Genzyme Molecular Oncology Announces Initiation of Kidney Cancer and Melanoma Cancer Vaccine Clinical
Trials
Trials for Promising Fusion Cell Technology Expand
FRAMINGHAM, Mass., Oct. 3 /PRNewswire/ -- Genzyme Molecular Oncology
(Nasdaq: GZMO) announced today the initiation of two phase 1-2 clinical trials
-- one in melanoma and one in kidney cancer -- sponsored by investigators
Donald Kufe, M.D., professor of medicine, the Dana-Farber Cancer Institute and
Harvard Medical School, David Avigan, M.D., director, bone marrow transplant
program at the Beth Israel Deaconess Medical Center and Harvard Medical
School, and Jianlin Gong, M.D., instructor of medicine, the Dana-Farber Cancer
Institute and Harvard Medical School.
Both trials will utilize a novel technology called dendritic/cancer cell
fusion, developed by Drs. Kufe, Avigan, and Gong. Genzyme Molecular Oncology
has exclusively licensed the fusion technology from Dana-Farber and is
providing funding for both trials through Dana-Farber/Partners CancerCare
(DF/PCC).
The dendritic/cancer cell fusion technology combines a patient's dendritic
cells-powerful immune stimulators-with their inactivated tumor cells in a
chemical fusion procedure. The fused cells are injected back into the patient
in order to stimulate an immune response against the patient's cancer.
Approximately 20 patients with advanced metastatic melanoma will be
enrolled and treated in the melanoma study and approximately 20 patients who
have been diagnosed with advanced stage renal cell carcinoma (kidney cancer)
will be enrolled and treated in the kidney cancer study. Both trials will
take place in Boston. Beth Israel Deaconess is now enrolling study
participants. In the coming months, DF/PCC institutions -- Dana-Farber Cancer
Institute, Brigham & Women's Hospital, and Massachusetts General Hospital --
will also begin treating patients enrolled in these trials. People who have
advanced stage melanoma or kidney cancer and who are interested in
participating in the trials should contact Carolyn Stone in Dr. Avigan's
office, 617-667-3029, to inquire about entry requirements for either trial.
"Cell fusion technology eliminates the need to identify specific antigens
for these vaccines because it incorporates the entire menu of antigens found
on the original tumor to provide targets to the immune system," said Dr. Kufe.
"This novel process allows us to develop a potentially life-saving cancer
treatment that could be used in a broad range of cancers," said Dr. Avigan.
Mark Goldberg, senior vice president medical affairs, Genzyme, said, "We
are very excited about starting the new fusion cell trials and proud of our
growing clinical program in immunotherapy. We now have three ongoing trials
utilizing this promising technology -- one each in breast cancer, melanoma,
and kidney cancer -- in addition to our two melanoma gene therapy cancer
vaccine trials currently underway. Fusion technology complements our antigen
specific vaccines and allows us to address cancers where antigens are not yet
known or well understood."
Genzyme Molecular Oncology is funding an ongoing investigator sponsored
phase 1-2 breast cancer vaccine trial utilizing dendritic/cancer cell fusion
at Beth Israel Deaconess Medical Center. Drs. Avigan, Kufe, and Gong are also
the principal investigators for this trial. Up to eighteen patients with late
stage metastatic breast cancer will be enrolled and treated in this study.
Patients with late stage breast cancer who are interested in this trial are
encouraged to call Dr. Avigan's office at 617-667-9920 and inquire about entry
requirements.
Data from preclinical studies utilizing dendritic/cancer cell fusion
technology were published in the May 1998 issue of the Proceedings of the
National Academy of Sciences (volume 95, pp. 6279-6283) and in Nature
Medicine (volume 3, pp. 558-561) in 1997.
Additional Dendritic/Cancer Cell Fusion Trials Planned
In March 2000, data from a German clinical study of a cancer vaccine to
treat metastatic kidney cancer based on a technology similar to Drs. Kufe,
Avigan, and Gong's dendritic/cancer cell fusion were published in Nature
Medicine (volume 6, number 3, pp. 332-336). The vaccine combined a patient's
tumor cells with dendritic cells obtained from another source in an
electrofusion process. The clinical response rate reported in the study was
significantly higher than has been achieved with standard therapy in that
patient population, and included several patients whose tumors were completely
eliminated in response to the vaccine.
In collaboration with Drs. Kufe and Avigan, Genzyme Molecular Oncology
plans to initiate two more phase 1-2 fusion cell cancer vaccine trials-one in
melanoma and one in kidney cancer-using a fusion vaccine produced with a
process similar to the electrofusion process used in the German study. These
trials are expected to provide Genzyme Molecular Oncology with patient safety
and efficacy data as well as a comparison of the two processes-chemical fusion
vs. electrofusion-for producing cell fusion vaccines.
Antigens are protein fragments that are present in cancer cells and
function as markers to prompt an immune response to those cells. Dendritic
cells are believed to be the most effective antigen presenting cells in the
human immune system. Once administered, a cancer vaccine stimulates the
immune system to seek out and destroy cancer cells that display the antigens
included in the vaccine. Because cancer vaccines elicit a systemic immune
response, they have the potential to destroy cancer wherever it is found in
the body.
The American Cancer Society estimates that approximately 48,000 people in
the United States will be diagnosed this year with melanoma. They also
estimate that approximately 7,700 people in the United States will die from
melanoma this year. In addition, less than five percent of patients with
metastatic melanoma will live five years or more. The lifetime incidence of
melanoma has increased from one in 500 to one in 105 since 1935.
Also according to the American Cancer Society, approximately 12,000 people
will die of kidney cancer and approximately 31,000 people will be diagnosed
with kidney cancer in 2000. The incidence rate of kidney cancer has increased
1.6 percent since 1995.
Genzyme Molecular Oncology is developing a new generation of cancer
products focusing on cancer vaccines and angiogenesis inhibitors. It is
shaping these new therapies through the integration of its genomics, gene and
cell therapy, small-molecule drug discovery, and protein therapeutic
capabilities.
A division of Genzyme Corporation, Genzyme Molecular Oncology has its own
common stock intended to reflect its economic value and track its performance.
This press release contains forward-looking statements, including those
regarding the number of patients to be enrolled in the melanoma and kidney
cancer trials, the ability of the dendritic cell fusion technology to be used
in a broad range of cancers, plans for initiating additional cancer vaccine
trials, the data the trials are expected to provide, and the incidence and
mortality rates for melanoma and kidney cancer in the United States. Actual
results may differ materially as a result of a number of factors, including
the ability to enroll patients in the clinical trials, decisions made by
regulatory authorities, the results of the analysis of trial data, and the
accuracy of information obtained on the melanoma and kidney cancer patient
populations. Further, because GZMO stock is a series of common stock of
Genzyme Corporation, GZMO shareholders are subject to all of the risks and
uncertainties described in reports filed by Genzyme with the SEC under the
Securities Exchange Act of 1934, as amended, including without limitation
Exhibit 99.2 to Genzyme's 1999 Annual Report on Form 10-K.
Genzyme's releases are on the World Wide Web at genzyme.com.
They are also available from Genzyme's fax-on-demand service at 1-800-436-1443
within the United States or 1-201-521-1080 outside the United States.
SOURCE Genzyme Molecular Oncology |
