Investigators from Children's National Medical Center in Washington and the University of Pittsburgh reported a gene therapy using an adeno-associated virus and the gene for the sarcoglycan protein was able to repair animal muscles crippled by limb girdle muscular dystrophy. Results were presented at the American Society of Human Genetics meeting in San Francisco.
Alza Corp., of Mountain View, Calif., and affiliate Crescendo Pharmaceuticals Corp. presented pivotal results of Concerta extended-release tablets at the 46th annual meeting of the American Academy of Child and Adolescent Psychiatry in Chicago. Concerta is under development as a once-daily treatment for attention deficit disorder and attention deficit hyperactivity disorder. Researchers noticed a significant reduction in inattention and overactivity of children on Concerta and the conventional methylphenidate compared with those on placebo in the double-blind crossover study. Similar results were seen in a second study.
Aurora Biosciences Corp., of San Diego, said the second module of the ultra-high-throughput screening system platform was accepted by Warner-Lambert Co., of Morris Plains, N.J., for shipment to its Parke-Davis Pharmaceutical Research facility in Ann Arbor, Mich. The module consists of eight subsystems that prepare compounds for testing using microfluidics to dispense reagents and compounds into the NanoWell Assay Plates.
Calydon Inc., of Sunnyvale, Calif., said prostate cancer patients have begun treatment at the Detroit Medical Center's radiation-oncology unit in a Phase I/II trial of CV787, a potent virus designed to kill 10,000 cancer cells for every one normal cell. The multi-center, open-label, dose-finding study will evaluate the drug at as many as nine locations in North America.
Celgene Corp., of Warren, N.J., said two pivotal trials of Attenade (d-methylphenidate) involving 200 children showed the drug met all efficacy parameters for controlling symptoms of attention deficit disorder and attention deficit hyperactivity disorder. The company expects to file a new drug application in the first half of next year. Results showed Attenade was significantly more effective than a placebo, and it demonstrated a longer duration of action than dl-methylphenidate, or Ritalin. It is a chirally pure version of Ritalin
Cell Pathways Inc., of Horsham, Pa., said the FDA accepted the company's new drug application for Aptosyn (exisulind) for the treatment of familial adenomatous polyposis, which puts those afflicted at high risk of developing colon cancer. The company submitted the NDA on Aug. 25.
Dyax Corp., of Cambridge, Mass., signed an agreement with Pasteur Merieux Connaught, a subsidiary of Paris-based Rhone-Poulenc SA, to collaborate on the development of systems to purify vaccines. Dyax will use its Phage Display technology to develop affinity ligands to provide purification of Pasteur's vaccines for infectious diseases. Pasteur will fund the effort and Dyax will receive milestone payments and royalties on the sale of resulting products.
Gilead Sciences Inc., of Foster City, Calif., said the European Medicines Evaluation Agency (EMEA) accepted the company's application for adefovir dipivoxil 60 mg as a once-daily, oral nucleotide reverse transcriptase inhibitor to treat patients with HIV infection. The application will be reviewed by the EMEA with authorities from Spain and the UK. Gilead submitted a new drug application to the FDA for adefovir dipivoxil in June.
Millennium Pharmaceuticals Inc., of Cambridge, Mass., extended its antibacterial collaboration with Wyeth-Ayerst Research, of Radnor, Pa., for two years. The companies first collaborated in December 1996 and Millennium has since delivered eight antibacterial, novel drug targets for screening. Earlier this year, the companies extended for two years a separate collaboration in central nervous system disorders. (See BioWorld Today, Sept. 1, 1999, p. 1.)
NeuroSearch, of Glostrup, Denmark, received FDA approval to begin a Phase II trial with NS2330 in patients with Alzheimer's disease. The trial will test the tolerance and safety of the compound. NS2330 increases the activity of acetylcholine, dopamine and noradrenaline.
Schering Berlin Inc., of Montville, N.J., said 11.2 million common shares of Diatide Inc., of Londonderry, N.H., were tendered in connection with its subsidiary BXA Acquisition Co.'s offer to purchase all outstanding common shares of Diatide for $9.50 per share. The tendered shares represent about 94 percent of the outstanding common shares of Diatide. (See BioWorld Today, Sept. 21, 1999, p. 1.)
StressGen Biotechnologies Corp., of Victoria, British Columbia, started a Phase II trial of its lead product, HspE7, in immunocompetent male and female patients with anal dysplasia. The goal is to determine whether HspE7 is more effective than placebo in inducing complete regression of dysplastic cells in subjects with biopsy-confirmed high-grade anal dysplasia.
The Medicines Company, of Cambridge, Mass., said its bivalirudin product, Hirulog, received its first marketing clearance in New Zealand for use as an anticoagulant in patients undergoing coronary angioplasty. The company also changed the name of the product from Hirulog to Angiomax in the U.S. and New Zealand. The drug is under regulatory review for marketing approval in the U.S. and Europe.
Trimeris Inc., of Durham, N.C., and Hoffmann-La Roche Inc., of Nutley, N.J., said 16-week results of a Phase II trial of T-20, a peptide that inhibits HIV, showed that anti-T-20 antibodies do not appear to affect the levels of T-20 in the blood over time. They also do not affect the tolerability of chronic T-20 therapy, the companies said. The data were released at the Seventh European Conference on Clinical Aspects and Treatment of HIV Infection in Lisbon, Portugal.