• CV Therapeutics Inc., of Palo Alto, Calif., said data from a preclinical study of the selective adenosine A1 agonist tecadenoson, in combination with a low dose of the beta blocker metoprolol, showed increased rate control compared to either agent alone (p<0.05) in an animal model of atrial fibrillation. Tecadenoson also demonstrated effective rate control at rest and during exercise in the preclinical model. Tecadenoson is in an ongoing Phase II study as a potential rate control agent for atrial fibrillation.

• Dynogen Pharmaceuticals Inc., of Waltham, Mass., has dosed the first patient in a Phase IIb trial of DDP733 (pumosetrag) as a treatment for irritable bowel syndrome with constipation (IBS-c). The randomized, double-blind, placebo-controlled study is enrolling female patients with IBS-c at multiple centers in the U.S. and Canada to assess efficacy using the Overall Subject Global Assessment (OSGA) of relief of IBS symptoms, as well as the safety and tolerability of the drug. Dynogen previously announced positive results from its Phase IIa study of DDP733 in IBS-c, with a statistically significant improvement over placebo in the clinical endpoint of OSGA of IBS.

• Genta Inc., of Berkeley Heights, N.J., presented positive preliminary Phase III data on its lead oncology drug Genasense (oblimersen sodium) Injection in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound; Abraxis BioScience Inc.) and Temodar (temozolomide; Schering Plough Inc.) in patients with advanced metastatic melanoma. Of the first seven evaluable patients, five have demonstrated clinical benefit, including three partial responses that occurred after the first treatment cycle, which have lasted for 40, 24 and 16 weeks, respectively. Two other patients have maintained stable disease lasting for a minimum of 24 weeks. Two patients had progressive disease, and one patient is too early to evaluate. There have been no episodes of life-threatening side effects. Four patients experienced Grade 3 leukopenia (i.e., reduction in white blood cell count), and one patient had Grade 3 thrombocytopenia (i.e., reduction in platelet count). The FDA previously denied the drug in advanced melanoma, as did European regulators. (See BioWorld Today, Aug. 22, 2007.)

• Immunosyn Corp., of La Jolla, Calif., announced positive results from limited feasibility clinical studies of SF-1019 on several progressive neurological auto-immune and inflammatory conditions. Studies of a small cohort of patients showed that neurological scores on average were elevated from 52.5 before SF-1019 to 74.2 after therapy. The improvement was statistically significant (p= 001). Comprehensive metabolic profile and complete blood counts were normal before and after injections of SF-1019.

• KeyNeurotek Pharmaceuticals AG, of Magdeburg, Germany, has started a placebo-controlled, double-blind, dose-escalating study in healthy individuals to evaluate the tolerability and pharmacokinetics of KN38-7271, a cannabinoid receptor agonist, to treat stroke patients. KN38-7271 already is being tested in an international Phase II study in patients with traumatic brain injury. The cannabinoid receptor agonist activates both CB1 and CB2 receptors in the brain, strengthening natural protection mechanisms and preventing overacting inflammatory reactions.

• Repligen Corp., of Waltham, Mass., announced positive results from a Phase IIa clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar disorder. In the multicenter study, 84 patients received either RG2417 or a placebo twice a day for six-weeks. Results demonstrated a statistically significant improvement in the two primary endpoints, symptoms of depression in patients receiving RG2417 when compared to placebo on the Montgomery-Asberg Depression Rating Scale (p=0.03) and a strong trend toward improvement on the Global Impression of Change in Bipolar Disorder scale (p=0.06). Secondary observations included a statistically significant decrease in mania score using the Young Mania Rating Scale (p=0.01) in the patients receiving RG2417 over the aggregate six-week treatment period when compared to placebo.

• Synta Pharmaceuticals Corp., of Lexington, Mass., has treated the first patient in a Phase I study of its heat shock protein 90 (Hsp90) inhibitor, STA-9090. It is a synthetic, small-molecule Hsp90 inhibitor with a novel chemical structure unrelated to the Hsp90 inhibitor geldanamycin or its family of related compounds, such as 17-AAG. Preclinical studies showed STA-9090 has the ability to inhibit multiple kinases with comparable potency to, and a broader activity profile than specific kinase inhibitors.