Hyperion Therapeutics Inc., of South San Francisco, said population pharmacokinetic (PK) modeling and dosing simulations from Ravicti (glycerol phenylbutyrate) and Buphenyl (sodium phenylbutyrate) were reported in The Journal of Clinical Pharmacology based on data from four Phase II and III trials that enrolled patients with urea cycle disorders (UCDs...Mei Pharma Inc., of San Diego, said the first patients were dosed in a Phase II trial of its lead candidate, HDAC inhibitor Pracinostat, in

Astex Pharmaceuticals Inc., of Dublin, Calif., presented updated clinical results of its hypomethylating agent, SGI-110, in a poster session at the 18th Congress of the European Hematology Association in Stockholm, Sweden...The update focused on details of the biological and clinical activity as well as safety in the group of intermediate or high-risk relapsed or refractory myelodysplastic syndromes patients treated in the dose-escalation, Phase I part of the SGI-110-01 study...Of the 15 patients, six

The study demonstrated the superiority of ozenoxacin 1 percent cream, applied topically for five days, compared to placebo on both clinical and bacteriological endpoints by end-of-therapy visit (day six to seven

Bioalliance Pharma SA, of Paris, started a Phase II trial evaluating the efficacy and safety of Validive (clonidine Lauriad) in the U.S...The study, initiated in July 2012, enrolled a total of 77 patients in clinical sites in the U.S., Canada, Jamaica, Egypt and Lebanon

With data from the first clinical trial of anti-TNF polyclonal antibody AVX-470 in ulcerative colitis (UC) due toward the end of this year, Avaxia Biologics Inc...The big pharma will be able to exercise its option upon the conclusion of Phase IIb testing of ALV003, a two-enzyme combination candidate designed to degrade gluten. (See BioWorld Today, May 15, 2013.) According to Avaxia, IBD refers to related but different diseases: ulcerative colitis (UC), which affects the colon, and Crohn's disease

Data from an ongoing Phase I/II study confirmed clinical evidence of the antitumor activity at multiple dose levels in patients with anaplastic lymphoma kinase-positive NSCLC, including brain metastases, and initial clinical evidence of antitumor activity in patients with EGFR receptor mutation NSCLC. (See BioWorld Today, Dec. 17, 2012...and the clinical benefit response rate was 82 percent

The first-in-man trial will be undertaken by the National Institute of Health Research Experimental Cancer Medicine Centre, based at the Northern Institute of Cancer Research at Newcastle University, as well as at least one other clinical center

Those results were presented at the New Clinical Drug Evaluation Unit meeting in Hollywood, Fla...Omeros Corp., of Seattle, said it filed a clinical trial application with European regulators to initiate clinical trials of OMS721, its lead human monoclonal antibody from its mannan-binding lectin-associated serine protease-2, or MASP-2, program...Zealand Pharma A/S, of Copenhagen, Denmark, and partner Helsinn Group, of Lugano, Switzerland, reported that Helsinn concluded a Phase IIa study with

Results of the PROLASTIN-C SPARK study, a multidose pharmacokinetic clinical trial, were presented at the annual meeting of the American Thoracic Society in Philadelphia

The study is being sponsored by the Alliance for Clinical Trials in Oncology, a cooperative group of the National Cancer Institute (NCI...In the trial, aldoxorubicin showed prolonged clinical activity, including partial tumor response, in two subjects with small-cell lung cancer who had failed other therapies...Promedior Inc., of Lexington, Mass., presented data from a clinical study of PRM-151 at the American Thoracic Society Conference in Philadelphia

SONAR is a multinational, double-blind, placebo-controlled clinical study that is expected to enroll more than 4,000 patients with diabetic nephropathy...Destiny Pharma Ltd., of Brighton, UK, reported progress in the Phase I U.S...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

Despite losing a potentially lucrative FLT3 inhibitor partnership with Astellas Pharma Inc...for $1.3 billion in 2004, began its second life when the big pharma spun out the firm and lead asset ETC-1002 in 2008. (See BioWorld Today, May 2, 2008.) It raised $22.8 million in a Series A round and recently added $33 million in a preferred stock deal...Proceeds would be used to fund clinical trials, R&D for additional alpha-1 antitrypsin (AAT) indications, expanding distribution capabilities for

BioAlliance Pharma SA, of Paris, reported the International Independent Board of Experts' data and safety monitoring board (DSMB) again recommended continuing the ReLive Phase III trial without modification...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

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

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

Astellas Pharma Inc., of Tokyo, and Drais Pharmaceuticals Inc., of Bridgewater, N.J., will repeat for the third time a spinout maneuver that has been successful with two other programs in the past...In April 2012, Astellas transferred ownership of ASP3291, a melanocortin receptor agonist for ulcerative colitis, to Telsar Pharma Inc., with a $14 million investment by InterWest and Sutter Hill, to begin Phase IIa testing. (See BioWorld Today, Nov. 1, 2013.) And in June 2012, Drais partnered with

shored up its balance sheet in a $36 million private offering to advance pipeline work, including planned clinical trials of ARC-520, an RNAi-based drug in chronic HBV infection...The firm also has programs in two big pharma partnerships...Shares of Supernus (NASDAQ:SUPN) lost 3 cents Monday to close at $5.12.

Critics of the firm, too, have pointed to the lack of a big pharma partner to expand Qsymia's reach. (See BioWorld Today, Oct. 23, 2012.) Lief said Belviq already has picked up some momentum...The drug was included in a recent diabetes management report from the American Association of Clinical Endocrinologists

clinical trials, for SMD and dry age-related macular degeneration (dry AMD...BHR Pharma LLC, of Herndon, Va., said the 1,000th patient has been enrolled in its SyNAPSe clinical trial, a global Phase III study evaluating the effectiveness of its intravenous progesterone infusion agent, BHR-100, to treat severe traumatic brain injury (TBI...BHR Pharma is sponsoring SyNAPSe with the intent to bring the first-ever approved TBI treatment to market