• 4SC AG, Planegg-Martinsried, Germany, reported that new data from the oral resminostat Phase II SHELTER trial in hepatocellular carcinoma confirmed previously reported trends with regard to clinical activity. The company said that after six weeks, 11 out of 18 (61 percent) patients showed confirmed tumor stabilization and after 12 weeks, eight out of 16 (50 percent) displayed continuous stable disease either on sorafenib and resminostat or resminostat alone. The company also reported new data from the Phase I/II SHORE trial in KRAS-mutant colorectal carcinoma in which resminostat is applied in combination with the colon cancer chemotherapy regimen FOLFIRI. The first dose level of 200 mg, one of four dose levels planned, was successfully completed and no dose-limiting toxicities were observed when 200 mg of resminostat and the standard dose of the FOLFIRI regimen were administered in combination. The results were presented at the European Society for Medical Oncology 13th World Congress on Gastrointestinal Cancer in Barcelona, Spain.

• Adeona Pharmaceuticals Inc., of Ann Arbor, Mich., said it is planning a multicenter, double-blind, placebo-controlled Phase IIb trial to evaluate the safety and efficacy of its AEN-100, a gastroretentive, sustained-release zinc-based tablet, and AEN-200, a copper tablet, for treatment of patients suffering from amyotrophic lateral sclerosis.

• Akebia Therapeutics Inc., of Cincinnati, initiated dosing in a Phase IIa dose-ranging study of AKB-6548 in stage 3 and 4 chronic kidney disease patients. The company said AKB-6548 is an orally bioavailable hypoxia-inducible factor-prolyl hydroxylase inhibitor designed to increase the natural production of erythropoietin and cause a controlled, gradual rise in hemoglobin in anemic patients. A controlled rise in hemoglobin and a corresponding decrease in ferritin were observed in a recently completed Phase IIa dose escalation study, the company said.

• Anacor Pharmaceuticals Inc., of Palo Alto, Calif., said partner GlaxoSmithKline plc, of London, initiated two separate Phase IIb trials of GSK 2251052 (formerly AN3365) in complicated urinary tract infections and complicated intra-abdominal infections. Anacor licensed the compound to GSK in July 2010 and is eligible to receive future development milestones of as much as $69 million, commercial milestones of as much as $175 million, and double-digit tiered royalties with the potential to reach the mid-teens on annual net sales.

• Arno Therapeutics Inc., of Parsippany, N.J., reported that its Phase II study of AR-67, a camptothecin analogue that inhibits Topoisomerase I activity, met pre-defined interim goals for patients with glioblastoma multiforme, an aggressive form of brain cancer, who were not previously treated with Avastin. The company said it is continuing to enroll patients in the Phase II study.

• Biothera, of Eagan, Minn., said data from its Phase II trial of Imprime PGG for treatment of patients with stage IV KRAS mutant colorectal cancer showed improved survival. The company said in a heavily pretreated subject population that is known not to respond to cetuximab (Erbitux), Imprime PGG improved several key patient outcomes compared to historical data based on the mean of three published studies for Erbitux alone. The company presented results at the European Society for Medical Oncology 13th World Congress on Gastrointestinal Cancer in Barcelona, Spain.

• Bristol-Myers Squibb Co. and Pfizer Inc., both of New York, announced topline results of the Phase III ARISTOTLE trial of Eliquis (apixaban) for treatment of patients with atrial fibrillation and at least one additional risk factor for stroke, that showed Eliquis met the primary efficacy objective of noninferiority to warfarin on the combined outcome of stroke (ischemic, hemorrhagic or unspecified type) and systemic embolism. In addition, Eliquis met the key secondary endpoints of superiority on efficacy and on ISTH (International Society on Thrombosis and Haemostasis) major bleeding compared to warfarin. The companies said they expect to submit regulatory filings in atrial fibrillation in the U.S. and Europe in the third or fourth quarter. Detailed results of the study will be presented in August at the European Society of Cardiology Congress 2011 in Paris.

• Diamyd AB, of Stockholm, Sweden, suspended dosing in the U.S. Phase III DiaPrevent study of antigen-based therapy Diamyd and will initiate closure of the study. DiaPrevent had enrolled more than 320 patients between 10 and 20 years of age who were diagnosed with Type I diabetes within three months of entering the study. The company said its decision followed a blinded review of the efficacy data collected to date and an earlier negative outcome of a European Phase III study of the same design. (See BioWorld Today, May 10, 2011.)

• Millennium, of Cambridge, Mass., a unit of the Takeda Oncology Co., presented data from an ongoing Phase II trial of Aurora A kinase inhibitor MLN8237 for B-cell and T-cell non-Hodgkin lymphoma. In 41 evaluable patients, MLN8237 treatment resulted in a 32 percent overall response rate and a 12 percent complete response rate. The data were presented at the International Congress on Malignant Lymphoma.

• NuPathe Inc., of Conshohocken, Pa., said it will present additional safety data from a 12-month study of its transdermal patch Zelrix (NP101) for migraine at the 15th Congress of the International Headache Society in Berlin that demonstrate a low rate of triptan-related adverse events.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., said The New England Journal of Medicine published in its June 23, 2011, issue data from two Phase III studies of Incivek (telaprevir) tablets, which showed Incivek combination therapy significantly improved rates of sustained viral response in a broad group of people with genotype 1 chronic hepatitis C who were new to treatment and those who were treated previously but not cured.