more OS data at the American Society of Clinical Oncology's Genitourinary Cancers Symposium in Orlando, Fla., next month, along with some data from subpopulations...Clinical Cancer Research included a paper that suggested the compound, ENMD-2076, acts

Cytos Biotechnology Ltd., of Zurich, Switzerland, said a technical issue was identified with the rubber stoppers used to close the injection vials containing clinical trial material for its Phase IIb study testing lead candidate CYT003 in allergic asthma...Cytos will replace that material with new material available at clinical sites in the second quarter

Versartis Inc., of Redwood City, Calif., closed a $25 million Series C financing round through Aisling Capital, Index Ventures, New Leaf Venture Partners and Advent Venture Partners to support clinical trials of VRS-317 for growth hormone deficiency in children...Proceeds will be used for general corporate purposes, ultimately focused on advancing the firm's clinical pipeline...Goldman, Sachs and Co., and J.P. Morgan Securities LLC are joint book-running managers for the offerings, which will be filed

The proposed trail is intended to cut through the undergrowth of current clinical trial requirements by allowing for smaller, more targeted studies that wouldn't take as long to complete...Clinical trials represent an aggregate expense of about $31.3 billion, or nearly 40 percent of the R&D budget of major drug developers – much of that due to systemic inefficiency, according to the report...It's hoped that the results will help guide decisions in the future on whether a drug warrants further clinical

Together, the three collaborated in the seminal discovery of the first biologically active stapled peptide and translation into a potential clinical application...Proceeds from any offering are expected to support general corporate purposes, including to R&D costs, payment obligations and capital expenditures.

Proceeds will help the firm continue to expand commercial operations and clinical trials, scale laboratory capabilities and develop additional genomic profiling and information services...Foundation, which closed the initial $42.5 million in its Series B in September, is working on a genomic assay for all solid tumors that analyzes tumor DNA to help doctors match patients with targeted drugs or clinical trials best suited to their cancers. (See BioWorld Today, Sept. 20, 2012

In the VIN trial, there was a correlation between immune response and clinical response, as measured by reduction or resolution of vulvar lesions...For us it was a very good clinical proof of concept," Mark Krul, the company's other joint managing director told BioWorld Today...The company intends to use the proceeds to continue the clinical development of its immunotherapy platform, a personalized combination of cancer cell vaccination and "killer" T-cell treatment

Durata said the secondary endpoint of clinical success at the end of treatment – the expected primary endpoint for regulatory review in Europe – also was met...NovaBay Pharmaceuticals Inc., of Emeryville, Calif., said the first patients have been enrolled in India into its global Phase IIb BAYnovation clinical study, investigating NVC-422 ophthalmic solution as a treatment of adenoviral conjunctivitis, a highly contagious form of "pink eye" for which there is an unmet ocular medical need...The results

Alnylam Pharmaceuticals Inc., of Cambridge, Mass., filed a clinical trial application with the U.K. Medicines and Healthcare Products Regulatory Agency to initiate a Phase I study of ALN-TTRsc, an RNAi therapeutic targeting transthyretin (TTR), in TTR-mediated amyloidosis...ALN-TTRsc is the first GalNAc-siRNA to enter clinical development...The authors based their conclusions on post-hoc analyses of clinical data from a 1,040-patient DNA substudy of ARCA's Phase III Beta-Blocker Evaluation of Survival

clinical development of the company's lead candidate, perhexiline, for the treatment of heart failure symptoms in patients with hypertrophic cardiomyopathy (HCM), an inherited heart muscle defect that leads to disordered cardiac energy metabolism, enlarged heart muscle, obstructed blood flow from the heart and eventual heart failure

Funds from the Series B, which the firm was expected to disclose today, also will be used to progress clinical and preclinical development of its bifunctional short hairpin RNA (shRNA) platform, but it was FANG that loosened the purse strings in the round...acted as exclusive placement agent.

Funds will be used for working capital and for continuation of clinical research and development of Cavatak, an oncolytic virus candidate

OMP-52M51 is OncoMed's fifth product candidate to enter clinical development, a proprietary monoclonal antibody that targets the Notch1 receptor

Acura intends to complete clinical testing for a new drug submission via the 505(b)(2) pathway in the first half of 2014...Data showed that 82.3 percent of patients who received oritavancin met the early clinical endpoint of cessation of spread, absence of fever and no rescue antibiotics, compared to 78.9 percent of patients receiving vancomycin...About 79.6 achieved clinical cure, compared to 80 percent of the vancomycin group

As a small biotech with one foot in infectious disease and the other in neurology while having one hand in commercial products and the other in clinical development, "we have a unique strategy, and so far it's working well," Musunuri said...Proceeds will be used for general corporate purposes, including the company's ongoing trials of NX-1207, in late-stage development for benign prostatic hyperplasia and in Phase II testing in prostate cancer.

Then they heard dozens of patients – many participants in the clinical trials – say they didn't care...The guidance generally applies to submissions of summary 22 level clinical site datasets within new drug applications, biologics license applications and NDA and BLA supplemental applications containing new clinical study reports that are submitted to the Center for Drug Evaluation and Research

Arno is conducting clinical and preclinical studies of three drug candidates to treat a variety of cancers...The company intends to use the net proceeds primarily to advance the clinical development of its lead drug candidate, pracinostat, an oral histone deacetylase inhibitor...NeRRe Therapeutics Ltd., of London, raised £11.5 million (US$18.4 million) to develop a portfolio of clinical and preclinical neurokinin receptor antagonists divested from GlaxoSmithKline plc, also of London. #kicker123

The protocol was crowdsourced, using telemonitoring for patient data collection, and Transparency said it was the first clinical trial protocol developed in such a way...The company is trying to reduce the cost of clinical trials by 50 percent or more, and is partnered with Advanced Monitored Caregiving, a telehealth provider, to that end...Study patients will have in-person visits with the clinical trial staff at the beginning and end of the trial, and all other data will be collected at home

Trevi Therapeutics Inc., of New Haven, Conn., closed a $10 million Series A financing to advance the clinical development of T111 in the lead indication of uremic pruritis...Proceeds are expected to advance T111, an oral, extended-release opioid, into clinical development, with an efficacy study expected to begin in the first quarter of 2014.