• Cell Medica Ltd., of London, treated the first patient in the CMV-ACE/ASPECT Phase II study testing its adoptive cellular therapy for the pre-emptive treatment of cytomegalovirus infections in patients who have received bone marrow transplants from unrelated donors. The randomized study is expected to include about 36 patients, who will receive either CMV-specific memory T cells or conventional antiviral treatment. The study is expected to be completed by the end of 2012, with results published in 2013.

• Diamyd Medical AB, of Stockholm, Sweden, is testing NP2 Enkephalin in a Phase II trial to reduce cancer pain. The study is recruiting about 32 subjects with severe pain and is designed to evaluate safety, as well as measure the drug's effect in pain relief, other pain medication usage and quality of life.

• Genta Inc., of Berkeley Heights, N.J., started a Phase II trial of oral taxane tesetaxel in patients with advanced prostate cancer. The study will evaluate two populations: men who are hormone/castrate-resistant who have not previously received chemotherapy and men who have developed progressive disease after having received at least three cycles of docetaxel. A maximum of 96 subjects will be enrolled. The primary endpoint is the estimation of the proportion of patients in each cohort who have not progressed for at least six months. Accrual is expected to complete within 12 months.

• Immunovaccine Inc., of Halifax, Nova Scotia, completed enrollment in a Phase I trial of DPX-0907, a therapeutic cancer vaccine, with 23 patients having receiving three subcutaneous injections of the candidate, three weeks apart. Safety and immune response data are expected in the second quarter.

• Medivir AB, of Huddinge, Sweden, started a Phase Ia trial of TMC649128, a nucleoside NS5B polymerase inhibitor aimed at chronic hepatitis C virus infection. The study will test safety, tolerability and pharmacokinetics in a single-ascending dose design in healthy volunteers. TMC649128 is being developed in collaboration with Tibotec Pharmaceuticals, a unit of New Brunswick, N.J.-based Johnson & Johnson, under a May 2008 deal, and the start of the Phase Ia study triggerea €7 million (US$9.5 million) milestone payment. (See BioWorld Today, May 20, 2008.)

According to a Phase I trial update by Neuralstem Inc., of Rockville, Md., the safety monitoring board unanimously approved advancing to the next group of three amyotrophic lateral sclerosis (ALS) patients after reviewing safety data from the first nine. The patients will receive 10 bilateral injections of spinal cord stem cells in the lumbar spinal cord. The trial design calls for another group of six patients to receive injections in the cervical region of the spine. The trial is designed to evaluate safety, but will include exploratory endpoints such as motor function, respiratory capacity and ALS functional rating scale.

• Novartis AG, of Basel, Switzerland, said data from the Phase III RADIANT-3 trial showed that mTOR inhibitor Afinitor (everolimus) plus best supportive care more than doubled progression-free survival vs. placebo plus best supportive care in patients with advanced pancreatic neuroendocrine tumors. Data were published in The New England Journal of Medicine.

• ProCertus BioPharm Inc., of Madison, Wis., said collaborators at the University of Wisconsin began enrolling patients in a trial testing whether its DermX product can prevent radiodermatitis in postsurgical breast cancer patients receiving radiation therapy.

• Promedior Inc., of Malvern, Pa., began Phase Ib trials of PRM-151 for idiopathic pulmonary fibrosis. The randomized, double-blind, placebo-controlled trial will assess safety, tolerability, pharmacokinetics and pharmacodynamics of PRM-151 at multiple ascending doses. Efficacy will be studied by monitoring plasma protein biomarkers and whole blood fibrocyte content. PRM-151 is in Phase IIa trials for prevention of scarring after glaucoma filtration surgery.