Ceregene Scientific Co-Founder Publishes Alzheimer's Disease Clinical Trial Results in Nature Medicine Promising Phase I Data Demonstrated in Gene Therapy

Study for Alzheimer's Disease



    SAN DIEGO, Calif., April 25 /PRNewswire/ -- Ceregene, Inc. scientific co-
 founder, Mark Tuszynski M.D., Ph.D., published today in the May 2005 online
 edition of Nature Medicine the results of the first ever Phase I clinical
 study for the treatment of Alzheimer's disease using gene therapy.  Ceregene,
 Inc. has licensed the technology and product rights used in this program and
 have utilized the data in its current Alzheimer's gene therapy clinical
 studies.
     "Ceregene is excited to be involved in such a promising breakthrough
 approach delivering growth factors to treat neurodegenerative diseases,"
 stated Jeffrey M. Ostrove, Ph.D., president and chief executive officer of
 Ceregene.  "The results of this Phase I study of nerve growth factor (NGF) in
 Alzheimer's disease are encouraging and strongly support our CERE-110 clinical
 program using an AAV2-based vector to deliver NGF to Alzheimer's patients."
 Ceregene is currently sponsoring a Phase I study of CERE-110, an off-the-self
 version that uses direct NGF gene delivery to the brain. This clinical study
 is currently underway at Rush University Medical Center in Chicago.
     "If validated in further clinical trials, this would represent a
 substantially more effective therapy than current treatments for Alzheimer's
 disease," said Mark Tuszynski, M.D., Ph.D., UCSD professor of neurosciences
 and the study's principal investigator.  "This would also represent the first
 therapy for a human neurological disease that functions by preventing cell
 death."
     The Phase I trial, sponsored by Mark Tuszynski, M.D., Ph.D., involved
 surgical implantation of cells producing nerve growth factor (NGF), a natural
 brain survival molecule.  The primary goal was to determine that the gene
 therapy procedure is safe.  The secondary goal was to determine whether NGF
 produced by the cells implanted into the brain could prevent the death of some
 nerve cells that are affected in Alzheimer's disease and whether it can
 enhance the function of some remaining brain cells.
     In the Nature Medicine published report, cognitive measurements were
 assessed pretreatment, at the time of treatment and at regular intervals
 following administration of the NGF producing cells.  The six patients who
 safely completed the NGF delivery procedure were evaluated using quantitative
 measurements of the Mini Mental Status Examination (MMSE) and the Alzheimer's
 Disease Assessment Scale-Cognitive Subscale (ADAS-Cog).  Over an average post-
 treatment period of 22 months, the rate of decline on the MMSE was reduced by
 as much as 51 percent.  The ADAS-Cog also showed improvements in rates of
 decline that paralleled the MMSE findings. Using PET brain-imaging studies,
 scans in four subjects showed significant increases in the brain's metabolic
 activity as measured by absorption of a radioisotope.  Gene therapy with NGF
 was well tolerated in this trial.  Two patients early in the study experienced
 hemorrhage during the neurosurgical procedure which has been modified and has
 eliminated this problem to date.
     In addition to this CERE-110 study for Alzheimer's disease, Ceregene has
 developed CERE-120, an AAV2-based vector to deliver Neurturin, another growth
 factor that is related to GDNF which has been reported to function in the
 treatment of Parkinson's disease.  CERE-120 has been reviewed by the Food and
 Drug Administration and has an effective IND as well as approval from the NIH
 Recombinant DNA Advisory Committee (RAC).  Clinical trials are expected to
 start in the near future.
 
     Ceregene, Inc. is a San Diego-based biotechnology company focused on the
 development of gene therapies for neurodegenerative disorders.  Ceregene is in
 the clinic with CERE-110, an AAV2 based vector expressing nerve growth factor
 that is being tested as a treatment for Alzheimer's disease. CERE-120 for
 Parkinson's disease will be tested in the clinic shortly and CERE-130 is in
 late preclinical development for ALS.  Ceregene was launched in January 2001
 and is a minority-owned subsidiary of Cell Genesys, Inc. (Nasdaq:   CEGE), which
 is headquartered in South San Francisco, CA.  Ceregene closed a $32M Series B
 financing in August 2004 that was co-led by Alta Partners and MPM Capital.
 
      Contact:       Jeffrey M. Ostrove, Ph.D.
                     President and Chief Executive Officer
                     Ceregene, Inc.
                     858-458-8808
 
 

SOURCE Ceregene, Inc.

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