• Adaptimmune Ltd., of Oxford, UK, opened a Phase I/II, dual site, two-cohort, open-label clinical trial in multiple myeloma at the University of Maryland and the University of Pennsylvania testing its enhanced T-cell receptor T-cell therapy. The company said that the trial is designed to investigate the safety, bioactivity and antitumor effect of infusion of patients' own T cells that have been genetically modified to express a high affinity T-cell receptor specific for a type of tumor antigen known as a cancer testis antigen.

• Argos Therapeutics, of Durham, N.C., announced that its Arcelis immunotherapy for the treatment of renal cell carcinoma (RCC), AGS-003, in combination with sunitinib demonstrated a strong immunologic response that correlated to improved clinical outcomes in a Phase II combination study in newly diagnosed, metastatic RCC patients with unfavorable prognosis.

• BioSpecifics Technologies Corp., of Lynbrook, N.Y., said Pfizer Inc., of New York, reported data showing no statistically meaningful differences between hands that had undergone previous surgery for Dupuytren's contracture vs. those that had not when all were treated with Xiapex (clostridial collagenase histolyticum for injection). After Xiapex treatment for metacarpophalangeal joints in previously operated hands, the mean decrease in fixed flexion contracture was 75±2.8 percent compared to of 80±2.0 percent in hands that had not undergone surgery, indicating that Xiapex could offer an alternative to patients who have had a recurrence of Dupuytren's contracture following surgery. Those data were presented at the Annual Federation of European Societies for Surgery of the Hand (FESSH) meeting in Oslo, Norway. Pfizer received European rights to Xiapex from developer Auxilium Pharmaceuticals Inc., of Malvern, Pa., which in-licensed the product from BioSpecifics and markets it in the U.S. as Xiaflex.

• CrystalGenomics Inc., of Seoul, South Korea, and CG Pharmaceuticals Inc., of Emeryville, Calif., said the first patient was enrolled in a Phase IIb study of CG100649, a nonsteroidal anti-inflammatory drug candidate, in patients with knee or hip osteoarthritis. The trial is expected to test the drug against Celebrex (celecoxib, Pfizer Inc.), and anti-arthritic efficacy will be evaluated using the standardized Western Ontario and McMaster Universities OA Index and its subscales for pain, stiffness and physical function. CG100649 is a dual inhibitor of COX-2 and carbonic anhydrase.

• Discovery Laboratories Inc., of Warrington, Pa., said the Journal of Neonatal-Perinatal Medicine published data analysis from the Surfaxin (lucinactant) Phase III program showing that, for preterm infants at risk for respiratory distress syndrome who received prophylactic surfactant therapy and were extubated, subsequent reintubation was a highly predictive risk factor for mortality and major complications of prematurity. The analysis also indicated that infants treated with Surfaxin had a significantly lower incidence of subsequent reintubation and improved survival without reintubation compared with infants who received comparator animal-derived surfactants. Discovery Labs received a complete response letter (CRL) for Surfaxin in 2009 and has been working on a preclinical program aimed at satisfying the FDA's requirements. Pending successful data, a response to the CRL is expected in the third quarter. (See BioWorld Today, April 21, 2009.)

• GlobeImmune Inc., of Louisville, Colo., said GI-4000, a series of Tarmogen products engineered to express the seven most common KRAS mutations, demonstrated good tolerability and disease-specific immune responses in a Phase I trial. GI-6207, a Tarmogen expressing human carcinoembryonic antigen (CEA), was tested as a monotherapy in treatment-refractory Stage IV, CEA-expressing cancers and also showed good tolerability, as well as stable disease by RECIST for three months or longer in 20 percent of patients in a Phase I/II trial.

• Immunovaccine Inc., of Halifax, Nova Scotia, reported that a Phase I trial of DPX-0907, a therapeutic cancer vaccine for advanced stage breast, ovarian or prostate cancer, met the primary objective of safety with overall results demonstrating that DPX-0907 is generally well tolerated by all patients and is considered safe at both dose levels.

• Profectus BioSciences Inc., of Baltimore, and the HIV Vaccine Trials Network started a Phase I HIV vaccine study involving a recombinant vesicular stomatitis virus that expresses the HIV-1 gag protein. Sixty HIV-uninfected adults will be enrolled, and the trial will evaluate safety and immunogenicity of increasing doses of the vaccine. The study is being sponsored by the National Institute of Allergy and Infectious Diseases.

• S*BIO Pte Ltd., of Singapore, said that additional data from multiple Phase I and II studies of its JAK2 inhibitor SB1518 confirmed safety and efficacy for the treatment of patients with symptomatic myelofibrosis and enlarged spleens. The company said results will be presented at the American Society of Clinical Oncology 2011 Annual Meeting in Chicago and the 16th Congress of the European Hematology Association in London.

• Somnus Therapeutics Inc., of Bedminster, N.J., completed a Phase II dose-ranging study of SKP-1041, a modified-release formulation of zaleplon, in non-elderly adults with primary insomnia characterized by middle-of-the-night awakening. The trial met its primary endpoint for wake after sleep onset, with no unwanted next-day cognitive or motor effects.