What particularly caught our attention was that the vaccine in question, was "developed by Prof. Ruth Arnon and had been proved effective in animal models". Prof. Arnon's name had been previously associated with the development of Copaxone, a drug produced by Israel's Teva Pharmaceuticals. Copaxone properties effectively reduces the disease's remission period from 1.6 attacks per year to one in six years.
Copaxone subsequently became Israel's first home-developed drug. Its 2004 sales are expected to exceed $1.0 billion.
IHTIR visited with Prof. Ruth Arnon at her modest office in the Department of Immunology in the Wolfson Building of the Weizmann Institute of Science, Rehovot, Israel. The second generation Israeli studied biotechnology at the Hebrew University in Jerusalem. "At that time the subject of immunology was still unknown", she comments. As other young Israelis Ruth Arnon served two years in the army and was fortunate enough to work as a chemist.
Multiple Sclerosis (MS) is a disease whereby the body's immune system attacks and damages the myelin sheath surrounding nerves in the central nervous system, which is comprised of the brain and spinal cord. The myelin sheath serves to facilitate conduction of nerve signals along pathways. The destruction of the myelin causes degradation of nerve signals resulting in impaired functioning of systems that those nerves serve.
"When we started the research, we didn't
even dream of discovering a drug," she said.
Instead, the team was trying to understand
the mechanisms of MS. In MS, the myelin
sheath, a coating that insulates nerve cells,
is attacked by the body's immune system,
causing debilitating and painful symptoms,
including paralysis. Prof. Arnon's team synthesized a polymer that mimicked the myelin
sheath in hopes of inducing an MS-like disease in animals so that they could study it. But the experiment, insofar as fulfilling their initial goal, was a failure. The polymer did not induce disease.
"We almost gave up on the whole project," she recalled.
But, with the resourcefulness that characterizes her
research, they switched tack and investigated whether the synthesized polymers could act as decoys for the body's myelin sheaths, preventing attack by the immune system.
She teamed with Weizmann Institute scientist Prof. Michael Sela, which proved to be a fruitful scientific partnership.
Applying biochemical ideas the two concentrated on antigenic properties of proteins, using synthetic antigens comprising of polymers and copolymers of amino acids. Antigens are substances, which can stimulate an immune response. They reasoned that there are proteins that not only can cause an immune response but also provide clues as to specificity.
Their attention focused on MS and they developed the first animal models of the disease. Subsequently human models were developed.
The experimentation that followed uncovered that a group of synthetic copolymers showed high efficacy in suppressing EAE, an acute neurological autoimmune disease resembling MS. It was designated as Experimental Allergic Encephalomyelitis. The inhibition experiment was "overwhelming" as not one but several of the synthetic copolymers showed high efficacy in suppressing EAE. The most active in the series was Copolymer 1 (Cop 1). The research had proved promising and patent applications were filed and received for various countries during 1972-4.
Eli Hurwitz, the head of Teva Pharmaceuticals, a close friend of Michael Sela, expressed interest in the development. An agreement was made between Yeda Research and Development Foundation, the development arm for Weizmann Institute research, and Teva. The latter, in 1987, was granted rights for the commercial development of Cop 1. The road was far from smooth as Teva had yet to develop production methods to replace laboratory procedures. Analytical and validation procedures needed to be established for each production batch. Subsequent testing, including a two-year clinical trial in the United States proved Cop 1 to be effective. Teva's road that called for the preparation of the material for submission to the regulatory agencies still lay ahead. "But for me as a scientists, together with my colleagues Dvora Teitelbaum and Michael Sela, the results were pure elation. Research, which we had conceived, designed and carried through, had matured into a budding pharmaceutical product with potential to alleviate the suffering of many people. I had seen the unbearable despair of young women sufferers. The feeling that one can alleviate this suffering brings fantastic satisfaction," states Prof. Arnon.
Prof. Arnon research is pure science and not product oriented. "From good research useful products will ensue," she comments.
The Business Plan described a startup company named BiondVax. Founded less than a year ago, the company is developing "an intranasal flu vaccine that is to provide an effective multi-season strain protection against the majority of existing and future influenza strains". Most of us, at some point in our lives, are vaccinated. However, it is always for a specific influenza.