• Avigen Inc., of Alameda, Calif., said it received approval from the FDA to begin Phase II clinical development of AV650 (tolperisone), a new chemical entity in the U.S. Tolperisone is approved in several European Union member countries for the treatment of spasticity and muscle spasms. The Phase II trial will assess the safety, tolerability and initial efficacy, as well as AV650's lack of sedation, in spinal cord injury patients suffering from spasticity. The study will be a multicenter, double-blind, placebo-controlled trial and will explore doses up to the EU-approved dose of 450 mg per day.

• Memory Pharmaceuticals Corp., of Montvale, N.J., has dosed the first subject in a randomized, double-blind, placebo-controlled Phase IIa clinical trial of MEM 3454, the company's lead nicotinic alpha-7 receptor partial agonist, in Alzheimer's disease. The trial will study the safety, tolerability and cognitive effects of three doses of MEM 3454 in subjects with mild to moderate Alzheimer's disease. The trial will enroll about 80 subjects at sites in the U.S.

• Napo Pharmaceuticals Inc., of South San Francisco, said it received approval from the principal independent review board overseeing the pivotal, Phase III ADVENT study of crofelemer for treating diarrhea in people with HIV/AIDS. Napo said it met with the FDA in January under the special protocol assessment process on the adaptive design of the ADVENT trial. The two-stage, double-blind, parallel-group, placebo-controlled study is designed to assess the efficacy and safety of three doses of crofelemer in 250 patients. Crofelemer is an agent extracted from Croton lechleri, a medicinal plant harvested from countries in South America.

• Pharmaxis, of Sydney, Australia, is planning further studies of Aridol, it's compound in chronic obstructive pulmonary disease (COPD) after receiving mixed results from a Phase II trial. The trial, of 79 COPD patients at 12 centers in Australia, showed that the Aridol response was positive in 76.5 percent of cases, with no serious adverse events. But because the inhaled corticosteroid did not improve lung function, as measured by spirometry, in either the Aridol-positive or the Aridol-negative groups, the primary hypothesis could not be tested satisfactorily. However, in subjects with a positive-Aridol challenge test, treatment with inhaled corticosteroids led to a highly statistically significant improvement in hyper-responsive airways as judged by a subsequent Aridol challenge test. In COPD, the severity of hyper-responsive airways is associated with the severity of the disease and is a major risk factor for the development of respiratory symptoms and worsening of the patients health. Pharmaxis is planning an additional, larger, study in COPD subjects in Switzerland. The first patient is expected to be enrolled in April, and the study should conclude during the first half of 2008.

• Sucampo Pharma Ltd., of Tokyo, a subsidiary of Bethesda, Md.-based Sucampo Pharmaceuticals Inc., has begun a repeated-dose Phase I clinical study in Japan of Amitiza (lubiprostone), its U.S.-approved drug for chronic idiopathic constipation in adults. The randomized, double-blind, placebo-controlled trial will evaluate the safety, tolerability and pharmacokinetic profile of Amitiza after repeated dosing in 12 Japanese men. Subjects will receive 24 mcg of Amitiza twice daily for six days, with a single 24-mcg dose on the seventh day to assess the drug's pharmacokinetics.

• Transgene SA, of Strasbourg, France, enrolled the first patients in a two-step Phase II trial of TG 1042, an immunotherapy candidate, in relapsing cutaneous B-cell lymphoma. The first stage will involve 13 patients, and if results are positive, the company will recruit an additional group of 28 patients in a second confirmatory stage. The primary objective of the trial is to evaluate the efficacy of a four-month treatment of intra-lesional injections of 5 x 1010 viral particles per lesion of TG 1042 in CBCL patients after standard first-line treatments. Clinical endpoints are regression and disappearance of lesions, safety and quality of life.