[Federal Register Volume 59, Number 245 (Thursday, December 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-31393]


[[Page Unknown]]

[Federal Register: December 22, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

Prospective Grant of Exclusive License: Method for Evaluating 
Chemotherapeutic Agents in Hollow Fibers In Vivo

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

ACTION: Notice

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SUMMARY: This is notice in accordance with 15 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i) that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive license in the United States to practice the invention 
embodied in U.S. Patent Application Serial Number 08/058,154, entitled 
``Method for Evaluating Chemotherapeutic Agents in Hollow Fibers In 
Vivo,'' to Spectrum Medical Industries, Inc., having a place of 
business in San Diego, California. The patent rights in this 
application have been assigned to the United States of America.
    The prospective exclusive license will be royalty-bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless, within 60 days 
from the date of this published Notice, NIH receives written evidence 
and argument that establishes that the grant of the license would not 
be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
    The present invention relates to a method of screening the efficacy 
of chemotherapeutic agents in vivo using target cells grown in 
biocompatible, selectively permeable macrocapsules. Most conventional 
methods (i.e., subcutaneous tumor model, sub-renal tumor model, 
peritoneal model and the metastasis model) permit only one type of 
tumor cell or cell line to be screened per experiment per animal, with 
the animal subsequently sacrificed for analysis. The present method 
allows for placing samples of syngeneic or xenogeneic cells into 
laboratory animals using cells or cell lines grown in selectively 
permeable hollow fibers or dialysis tubing. The invention provides a 
rapid and reliable method to screen potential chemotherapeutic agents 
for therapeutic uses in cancer or other human diseases. Additionally, 
the method allows a single experimental animal to carry implants in 
multiple sites allowing simultaneous evaluation of a chemotherapeutic 
agent capacity to reach various physiologic compartments such as 
subcutaneous, intraperitoneal or intra-organ regions. The advantages of 
this system over the classical antitumor animal models include: 1) the 
requirement for a smaller amount of test agent to assess preliminary in 
vivo efficacy; 2) rapid turn-around time, 3) the ability to test 
potential activity against multiple tumor types simultaneously in the 
same experimental animal; 4) a reduction in the number of experimental 
animals required for assessing efficacy, 5) the possibility of 
assessing multiple treatment schedules in a short time frame, 6) the 
ability to recover the entire implant, 7) the lack of contamination of 
the implanted cells by host cell, and 8) the ability to screen a test 
agent against target cells cultivated in various physiologic 
compartments in the same laboratory animal.
    The present invention can be used in transgenic animals to 
determine the effect of a transgenic or protein product thereof on a 
target cell line. Further, re-cultivating and re-screening the cells 
after analysis makes its possible to assess the regrowth potential of 
cells surviving treatment and then determine their susceptibility to a 
second treatment with the same or alternate chemotherapeutic agent(s).
    The contemplated fields of use for licensing would be for 1) 
preclinical testing in animals of products for toxicity and efficacy, 
and 2) diagnostic testing in animals of human tissue specimens for 
resistance and sensitivity to alternative therapeutic regimes. Spectrum 
Medical Industries intends to make, use and sell products, falling 
within the scope of the patent application for the research and 
clinical diagnostic markets.

ADDRESSES: Requests for a copy of this patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: John Fahner-Vihtelic, Office of Technology 
Transfer, National Institutes of Health, Suite 325, 6011 Executive 
Blvd., Rockville, Maryland 20852. Telephone: (301) 496-7735, extension 
285, or fax (301) 402-0220. A signed Confidentiality Agreement will be 
required to receive copies of the patent application. Properly filed 
competing applications for a license filed in response to this notice 
will be treated as objections to the contemplated license. Only written 
comments and/or application for a license which are received by the NIH 
Office of Technology Transfer within sixty (60) days of this notice 
will be considered.

    Dated: December 12, 1994.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 94-31393 Filed 12-21-94; 8:45 am]
BILLING CODE 4140-01-P