[Federal Register Volume 59, Number 34 (Friday, February 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-3733]


[[Page Unknown]]

[Federal Register: February 18, 1994]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

 

Opportunity for a Cooperative Research and Development Agreement 
(CRADA) for Development of an Immortalized Fetal Glial Cell Line as a 
Delivery System for Treatment of Various Neurological Disorders

AGENCY: National Institutes of Health, PHS, DHHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The National Institutes of Health, (NIH) seeks an agreement 
with a company(ies) which will assist in the further development and 
commercialization of an immortalized fetal glial cell line for its use 
as a delivery system for recombinant proteins, drugs, and other 
pharmaceutical therapeutics for the treatment of various neurological 
disorders. The National Institute of Neurological Disorders and Stroke 
(NINDS) believes the technology can be utilized in the treatment of 
several neurological disorders. The NINDS reserves the right to 
entertain the possibility of being involved in CRADAs with multiple 
Companies for the co-development of this delivery system for its use in 
different neurological disorders.

DATES: Proposals must be received by April 29, 1994.

ADDRESSES: Questions about this opportunity may be addressed to Stephen 
Finley, Ph.D., National Institutes of Health, NINDS, 9000 Rockville 
Pike, Building 31, room 8A46, Bethesda, MD 20892. Telephone 301-496-
4697.

SUPPLEMENTARY INFORMATION: The NINDS has been issued a patent (Patent 
#4,707,448) entitled ``Immortal Line of Human Fetal Glial Cells,'' and 
currently has a patent application (Serial # 08/046,527), entitled 
``Use of Neuro-derived Fetal Cell Line for Transplantation Therapy'' 
for the use of the patented cell line as a delivery system. The NINDS's 
Laboratory of Molecular Medicine & Neuroscience/Molecular Medicine and 
Virology Section (MMN/MMV) has continued its characterization and 
investigation into the use of this cell line, designated SVG, as a 
delivery system for recombinant proteins, drugs, or therapeutics into 
the central nervous system and potentially other organs.
    The use of transplanted fetal cells for the treatment of 
Parkinson's disease, as well as other neurological disorders, has met 
with varying degrees of success. The use of fresh fetal cells are known 
to have several disadvantages. For example, even though rigorous 
screening methods are conducted, there is no guarantee of having 
infectious free, fresh fetal cells for transplantation. The physical 
characteristics of fresh fetal cells are uncontrollable (i.e. age, cell 
type) and generally lack experimental support data. Also, the use of 
immunosuppressives are required to prevent host rejection of these 
cells.
    Cell lines are easily modified for research and are considered to 
be a viable alternative to the transplantation of fresh fetal cells. 
Unfortunately, cell lines also have inherent transplantation problems. 
Genetically unrelated cells require immunosuppressives to prevent host 
rejection, and a transformed cell line carries a pre-disposition to 
tumor formation.
    We believe the SVG cell line to be a solution to these and other 
transplantation problems. These brain derived cells have the same 
physical characteristics and are easily modified by conventional 
molecular genetic techniques. In vitro and in vivo testing has shown 
the SVG cell lines to be non-oncogenic and non-inflammatory. Also, 
transfected SVG cells were shown to cause the expression of the desired 
gene.
    Role of NINDS:
    1. The Government will continue to proceed with the development of 
SVG for clinical trials and may provide access to NINDS facilities for 
the clinical trials to CRADA selectee(s).
    2. NINDS will derive in vivo data in non-human primate and in vitro 
data establishing SVG's efficacy for FDA support.
    The role of successful company(ies) under the CRADA will include 
the following:
    1. Provide expertise for the clinical development of the SVG cell 
line leading to FDA approval for the marketing of products for 
therapeutic use.
    2. Cost sharing with the NINDS's MMN/MMV for continued clinical 
development of the cell line.
    Criteria for selecting the company(ies) include but are not limited 
to the following:
    1. Experience in the development of products for clinical use.
    2. Experience in preclinical and clinical drug development.
    3. Experience and ability to produce, package, market and 
distribute products in the United States and to provide the product at 
a reasonable cost.
    4. Experience in the monitoring, evaluation, and interpretation of 
the data from an investigational agent clinical studies under an IND.
    5. A willingness to cost share in the development of SVG as 
outlined above. This includes evaluation of SVG cells in non-human 
primates, production of SVG cells and its modified recombinant in 
adequate amounts for future clinical trials and marketing.
    6. The execution of an agreement to be bound by the DHHS rules 
involving human and animal subjects.
    7. The aggressiveness of the development plan, including the 
appropriateness of milestones and deadlines for preclinical and 
clinical trials.

    Dated: February 3, 1994.
Donald Christoferson,
Acting Director, Office of Technology Transfer, National Institutes of 
Health.
[FR Doc. 94-3733 Filed 2-17-94; 8:45 am]
BILLING CODE 4140-01-M