• Diamyd Medical AB, of Stockholm, Sweden, submitted an investigational new drug application for NP2, the first drug candidate from its Nerve Targeting Drug Delivery System gene therapy platform. NP2 is designed to produce enkephalin locally in the targeted sensory neurons to block pain signals before they are transmitted through the spinal cord to the brain. Upon FDA clearance, the company expects to start a Phase I trial involving 12 patients with severe cancer-related pain.

• Humanetics Corp., of Minneapolis, completed a Phase I trial of BIO 300, a medical radiation countermeasure, which successfully met all objectives and was well tolerated at all dose levels studied. The company is seeking to market BIO 300 for the prevention and mitigation of acute radiation syndrome, and will conduct efficacy studies under the FDA's animal efficacy rule. To date, Humanetics has received nearly $7 million from the Department of Defense to continue research in medical radiation countermeasures.

• Nucleonics Inc., of Horsham, Pa., has begun treating patients in a Phase I human safety study of its experimental treatment for chronic hepatitis B virus (HBV) infection, NUC B1000. The compound is an expressed interfering RNA-based product consisting of a plasmid DNA construct designed to produce four short interfering RNA molecules, formulated with a proprietary cationic-lipid delivery system. The trial will involve 15 patients with mild to moderate HBV and no evidence of cirrhosis at sites in the U.S. and Eastern Europe.

• Protherics plc, of London, and partner Advancell sl, of Barcelona, Spain, said the first patient has been enrolled in a recently initiated Phase i/II clinical study of Acadra (acadesine) in B-cell chronic lymphocytic leukemia (B-CLL). The study will be conducted at sites in Belgium, France and Spain, and will enroll up to 30 B-CLL patients who have relapsed or are refractory to existing chemotherapy. The open-label study will assess the safety, tolerability, pharmacokinetics and the effects of Acadra, a novel nucleoside analogue, on B-cell and T-cell counts. Part I of the study will investigate escalating single doses of Acadra following in Part II by an assessment of repeated doses. Results from Part I of the study are expected in the second half of 2008 and the final study results are expected in the first half of 2009.