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Executive Summary

BIOGEN's BETA INTERFERON NIH MULTIPLE SCLEROSIS TRIAL TO BE COMPLETED BY MID-1994 in 300 patients with relapsing-remitting and relapsing-progressive forms of the disease. The study's principal investigator Lawrence Jacobs, MD, University of Buffalo, said the Phase III, double-blind, placebo-controlled trial involves once-a- week intramuscular injections of 600 mil. IUs of Biogen's recombinant beta interferon product. [Editor's Note: The beta interferon is Biogen's, not Asta Medica's product as reported in "The Pink Sheet" (March 22, p. 5). Asta is the European marketing partner for the product.] The NIH- sponsored trial has been ongoing since June 1990 and is expected to be completed before May 1994. The primary endpoint of the study is effect on disability and the secondary endpoints are exacerbations and magnetic resonance imaging scans. Biogen's beta interferon, which is designated as an orphan product, is expressed in mammalian cells and is identical in amino acid sequence to naturally occurring beta interferon, Jacobs said. Chiron/Berlex' recombinant beta interferon Betaseron is the MS product most advanced in the development/approval process with an approval recommendation March 19 by FDA's Peripheral & Central Nervous System Drugs Advisory Committee for decreasing neurological exacerbations in patients with relapsing-remitting multiple sclerosis. A number of other companies have multiple sclerosis therapies in development. They include Lemmon, AutoImmune Inc., Elan, Athena, Centocor, Alkermes and Bristol-Myers Squibb. Lemmon is studying the designated orphan product Copolymer 1 (Cop 1), a polypeptide simulating myelin basic protein for treatment of exacerbating-remitting MS. Lemmon has enrolled 251 patients for a Phase III trial of a 20 mg daily injection of Cop 1 ("The Pink Sheet" Jan. 11, T&G-2). The company expects to complete the study in May 1994. Cop 1 will soon be distributed under a Treatment IND, which was approved based on results from a Phase II trial. Treatment centers are awaiting IRB approval before patients can be enrolled. Under the Treatment IND, Lemmon has approval for partial cost recovery of $20 per dose. Lemmon also has provisions to provide the product to patients who cannot afford it. AutoImmune Inc. is studying the orphan drug AI-100, an oral drug made from bovine myelin, for treatment of relapsing-remitting MS. This autumn, the Lexington, Mass.-based start-up expects to begin a two-year multicenter, controlled, Phase II/III trial of AI-100 in approximately 300 patients with early relapsing-remitting MS. The details of the trial design, such as the endpoints to be used, are under discussion by the study's protocol committee. The results from a one-year, double-blind, pilot study of AI-100 in 30 patients with early relapsing-remitting MS was published in the Feb. 26 issue of Science. The study showed that use of AI-100 results in six of 15 patients experiencing a major exacerbation over the one year, where 12 of 15 patients in the control group had a major exacerbation. Gender differences were noted in the study. None of the eight men in the treated group had an attack, but six of the seven women did. "All measures of disease activity were different between the males and females in the myelin-treated group, including use of steroids, disability status scale charges and physicians' impressions," the study states. Elan is investigating EL-970 (4-aminopyridine) for symptomatic relief of the effects of damage to the myelin sheath from MS. EL- 970 has orphan drug status. Elan said in July that it was "ready to start" Phase III trials in the U.S. and Europe of EL-970 ("The Pink Sheet" July 20, 1992, p. 10). Elan described EL-970 as having "calcium channel blocking effects" that result in "restoration of conduction" in demyelinating nerve fibers. EL-970 "produces rapid symptomatic relief of motor impairment, particularly in heat sensitive patients and particularly also in the chronic progressive stage of the illness, traditionally unresponsive to steroids," Elan said. Athena is studying tizanidine, an alpha 2 agonist, for treating spasticity associated with MS and with spinal cord injuries. A placebo-controlled, Phase III trial of tizanidine over 200 patients with mild to moderate MS will be completed in August, Athena said. A Phase III trial of 90 patients with spinal cord injuries has just started. Athena plans to file an NDA for the drug's use in treating spasticity associated with MS and spinal cord injuries by the end of 1993. The NDA will include a Phase III trial of tizanidine, that showed diminished spasticity in MS patients conducted by Sandoz in the U.K. Athena licenses the drug from Sandoz. Other products under study for treating MS are Centocor's Centara (IgG monoclonal antibody), Alkermes' adrenocorticotropic hormone (ACTH) and Bristol-Myers Squibb's deoxyspergualin (DSG).

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