Ceregene Confirms Treatment of First Patient in Phase 1 Study of Alzheimer's Disease Gene Therapy

First Patient Ever Treated in Human Gene Therapy Study for Alzheimer's Disease



Apr 10, 2001, 01:00 ET from Ceregene, Inc.

    SAN DIEGO, April 10 /PRNewswire/ -- Ceregene, Inc. confirmed today that
 the first patient has been treated in a Phase 1 clinical study for Alzheimer's
 disease gene therapy at the University of California, San Diego (UCSD) School
 of Medicine.  Ceregene, Inc., a majority-owned subsidiary of
 Cell Genesys, Inc. (Nasdaq:   CEGE) is the exclusive licensee of the technology
 and product rights for this therapy.
     "Ceregene is excited by this groundbreaking study involving the first ever
 gene therapy trial for Alzheimer's disease," said Jeffrey M. Ostrove, Ph.D.,
 president and chief operating officer of Ceregene.  "Several successful
 preclinical gene therapy studies for both Alzheimer's disease and Parkinson's
 disease have demonstrated the potential of Ceregene's gene therapy
 technologies, and we are pleased that human clinical studies are now under
 way."
     The Phase 1 trial, sponsored by UCSD and led by UCSD neurologist,
 Mark Tuszynski, M.D., Ph.D., involves surgical implantation of cells producing
 nerve growth factor (NGF), a naturally occurring protein that maintains
 survival of nerve cells in the brain.  The primary goal of this study is to
 determine that the gene therapy procedure is safe.  The secondary goal is to
 determine whether NGF produced by the cells implanted into the brain can
 prevent the death of some nerve cells that are affected by Alzheimer's disease
 and whether it can enhance the function of certain remaining brain cells.
     During the study, the cells, which originally are extracted from the
 patient's skin, are genetically modified to express NGF.  The cells are then
 administered by stereotactic injection, a common neurosurgical procedure, into
 the region of the brain called the nucleus basalis of Meynert -- an area of
 the brain known to undergo serious degeneration in Alzheimer's disease.  The
 patient will be closely monitored for a year and then evaluated annually for
 an indefinite period.  Eight patients are expected to be enrolled into the
 Phase 1 study.  In the future, Ceregene plans to conduct in vivo (genetic
 modification inside the body) studies for both Alzheimer's disease and
 Parkinson's disease.
     This human clinical study follows a number of encouraging animal studies
 conducted by Dr. Tuszynski and colleagues previously reported in the
 scientific literature.  In a September issue of the journal, Proceedings of
 the National Academy of Sciences (PNAS), Dr. Tuszynski's team reported that
 monkeys exhibited atrophy of 40 percent of cholinergic neurons due to the
 normal aging process; these atrophic changes were reversed upon administration
 of NGF by this procedure.  In a separate PNAS article in February 2001, these
 scientists demonstrated that the delivery of the NGF gene to monkeys restored
 normal levels and activity of axons (message transmitters between neurons),
 after observing that quantities of axons in aged monkeys had significantly
 declined compared with younger monkeys.
     Ceregene, Inc. is a San Diego-based biotechnology company focused on the
 development and commercialization of gene therapies for neurologic disorders.
 Ceregene was launched in January 2001 as a majority-owned subsidiary of
 Cell Genesys, Inc. through the acquisition of Neurologic Gene Therapeutics, a
 private start-up company based in San Diego.  Cell Genesys contributed
 $10 million to Ceregene, together with access to technology and patents in the
 central nervous system (CNS) gene therapy area, in exchange for approximately
 60 percent ownership of the new company.  Ceregene has exclusively licensed
 technology related to the Phase 1 human clinical trial for Alzheimer's disease
 currently under way.  In addition, Ceregene is conducting advanced preclinical
 studies in Parkinson's disease.  These programs were pioneered by the founders
 of Neurologic Gene Therapeutics prior to the formation of Ceregene.
 
     Statements made herein about Ceregene and Cell Genesys, other than
 statements of historical fact, including statements about the progress and
 reports of neurologic gene therapy clinical trials, including those in
 Alzheimer's gene therapy, and progress and reports of preclinical programs,
 marketability and success of potential products and nature of product
 pipelines, licenses and intellectual property 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, license agreements including
 the agreement with UCSD, the success and results of clinical trials, the
 regulatory approval process, competitive technologies and products, patents
 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 April 2, 2001 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:  Jeffrey M. Ostrove, Ph.D., President and Chief Operating Officer
 of Ceregene, Inc., 650-425-4432; or Jennifer Cook Williams, 650-425-4432.
 
 

SOURCE Ceregene, Inc.
    SAN DIEGO, April 10 /PRNewswire/ -- Ceregene, Inc. confirmed today that
 the first patient has been treated in a Phase 1 clinical study for Alzheimer's
 disease gene therapy at the University of California, San Diego (UCSD) School
 of Medicine.  Ceregene, Inc., a majority-owned subsidiary of
 Cell Genesys, Inc. (Nasdaq:   CEGE) is the exclusive licensee of the technology
 and product rights for this therapy.
     "Ceregene is excited by this groundbreaking study involving the first ever
 gene therapy trial for Alzheimer's disease," said Jeffrey M. Ostrove, Ph.D.,
 president and chief operating officer of Ceregene.  "Several successful
 preclinical gene therapy studies for both Alzheimer's disease and Parkinson's
 disease have demonstrated the potential of Ceregene's gene therapy
 technologies, and we are pleased that human clinical studies are now under
 way."
     The Phase 1 trial, sponsored by UCSD and led by UCSD neurologist,
 Mark Tuszynski, M.D., Ph.D., involves surgical implantation of cells producing
 nerve growth factor (NGF), a naturally occurring protein that maintains
 survival of nerve cells in the brain.  The primary goal of this study is to
 determine that the gene therapy procedure is safe.  The secondary goal is to
 determine whether NGF produced by the cells implanted into the brain can
 prevent the death of some nerve cells that are affected by Alzheimer's disease
 and whether it can enhance the function of certain remaining brain cells.
     During the study, the cells, which originally are extracted from the
 patient's skin, are genetically modified to express NGF.  The cells are then
 administered by stereotactic injection, a common neurosurgical procedure, into
 the region of the brain called the nucleus basalis of Meynert -- an area of
 the brain known to undergo serious degeneration in Alzheimer's disease.  The
 patient will be closely monitored for a year and then evaluated annually for
 an indefinite period.  Eight patients are expected to be enrolled into the
 Phase 1 study.  In the future, Ceregene plans to conduct in vivo (genetic
 modification inside the body) studies for both Alzheimer's disease and
 Parkinson's disease.
     This human clinical study follows a number of encouraging animal studies
 conducted by Dr. Tuszynski and colleagues previously reported in the
 scientific literature.  In a September issue of the journal, Proceedings of
 the National Academy of Sciences (PNAS), Dr. Tuszynski's team reported that
 monkeys exhibited atrophy of 40 percent of cholinergic neurons due to the
 normal aging process; these atrophic changes were reversed upon administration
 of NGF by this procedure.  In a separate PNAS article in February 2001, these
 scientists demonstrated that the delivery of the NGF gene to monkeys restored
 normal levels and activity of axons (message transmitters between neurons),
 after observing that quantities of axons in aged monkeys had significantly
 declined compared with younger monkeys.
     Ceregene, Inc. is a San Diego-based biotechnology company focused on the
 development and commercialization of gene therapies for neurologic disorders.
 Ceregene was launched in January 2001 as a majority-owned subsidiary of
 Cell Genesys, Inc. through the acquisition of Neurologic Gene Therapeutics, a
 private start-up company based in San Diego.  Cell Genesys contributed
 $10 million to Ceregene, together with access to technology and patents in the
 central nervous system (CNS) gene therapy area, in exchange for approximately
 60 percent ownership of the new company.  Ceregene has exclusively licensed
 technology related to the Phase 1 human clinical trial for Alzheimer's disease
 currently under way.  In addition, Ceregene is conducting advanced preclinical
 studies in Parkinson's disease.  These programs were pioneered by the founders
 of Neurologic Gene Therapeutics prior to the formation of Ceregene.
 
     Statements made herein about Ceregene and Cell Genesys, other than
 statements of historical fact, including statements about the progress and
 reports of neurologic gene therapy clinical trials, including those in
 Alzheimer's gene therapy, and progress and reports of preclinical programs,
 marketability and success of potential products and nature of product
 pipelines, licenses and intellectual property 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, license agreements including
 the agreement with UCSD, the success and results of clinical trials, the
 regulatory approval process, competitive technologies and products, patents
 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 April 2, 2001 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:  Jeffrey M. Ostrove, Ph.D., President and Chief Operating Officer
 of Ceregene, Inc., 650-425-4432; or Jennifer Cook Williams, 650-425-4432.
 
 SOURCE  Ceregene, Inc.