I assume that you have seen the press releases concerning the National Cancer Institute. In case you haven't, it follows:
NCI And Genzyme Transgenics Collaborate To Expand Cancer Vaccine
Clinical Trials
FRAMINGHAM, Mass., May 15 /PRNewswire/ -- Genzyme Transgenics Corp. (Nasdaq:GZTC) announced today that it
has signed a letter of intent to expand clinical trials and gain development rights to idiotypic cancer vaccines being developed
by the National Cancer Institute (NCI).
Idiotypic vaccines contain proteins derived from a patient's own cancerous tumors.
Genzyme Transgenics has been producing idiotypic vaccines for NCI for three years. The letter of intent is the next step in
expanding the collaboration and allows the two parties to begin joint research before signing a Cooperative Research and
Development Agreement (CRADA). The parties expect to sign a 5-year CRADA this summer.
Under the terms of the CRADA, Genzyme Transgenics will optimize and expand the production process for the vaccines. In
1997, the company plans to sponsor an expansion of the vaccine clinical trials in patients with B-cell lymphoma. NCI is
currently conducting phase I clinical trials with the vaccine and expects to begin phase II trials in 1997. Genzyme
Transgenics will manage the regulatory process.
In addition, Genzyme Transgenics will have the option to acquire exclusive rights to proprietary technology developed by the
collaboration. If clinical trials are successful and the vaccine is approved for use, the company will produce the vaccines
commercially.
"This program builds on Genzyme Transgenics' existing strengths in drug production and development and expands our
participation into pivotal clinical trials," said James A. Geraghty, president and chief executive officer of Genzyme
Transgenics. "Idiotypic vaccine production has the potential to become a third leg of our business strategy, complementing
our transgenic production and preclinical development businesses."
An Innovative Cancer Therapy
Once a cancer patient has completed chemotherapy, the idiotypic vaccine is injected into the patient to stimulate the patient's
immune system to destroy any remaining cancer cells. In initial clinical studies by NCI, published in the New England
Journal of Medicine, four of nine B-cell lymphoma patients treated with the vaccine have been disease-free for five years
following treatment. In a separate study, published in Lancet, one multiple myeloma patient has been in remission for three
years after being treated.
B-cell lymphoma affects an estimated 40,000 patients in the United States per year. The disease is characterized by tumors
occurring in the lymph nodes. The cancer has a 70-90 percent mortality rate. Patients typically relapse within three and a half
years after receiving chemotherapy.
The vaccines operate under the principal that even if a patient is in remission after chemotherapy, some cancer cells remain.
These cells are hidden from a patient's immune system, leaving the body defenseless against them. Idiotypic vaccines are
made up of a conjugation of immunoglobulin, derived from the patient's tumor cells, and an additional protein. Once
injected, the vaccine alerts the patient's immune system to the presence of the patient's unique cancer cells and instructs it to
destroy them.
Market Opportunity
Genzyme Transgenics and NCI will focus the majority of their initial efforts on B-cell lymphoma. The collaboration may be
extended to include vaccines for other cancers, such as multiple myeloma.
This work grows out of the antibody production business that is part of Genzyme Transgenics' testing services division. The
company's testing services group provides preclinical and other regulatory testing services to pharmaceutical, biotechnology,
and chemical companies. Genzyme Transgenics is also engaged in the application of transgenic technology to enable the
development and production of recombinant proteins and monoclonal antibodies for medical uses. Genzyme Corp.'s General
Division (Nasdaq:GENZ) owns approximately 48 percent of the outstanding stock of Genzyme Transgenics.
This press release contains forward-looking information, including statements about the signing of a CRADA with NCI, the
potential market size for idiotypic vaccines, and potential commercialization of Genzyme Transgenics' products. Actual
results may differ materially from these projections due to a number of factors, including the content and timing of decisions
made by NCI and the U.S. Food and Drug Administration, the company's ability to complete preclinical and clinical
development successfully and obtain timely proprietary rights protection of its products, and the accuracy of information
about competitors, market sizes, and the price-sensitivity of customers. Investors are advised to consult the company's Form
10-K for a complete discussion of factors affecting future operating results.
Genzyme's releases are on the World Wide Web at prnewswire.com and PR Newswire's fax-on-demand service
at 1-800-758-5804, ext. 104284.
REFERENCES:
Kwak LW, Taub DD, Duffey PL, Bensinger WI, Bryant EM, Reynolds CW, Longo DL. "Transfer of Myeloma
Idiotype-Specific Immunity From an Actively Immunised Marrow Donor." Lancet, 1995;345:1016-1020.
Kwak LW, Campbell MJ, Czerwinski DK, Hart S, Miller RA, Levy R. "Induction of Immune Responses in Patients with
B-Cell Lymphoma Against the Surface-Immunoglobulin Idiotype Expressed by Their Tumors." New England Journal of
Medicine, October 22, 1992;327:1207-1215.
/CONTACT: Cheryl Greenhouse of Genzyme, 617-252-7570/
12:53 EDT |
