05-15345. Prospective Grant of an Exclusive License: Therapeutics for the Treatment of Kidney Cancer and Thyroid Neoplasms

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

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

1. E-199-2002/0-US-01, “Treatment Method and Therapeutic Agent of Kidney Cancer”, by Susan Bates, and Yoshinori Naoe, Pat. Application No. 60/369,868 (filing date April 5, 2002);

2. E-199-2002/0-PCT-02, “Treatment Method and Therapeutic Agent of Kidney Cancer”, by Susan Bates, and Yoshinori Naoe, Pat. Application No. PCT/US03/03823 (filing date March 27, 2003);

3. E-199-2002/0-US-04, “Depsipeptide for Therapy of Kidney Cancer”, by Susan Bates, and Yoshinori Naoe, Pat. Application No. 10/508,958 (filing date October 5, 2004);

4. E-199-2002/0-JP-08, “Depsipeptide for Therapy of Kidney Cancer”, by Susan Bates, and Yoshinori Naoe, Pat. Application No. 20003581847 (filing date October 5, 2004);

5. E-199-2002/0-EP-05, “Depsipeptide for Therapy of Kidney Cancer”, by Susan Bates, and Yoshinori Naoe, Pat Application No.037155033-2107 (filing date October 8, 2004);

6. E-286-2000/0-US-01, “Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms”, by Tito Fojo and Susan Bates, Pat. Application No. 60/260,733 (filing date January 10, 2001);

7. E-286-2000/0-US-02, “Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms”, by Tito Fojo and Susan Bates, Pat. Application No. PCT/US02/0714 (filing date January 9, 2001);

8. E-286-2000/0-EP-03, “Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms”, by Tito Fojo and Susan Bates, Pat. Application No. 02718823.4 (filing date January 9, 2001);

9. E-286-2000/0-AU-04, “Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms”, by Tito Fojo and Susan Bates, Pat. Application No. 2002249938 (filing date January 9, 2001);

10. E-286-2000/0-CA-04, “Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms”, by Tito Fojo and Susan Bates, Pat. Application No. 2434269 (filing date January 9, 2001);

11. E-286-2000/0-US-07, “Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms”, by Tito Fojo and Susan Bates, Pat. Application No. 10/250,320 (filing date June 26, 2003);

12. E-286-2000/0-JP-05, “Histone Deacetylase Inhibitors in Diagnosis and Treatment of Thyroid Neoplasms”, by Tito Fojo and Susan Bates, Pat. Application No. 2002-556736 (filing date July 10, 2003)

to Gloucester Pharmaceticals, having a place of business in Cambridge, MA. 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 therapeutics for the treatment of Kidney Cancer and Thyroid Neoplasms.

DATES:

Only written comments and/or license applications which are received by the National Institutes of Health on or before October 3, 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: John Stansberrry, 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 inventions describe methods of treating kidney cancer and thyroid neoplasms with FK228, which is a histone deacetylase (HDAC) inhibitor. FK228 is currently in Phase II clinical trials, and has been shown to inhibit histone deacetylation, a process instrumental in the regulation of gene expression. FK228 modulates cell cycle arrest and can promote differentiation and apoptosis. To date, FK228 has been administered to more than 300 patients and has shown promising clinical activity in Phase II trials for patients with cutaneous T-cell lymphoma (CTCL). Clinical responses have also been observed in Phase II studies in peripheral T-cell lymphoma, renal cell carcinoma (RCC) and hormone refractory prostate cancer (HRPC).

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 establish 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.