Prospective Grant of Exclusive License: Use of Thymosin β4 for Wound Healing Applications

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 world-wide license to practice the inventions embodied in any domestic or foreign applications corresponding to PCT Patent Application PCT/US99/17282 and USSN 60/094,960, both entitled “Thymosin β4 Promotes Wound Repair” to Alpha1 Biomedicals, Inc., of Bethesda, Maryland. The patent rights in this invention have been assigned to the United States of America and Alpha1 Biomedicals, Inc. The prospective exclusive license may be limited to the development of therapeutic applications, including compositions and methods, to be used in the treatment of wounds and tissue repair.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before May 30, 2000 will be considered.

ADDRESSES:

Requests for a copy of these patent applications, inquiries, comment and other materials relating to the contemplated license should be directed to Susan S. Rucker, J.D., Patent and Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7056 ext 245; fax: 301/402-0220. A signed Confidentiality Agreement will be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION:

The patent applications describe the use of the compound thymosin β4, isoforms of thymosin β4 (Tβ4 ^ala, Tβ9, Tβ11, Tβ12, Tβ13, Tβ14, or Tβ15) or a peptide derived therefrom, LKKTET, (aa residues 17-22) as an agent for promoting wound healing. Thymosin β4 is a small, 43 mer, 4.9 kDa, peptide which can be produced by chemical synthesis or recombinantly. Studies using a punch model for wounds in rats have shown that providing thymosin β4 either by systemic delivery (intraperitoneal) or topical delivery accelerates wound healing and that extracellular matrix deposition occurs in the wound bed. In addition, Thymosin β4 has been shown previously to promote endothelial cell migration and to promote angiogenesis.

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. This prospective exclusive license may be granted unless within ninety (90) 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.

Applications for a license (i.e., a completed “Application for License to Public Health Service Inventions”) in the indicated exclusive field of use filed in response to this notice will be treated as objections to the grant of the contemplated license. Comments and objections will not be made available for public inspection and, to the extent permitted by law, will not be subject to disclosure under the Freedom of Information Act 35 U.S.C. 552.