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发表于 2004-2-4 03:17
Genencor International (GCOR) To Start Phase I Study For Therapeutic Vaccine For Hepatitis B
PALO ALTO, Calif. and SAN DIEGO, Feb. 2 /PRNewswire-FirstCall/ -- Genencor International, Inc. today announced it will begin Phase I safety and immunogenicity testing for its DNA-based therapeutic vaccine to treat hepatitis B. Trials are scheduled to begin later this month under an Investigational New Drug Application (IND) filed by Genencor in December. Epimmune Inc. collaborated on the design and preclinical development of the vaccine under its collaboration agreement with Genencor and will receive a milestone payment as a result of the IND filing.
"This first IND for Genencor represents important progress in our health care business," said Mark A. Goldsmith, M.D., Ph.D. Genencor's senior vice president, Health Care. "In less than 3 years, we've shown that we can leverage Genencor's core technology to envision and build an innovative immunotherapeutic product candidate for treating chronic hepatitis B infection, to prepare and qualify this candidate for advancement into the next stage of development, and to design a quality plan for human studies. Genencor looks forward to the launch this month of a Phase I study to establish safety and immunogenicity profiles for this product candidate."
"Hepatitis B is an enormous world wide health problem without a solution," said Frank Chisari, M.D., Professor and Head of Experimental Pathology, and Director of the General Clinical Research Center at the Scripps Research Institute and a leading investigator of hepatitis viruses. "As a member of both Genencor's and Epimmune's Vaccine Scientific Advisory Boards, I have followed the progress of this program and contributed to it scientifically. I am thrilled that this well-designed vaccine candidate is moving into clinical development for evaluation in people."
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 concerning the commencement of Phase I safety and immunogenicity testing for Genencor's DNA-based therapeutic vaccine to treat hepatitis B. 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. Drug and vaccine research and development involves a high degree of risk. 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; regulatory actions or delays, or uncertainties related to product development, testing or manufacturing; dependence on certain intellectual property rights of both Genencor and third parties including Epimmune, Inc.; the competitive nature of Genencor's industry; risks of obsolescence of certain technology; and the possibility that clinical testing reveals unsuccessful results or undesirable side effects. These and other risk factors are more fully discussed in Genencor's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q 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 press release. Genencor disclaims, however, any intent or obligation to update any forward-looking statements.
Genencor International, Inc.
CONTACT: investors, Tom Rathjen +1-650-846-7500, or media, ValerieTucker, +1-650-846-7571, both of Genencor International, Inc.
Web site: http://www.genencor.com/
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