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

Funds will be used for general corporate purposes, including expenses related to the potential commercialization of OMS302 for intraocular lens replacement, as well as for R&D expenses such as funding planned clinical trials for its OMS103HP, PDE10, MASP-2 and PDE7 programs

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

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

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

The first clinical trials of the drug, GLPG1790, are expected to start within the next year...On Friday, the company's NASDAQ-listed American depository shares (NASDAQ:PRAN) gained 1 cent, closing at $2.27.

The drug was included in a recent diabetes management report from the American Association of Clinical Endocrinologists

Ltd., of Germantown, Md., said it filed an investigational new drug application (IND) to begin clinical trials of its adipose-derived stem cell product, RNL-JointStem, for the treatment of osteoarthritis...Seaside Therapeutics Inc., of Cambridge, Mass., said its Phase IIb trial evaluating arbaclofen (STX209) in core impairments of autism spectrum disorder (ASD) failed to show improvement on the primary endpoint of social withdrawal but demonstrated improvement on the clinical global impression of

The open-label trial will randomize 20 postmenopausal women with estrogen receptor-positive disease who have responded previously to hormone therapy to receive 9 mg of enobosarm once daily until they show clinical progression or have completed 336 days of treatment...The primary endpoint is clinical benefit, which will be assessed at six months...RepliCel Life Sciences Inc., of Vancouver, British Columbia, said it started clinical development of an autologous cell therapy for the treatment of a

The following data were reported from European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Berlin...Trius Therapeutics Inc., of San Diego, announced a range of clinical data for the experimental antibiotic tedizolid phosphate (TR-701) and a presentation on linezolid-resistant strain of bacteria...The results of a separate clinical cardiovascular safety study showed that tedizolid was not associated with heart beat abnormalities at up to six times its effective dose