[Federal Register Volume 63, Number 229 (Monday, November 30, 1998)]
[Notices]
[Page 65799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31731]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing: Drug and 
Method for the Therapeutic Treatment of Primary Brain Tumors (Such as 
Intracranial Human Glioma, Astrocytomas, Medulloblastomas and 
Metastatic Tumors to the Central Nervous System)

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: The National Institutes of Health (NIH) is seeking Licensees 
to further develop, evaluate, and commercialize a Transforming Growth 
Factor-alpha-Pseudomonas Exotoxin fusion protein, known a TGF-alpha-
PE38, for the therapeutic treatment of refractory brain tumors such as 
intracranial human glioma, astrocytomas, medulloblastomas and 
metastatic tumors to the central nervous system (``SNS'').
    The invention claimed in USPN 4,892,827, Entitled: ``Recombinant 
Pseudomonas Exotoxins: Construction of an Active Immunotoxin with Low 
Side Effects,'' is available for licensing on an exclusive or non-
exclusive basis (in accordance with 35 USC 207 and 37 CFR part 404) 
with the Field of Use limited to the therapy of primary brain tumors, 
metastatic carcinomas, and leptomeningeal carcinomatosis.

ADDRESSES: Licensing information and copies of the U.S. patent 
referenced above may be obtained by contacting J.R. Dixon, Ph.D., 
Technology Licensing Specialist, Office of Technology Transfer, 
National Institutes of Health, 6011 Executive Boulevard, Suite 325, 
Rockville, Maryland 20852-3804; telephone: 301/496-7056 ext. 206; fax: 
301/402-0220; e-mail: ``[email protected]''. Respondees interested in 
licensing the invention will be required to submit an ``Application for 
License to Public Health Service Inventions.''

SUPPLEMENTARY INFORMATION: Epidermal growth factor receptor (``EGFR'') 
is amplified or over expressed in many malignant gliomas, other primary 
brain tumors, and carcinomas of epithelial origin (e.g., breast, lung, 
etc.) but is low or undetectable in normal brain tissue. TGF-alpha-PE38 
represents a growing class of recombinant toxins designed for use in 
targeted cancer therapy. These genetically engineered chimeric proteins 
consist of a targeting moiety and a cytotoxic moiety. While TGF-alpha-
PE38 is extremely toxic to tumor cells that have a relatively high 
expression of EGFR, it is also active against primary human brain tumor 
cells which are known to have moderate to high EGFR expression. Direct 
delivery of TGF-alpha-PE38 into brain tumors by intratumoral implanted 
catheters or controlled-release biodegradable polymers or intrathecal 
administration into the cerebrospinal fluid of patients with 
leptomeningeal carcinomatosis, may represent clinically useful 
applications of recombinant toxin therapy in tumors with high EGFR 
expression.
    Anaplastic astrocytoma and glioblastoma, the most common primary 
brain tumors in adults, respond poorly to all current therapies: Median 
survival for patients with these tumors ranges from 19 to 57 weeks. 
Local tumor recurrence also constitutes a significant problem in 
medulloblastoma, the most common childhood brain tumor. Despite 5-year 
survivals for medulloblastoma exceeding 80% in some studies, nearly 
half of these patients will eventually die from progressive tumor. 
Treatment failure in patients with brain tumors is a multifactorial 
process involving the intrinsic resistance of these tumors to radiation 
therapy and chemotherapy, the development of acquired treatment 
resistance, and limitations of drug delivery due to blood-brain barrier 
restrictions. Local recurrence of brain tumors represents the most 
common pattern of treatment failure. Accordingly, the identification of 
new therapeutic agents that have high intrinsic activity against brain 
tumors and are appropriate for local therapy remains a major goal of 
the NIH.

    Dated: November 16, 1998.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 98-31731 Filed 11-27-98; 8:45 am]
BILLING CODE 4140-01-M