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Biotech / Medical : Neotherapuetics possibly has a breakthrough drug - NEOT -- Ignore unavailable to you. Want to Upgrade?

To: Nikole Wollerstein who wrote (180)	8/22/2001 9:52:35 AM
From: tuck	Respond to of 204

>>IRVINE, Calif., Aug. 22 /PRNewswire/ -- NeoTherapeutics, Inc. (Nasdaq: NEOT; NEOTW) announced today that it has expanded its Neotrofin(TM) spinal cord injury trial to include Thomas Jefferson University Hospital (Pennsylvania) and Craig Rehabilitation Center (Denver). Seven patients are currently receiving Neotrofin: five at Rancho Los Amigos Hospital in Los Angeles and one each at Craig Rehabilitation Hospital and Thomas Jefferson University Hospital. The four currently active centers are expected to enroll a total of 30 to 40 patients for 12 weeks of dosing. Craig Hospital in Denver has long been recognized as a premier national 'Center of Excellence' in the specialty of rehabilitation and research for patients with spinal cord injury and acquired brain injury. Craig Hospital has treated more than 23,000 patients since 1956 -- more than any other single facility in the world. The principal investigator at this site is Daniel Lammertse, M.D. Thomas Jefferson University Hospital, in affiliation with the Magee Rehabilitation Hospital, is designated as one of the nation's 18 regional Research Spinal Cord Injury Centers and a Center of Excellence in the treatment of spinal cord injury. Located just outside Philadelphia, the center has treated more than 2,500 patients. The principal investigator at this site is Anthony Burns, M.D. ``We are pleased to have four of the leading centers for spinal cord injury participating in this clinical study,'' said F. Jacob Huff, M.D., Vice President, Medical Affairs at NeoTherapeutics. ``Craig Rehabilitation Hospital, Rancho Los Amigos and Thomas Jefferson University are three of the eighteen regional Centers of Excellence for treatment of spinal cord injury in the United States, and Gaylord Hospital in Wallingford, Connecticut, has a long tradition of providing high quality patient rehabilitation.'' ``The expansion of our Neotrofin clinical trials into spinal cord injury and Parkinson's disease reflects the broad range of activity the drug has demonstrated in pre-clinical neuro-degenerative models,'' stated Rajesh C. Shrotriya, M.D., President and Chief Operating Officer of NeoTherapeutics. ``We have compelling pre-clinical data showing neuro-protection and nerve regeneration potential in the brain, the spine and the peripheral nervous system. Our clinical trial program for Neotrofin continues to expand to reflect the growing number of potential applications for our lead drug.'' In this 12-week open-label study, patients with sub-acute, complete spinal cord injury will receive Neotrofin for 12 weeks, and will be evaluated at regular intervals. In addition to extensive assessments for tolerance and safety, the Standard Neurological Classification of Spinal Cord Injury (SNCSCI) - manual motor exam score will be used as the primary evidence of preliminary efficacy. Secondary efficacy measures include the American Spinal Injury Association (ASIA) impairment scale (ASIA-IS), Functional Independence Measure (FIM) and SNCSCI-sensory exam. The Christopher Reeve Paralysis Foundation estimates that there are approximately 250,000 spinal cord injured individuals (SCI) living in the United States. Sixty percent are first affected between 16 and 30 years of age, and ninety percent of SCI individuals survive and have near normal life spans. There are approximately 10,000 new spinal cord injury cases per year. Initial hospitalization lasts 100 days, on average, and lifetime costs for individuals with SCI average $600,000. Current clinical practice recommends the early use of high doses of methylprednisolone for 24 to 48 hours after injury, but the effects of this treatment are limited, and there are no specific FDA-approved treatments for spinal cord injury.<< snip Cheers, Tuck