• CytRx Corp., of Los Angeles, reported safety and tolerability results from a previously announced double-blind, placebo-controlled trial of arimoclomol in healthy volunteers. CytRx said the results support the use of arimoclomol in future clinical trials, including its Phase IIb trial in amyotrophic lateral sclerosis, at doses up to sixfold higher than used in previous Phase IIa trials for ALS. Subject to FDA clearance, CytRx plans to begin the Phase IIb trial in the second half of this year. Following consultation with the FDA, CytRx is considering various options, including increasing the size and duration of the planned trial and/or conducting a second efficacy trial for ALS, possibly in parallel with the Phase IIb trial.
• DeCode Genetics Inc., of Reykjavik, Iceland, presented data from a Phase IIa study of DG041 that confirmed its potential as a next-generation oral anti-platelet therapy. DG041 is an antagonist of the EP3 receptor for prostaglandins E2. The trial in peripheral arterial disease patients demonstrated reductions in several markers of inflammation in a dose-dependent manner: C-reactive protein, monocyte chemotactic protein 1 and soluble intracellular adhesion molecule. Pharmacology data also showed the compound inhibits platelet activation mediated through VASP as well as platelet aggregation. And it reduced levels of another indicator of platelet activation, p-selectin.
F. Hoffmann-La Roche Ltd., of Basel, Switzerland, said a retrospective analysis of a pivotal pediatric study indicated that earlier initiation of treatment with Tamiflu (oseltamivir phosphate) is associated with greater reduction in illness duration, symptom severity and secondary complications in children with influenza. Treatment initiated within 24 hours of symptom onset provides clinically meaningful improvements, compared with treatment initiated within 24 to 48 hours. The drug, approved for preventing and treating influenza types A and B, was developed with Gilead Sciences Inc., of Foster City, Calif.
• Gilead Sciences Inc., of Foster City, Calif., said Study 103, its second Phase III trial of the anti-HIV drug Viread (tenofovir disoproxil fumarate) in treating hepatitis B virus infection, met its primary efficacy endpoint. The data show that Viread is non-inferior to the company's once-daily antiviral drug Hepsera (adefovir dipivoxil) among patients with "e" antigen (HBeAg)-positive chronic hepatitis B. The primary efficacy endpoint, the proportion of patients with a complete response at week 48, was defined by serum HBV DNA levels below 400 copies/mL and histologic improvement characterized by at least a two-point reduction in a necroinflammatory score, with no concurrent worsening of fibrosis. At 48 weeks, 66.5 percent of patients in the Viread arm (n=176) had a complete response compared to 12.2 percent in the Hepsera arm (n=90; p<0.001). Positive data from the first Phase III trial were reported earlier this month. Gilead plans to file for approvals in the U.S. and Europe in the fourth quarter. (See BioWorld Today, June 8, 2007.)
• MediQuest Therapeutics Inc., of Bothell, Wash., completed its confirmatory Phase III study of Vascana, a topical formulation designed to treat Raynaud's disease. The trial met its primary endpoint and demonstrated statistical significance for the intent-to-treat population. MediQuest said those results bring the company a step closer to submitting a new drug application for Vascana, which, if approved, could become the first drug on the market to specifically treat Raynaud's disease, a condition caused by a disorder of the blood vessels that limits blood circulation to certain areas of the body, such as fingers, toes, tips of the nose and ears.
• Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass., started a pivotal Phase II trial with Zemiva (iodofiltic acid I 123, or BMIPP) for the diagnosis of cardiac ischemia, or lack of sufficient blood supply to an area of the heart, in patients with suspected acute coronary syndrome in the emergency-room setting. Zemiva is a metabolic, molecular imaging pharmaceutical that previously has demonstrated the ability to detect cardiac ischemia up to 30 hours after an ischemic event, as compared to currently available techniques, which are limited to an approximate two-hour imaging window. The current trial is designed to be a pivotal registration study that, upon replication in a successive confirmatory Phase III trial, could form the basis of an application with the FDA. Molecular Insight expects to report top-line data from this trial in the second half of 2008.
• Neurogen Corp., of Branford, Conn., announced positive top-line results from two dose-ranging Phase IIb trials in chronic insomnia patients with NG2-73, an alpha-3 preferring GABA(A) partial agonist. In Study 202, NG2-73 achieved statistically significant results vs. placebo (p<0.001) at all doses tested in the primary endpoint of sleep maintenance. That study was the first to test NG2-73 in sleep maintenance in chronic insomnia. It included eight different controlled-release doses of the compound. In the second trial, Study 203, NG2-73 achieved statistically significant results vs. placebo (p<0.0001) at all doses tested in the primary endpoint of sleep onset. That trial included two immediate-release forms and three controlled-release doses of NG2-73.
• Novagali Pharma SA, of Evry, France, reported positive Phase III results of Vekacia in children with vernal keratoconjunctivitis, showing that the drug improved both symptoms and signs and disease. In the 118-patient trial, those treated with Vekacia demonstrated statistically significant improvement in both objective signs of VKC and keratitis, and overall improvement of subjective symptoms, such as burning/stinging, tearing, itching, pain, sticky eyelids, foreign body sensation, mucus discharge and photophobia. The drug was superior to the vehicle for both doses of Vekacia. Data were presented at the Afro-Asian Congress of Ophthalmology meeting in Morocco.
• Obecure Ltd., of Ramat Gan, Israel, said the last patient to be enrolled in its Phase II trial of OBE101 for obesity has completed treatment. The double-blinded, placebo-controlled, dose-ranging study enrolled 281 patients at 20 centers in the U.S. The company expects to present top-level results of the trial in the early fall. Obecure is conducting two other Phase II studies using OBE101 in the area of weight management. OBE101 is comprised of betahistine, a drug approved outside the U.S. for treating Meniere's disease (vertigo). Obecure is repurposing betahistine, an H1 receptor agonist and partial H3 receptor antagonist, for weight management indications.
• Peregrine Pharmaceuticals Inc., of Tustin, Calif., began a new trial designed to evaluate the safety and efficacy of its tumor necrosis therapy agent Cotara in patients with glioblastoma multiforme. The Phase II study, to be conducted in India, is designed to enroll up to 40 glioblastoma patients who have experienced a first relapse. Cotara consists of a radioactive isotope linked to a monoclonal antibody designed to bind to dead and dying tumor cells.