• Researchers from UCLA's Jonsson Comprehensive Cancer Center, together with scientists from 12 additional sites in the U.S. and Australia, reported in the New England Journal of Medicine that Zelboraf (vemurafenib), from Plexxikon Inc., a unit of Tokyo-based Daiichi Sankyo Group, and partner Roche AG, of Basel, Switzerland, nearly doubled median survival times in metastatic melanoma. The data came from an international Phase II study of Zelboraf that included 132 patients followed for at least one year. Patients with metastatic melanoma typically survive about nine months, but those taking Zelboraf, which blocks a mutated BRAF protein, survived an average of 15.9 months, said senior author Antoni Ribas, a professor of hematology/oncology and a researcher at UCLA's Jonsson Cancer Center. Zelboraf was approved by the FDA in metastatic melanoma in August 2011. (See BioWorld Today, Aug. 18, 2011.)

• Hutchison MediPharma Ltd., of London, began a first-in-human Phase I trial of oncology candidate volitinib (HMPL-504), a c-Met receptor tyrosine kinase. The primary objectives of the study are safety, tolerability and determining the maximum dose. Secondary objectives are efficacy against tumors, including lung and gastric. Patients will be selected based on c-Met gene amplification status and protein expression levels. The trial is being conducted in Australia.

• Inspiration Biopharmaceuticals Inc., of Laguna Niguel, Calif., reported results for its lead product candidate, an intravenous recombinant Factor IX (FIX) product to treat and prevent bleeding in individuals with hemophilia B, suggesting that FIX provided effective surgical hemostasis in people with hemophilia B undergoing major surgical procedures. The data were highlighted in a poster presentation at the European Association for Haemophilia and Allied Disorders meeting in Rome. Inspiration has a strategic partnership with Ipsen SA, of Paris, to develop a broad portfolio of hemophilia products. (See BioWorld Today, Jan. 22, 2010.)

• Novelos Therapeutics Inc., of Madison, Wis., said it enrolled the first patient in a Phase I/II positron emission tomography (PET) imaging trial of I-124-CLR1404 (LIGHT), a cancer-targeted PET imaging agent, in patients with advanced non-small-cell lung cancer. LIGHT is a small molecule in development for the selective detection of tumors and metastases in a range of cancers. It comprises a nonpharmacological quantity of CLR1404 labeled with the short-lived radioisotope, iodine-124.

• PhaseBio Pharmaceuticals Inc., of Malvern, Pa., began dosing its first subjects in a Phase I trial of Vasomera (PB1046) in hypertension. The double-blind, placebo-controlled trial will have safety, tolerability and pharmacokinetics and pharmacodynamic profiling of single ascending doses as a primary objective. The trial is being carried out in the U.S. and will be complete by the end of 2012.

• SK Biopharmaceuticals, of Seoul, South Korea, began a Phase II trial of new chemical entity SKL11197 for diabetic peripheral neuropathy, after successfully completing Phase I trials. The trial will be carried out in the U.S.

• UCB SA, of Brussels, Belgium, started a Phase III trial of C-Early (certolizumab pegol) in combination with methotrexate for rheumatoid arthritis (RA). The double-blind, placebo-controlled trial will enroll 800 RA patients who have not been previously treated with disease-modifying antirheumatic drugs with the goal of inducing and sustaining a clinical response. An additional goal of the study will be to assess the possibility of reducing frequency of certolizumab pegol administration after sustained low disease activity is achieved. The drug, a TNF-alpha blocker, is marketed as Cimzia.