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Cell Genesys Reports Additional Successful Preclinical Studies of Hemophilia Gene Therapy
MONDAY, JUNE 05, 2000 7:30 AM
- PRNewswire
FOSTER CITY, Calif., Jun 5, 2000 /PRNewswire via COMTEX/ -- Cell Genesys (Nasdaq:CEGE) and collaborators from the National Institutes of Health
(NIH) today announced that in non-human primate models of hemophilia B, therapeutic levels of factor IX, a blood clotting protein, were restored
following a single administration of hemophilia gene therapy. The therapy, which was delivered to the liver using the company's proprietary
adeno-associated viral (AAV) gene delivery system, was shown to be safe and well-tolerated in a variety of clinical assays. Importantly, a potentially
harmful immune response against the gene therapy, as measured by the development of anti-factor IX antibodies, was not observed. These data were
presented at the American Society for Gene Therapy Conference by Brian A. Donahue, Ph.D. and colleagues at Cell Genesys in collaboration with
Richard A. Morgan, Ph.D., Jay N. Lozier, M.D., Ph.D. and colleagues at the NIH.
"These encouraging results have set the stage for our human clinical trials in hemophilia gene therapy which we expect to initiate in 2001. Moreover,
Cell Genesys' large scale manufacturing capability for AAV vectors will facilitate the clinical development and product commercialization of this and other
AAV gene therapies," stated Joseph J. Vallner, Ph.D., executive vice president and chief operating officer at Cell Genesys. "In our hemophilia gene
therapy studies, we have emphasized the administration of therapy directly to the liver in order to achieve optimal therapeutic levels of blood clotting
factors since these proteins are naturally produced in the liver. In addition, we believe that gene therapy to the liver could reduce the possibility of
forming harmful antibodies directed against the clotting factor since biochemically correct production of the protein is more likely."
In prior preclinical studies in Cell Genesys' hemophilia program, a significant reduction in bleeding episodes in a canine model of hemophilia B was
achieved with a single administration of factor IX gene therapy. Additionally, the treated animals produced the factor IX protein for more than two years
following the single injection. These studies utilized Cell Genesys' AAV vector system which inserts the therapeutic gene into the DNA of the patient's
cells, thereby allowing long term therapeutic benefit. A single administration of gene therapy could therefore potentially reduce the need for repetitive
treatment regimens in hemophilia patients and decrease the serious and disabling complications arising from spontaneous bleeding episodes.
Cell Genesys is pursuing gene therapies for both hemophilia A and hemophilia B -- genetic deficiencies in factor VIII and factor IX clotting factor genes,
respectively. Cell Genesys has four different gene delivery systems and is using this technology "toolbox" to capture multiple product opportunities. The
company's proprietary vector technologies include AAV, lentiviral, adenoviral and retroviral vectors engineered to provide safe and efficient therapeutic
gene expression. The choice of vector depends upon such considerations as the disease indication, production efficiencies and the size of the gene.
For example, in Cell Genesys' preclinical program for hemophilia B, an AAV vector system is employed since the factor IX gene is small enough to fit in
this vector. For hemophilia A, the company has the option of employing an AAV vector system if a truncated form of the factor VIII gene can be
successfully applied or a lentiviral vector system if the full length gene is required for optimal production of the deficient clotting factor protein.
Successful delivery of the clotting factor genes is expected to result in production of the clotting factor proteins, representing a potential new approach
to the treatment for hemophilia patients.
Cell Genesys currently has one of the largest patent portfolios in the gene therapy field including more than 230 issued or granted patents and over
320 pending patent applications. The portfolio includes issued or granted patents for multiple gene delivery systems, specific therapeutic genes and
gene therapy applications and multiple genetically modified cell types used in gene therapy independent of the gene delivery system or therapeutic
gene. For example, the portfolio currently contains over 90 filings pertaining to the two types of gene delivery systems -- lentiviral and AAV -- with
potential applicability to the treatment of hemophilia and other genetic deficiency diseases.
Cell Genesys is focused on the development and commercialization of cancer vaccines and gene therapies to treat major, life-threatening diseases.
The company is conducting two multicenter Phase II human clinical trials for its GVAX(R) cancer vaccine in prostate cancer, a multicenter Phase I/II trial
of GVAX(R) vaccine in lung cancer and expects to initiate additional GVAX(R) vaccine trials in pancreatic cancer, myeloma and leukemia during the
coming year. Preclinical stage programs include gene therapy for hemophilia, cancer, cardiovascular disorders and Parkinson's disease. Cell Genesys'
assets outside gene therapy include its approximately 12 percent ownership of Abgenix, Inc. and the company's licensing program in gene activation
technology. For additional information, please visit the company's web site at www.cellgenesys.com .
Statements made herein, other than statements of historical fact, including statements about the company's progress and results of hemophilia and
other preclinical studies, clinical trials, marketability of potential products and nature of product pipelines, corporate partnerships, licenses and
intellectual property including that pertaining to AAV, lentiviral and other gene delivery technology and the company's patent portfolio are
forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made,
including risks associated with the success of research and development programs, results achieved in future preclinical studies and clinical trials, the
regulatory approval process, competitive technologies and products, the scope and validity of patents, corporate partnerships and additional
financings. For information about these and other risks which may affect Cell Genesys, please see the company's Annual Report on Form 10-K dated
March 30, 2000 as well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed from time to time with the Securities and Exchange
Commission.
CONTACT: Jennifer Cook Williams, Manager, Corporate Communications of Cell Genesys, Inc., 650-425-4542.
SOURCE Cell Genesys, Inc.
CONTACT: Jennifer Cook Williams, Manager, Corporate Communications of
Cell Genesys, Inc., 650-425-4542
/Company News On-Call: www.prnewswire.com/comp/134113.html or fax,
800-758-5804, ext. 134113
URL: www.cellgenesys.com
www.prnewswire.com
(C) 2000 PR Newswire. All rights reserved.
KEYWORD: California
INDUSTRY KEYWORD: MTC
HEA
SUBJECT CODE: OTC
ABGX
112 5/8
+7 5/16
RELATED SYMBOLS
CEGE
24 1/2
-7/16
Enter Symbol:
Enter Keyword:
Article for Abgenix Inc (NASDAQ NM:ABGX)
7:30 AM
most recent headlines
next article:
Cell Genesys Reports Additional Successful Preclinical Studies of Hemophilia Gene Therapy
MONDAY, JUNE 05, 2000 7:30 AM
- PRNewswire
FOSTER CITY, Calif., Jun 5, 2000 /PRNewswire via COMTEX/ -- Cell Genesys (Nasdaq:CEGE) and collaborators from the National Institutes of Health
(NIH) today announced that in non-human primate models of hemophilia B, therapeutic levels of factor IX, a blood clotting protein, were restored
following a single administration of hemophilia gene therapy. The therapy, which was delivered to the liver using the company's proprietary
adeno-associated viral (AAV) gene delivery system, was shown to be safe and well-tolerated in a variety of clinical assays. Importantly, a potentially
harmful immune response against the gene therapy, as measured by the development of anti-factor IX antibodies, was not observed. These data were
presented at the American Society for Gene Therapy Conference by Brian A. Donahue, Ph.D. and colleagues at Cell Genesys in collaboration with
Richard A. Morgan, Ph.D., Jay N. Lozier, M.D., Ph.D. and colleagues at the NIH.
"These encouraging results have set the stage for our human clinical trials in hemophilia gene therapy which we expect to initiate in 2001. Moreover,
Cell Genesys' large scale manufacturing capability for AAV vectors will facilitate the clinical development and product commercialization of this and other
AAV gene therapies," stated Joseph J. Vallner, Ph.D., executive vice president and chief operating officer at Cell Genesys. "In our hemophilia gene
therapy studies, we have emphasized the administration of therapy directly to the liver in order to achieve optimal therapeutic levels of blood clotting
factors since these proteins are naturally produced in the liver. In addition, we believe that gene therapy to the liver could reduce the possibility of
forming harmful antibodies directed against the clotting factor since biochemically correct production of the protein is more likely."
In prior preclinical studies in Cell Genesys' hemophilia program, a significant reduction in bleeding episodes in a canine model of hemophilia B was
achieved with a single administration of factor IX gene therapy. Additionally, the treated animals produced the factor IX protein for more than two years
following the single injection. These studies utilized Cell Genesys' AAV vector system which inserts the therapeutic gene into the DNA of the patient's
cells, thereby allowing long term therapeutic benefit. A single administration of gene therapy could therefore potentially reduce the need for repetitive
treatment regimens in hemophilia patients and decrease the serious and disabling complications arising from spontaneous bleeding episodes.
Cell Genesys is pursuing gene therapies for both hemophilia A and hemophilia B -- genetic deficiencies in factor VIII and factor IX clotting factor genes,
respectively. Cell Genesys has four different gene delivery systems and is using this technology "toolbox" to capture multiple product opportunities. The
company's proprietary vector technologies include AAV, lentiviral, adenoviral and retroviral vectors engineered to provide safe and efficient therapeutic
gene expression. The choice of vector depends upon such considerations as the disease indication, production efficiencies and the size of the gene.
For example, in Cell Genesys' preclinical program for hemophilia B, an AAV vector system is employed since the factor IX gene is small enough to fit in
this vector. For hemophilia A, the company has the option of employing an AAV vector system if a truncated form of the factor VIII gene can be
successfully applied or a lentiviral vector system if the full length gene is required for optimal production of the deficient clotting factor protein.
Successful delivery of the clotting factor genes is expected to result in production of the clotting factor proteins, representing a potential new approach
to the treatment for hemophilia patients.
Cell Genesys currently has one of the largest patent portfolios in the gene therapy field including more than 230 issued or granted patents and over
320 pending patent applications. The portfolio includes issued or granted patents for multiple gene delivery systems, specific therapeutic genes and
gene therapy applications and multiple genetically modified cell types used in gene therapy independent of the gene delivery system or therapeutic
gene. For example, the portfolio currently contains over 90 filings pertaining to the two types of gene delivery systems -- lentiviral and AAV -- with
potential applicability to the treatment of hemophilia and other genetic deficiency diseases.
Cell Genesys is focused on the development and commercialization of cancer vaccines and gene therapies to treat major, life-threatening diseases.
The company is conducting two multicenter Phase II human clinical trials for its GVAX(R) cancer vaccine in prostate cancer, a multicenter Phase I/II trial
of GVAX(R) vaccine in lung cancer and expects to initiate additional GVAX(R) vaccine trials in pancreatic cancer, myeloma and leukemia during the
coming year. Preclinical stage programs include gene therapy for hemophilia, cancer, cardiovascular disorders and Parkinson's disease. Cell Genesys'
assets outside gene therapy include its approximately 12 percent ownership of Abgenix, Inc. and the company's licensing program in gene activation
technology. For additional information, please visit the company's web site at www.cellgenesys.com .
Statements made herein, other than statements of historical fact, including statements about the company's progress and results of hemophilia and
other preclinical studies, clinical trials, marketability of potential products and nature of product pipelines, corporate partnerships, licenses and
intellectual property including that pertaining to AAV, lentiviral and other gene delivery technology and the company's patent portfolio are
forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made,
including risks associated with the success of research and development programs, results achieved in future preclinical studies and clinical trials, the
regulatory approval process, competitive technologies and products, the scope and validity of patents, corporate partnerships and additional
financings. For information about these and other risks which may affect Cell Genesys, please see the company's Annual Report on Form 10-K dated
March 30, 2000 as well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed from time to time with the Securities and Exchange
Commission.
CONTACT: Jennifer Cook Williams, Manager, Corporate Communications of Cell Genesys, Inc., 650-425-4542.
SOURCE Cell Genesys, Inc.
CONTACT: Jennifer Cook Williams, Manager, Corporate Communications of
Cell Genesys, Inc., 650-425-4542
/Company News On-Call: www.prnewswire.com/comp/134113.html or fax,
800-758-5804, ext. 134113
URL: www.cellgenesys.com
www.prnewswire.com
(C) 2000 PR Newswire. All rights reserved.
KEYWORD: California
INDUSTRY KEYWORD: MTC
HEA
SUBJECT CODE: OTC
ABGX
112 5/8
+7 5/16
RELATED SYMBOLS
CEGE
24 1/2
-7/16
Enter Symbol:
Enter Keyword:
