[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] ----------------------------------------------------------------------- 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 ----------------------------------------------------------------------- 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