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Genencor Scientists Discover Protein Sequences That May Trigger an Unwanted Immune Response to Multiple Sclerosis Drug

Data Illuminate Possibilities for a Second-Generation Drug with Reduced Antigenicity

January 21, 2004
Source: Genencor International, Inc

Scientists from Genencor International, Inc., along with collaborators from the University Campus Bio-Medico, Rome have identified an immunogenic region (called an "epitope") in the human interferon-beta protein sequence that activates human CD4+ helper T cells, the obligatory first step in the cascade that can lead to the production of neutralizing antibodies that inhibit the beneficial actions of interferon-beta.

Administration of recombinant interferon-beta is the standard of care treatment for Relapsing Remitting Multiple Sclerosis (RRMS) patients, and the production of neutralizing antibodies may reduce the effectiveness of this treatment in up to 30 percent of MS patients. The data, published in today's issue of Genes and Immunity, provide insights into how a second-generation molecule can be developed for more effective long-term therapy with reduced likelihood of inducing inhibitory antibodies.

In the manuscript, the scientists describe experiments using Genencor's proprietary I-mune(R) methods in which specific amino acid changes are made to the immunogenic epitope that result in a significantly lower activation of human CD4+ helper T cells. This information can guide modifications to the molecule that may reduce or eliminate the immunogenicity of the drug and thereby improve its effectiveness.

The researchers also determined the genetic signatures, known as HLA haplotypes, of those individuals in the population who are likely to produce an immune response to the CD4+ T cell epitope in interferon-beta. Curiously, these studies also revealed that individuals with this genetic predisposition to developing an immune response against interferon-beta also have a higher tendency to developing MS.  An intriguing possibility raised by this unexpected finding is that the HLA association between a response to interferon-beta and susceptibility for the development of RRMS might play a role in the etiology of the disease.

"The data reveal a potential pathway to a better second-generation drug for this disease," said Mark A. Goldsmith, M.D., Ph.D. Genencor's senior vice president, Health Care. "Broadly, the value of Genencor's I-mune technology may be to enable more effective therapies to reach patients by reducing immunogenicity problems that are often encountered in late stages of clinical trials of protein drugs."

About Genencor

Genencor International is a diversified biotechnology company that develops and delivers innovative products and services into the health care, agri-processing, industrial and consumer markets. Using an integrated set of technology platforms, Genencor's products deliver innovative and sustainable solutions to many of the problems of everyday life. Genencor traces its history to 1982 and has grown to become a leading biotechnology company, with over $350 million in year 2002 annual revenues. Genencor has principal offices in Palo Alto, California; Rochester, New York; and Leiden, the Netherlands.

This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. These include statements concerning plans, objectives, goals, strategies, future events or performance and all other statements which are other than statements of historical fact, including without limitation, statements containing words such as "believes," "anticipates," "expects," "estimates," "projects," "will," "may," "might" and words of a similar nature. Such statements involve risks and uncertainties that could cause actual results to differ materially from those projected. Some important factors that could cause actual results to differ include dependence on the efforts of third parties; dependence on new and uncertain technology and its uncertain application to new business ventures; regulatory actions or delays, or uncertainties related to product development, testing or manufacturing; ability to form and maintain strategic alliances; dependence on certain intellectual property rights of both Genencor and third parties; the competitive nature of Genencor's industry; and risks of obsolescence of certain technology. These and other risk factors are more fully discussed in Genencor's most recent Annual Report on Form 10-K filed with the United States Securities and Exchange Commission. The forward-looking statements contained in this release represent the judgment of Genencor as of the date of this report. Genencor disclaims, however, any intent or obligation to update any forward-looking statements.

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