Adaptimmune Ltd., of Oxford, UK, opened a Phase I/II, two-cohort, open-label trial in multiple myeloma at the University of Maryland and the University of Pennsylvania to test its enhanced T-cell receptor therapy. The trial will investigate the safety, bioactivity and anti‐tumor effect of the infusion of patients' own T cells that have been genetically modified to express a high-affinity T-cell receptor specific for cancer testis antigens Mage‐A3/6 and NYESO‐1. The trial will enroll 12 patients over the next two years who have received treatment for their myeloma and who are eligible for an autologous stem cell transplant.

• Agennix AG, of Planegg, Germany, said Phase II data published in the Journal of Thoracic Oncology showed that oral talactoferrin increased the confirmed response rate compared to placebo in non-small-cell lung cancer patients. The response rate in the 100-patient evaluable population, which was the pre-defined primary endpoint, increased from 29 percent (placebo) to 47 percent (talactoferrin), with a "p" value of 0.05. The evaluable population was defined as patients who received at least one dose of study drug and had at least one CT scan after the start of treatment. Median progression-free survival, overall survival and duration of response all were longer in the talactoferrin arm, though the differences were not statistically significant.

ARCA Biopharma Inc., of Broomfield, Colo., plans to begin enrollment in a Phase III trial in the first half of 2012, subject to funding, to evaluate Gencaro (bucindolol) in subjects with symptomatic atrial fibrillation and heart failure with reduced left ventricular ejection fraction. The multicenter, randomized, double-blind trial will compare Gencaro with the beta-blocker metoprolol CR/XL in 300 to 400 patients with a specific genotype. The primary endpoint will be time to recurrent symptomatic atrial fibrillation after electrical cardioversion. In a 1,040-patient DNA substudy of the Phase III BEST advanced heart failure study, Gencaro exhibited pharmacogenetic enhancement and differentiation for atrial fibrillation prevention in patients with the beta1389 arginine homozygous adrenergic receptor genotype. (See BioWorld Today, March 12, 2010.)

Ardea Biosciences Inc., of San Diego, presented data from an ongoing blinded extension of its Phase IIb lesinurad trial that show adding lesinurad to allopurinol produced a 91 percent response rate at 28 weeks in gout patients who failed to respond to allopurinol alone. The results, along with final results from the main portion of the study, were presented at the Annual European Congress of Rheumatology in London. Earlier this year, Ardea reported that the primary and key secondary endpoints of the main 28-day study were achieved, with highly statistically significant reductions in serum uric acid (sUA). Final results showed the number of patients taking the combination who achieved the target sUA was more than three times the number who achieved the target on allopurinol alone. Also presented at the congress were final results of a Phase Ib trial evaluating the combination of lesinurad and febuxostat in gout patients with an sUA of at least 8 mg/dL. All of the patients treated with the combination achieved sUA levels below 6 mg/dL. (See BioWorld Today, Jan. 21, 2011.)

Arena Pharmaceuticals Inc., of San Diego, presented meta-analyses of the three trials in its lorcaserin Phase III program that showed the investigational drug caused statistically significant weight loss compared with placebo at one year among 7,500 obese and overweight, diabetic and nondiabetic adults. The weight loss was associated with favorable changes in biomarkers that may be predictive of cardiovascular and metabolic risk. Arena plans to apply for marketing authorization in Europe next year. The company, which received a complete response letter from the FDA last October, has said it plans to resubmit a new drug application in the U.S. by the end of this year. The meta-analyses were presented at ECO 2011, the 18th European Congress on Obesity. Shares of Arena (NASDAQ:ARNA) were up 9 cents Thursday, closing at $1.47. (See BioWorld Today, Dec. 23, 2010.)

• BioCryst Pharmaceuticals Inc., of Research Triangle Park, N.C., reported data from two Phase II trials of enzyme inhibitor BCX4208 in patients with gout, with one study showing that the combination of the drug with allopurinol brought a larger proportion of patients to serum uric acid levels below 6 mg/dL compared to allopurinol alone. Results from the second study concluded that the adverse event profile was similar in recipients of BCX4208, allopurinol, placebo or both drugs combined. Those data were presented at the European League Against Rheumatism meeting in London.

• Dynavax Technologies Corp., of Berkeley, Calif., said it completed the 12-month follow-up of all 2,449 subjects enrolled in its Phase III study of Heplisav designed to evaluate immunogenicity in comparison to marketed hepatitis B vaccine Engerix (GlaxoSmithKline plc), lot-to-lot consistency and safety. Results are anticipated within eight weeks.

• Lytix Biopharma A/S, of Oslo, Norway, completed two Phase I/IIa studies of topical antimicrobial candidate Lytixar (LTX-109) – one for nasal decolonization of methicillin-resistant Staphylococcus aureus and methicillin-sensitive Staphylococcus aureus bacteria and one for treatment of Gram-positive skin infections. The topical application of Lytixar to the anterior nares or on infected skin was shown to be tolerated and safe, with negligible systemic uptake. And in the nasal decolonization study, the drug clearly demonstrated proof of concept.

• Mymetics Corp., of Epalinges, Switzerland, said HIV vaccine MYM-V101 was well tolerated when administered intramuscularly and intranasally in a Phase I trial. All vaccinated women rapidly developed lipopeptide P1-specific antibodies.

• Neurologix Inc., of Fort Lee, N.J., presented one-year follow-up data from its Phase II trial of gene therapy NLX-P101 for Parkinson's disease. The analysis showed that 63 percent of patients receiving NLX-P101 achieved moderate-to-large clinically meaningful symptom improvements at 12 months, compared to 50 percent at six months. No serious drug-related adverse events were reported. The data were presented at the International Neuromodulation Society's world congress. (See BioWorld Today, March 17, 2011.)

• OncoSec Medical Inc., of San Diego, is initiating three open-label, physician-sponsored Phase II trials of its ElectroImmunotherapy in melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma. The ElectroImmunotherapy candidate for these studies is a DNA plasmid coding for IL-12 that is delivered using electroporation. The technology was licensed from Inovio Pharmaceuticals Inc., of Blue Bell, Pa.

• Pharmasset Inc., of Princeton, N.J., initiated a Phase IIa trial of nucleotide polymerase inhibitor PSI-7977 combined with Bristol-Myers Squibb Co.'s NS5A replication complex inhibitor BMS-790052 for hepatitis C. The trial will enroll 84 treatment-naïve patients, and four dosing groups will give the two drugs without standard-of-care ribavirin and pegylated interferon, while two dosing groups will add ribavirin.

• Protea Biosciences Inc., of Morgantown, W. Va., and French pharmaceutical firm Laboratoires Mayoly-Spindler completed a Phase I/IIa trial of recombinant lipase product MS1819 for exocrine pancreatic insufficiency in chronic pancreatitis. Phase II trials are expected to begin in 2012.

• Tigris Pharmaceuticals Inc., of Bonita Springs, Fla., initiated a randomized Phase II trial of AFP-464 for estrogen receptor-positive breast cancer. AFP-464 is an aminoflavone prodrug that activates p53 and apoptosis. Molecular profiling will be used to pre-screen patients for a biomarker called Aryl Hydrocarbon Receptor, which has been shown to predict sensitivity to AFP-464.