• Acadia Pharmaceuticals Inc., of San Diego, started a Phase IIb trial of ACP-104 in about 250 patients with schizophrenia who are experiencing an acute psychotic episode. Patients will be randomized to three different study arms, which will include two different doses of ACP-104 (100 mg twice daily and 200 mg twice daily) and a placebo arm. The primary endpoint of the six-week study will be antipsychotic efficacy, as measured using the Positive and Negative Syndrome Scale. ACP-104, or N-desmethylclozapine, is the major metabolite of clozapine and is designed to provide an atypical antipsychotic efficacy profile with the added potential benefit of enhanced cognition.

• Advanced Viral Research Corp., of Yonkers, N.Y., said Health Canada's Therapeutic Products Division approved a clinical trial application to start studies of AVR118 in patients with histologically confirmed malignancies who present with clinically demonstrable anorexia or anorexia-cachexia syndrome. AVR118 is in development as a cytoprotective agent that targets cachexia-related disorders, which are associated with cancer, HIV/AIDS and chronic inflammation.

• Advancis Pharmaceutical Corp., of Germantown, Md., concluded a pre-Phase III meeting with the FDA and believes its planned non-inferiority trial design and regulatory strategy for Keflex Pulsys for adults and adolescents with uncomplicated skin infections were acceptable to the agency. The planned Phase III study is designed as a two-arm, double-blind, non-inferiority trial with a minimum enrollment of 600 patients to receive either 1,200 mg of Keflex Pulsys product administered once daily for 10 days or 250 mg of Keflex dosed four times daily for 10 days. As previously announced, Advancis' future development efforts for its Pulsys product candidates will be dependent upon its ability to secure additional capital or to find a partner to fund continued development. Last month, the FDA accepted for filing the company's new drug application for its Amoxicillin Pulsys product to treat adults and adolescents with strep throat.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., started a Phase II trial with ALN-RSV01 in respiratory syncytial virus infection, which will involve adult subjects experimentally infected with RSV. A total of 90 subjects are expected to be enrolled, and the study is expected to evaluate the effects of ALN-RSV01, an RNAi therapeutic, on defined parameters of RSV infection, namely the incidence of infection, measures of viral load and occurrence of clinical symptoms. Subjects will receive ALN-RSV01 both before and after inoculation with RSV, and drug, virus and placebo all will be administered intranasally. Data are expected toward the end of the year.

• Biogen Idec Inc., of Cambridge, Mass., and UCB SA, of Brussels, Belgium, initiated a Phase II study of CDP323, an oral VLA-4 antagonist, in relapsing-remitting multiple sclerosis. The study is designed to enroll more than 200 patients who have failed earlier treatment with beta-interferon and will compare two doses of CDP323 monotherapy to placebo over a six-month period. Results are expected by the end of the 2008. The companies signed a potential $200 million deal in October to co-develop and co-commercialize the small-molecule compound. (See BioWorld Today, Oct. 4, 2006.)

• Critical Therapeutics Inc., of Lexington, Mass., said data from a 12-week, 320-patient study suggested that combining zileuton (400 mg or 600 mg QID) with a low-dose inhaled corticosteroid (ICS) improves pulmonary lung function and might be an effective therapeutic approach to achieving asthma control in moderate to severe persistent disease. There were significant improvements in peak expiratory flow in the 400-mg and 600-mg zileuton groups, and results suggested that the addition of zileuton might be an alternative to using higher doses of ICS in patients unable to achieve asthma control on a low-dose ICS therapy. Data were published in Respiratory Medicine.

• Hemispherx Biopharma Inc., of Philadelphia, initiated an Australian Phase IIb trial of Ampligen, a Toll-like receptor 3 ligand designed to function as an immune system activator, in combination with trivalent seasonal influenza vaccine. The study focuses on populations at risk for virulent cases of influenza, especially those older than age 60 who may lack a robust immune system. Thirty patients will be enrolled in the trial, which will use a 2-mg dose of Ampligen. Measurements of initial immune response are expected to occur within several weeks.

• Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, said a review of study reports for IPL455,903, a PDE4 inhibitor, showed that data might support further clinical studies, as well as support development of Inflazyme's other PDE4 inhibitors. Study reports were provided by New York-based Helicon Therapeutics Inc., which reported in April unfavorable efficacy data of the product in age-associated memory impairment. Inflazyme said it currently does not have the financial resources to invest in the future development of IPL455,903, and is pursuing several strategic options, including a merger, sale or licensing of its PDE4 inhibitor program.

• Koronis Pharmaceuticals Inc., of Seattle, started enrolling patients in a Phase IIa study of KP-1461, an oral, small-molecule therapeutic designed to work through Viral Decay Acceleration to treat HIV infection. The trial will involve up to 32 patients who have significant resistance to conventional antiretroviral therapies. They will receive 1,600 mg of KP-1461 twice daily for 124 days, and investigators will examine safety, tolerability and efficacy. KP-1461 aims to treat HIV infection by inducing mutations within the HIV genome that lead to the degrading of viral fitness and to viral collapse.

• Kythera Biopharmaceuticals Inc., of Los Angeles, initiated and completed enrollment of its Phase II study of ATX-201 for actinic keratosis. The study involves 48 patients with actinic keratosis on the scalp and face who are undergoing at least one treatment with ATX-201 or placebo over a four- to 12-week period. An assessment of efficacy, safety and tolerability will be made in multiple treatment regimens based on both primary and exploratory scales. Kythera gained exclusive worldwide rights to the product in November from Basel, Switzerland-based Novartis Pharma AG. ATX-201 is from a family of compounds designed to inhibit microtubule polymerization.

• Replidyne Inc., of Louisville, Colo., reported results from three Phase I trials involving more than 400 patients receiving REP8839, a topical antibiotic, showing that the product appears safe, well tolerated and is associated with low systemic exposure. Based on those data, the company plans to initiate Phase II trials in children with impetigo, the most common bacterial skin infection, by the end of the year. REP8839, which is designed to target the bacterial methionyl tRNA enzyme, is in development against major skin pathogens and has shown in vitro activity against methicillin-resistant Staphylococcus aureus.

• Theravance Inc., of South San Francisco, reported positive results from its 400-patient Phase II ACCORD study of its selective 5-HT4 agonist TD-5108 in chronic constipation. It showed that all three doses (15 mg, 30 mg and 50 mg, all given once daily) of the drug achieved statistical significance in the primary endpoint of an increased number of spontaneous bowel movements (SBM) per week over baseline compared to placebo. The average weekly increases over the four-week period in SBM from baseline were 3.6 for the 15-mg group, 3.3 for the 30-mg group and 3.5 for the 50-mg group, all vs. placebo. At the lowest doses, TD-5108 was well tolerated with a low incidence of adverse events. Theravance plans to meet with the FDA to discuss the development path for TD-5108. Pursuant to a 2004 alliance agreement, London-based GlaxoSmithKline plc holds an option to license the drug for further development and commercialization.