• Altus Pharmaceuticals Inc., of Cambridge, Mass., initiated a Phase I trial of ALTU-237, an orally delivered crystalline formulation of an oxalate-degrading enzyme. It is being developed for the treatment of hyperoxalurias and the possible prevention of recurrent kidney stones in those with a high risk or history of kidney stones. The single-center, double-blind, placebo-controlled, dose-escalating trial will evaluate safety and tolerability in 64 normal, healthy adults. A secondary objective is to assess clinical activity, as measured by changes in urinary oxalate levels in healthy adults on a controlled, high-oxalate diet, and to identify a dose for future studies.

• Biogen Idec Inc., of Cambridge, Mass., said positive results of a Phase II study of oral Adentri, an A1 adenosine receptor antagonist, in stable heart failure patients were published in the Journal of the American College of Cardiology. Results showed that administration of Adentri for 10 days, in addition to standard heart failure therapy for the 50 patients, was well tolerated and resulted in clinically significant increases in sodium excretion while preserving renal function. Trends toward beneficial effects in clinical measures of heart failure, including body weight, edema, and physician global assessment, also were observed. Preliminary results of the study were presented in 2003 at the annual meeting of the American Heart Association.

• Biopartners Holdings AG, of Baar, Switzerland, said its biosimilar recombinant human growth hormone, Valtropin, demonstrated equivalent safety and efficacy to its reference product in a Phase III trial. One-year safety and efficacy were equivalent to the approved reference product, it said. The study in treatment-naïve children with growth hormone deficiency was published online and will be in the September issue of Hormone Research. The product was approved last year in Europe.

• Generex Biotechnology Corp., of Worcester, Mass., said results of a study of Oral-lyn study were published in Diabetes Technology & Therapeutics. The conclusion was that regular insulin and Generex's oral Oral-lyn product had similar glucodynamic effects in subjects with Type I diabetes receiving a twice-daily insulin analogue as baseline therapy. Generex said its plans to begin Phase III trials this year in North America and Europe in Types I and II diabetes.

• NasVax Ltd., of Ness Tziona, Israel, received approval from the Helsinki Committee and the Israel Ministry of Health to perform a Phase I/IIa study of an influenza vaccine, through the intramuscular route. The study, which already was initiated in about 100 volunteers, will evaluate safety and efficacy of the immune response to vaccination. The product uses CCS/C technology, a biocompatible adjuvant and delivery system that has been shown to stimulate an increased antibody response and produce a response in T cells.

• NeurAxon Inc., of Waltham, Mass., reported positive data from a Phase I trial of NXN-188 that assessed safety and pharmacokinetics. The small-molecule product being developed for acute migraine incorporates both 5-HT agonism and inhibition of neuronal nitric oxide synthase (nNOS). Results of the Phase I study in healthy volunteers showed NXN-188 was well tolerated, with no drug-related adverse events reported. NeuroAxon said it plans to move into a Phase IIa trial this quarter.

• Oramed Pharmaceuticals Inc., of Jerusalem, said it successfully completed an exploratory Phase Ia trial of its oral insulin gel capsule. The trial examined changes in insulin, glucose and C-peptide plasma concentrations in healthy volunteers. With the exception of the anticipated insulin-related hypoglycemic side effects, no significant adverse effects were noted in the drug group. Additional Phase I trials to evaluate bioavailability and pharmacokinetics are expected to begin later this year.

• Pharmacopeia Inc., of Princeton, N.J., said partner Schering-Plough Corp., of Kenilworth, N.J., suspended Phase I clinical development of a compound targeting a metabolic disease. The compound was discovered in a collaboration between the companies. Pharmacopeia said Schering-Plough plans to continue preclinical development of the product and also is developing other products from their collaboration.

• Sinovac Biotech Ltd., of Beijing, said it began vaccination of volunteers in a continuation of the Phase I portion of its program for a pandemic influenza vaccine. The open-label studies will assess the tolerance and safety of the vaccine. The company anticipates Phase II trials will commence shortly and the preliminary results from both vaccines will be available early next year. It is studying a whole-viron H5N1 vaccine and a split H5N1 vaccine.

• Urigen Pharmaceuticals Inc., of Burlingame, Calif., initiated a double-blind, placebo-controlled, crossover study to investigate URG-101 as a treatment for acute symptoms of painful bladder syndrome/interstitial cystitis. The URG101-104 Phase II study will compare the efficacy of URG101 (intravesical lidocaine-heparin formulation) and placebo in reducing acute symptoms of PBS.