* Celgene Corp., of Warren, N.J., said initial Phase I/II studies for its chirally pure formulation of d-methylphenidate hydrochloride (d-MPH) showed that the compound is statistically superior to a placebo in improving academic productivity and controlling behavioral symptoms in children with attention deficit hyperactivity disorder. The doses given were one-half the usual doses of racemic methylphenidate hydrochloride (dl-MPH). The trial also suggested the lower-dose drug has a longer duration of efficacy.
* CoCensys Inc., of Irvine, Calif., was awarded a $100,000 Phase I Small Business Innovation Research grant from the National Institutes of Health. The grant is for development and identification of therapeutic candidates for stroke and other neurodegenerative disorders that involve apoptosis or programmed cell death.
* Cypros Pharmaceutical Corp., of Carlsbad, Calif., said a Phase II trial of its cytoprotective drug, CPC-111, significantly reduced pain during crisis in sickle cell anemia patients. The placebo-controlled, double-blind study used 47 patients. Two separate in vitro studies have shown the drug reduces blood cell sickling that causes the tissue damage, which is induced by blood starvation, in sickle cell crisis.
* Incyte Pharmaceuticals Inc., of Palo Alto, Calif., announced a two-for-one stock split. The split doubles the shares outstanding to about 24 million. Incyte designs, develops and markets genomic database products.
* Lidak Pharmaceuticals Inc., of La Jolla, Calif., reported results from a Phase I/II clinical study of patients with advanced Stage IV malignant melanoma. Sixteen patients were vaccinated with the company's melanoma vaccine, LP2307, in the study. Ten showed specific immunological activity, and five showed stabilization or remission.
* Quintiles Transnational Corp., of Research Triangle Park, N.C., opened an office in Mexico City to provide clinical trial services. The company manages clinical trials in Mexico and four other Latin American countries. Ten employees work in the Mexico City office, providing clinical trial monitoring, regulatory assistance and marketing consultation services.
* NeoTherapeutics Inc., of Irvine, Calif., found in preclinical studies that its drug, AIT-082 for memory impairments associated with Alzheimer's disease, proved effective in animals with neurological deficits. The small molecule is designed to cross the blood-brain barrier and enhance nerve cell function by increasing levels of neurotrophic factors. Laboratory studies have shown AIT-082 stimulates production of neurotrophins, natural proteins that promote the growth and regeneration of nerve cells.
* PathoGenesis Corp., of Seattle, initiated an open-label, 15 to 20 patient Phase II trial of its aerosolized antibiotic TOBI (tobramycin solution for inhalation) in patients with contagious pulmonary tuberculosis.
* SUGEN Inc., of Redwood City, Calif., will proceed with registrational studies of SU101 for malignant glioma based on the positive interim data from an uncontrolled Phase II study. Six of 12 evaluable patients achieved stable disease for more than 16 weeks. The median time to progression was 15 weeks, an improvement over the median of 10 weeks for current therapies. SUGEN has started a new Phase I/II study of the drug in combination with BCNU in newly diagnosed malignant gliomas, and has expanded SU101 trials in prostate, ovarian and non-small cell lung tumors based on the encouraging interim data from Phase I/II clinical trials.