SONAR is a multinational, double-blind, placebo-controlled clinical study that is expected to enroll more than 4,000 patients with diabetic nephropathy...The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), is being conducted at the NIAID Phase I Clinical Trials Unit at Case Western Reserve University in Cleveland

The money should carry the new company "for about three years-plus," Worlund said, long enough to get clinical proof of concept with a lead program...Karyopharm is expected to present data from its Phase I study testing lead SINE program KPT-330 in solid tumors at the upcoming American Society of Clinical Oncology meeting in Chicago...Founded in 2009, Karyopharm previously raised about $32 million, including a $20 million Series A round in late 2010 and a $10 million Series A2 round in 2011. (See

In its filing, the company said it plans to use proceeds from the IPO to fund the clinical development of lead candidate ataluren (formerly PTC124) in Duchenne's muscular dystrophy caused by nonsense mutations (nmDMD) and cystic fibrosis caused by nonsense mutations (nmCF), to seek marketing approval of ataluren in the indications in the U.S...On Friday, the Vetex's shares (NASDAQ:VRTX) gained $1.60, closing at $79.49.

The analyses included the description of new predictive biomarkers of clinical response to Vectibix, activating mutations in KRAS (beyond exon 2) and in NRAS, collectively referred to as RAS...Additional edata will be presented at the annual meeting of the American Society of Clinical Oncology in Chicago...ACT is currently enrolling patients in three clinical trials in the U.S

Sangamo BioSciences Inc., of Richmond, Calif., said it presented new clinical data, which demonstrated that SB-728-T treatment resulted in a reduction in the HIV reservoir in HIV-infected subjects, at the 16th Annual Meeting of the American Society of Gene and Cell Therapy in Salt Lake City...HIV-infected subjects enrolled in an ongoing SB-728-902 clinical trial (Cohorts 1-3) received a single infusion of SB-728-T, which resulted in a durable increase in total CD4 T-cells driven by increased ZFN

The PROCEED (PROve Clinical Efficacy and Effect of Delafloxacin) study is designed to test delafloxacin 300 mg, given intravenously every 12 hours, compared to vancomycin 15 mg/kg plus aztreonam 2 g I.V., also given every 12 hours...The study includes clinical and microbiological endpoints to assess the efficacy...Syndax Pharmaceuticals Inc., of Waltham, Mass., said Phase II results published in the Journal of Clinical Oncology showed that HDAC inhibitor entinostat extended both progression-free

With an eye on streamlining the review of clinical trials with low biosafety risks, the National Institutes of Health's Office of Biotechnology Activities is proposing a revision to its guidelines for research involving recombinant or synthetic nucleic acid molecules

Mirna Therapeutics Inc., of Austin, Texas, has initiated a Phase I study of MRX34, the first miRNA to advance to a clinical trial for cancer

is more than doubling its cash position with a $30 million registered direct offering, with proceeds to fund R&D activities, namely clinical development of DX-2930, a drug slated to start clinical development for prophylactic use in hereditary angioedema (HAE...Shares of the company (NASDAQ:MNOV) gained 58 cents, or 16.5 percent, to close Monday at $4.10.

Eisai Inc., of Woodcliff Lake, N.J., said antiepileptic drug Fycompa (perampanel) showed a clear therapeutic benefit in difficult-to-treat patients with partial epilepsy, according to two new analyses of early clinical experience

clinical development plan and financial terms relating to ISIS-TTRRx to reflect an accelerated development plan for that antisense drug...Isis has 28 candidates in preclinical and clinical development across a wide variety of indications, with nine scheduled to report data in the next 12 months

There may be value in discussing the benefit-risk framework at end-of-Phase II meetings, in order to ensure alignment on identified and potential risks and benefits, critical efficacy and safety assessments, and risk mitigation strategies in Phase III clinical trials," PhRMA noted...Imposition of a de-facto comparative effectiveness standard would make many worthy drug development programs infeasible," the organization said.

Data demonstrated that EBI-005 was safe and well tolerated in both preclinical testing and in a clinical Phase Ia study in healthy volunteers...These data led to Eleven's Phase Ib clinical study of EBI-005 in subjects with dry eye disease, with top-line data from the Phase Ib study expected in the second half of 2013

Using ViS' online analytics platform, the initiative is expected to reduce the barriers to global pediatric clinical research by helping drugmakers identify patients, enabling streamlined trial enrollment and site selection...Eventually, it could be used to find research centers, staffing talent and other resources needed to conduct a pediatric clinical trial in a specific region...To get FDA authorization to charge for an investigative drug or for an unapproved use of an approved drug in a clinical

The study, dubbed Gammaglobulin Alzheimer's Partnership, was conducted in collaboration with the Alzheimer's Disease Cooperative Study, a clinical trial consortium supported by the National Institute on Aging

spun out in 2011, and Flexion Therapeutics Inc., of Woburn, Mass., founded by veterans of Eli Lilly and Co.'s Chorus division to advance abandoned early clinical programs through proof of concept. (See BioWorld Today, Feb. 1, 2010, and July 28, 2011.) The $15 million investment in Tacurion will support a Phase II proof-of-concept trial for the drug that should take 18 months to two years to complete...Portola, which seeks a listing on Nasdaq under the ticker "PTLA," filed for the IPO last month

An interchangeable biologic is expected to produce the same clinical results as the reference drug in any given patient...CER Projects Funded The Patient-Centered Outcomes Research Institute approved 51 new awards, totaling $88.6 million over three years, to fund comparative clinical effectiveness research (CER) projects that fall under the first four areas of its research agenda...Editor's note: For a copy of BioWorld's new biosimilars report, please contact the BioWorld Data account managers for

CytRx Corp., of Los Angeles, said the independent data safety monitoring committee overseeing the company's international Phase IIb trial with aldoxorubicin as a first-line treatment for patients with late-stage metastatic soft tissue sarcoma has recommended conducting the clinical trial through completion...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

clinical trials where a single dose of NX-1207 has been found to produce on average symptomatic improvements about double that reported for currently approved BPH drugs without causing the sexual or cardiovascular side effects associated with those drugs