* Acute Therapeutics Inc., of Doylestown, Pa., is initiating a pivotal Phase II/III trial to evaluate the efficacy of Surfaxin, a peptide-containing pulmonary surfactant for the treatment of Acute Respiratory Distress Syndrome (ARDS). The multi-center, 400-patient trial will focus on direct causes of ARDS, such as pneumonia, aspiration of gastric contents, inhalation of noxious substances, contusions and near drowning. Acute Therapeutics is a majority-owned subsidiary of New York-based Discovery Laboratories Inc.
* Boston Life Sciences Inc., of Boston, said results of a physician-sponsored Phase I/II study of Altropane appear in the current issue of the neuroscience journal Synapse (Volume 29, No. 2), along with three related articles on the product's utility. Altropane is a radio-imaging agent for diagnosis of Parkinson's disease. In the trial, seven healthy volunteers and eight patients with early or moderate Parkinson's Disease (PD) underwent SPECT (photon emission computed tomography) scanning one hour after injection of Altropane. Striatal Altropane uptake was significantly reduced in the patients with the disease, suggesting "this technique is likely to be of considerable value for detecting early PD, probing the fundamental pathophysiology of the disease, and for monitoring the effects of new and novel medical and surgical therapies."
* Genelabs Technologies Inc., of Redwood City, Calif., completed enrollment in a second Phase III clinical trial of the dehydroepiandrosterone-based drug GL701 in women with systemic lupus erythematosus. The 370-patient trial, designed to determine whether a 200 mg daily dose of GL701 can improve clinical outcome or disease symptoms in patients with SLE, is expected to conclude at the end of March 1999. Results from Genelabs' first Phase III trial of the product were mixed, but data indicated that a beneficial effect was most evident in patients with active disease who received 200 mg daily. (See BioWorld Today, April 28, 1997, p. 1.)
* Genset, of Paris, and Synthelabo SA, of Montrouge, France, have agreed to extend by one year their two-year prostate cancer research agreement. Thus far, the collaboration has produced a gene associated with prostate cancer and has identified other genes that may also be involved in the disease. The companies aim to use the yearlong extension to complete the search for additional genes related to the cancer.
* Life Medical Sciences Inc., of Edison, N.J., won FDA approval to initiate a 140-patient, multi-center pivotal trial of Repel, a bioresorbable adhesion barrier film designed to prevent or reduce post-operative scarring stemming from gynecological surgeries. The company estimates the worldwide market opportunity for the product at more than $300 million per year. Life Medical's portfolio of related prospective products includes Repel-CV, which the FDA has approved for a pilot clinical trial in open-heart surgical procedures.
* Magainin Pharmaceuticals Inc., of Plymouth Meeting, Pa., made four presentations of preclinical data related to the company's asthma gene candidates, interleukin-9 (IL-9) and the IL-9 receptor, at the International Conference of the American Lung Association/American Thoracic Society, held in Chicago this week. Among other things, the findings suggest a role for IL-9 in the pathogenesis of asthma. Genetic mapping data in mice, corroborated by human gene linkage previously published, correlate high IL-9 expression to bronchial hyperresponsiveness, a risk factor for asthma.
* Myriad Genetics Inc., of Salt Lake City, licensed certain genes involved in control of cancer cell growth from Rockefeller University, of New York. The license provides Myriad with worldwide, exclusive rights to therapeutic and diagnostics products based on the genes.
* Nabi, of Boca Raton, Fla., said an abstract on the company's enterococcal vaccine will be presented May 19 at the Annual Meeting of the American Society for Microbiology, in Atlanta. The abstract is titled "Antibodies to an Enterococcus Type 1 Capsular Polysaccharide Clear Bacteremia and Organ Seeding in Mice Challenged with a Sublethal Dose of E. faecalis Bacteria." The study demonstrates the ability of polyclonal antibodies raised using the company's vaccine to protect mice from challenge with a vancomycin-resistant clinical isolate of Enterococcus faecalis.
* NeoRx Corp., of Seattle, received a $750,000 grant from the National Institutes of Health to develop the firm's Pretarget technology for alpha particles, a form of radiation that in the past has proved difficult to deliver safely. The Small Business Innovation Research grant is NeoRx's second in support of the project.
* Osi Pharmaceuticals Inc., of Uniondale, N.Y., entered a collaboration with the Vanderbilt University Diabetes Center, in Nashville, Tenn., to discover and develop small molecule drugs for the treatment of non-insulin-dependent diabetes. The initial research plan focuses on four novel targets, including Hexokinase II and other gene expression targets. Modulation of the targets is believed to have a direct effect on blood glucose levels, independent of underlying causes of the disease.
* Signal Pharmaceuticals Inc., of San Diego, received a $750,000 Phase II Small Business Innovation Research grant form the National Institute of Diabetes and Kidney Diseases. The company will use the funds, to be allocated over a two-year period, to advance an interleukin-6 gene regulation program, including preclinical development of classes of new anti-resorptive drugs for the treatment of osteoporosis.
* Vical Inc., of San Diego, and Pasteur Merieux Connaught, of Lyon, France, reported that the first human trial of a DNA vaccine against malaria showed the product to be safe and well-tolerated, and that preliminary analysis of specimens from trial participants suggested a good cellular immune response. Physicians who conducted the study presented results at the Third National Symposium on Basic Aspects of Vaccines, in Washington, D.C.