05-15349. Prospective Grant of Exclusive License: Adaphostin as a Novel Cancer Therapy

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in:

1. E-013-1998/0-US-01, “Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs”, by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number 60/076,330 (filed February 27, 1998);

2. E-013-1998/0-PCT-02, “Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs”, by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number PCT/US99/04002 (filed February 24, 1999);

3. E-013-1998/0-EP-03, “Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs”, by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number 99910987.9 (filed February 24, 1999);

4. E-013-1998/0-JP-04, “Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs”, by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number 2000-533395 (filed February 24, 1999);

5. E-013-1998/0-AU-05, “Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs”, by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, patent number 760046 (filed February 24, 1999);

6. E-013-1998/0-CA-06, “Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs”, by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number 60/076,330 (filed February 24, 1999);

7. E-013-1998/0-US-07, “Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs”, by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number 09/623,000 (filed February 24, 1999);

8. E-013-1998/0-EP-08, “Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs”, by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number 03009396.7 (filed February 24, 1999);

to Ascenta Therapeutics, Inc, which is located in San Diego, CA. 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 human therapeutics for cancer.

DATES:

Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before October 3, 2005 will be considered.

ADDRESSES:

Requests for copies of the patent applications, inquiries, comments, and other materials relating to the contemplated exclusive license should be directed to: John Stansberry, Ph.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 patent applications for this technology contain composition of matter claims and method claims for treating proliferative diseases. The technology describes tyrphostins, which are a class of small molecules that were designed to act as tyrosine kinase inhibitors. One of these compounds, adaphostin (NSC 680410), was originally identified as an inhibitor of p210Bcr/abl kinase and a potent inducer of myeloid cell death in p210B^cr/abl -positive K562 cells in vitro. Recent studies report that adaphostin can induce cell death in Bcr/abl-negative leukemia cells, including B-cell chronic lymphocytic leukemia. Additional studies have demonstrated that this agent might induce cell death through elevation of reactive oxygen species (ROS) or down-regulation of VEGF rather than inhibition of p210B^cr/abl. Moreover, adaphostin in combination with other anti-cancer agents induces apoptosis in CLL-B cells.

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 sixty (60) days from the date of this published notice, the 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 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: July 26, 2005.

Steven M. Ferguson,

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