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Invention disclosure from NIH form October 23 1997 (forwarded for publication in the Federal Register)

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Identification of a Viral Etiology for B-Precursor Acute Lymphoblastic Leukemia of Childhood

Description of Invention:
The present invention claims that the possible etiologic agent for some cases of acute lymphoblastic
leukemia (ALL) in children is JC virus (a human polyomavirus), and that infection in utero can lead to
subsequent development of ALL during childhood. JC virus was identified as a possible etiologic agent
based on specific properties associated with the virus, including: (1) specificity for B-lymphocytes as
compared to T-lymphocytes; (2) the ability to induce genomic instability via its T antigen, which interacts
with cellular p53; and (3) epidemiological data showing concordance between the frequency of
"susceptible" (i.e. previously not exposed to JC virus and therefore susceptible to a primary infection)
women of reproductive age in a population and the rate of ALL in the population.

Since women at risk for JC virus infection that might result in ALL in their child during pregnancy are
those who have not yet had a primary infection, methods to achieve immunization are disclosed in the
application. Since immunization could be specifically targeted to women who have never been
exposed to JC virus, the application also discloses methods of screening women for prior exposure to
the virus. In addition, methods for diagnosis of susceptibility are disclosed which can be applied to cord
blood samples which may allow identification of children at high risk and allow early intervention. These
methods of screening can be performed using either serological or molecular methods of analysis and
both types are claimed in the application.

Inventor:
MA Smith (NCI)

Patent Status:
Serial No. 60/036,991 filed 30 Jan 97

For additional information, please contact:
Joseph Contrera, M.S., J.D.
Technology Licensing Specialist
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, MD 20852-3804
Phone: 301/496-7056 ext. 244
Fax: 301/402-0220
E-mail: ContrerJ@od.nih.gov

raf Protein Kinase Therapeutics

Description of Invention:
Novel raf protein kinases may be valuable for the treatment of cancers. raf protein kinases are enzymes
that stimulate cell growth in a variety of cell systems and, when expressed in specifically altered forms,
can initiate malignant cell growth. These novel raf protein kinases, which are mutant constructs or are
transcribed from raf antisense DNA, can be used to inhibit the activity of cellular raf protein kinases and
prevent or reverse malignant cell growth.

Potential Areas of Application:
* Cancer, all major forms; other proliferative diseases (e.g., psoriasis, restenosis)
* Inflammatory diseases

Main Advantages of Invention:
* raf is by now a verified cancer target
* raf directed drugs promise to be widely applicable and nontoxic based on clinical studies with
antisense ODN

Stage of Development:
Ready to be used for drug screens, application in gene therapy

Further Development Required:
Use of inhibitory raf mutants in gene therapy requires clinical studies

Inventors:
U Rapp, H App, SM Storm (NCI)

Patent Status:
Serial No. 08/207,954 filed 18 Mar 94 (priority to 23 Aug 91)

Relevant Publication:
G Daum, I Eisenmann-Tappe, H-W Fries, J Troppmair, UR Rapp: Ins and Outs of Raf kinases. Trends in
Biochem. Sci. 19: 474-480, 1994

Portfolio:
Cancer - Therapeutics, biological response modifiers, growth factors

For additional information, please contact:
Ken Hemby
Technology Licensing Specialist
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, MD 20852-3804
Phone: 301/496-7735 ext. 265
Fax: 301/402-0220
E-mail: HembyJ@od.nih.gov