[Federal Register Volume 64, Number 137 (Monday, July 19, 1999)]
[Notices]
[Page 38686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18377]



[[Page 38686]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Opportunity for Licensing: Vasostation, an Inhibitor of 
Endothelial Cell Growth and Angiogenesis

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

ACTION: Notice.

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SUMMARY: The National Institute of Health (NIH), Public Health Service 
(PHS), Department of Health and Human Services (DHHS), seeks 
licensee(s) to develop a therapeutic anti-angiogenic agent(s) that 
would be effective in the treatment of a variety of disease states, in 
particular, cancer. Scientists at the Food and Drug Administration 
(FDA) have isolated at NH2-terminal fragment (1-180 a.a.), 
vasostatin, from calreticulins which can inhibit endothelial cell 
proliferation in vitro, suppress neovasculariztion in vivo and prevent 
or reduce growth of experimental tumors while having minimal effect on 
other cell types. Vasostatin is the most conserved domain among 
calrecticulins so far cloned and has no homology to other protein 
sequences. Data suggests that the antitumor effects of vasostatin are 
related to inhibition of new blood vessel formation rather than a 
detrimental effect on established tumor vasculature.
    The NIH seeks licensee(s), who in accordance with requirements and 
regulations governing the licensing of government-owned inventions (37 
CFR Sec. 404), has the most meritorious plan for the development of a 
therapeutic agent(s) to meet the needs of the public and with the best 
terms for the government. NIH intends to grant the selected firm(s) a 
world-wide royalty-bearing license(s) to practice the inventions 
embodied in USSN 60/103,438 from Dr. Giovanna Tosato and Dr. Sandra 
Pike entitled ``Use of Calreticulin and Calreticulin Fragments to 
Inhibit Endothelial Cell Growth and Angiogenesis, and Suppress Tumor 
Growth'' (DHHS Ref. No. E-082-98/0). The patent rights in these 
inventions have been assigned to the United States of America.

EFFECTIVE DATE: In view of the priority for developing new antitumor 
agents, all proposals for either exclusive or non-exclusive licensing 
must be received on or before September 17, 1999.

ADDRESSES: Licensing information, copy of the U.S. patent application 
referenced above or a copy of the NIH License Application may be 
obtained by contacting Richard U. Rodriguez, M.B.A., at the Office of 
Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, Maryland 20852-3804 (telephone 301/
496-7056 ext 287, fax 301/402-0220; and E-mail [email protected]). A 
signed Confidential Disclosure Agreement is required to receive a copy 
of any patent application.

SUPPLEMENTARY INFORMATION: Vasostatin has key differences from other 
inhibitors of angiogenesis, for example, angiostatin, thrombospondin 
and endostatin. It is small, soluble, stable for greater than 9 months 
in aqueous solution and is easily produced and delivered. By 
comparison, angiostatin, endostatin and thrombospondin can be difficult 
to isolate, purify and deliver. Additionally, studies have shown that 
the effective dose of vasostatin is 4-10 fold lower than the effective 
doses of endostatin and angiostatin. Therefore, this new and potent and 
anti-angiogenic molecule should prove highly useful for the prevention 
and treatment of human disease states that involve mis-regulated 
endothelial cell proliferation and/or angiogenesis.
    In addition to the criteria set forth in 37 CFR Sec. 404.7(a)(1) 
(ii)-(iv), the NIH is particularly interested in the following 
capabilities:
    1. Prior manufacturing experience for GMP (Good Manufacturing 
Practice) production of a therapeutic agent(s) and a production plan 
for said agent(s);
    2. Experience in preclinical and clinical drug development;
    3. Experience in the evaluation, monitoring and interpretation of 
data for investigational biologics under an IND;
    4. Experience in the evaluation, monitoring and interpretation of 
data from Phase I and Phase II clinical studies;
    5. Ability to produce, package, market and distribute 
pharmaceutical products in the United States;
    6. Willingness to sustain the cost of vasostatin development as 
outlined above (i.e., bulk drug synthesis, data management, animal 
studies, clinical studies, etc.);
    7. Agreement to be bound by DHHS rules involving human and animal 
studies; and
    8. An aggressive development plan that includes appropriate 
milestones and deadlines for preclinical and clinical development and 
for marketing approval.

    Dated: July 12, 1999.
Jack Spiegel,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer.
[FR Doc. 99-18377 Filed 7-16-99; 8:45 am]
BILLING CODE 4140-01-M