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GUILFORD PHARMACEUTICALS' GLIADEL NDA IS IN PREPARATION

Executive Summary

GUILFORD PHARMACEUTICALS' GLIADEL NDA IS IN PREPARATION with Phase III clinicals trials of the biodegradable implant for primary brain cancer completed. Gliadel is the lead product for Guilford, a new venture of Scios-Nova established in Baltimore to discover, develop and commercialize therapies and diagnostics for neurological, neurosurgical and psychiatric diseases. Mountain View, Calif.-based Scios-Nova announced the establishment of Guilford Oct. 4. No timetable for the NDA filing has been set. Gliadel is a surgically implantable polymer wafer impregnated with BCNU (carinustine) that is designed to deliver the chemotherapeutic agent on a timed-release basis. The wafer has been under development by Nova since before its merger with Scios in 1992. Nova licensed the Bioerodible Polymer Implant (Biodel) delivery system from MIT in 1986. Phase III trials for the primary brain cancer indication began in February 1989 and were completed in the summer of 1992 in approximately 220 patients. Scios-Nova said Gliadel has demonstrated prolonged survival of primary brain cancer patients in clinical trials. The company estimates there are 17,500 cases of primary brain cancer in the U.S. annually with no effective treatment currently available. Gliadel has an orphan designation. Next in Guilford's pipeline is RTI-55 for the diagnosis and monitoring of Parkinson's disease. RTI-55, a dopamine imaging agent for use in conjunction with SPECT scanning, is licensed from the Research Triangle Institute. The agent is in Phase II under an investigator-sponsor IND. Guilford has a competitive glutamate receptor antagonist, NPC- 17742, in preclinicals for epilepsy, stroke and trauma. The excitatory amino acid receptor antagonist is being developed in oral form for epilepsy and I.V. form for stroke. Scios-Nova said "preclinical studies in several animal models indicate the potential of NPC-17742 as a treatment for status epilepticus and serial seizures. NPC-17742 has also been shown in animal models to prevent tolerance to and physical dependence on morphine and other opiates, which may facilitate the use of morphine to treat pain in cancer patients." The compound was previously in development by Nova. The Scios-Nova venture's focus on new drug development centers on inhibitors of nitric oxide, which is thought responsible for the brain damage associated with stroke. Guilford is licensing the NO synthase inhibitor technology from Johns Hopkins University School of Medicine. Solomon Snyder, MD, Johns Hopkins, chairs Guilford's science advisory board. His work on NO inhibition is the basis for the company's research effort. Funded initially with $2.5 mil. from Scios-Nova, Guilford was formed jointly by the company, Snyder and Craig Smith, MD, who is president and CEO. Smith was formerly senior VP-business and market development at Centocor. He joined Centocor in 1988 as VP- clinical research from Johns Hopkins, where he had been on the faculty for 13 years. Nova was previously headquartered in Baltimore and chemistry and computer modeling lab facilities are still located there. Scios-Nova's biotechnology labs are in Mountain View.
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