• Aastrom Biosciences Inc, of Ann Arbor, Mich., said the FDA granted orphan drug designation to its Tissue Repair Cells for use in the treatment of dilated cardiomyopathy, a disease of the heart. Aastrom's TRC-based products consist of a mixture of stem and progenitor cell populations, produced from a small amount of bone marrow taken from the patient.

• Apollo Life Sciences, of Sydney, Australia, has received results of Phase I toxicology trials of its oral insulin delivery technology, Oradel. The toxicology study was designed to test the safety of Apollo's oral insulin for people with diabetes. Oradel insulin was administered daily to two animal species for 14 days, followed by a 14-day recovery period. Control groups received treatment with the vehicle alone. The key findings indicated that Oradel insulin caused no toxic effects or treatment-related changes in body weights, food consumption, blood analysis, urinalysis, gross necroscopy or histopathology.

• Chelsea Therapeutics International Ltd., of Charlotte, N.C., said results from a primate study indicated that the disodium salt of its lead antifolate drug candidate, CH-1504, demonstrates significant improvement in peak plasma levels and systemic exposure compared to the original free acid formulation. That discovery marks one of two initiatives by Chelsea to enhance solubility and bioavailability and to reduce PK variation of the compound. The second initiative involves implementing standard formulation strategies. The company reported positive preliminary results from a Phase I trial for all oral indications of CH-1504 and anticipates starting Phase II studies in rheumatoid arthritis this year.

• Generex Biotechnology Corp., of Toronto, entered into a Phase II trial using its novel peptide vaccine in breast cancer patients in conjunction with the U.S. Military Cancer Institute's Clinical Trials Group under a Clinical Trial Agreement. The immunotherapeutic vaccine, AE37, is being developed by Generex's Antigen Express division in the United States. A Phase I trial of AE37 in 2005 showed good immunostimulatory activity, as well as safety and tolerance. The Phase II study will be a randomized, multicenter trial in patients who have completed standard therapy for node-positive or high-risk node-negative breast cancer expressing at least low levels of the HER-2/neu oncogene. The endpoint for this study will be a 50 percent reduction in the rate of relapse of disease at two years. The trial is designed to take advantage of changing paradigms (not yet adopted) for the study of therapeutic cancer vaccines, which proposes a two-phase rather than a three-phase clinical investigation strategy.

• La Jolla Pharmaceutical Co., of San Diego, said that after discussions with the FDA, it is making some changes to an ongoing Phase III trial of Riquent (abetimus sodium) for treatment of lupus renal disease. Changes include focusing on the higher doses, increasing the number of patients from 600 to 730, a broadened analysis of the patient population, and combining data from the Phase II pharmacology study with the Phase III study. To date, 202 patients have been enrolled in the study. The completion of an analysis measuring antibody reductions is expected by the end of the first quarter or early in the second quarter, as planned.

• Metabasis Therapeutics Inc., of San Diego, said it completed enrollment in its Phase IIb trial of CS-917 in Type II diabetes. The 392-patient randomized, double-blind, placebo-controlled trial is designed to evaluate safety and tolerability after three months of dosing of CS-917, as well as its effect on blood levels of HbA1c. Rights to the product, designed to inhibit gluconeogenesis, are held by Daiichi Sankyo Co. Ltd., of Tokyo. Metabasis retains co-promotion rights in North America.

• Neurochem Inc., of Laval, Quebec, said it completed its 18-month North American Phase III clinical trial of Alzhemed (tramiprosate) for the treatment of Alzheimer's disease. The study involved 1,052 patients, at 67 clinical sites in the U.S. and Canada. The dropout rate in the study was 24.8 percent, and 791 patients were exposed to study medication for 18 months. Neurochem said it plans to release the top-line results of the trial in the spring, as previously announced. About 90 percent of the patients who completed the trial continued into an ongoing Phase III extension study, which was initiated in May.

• SGX Pharmaceuticals Inc., of San Diego, said it selected a MET tyrosine kinase inhibitor development candidate, SGX-523, for investigational new drug application-enabling preclinical development. SGX-523 is a small-molecule kinase inhibitor that has shown in vitro and in vivo activity as a potential anticancer therapy. It expects to file an IND application with the FDA within 12 months.

• United Therapeutics Corp., of Silver Spring, Md., reported the publication of two studies. A long-term outcome study in patients with pulmonary arterial hypertension published in the European Respiratory Journal demonstrated improved survival with Remodulin (treprostinil) vs. predicted survival over a four-year period. Also, results reported the Journal of Cardiovascular Pharmacology showed that rapid transition from intravenous epoprostenol to intravenous Remodulin in 12 PAH patients was achieved with no serious adverse events, and baseline clinical status was maintained over 12 weeks.