Aastrom Biosciences Inc., of Ann Arbor, Mich., reported positive interim results from two research groups using autologous stem cell products manufactured with the company s Tissue Repair Cell technology platform. Data from the first 13 patents treated in a Phase I/II trial testing the safety of Vascular Repair Cells (VRCs) and normal bone marrow cells in chronic diabetic foot wounds associated with critical limb ischemia showed that all patients treated with VRCs reported no major amputations, no cell-related adverse events and healing of all open wounds. A separate study evaluating the use of Bone Repair Cells in osteonecrosis of the femoral head showed that four patients tolerated the procedure and reported a reduction in hip pain with no signs of disease progression. Those data were presented at the stem cell conference in Wurzburg, Germany.

Anesiva Inc., of South San Francisco, said the first patient has been treated in a Phase II study of the company s compound Adlea (formerly 4975) for post-operative pain in patients who undergo total hip replacement surgery. Adlea is a long-acting, non-opiate analgesic drug candidate designed to provide long-term pain relief after a single local application during the surgical procedure. The trial will enroll about 160 patients, randomized to receive either a single 15-mg dose of Adlea or placebo instilled into the surgical wound prior to closure. The trial will evaluate safety, tolerability, pharmacokinetics, and the ability of Adlea to reduce post-operative pain following total hip replacement surgery.

Gilead Sciences Inc., of Foster City, Calif., reported detailed results from its Phase III AIR-CF1 (CP-AI-007) study of aztreonam lysine for inhalation in cystic fibrosis patients who have pulmonary pseudomonas aeruginosa, showing that a 28-day treatment course improved respiratory symptoms as assessed by the Cystic Fibrosis Questionnaire-Revised (CFQ-R), a patient-reported outcome tool. Data from the 164-patient trial showed that patients in the aztreonam lysine group experienced an improvement in mean change from baseline of 9.71 points in the respiratory symptoms domain of the CFQ-R compared to those on placebo. Aztreonam lysine improved pulmonary function in the study, as measured by relative improvement of forced expiratory volume in one second (FEV1), with patients in the treatment group showing a mean change from FEV1 baseline of 10.3 percent vs. placebo. The drug also was associated with significantly greater reductions in P. aeruginosa colony forming units at 28 days compared to placebo, with a treatment difference in mean change from baseline of -1.45 (log reduction.) Data were presented at the cystic fibrosis conference in Anaheim, Calif. The company first reported top-line results from the Phase III study in May, and said it anticipated filing a new drug application for aztreonam lysine later this year. (See BioWorld Today, May 31, 2007.)

Immtech Pharmaceuticals Inc. said an interim analysis of Phase III pivotal trial data for its African sleeping sickness candidate pafuramidine has resulted in an independent Data Safety Monitoring Board recommending that the trial continue. The interim analysis was to evaluate the efficacy of pafuramidine compared to pentamidine, as well as safety and tolerability. The analysis was performed after half of the enrolled patients had completed the 12-month follow up protocol. The DSMB reviewed the data in an unblinded manner, but Immtech is blinded to the results until all patients have completed the protocol. African sleeping sickness is a fatal, vector-borne parasitic disease spread by tsetse flies that threatens approximately 60 million people in sub- Saharan Africa.

Inspire Pharmaceuticals Inc., of Durham, N.C., completed enrollment in TIGER-1, the first of two planned pivotal Phase III trials with inhaled denufosol tetrasodium solution for the treatment of cystic fibrosis. The company expects top-line efficacy data from TIGER-1 in mid-year 2008, earlier than previously projected. TIGER-1 is a double-blind, placebo-controlled, randomized study comparing 60 mg of denufosol to placebo, administered three times daily by jet nebulizer, in about 350 patients with mild CF lung disease. The primary efficacy endpoint is change from baseline in forced expiratory volume in 1 second, in liters at the 24-week checkpoint.

Isis Pharmaceuticals Inc., of Carlsbad, Calif., announced new results from its Phase II clinical trial of ISIS 301012 in patients with heterozygous familial hypercholesterolemia (HeFH) on stable maximally tolerated lipid-lowering therapies. HeFH patients being treated with maximally tolerated lipid-lowering therapies were treated with ISIS 301012 for six or 13 weeks. Median baseline LDL-C levels for the dose cohorts ranged from 159-204 mg/dL. ISIS 301012 add-on treatment produced potent, dose-dependent, prolonged reductions in all atherogenic lipids, and results were consistent with those reported for patients with routine high cholesterol, the company said. The study also confirmed that ISIS 301012 treatment results in meaningful reductions in Lp(a), another predictor of cardiovascular disease. The data were presented in a poster session today at the Drugs Affecting Lipid Metabolism (DALM) XVI International Symposium in New York City.

Speedel Holding Ltd., of Basel, Switzerland, started Phase I trials with the rennin inhibitor SPP676, from the SPP600 series of renin inhibitors for the treatment of hypertension and related end-organ diseases. The Phase I trial will test the safety and tolerability of single and multiple oral doses in healthy volunteers and first results are expected in 2008. SPP676 is one of several novel compounds developed by Speedel Experimenta, the company s late-stage research unit.