• Amira Pharmaceuticals Inc., of San Diego, has completed a Phase I clinical trial of AM103, its oral drug candidate for the treatment of inflammatory diseases linked to the leukotriene pathway. Results showed that AM103 is safe and well tolerated at doses up to 1,000 mg per day with no evidence of significant side effects. The systemic exposure of AM103 increased linearly from 50 mg to 1,000 mg. Amira also announced the start of a Phase I trial for AM803, a second oral drug candidate that targets the same inflammatory response. AM103 and AM803 are novel inhibitors of 5-lipoxygenase-activating protein (FLAP) that have demonstrated potential to treat asthma and cardiovascular disease by preventing the synthesis of leukotrienes, which trigger inflammation.

• Arete Therapeutics Inc., of Hayward, Calif., has initiated a Phase I trial for its lead compound, AR9281, for the treatment of hypertension. AR9281 is a first-in-class orally active inhibitor of soluble epoxide hydrolase (s-EH) for the treatment of hypertension. The trial will enroll up to 32 healthy adult volunteers and will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics for single ascending doses of AR9281.

• Human Genome Sciences Inc., of Rockville, Md., said it has completed enrollment and initial dosing ahead of schedule in ACHIEVE 2/3, the second of two pivotal global Phase III trials with Albuferon (albinterferon alfa-2b) in combination with ribavirin in treatment-naive patients with chronic hepatitis C. ACHIEVE 2/3 is being conducted in patients with genotypes 2 and 3 disease. The firm expects to file global marketing applications by the fall of 2009.

• Neuromed Pharmaceuticals, of Conshohocken, Pa., has dosed the first patient in its pivotal Phase III clinical trial of NMED-1077 (OROS Hydromorphone) for the treatment of chronic moderate to severe pain. The study of 272 patients is a randomized withdrawal, placebo-controlled, double-blind trial being conducted at multiple centers in the U.S. The aim is to evaluate the safety and efficacy of NMED-1077 in chronic low back pain. The trial is being studied under a special protocol assessment agreement with the FDA. Neuromed acquired U.S. rights to NMED-1077, formerly known as OROS Hydromorphone, from Johnson & Johnson subsidiary ALZA Corp. The product previously failed a Phase III trial and received an approvable letter, but the company has said a single, positive Phase III trial should be sufficient for approval. (See BioWorld Today, April 25, 2007.)

• Orexo AB, of Uppsala, Sweden, said licensing partner Endo Pharmaceuticals Inc., of Chadds Ford, Pa., has decided to conduct an interim analysis of the Phase III trial with Rapinyl, the sublingual fentanyl tablet for breakthrough cancer pain, as soon as possible, when a predetermined number of patients (based upon a power calculation) with evaluable data have completed the trial. Endo cited the continued challenge of recruiting cancer patients.

• Protox Therapeutics Inc., of Vancouver, British Columbia, announced positive final results from its Phase I clinical trial evaluating PRX302 in patients with localized, recurrent prostate cancer following radiation failure. The trial results, an extension of those released July 10, indicated that PRX302 is well tolerated and shows promising signs of therapeutic activity. Protox concluded that despite a 100-fold escalation in dose, the maximum tolerated dose was not reached in the study while evidence of therapeutic activity was observed.

• Regado Biosciences Inc., of Durham, N.C., enrolled the first patient in a Phase IIa study of REG1 Anticoagulation System. The REVERSAL-PCI study will involve 26 patients undergoing elective percutaneous coronary intervention to assess whether REG1 can replace standard heparin therapy during the performance of coronary balloon angioplasty dilation and stenting on patients at low risk for complications associated with therapy-related bleeding or heart attack. The REG1 Anticoagulation System is a combination of RB006, an intravenous anticoagulant, and its rapidly acting antidote, RB007.

• Seattle Genetics Inc., of Bothell, Wash., started a Phase IIb trial with SGN-40 in combination with Revlimid (lenalidomide), from Celgene Corp., of Summit, N.J., and the steroid dexamethasone for patients with relapsed or refractory multiple myeloma. As a result, the company will receive a $4 million milestone payment from its collaborator Genentech Inc., of South San Francisco. SGN-40 is a humanized monoclonal antibody that targets the CD40 antigen.

• Theravance Inc., of South San Francisco, said partner GlaxoSmithKline plc, of London, started a Phase II study with GSK961081, an investigational bifunctional muscarinic antagonist-beta2 agonist compound for the treatment of chronic obstructive pulmonary disease. The compound was discovered by Theravance and is being developed by GSK under their strategic alliance. The drug is described as a potent, long-acting, inhaled bronchodilator. (See BioWorld Today, April 1, 2004.)