• Agenus Inc., of Lexington, Mass., said The New England Journal of Medicine published results of a Phase III trial testing London-based GlaxoSmithKline plc's RTS,S malaria vaccine candidate containing Agenus' QS-21 Stimulon adjuvant. Results showed that RTS,S provided young African children with significant protection against clinical and severe malaria, reducing the risk by 56 percent and 47 percent, respectively, for the 12-month period following vaccination. Data also were presented at the Malaria Forum hosted by the Bill & Melinda Gates Foundation in Seattle. Agenus' QS-21 adjuvant also is contained in other GSK vaccines, including four programs that are in Phase III. Under the terms of the companies' deal, Agenus is entitled to milestone payments, as well as royalties for 10 years after commercial launch. Shares of Agenus (NASDAQ:AGEN) jumped 58 cents, or 21.3 percent, to close Tuesday at $3.30.

• Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., reported results from a randomized, placebo-controlled, double-blind proof-of-concept study that showed intranasal Optina (danazol) has an impact on allergic rhinitis. Rather than being powered to show statistical significance of Optina as an effective treatment for rhinitis, the study investigated the effect of the low-dose danazol in a clinical condition associated with vascular permeability and edema. In the study, a trend of improvements in reflective total nasal symptom scores was observed in all parameters in the Optina group but not in the placebo group. Results from a dose-ranging trial of an oral formulation of Optina in diabetic macular edema are expected in the second quarter of 2012.

• MethylGene Inc., of Montreal, received FDA approval for its investigational new drug application to start a Phase II trial evaluating MGCD290, an oral Hos2 fungal inhibitor, in subjects with acute vaginal yeast infection. The randomized, placebo-controlled trial, which will enroll about 200 women, is expected to begin by year-end. MGCD290 has been tested in four Phase I trials in more than 100 healthy volunteers both as a single agent and in combination with fluconazole. (See BioWorld Today, March 25, 2011.)

• Nile Therapeutics Inc., of San Mateo, Calif., completed dosing in an open-label Phase I trial of subcutaneous bolus and subcutaneous infusion of cenderitide in patients with chronic heart failure. Nile is developing cenderitide, in collaboration with Minneapolis-based Medtronic Inc. and under fast-track status, as a 90-day outpatient treatment for heart failure patients following admission for acutely decompensated heart failure.

• Noscira SA, of Madrid, said the last patient completed treatment in its year-long Phase II trial of tideglusib, a glycogen synthase kinase 3 inhibitor, in progressive supranuclear palsy. The primary endpoint is to evaluate the changes in the overall clinical status using the Golbe scale after 52 weeks of treatment with two different doses of the drug vs. placebo in 146 patients with possible or probable mild to moderate PSP. Data are expected by the end of the year.

• Oxford BioMedica plc, of Oxford, UK, said the FDA cleared its investigational new drug application for a Phase I/IIa trial of UshStat, a gene-based treatment for Usher syndrome Type Ib. The open-label, dose-escalation study, set to start by the end of the year, will test three dose levels for safety, tolerability and aspects of biological activity. UshStat, which was designed using Oxford's LentiVector platform, is partnered with Paris-based Sanofi SA under a 2009 agreement. (See BioWorld Today, April 30, 2009.)

• Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said it started a Phase III program of TAK-875, a GPR40 agonist, in Type II diabetes. The first Phase III study is expected to enroll about 450 patients who are not adequately controlled on diet and exercise, and the primary endpoint of the 24-week study is the change in HbA1c. Other endpoints include the assessment of a clinically meaningful response based on reaching HbA1c targets, changing in fasting plasma glucose and two-hour postprandial plasma glucose. Data are expected by 2014. GPR40, one of the G protein-coupled receptors express in pancreatic islet cells, is believed to work by selectively improving glucose-dependent insulin secretion with a potential for reduced risk of hypoglycemia.