04-28686. Prospective Grant of an Exclusive License: “Vasostatin as Marrow Protectant” and “Use of Calreticulin and Calreticulin Fragments To Inhibit Endothelial Cell Growth and Angiogenesis and Suppress Tumor Growth”

AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

SUMMARY:

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent No. 6,596,690 B2 entitled “Vasostatin as Marrow Protectant” (DHHS Reference E-230-2000/0); U.S. Patent Application No. 09/807,148 filed April 5, 2001, entitled “Use of Calreticulin and Calreticulin fragments to inhibit endothelial cell growth and angiogenesis and suppress tumor growth” (DHHS Reference E-082-1998/0-US-03); PCT Application No. PCT/US99/23240 filed October 5, 1999 entitled “Use of Calreticulin and Calreticulin fragments to inhibit endothelial cell growth and angiogenesis and suppress tumor growth” (DHHS Reference E-082-1998/0-PCT-02); to BioAccelerate, Inc., a venture capital group controlling the following twelve companies: Bioenvision, Enhance Biotech, Evolve Oncology, CNS Thera, Innova Lifestyle, Inncardio, Anvira, Neuro Bioscience, Biocardio, Oncbio, Innovative Oncology and Genar Oncology. The patent rights in these inventions have been assigned to the United States of America.

The prospective exclusive license territory may be worldwide and the field of use may be limited to development and sale of a pharmaceutical product useful in protecting bone marrow stem cells from the toxic effects of chemotherapy and radiotherapy.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before March 4, 2005 will be considered.

ADDRESSES:

Requests for copies of the patent and/or patent applications, inquiries, comments and other materials relating to the contemplated exclusive license should be directed to: Mojdeh Bahar, J.D., Technology Licensing Specialist, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804. Telephone: [phone]; Facsimile: [phone]; E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The technology claimed in the aforementioned patents is based on the discovery of the calreticulin N-domain (vasostatin) and the three previously uncharacterized properties of calreticulin. First, calreticulin N-domain is shown to stimulate the proliferation and survival in vitro of hematopoietic cells in the presence of previously identified growth factors. Second, Vasostatin is shown to protect hematopoietic cells in vitro from toxicity induced by a variety of chemotherapeutic agents. Third, Vasostatin is shown to protect a subject from toxicity to the hematopoietic system induced by chemotherapy or irradiation.

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 part 404.7. The prospective exclusive license may be granted unless within sixty (60) days from the date of this published notice, the NIH receives written evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.7.

Applications for a license in the field of use filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

Dated: December 20, 2004.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.