[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
