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Cop 1 (Copaxone®): The Story of a Drug

01.05.1997

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Cop 1 (Copaxone®): now FDA approved


In December 1996, following nearly three decades of research, the multiple sclerosis drug copolymer-1 (Copaxone®) became one of the first Israeli medications to receive the approval of the U.S. Food and Drug Administration. Prof. Ruth Arnon, the Institute's Vice President for International Scientific Relations, who, along with Weizmann Institute colleagues Prof. Michael Sela and Dr. Dvora Teitelbaum, originally synthesized and developed copolymer-1, recently documented the drug's dramatic history in the scientific journal Immunology Letters. Interface presents a chronology of the drug's development, along with excerpts from Prof. Arnon's personal account.

1968. Profs. Ruth Arnon and Michael Sela and Dr. Dvora Teitelbaum synthesize several molecules, known as copolymers, that mimic a component of myelin, the protective coating of nerves. Because this component is believed to trigger multiple sclerosis, the scientists hope that their molecules can help create an animal model for the study of MS. However, the copolymers fail to produce an MS-like disease in laboratory animals.

"Disappointment. Was our hypothesis wrong? Did the synthetic approach fail us in this case? Should we give up?"

1971. Despite the initial failure, the scientists persist in their study of the molecules' properties and stumble on a surprising finding: rather than causing MS symptoms, the copolymers actually block an MS-like disease.
 
"The results ... were overwhelming -- not one, but several of the synthetic copolymers showed high efficacy in suppressing the MS-like disease in animals! Already at that early stage, we realized that this might eventually lead to a therapeutic agent."

1972-74. Patent applications for copolymer-1, dubbed Cop 1, are submitted in Israel and several other countries. Meanwhile, the scientists show that while suppressing the symptoms of the MS-like animal disease, called EAE, Cop 1 does not depress the entire immune system indiscriminately. They also show that it works in several species of laboratory animals.
 
"The next logical step was to investigate whether Cop 1 was of any benefit to MS patients."
 
1977. The first clinical trial is conducted at the Hadassah-Hebrew University Medical Center in Jerusalem, in collaboration with Dr. Oded Abramsky, a former Ph.D. student of Arnon's, who at the time was Head of Neurology and then served as Dean of the Medical School at Hadassah. Four MS patients in the terminal stages of the disease receive Cop 1 and show no major side effects.
 
"This information paves the way for further clinical trials in less severely affected patients."
 
1978-81. The Weizmann Institute scientists embark on the formidable task of convincing clinicians to perform larger-scale clinical trials. Two physicians respond to their call: Dr. Helmut J. Bauer of the University of Gottingen, Germany, and Dr. Murray B. Bornstein of the Albert Einstein College of Medicine in New York.
 
"I recall this time as the 'peddling period': I participated in almost any conference, large or small, that dealt with MS. I presented our experimental data ... and talked to anyone who was prepared to listen."
 
1980-85. Preliminary results both in Gottingen and in New York are encouraging, and Bornstein decided to extend the evaluation of Cop 1 to a rigorous double-blind study. Fifty patients are recruited for the study, a complicated process involving the interviewing of several hundred people.
 
"This trial lasted more than three years, and in the beginning the suspense was nervewracking. I used to call Dr. Bornstein at least once a month, to find out how it was going."
 
1987. The results of the double-blind trial are published in the New England Journal of Medicine. Cop 1 is found to reduce the number of attacks in patients with relapsing-remitting MS while having minimal side effects.
 
"The results of the pilot trial justified all the efforts of everyone involved in it."
 
1987. Cop 1 is licensed to Teva Pharmaceutical Industries Ltd., Israel. Commercial development of the drug is launched.
 
"A new era has begun."
 
1987. Meanwhile, the scientists continue to pursue research aimed at clarifying Cop 1's mechanism of action.
 
"Our studies provided a plausible theoretical basis for the drug's therapeutic effect."
 
1994. Weizmann Institute scientists are invited to the presentation of the results of an extensive trial conducted by Teva at 11 medical centers throughout the United States.
 
"It is difficult to describe in words the wonderful sensation of satisfaction and accomplishment which arises from the realization that our research has brought relief to somebody, be it only to a single individual."
 
June 14, 1995. The file on Cop 1 is submitted by Teva to the U.S. Food and Drug Administration.
 
"For Prof. Michael Sela and myself, together with our colleague Dr. Dvora Teitelbaum, this was a high point after over 27 years of persistent research effort, perseverance and tenacity of purpose... The promise is there and the hopes for success, and the desire to be able to help alleviate the suffering of MS patients worldwide, many of whom I learned to know, love and respect during our long years of research."
 
December 23, 1996. Copaxone® is approved by the FDA for use in patients with MS.

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