[Federal Register Volume 71, Number 51 (Thursday, March 16, 2006)]
[Notices]
[Pages 13621-13622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-3764]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: The inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing in the U.S. in accordance 
with 35 U.S.C. 207 to achieve expeditious commercialization of results 
of federally-funded research and development. Foreign patent 
applications are filed on selected inventions to extend market coverage 
for companies and may also be available for licensing.

ADDRESSES: Licensing information and copies of the U.S. patent 
applications listed below may be obtained by writing to the indicated 
licensing contact at the Office of Technology Transfer, National 
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, 
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A 
signed Confidential Disclosure Agreement will be required to receive 
copies of the patent applications.

Use of CYP1B1*3 Genotyping To Predict Survival to Docetaxel Treatment 
in Androgen-Independent Prostate Cancer

William D. Figg et al. (NCI).
U.S. Provisional Application No. 60/716,439 filed September 12, 2005 
(HHS Reference No. E-307-2005/0-US-01).
Licensing Contact: Mojdeh Bahar; 301/435-2950; [email protected].

    Androgen-independent prostate cancer (AIPC) remains the second 
leading cause of cancer death in men in developed nations, and it is 
estimated that one in six men will be diagnosed with prostate cancer. 
The use of docetaxel has been shown to prolong survival rate and 
improve the quality of life in patients suffering from AIPC.
    Scientists at NIH have identified a genetic marker called CYP1B1*3 
(4326C>G; L432V) that can predict survival in patients with prostate 
cancer prior to treatment with docetaxel. In a study of 25 patients 
suffering from AIPC, patients that were homozygous or heterozygous 
wild-type for the 4326C>G transition had an increased mean survival 
time after docetaxel treatment when compared to patients carrying the 
homozygous variant. These patients showed a survival rate of 15.3 
months compared to 7.5 months for those homozygous with the variant 
CYP1B1*3.
    This genetic marker (CYP1B1*3) can be measured in DNA obtained from 
a blood sample. This technology can be potentially used as a diagnostic 
tool to predict the patient's propensity to respond to docetaxel 
treatment when being treated for AIPC.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Adoptive Immunotherapy With Enhanced T Lymphocyte Survival

Steven A. Rosenberg et al. (NCI).
PCT Application No. PCT/US05/3640 filed October 7, 2005 (HHS Reference 
No. E-340-2004/2-PCT-01);
U.S. Provisional Application No. 60/617,340 filed October 8, 2004 (HHS 
Reference No. E-340-2004/0-US-01).
Licensing Contact: Michelle A. Booden; 301/451-7337; 
[email protected].

    Adoptive immunotherapy strategies have existed for several years 
now and many have proven to be highly successful in a limited subset of 
patients. This limited response rate among a diverse patient population 
may not be surprising, given the complexity of the immune system and 
the complicated evolution of a normal cell to a immune evading 
malignancy. A common observation amongst most patients that did not 
respond to adoptive therapy strategies is that the immune response to 
the cancer was not sustained.
    A number of cytokines have been shown to sustain a T-cell response 
when administered systemically with autologous isolated T-cells. 
However, the systemic delivery of many cytokines, such as IL-2, will 
cause significant toxicity before the beneficial immunologic effects of 
the autologous T-cells can occur. This invention describes a method of 
transfecting isolated autologous T-Lymphocytes with endogenous 
cytokines, for example IL-7 and IL-15, to sustain an adoptive T-
lymphocyte response without systemic toxicity. The invention also 
describes a method for improving expression of transfected cytokines 
via a codon optimized IL-15 vector. Applications of this technology 
beyond cancer include the potential use of cytokine expressing cells in 
treating

[[Page 13622]]

infectious and autoimmune diseases and vaccination.
    This invention was developed at the NCI Surgery Branch. The Surgery 
Branch plans to initiate clinical studies utilizing this technology and 
collaborative opportunities may be available. Publications which may 
provide background information for this technology include:
    1. Hsu C, Hughes MS, Zheng Z, Bray RB, Rosenberg SA, Morgan RA. 
Primary human T lymphocytes engineered with a codon-optimized IL-15 
gene resist cytokine withdrawal-induced apoptosis and persist long-term 
in the absence of exogenous cytokine. J Immunol. 2005 Dec 
1;175(11):7226-34.
    2. Rosenberg, SA and Dudley, ME. Cancer regression in patients with 
metastatic melanoma after the transfer of autologous antitumor 
lymphocytes. Proc Natl Acad Sci USA 2004 Oct 5;101 Suppl 2:14639-45. 
Epub 2004 Sep 20.
    3. Klebanoff CA, Finkelstein SE, Surman DR, Lichtman MK, Gattinoni 
L, Theoret MR, Grewal N, Spiess PJ, Antony PA, Palmer DC, Tagaya Y, 
Rosenberg SA, Waldmann TA, Restifo NP. IL-15 enhances the in vivo 
antitumor activity of tumor-reactive CD8+ T cells. Proc Natl Acad Sci 
USA 2004 Feb 17;101(7):1969-74. Epub 2004 Feb 04.
    4. Dudley ME, Rosenberg SA. Adoptive-cell-transfer therapy for the 
treatment of patients with cancer. Nat Rev Cancer. 2003 Sep;3(9):666-
75. Review.
    5. Liu K, Rosenberg SA. Interleukin-2-independent proliferation of 
human melanoma-reactive T lymphocytes transduced with an exogenous IL-2 
gene is stimulation dependent. J Immunother. 2003 May-Jun;26(3):190-
201.
    6. Liu K, Rosenberg SA. Transduction of an IL-2 gene into human 
melanoma-reactive lymphocytes results in their continued growth in the 
absence of exogenous IL-2 and maintenance of specific antitumor 
activity. J Immunol. 2001 Dec 1;167(11):6356-65.

Gene Therapy by Administration of Genetically Engineered CD34+ Obtained 
by Cord Blood

Robert M. Blaese (NCI), et al.
U.S. Patent No. 6,984,379 issued January 10, 2006 (HHS Reference No. E-
045-1995/0-US-01).
Licensing Contact: John Stansberry, Ph.D.; 301/435-5236; 
[email protected].

    This invention provides a method of providing a therapeutic effect 
in human patients by administering to the patient CD34+ cells obtained 
from umbilical cord blood. The CD34+ cells have been engineered with at 
least one nucleic acid sequence encoding a therapeutic agent. Such 
CD34+ cells could be engineered by transducing the cells with a 
retroviral vector including the nucleic acid sequence encoding the 
therapeutic agent. This method has been applied in treating new born 
infants suffering from adenosine deaminase (ADA) deficiency. This 
application was filed pre-GATT and is therefore valid 17 years from 
issued date of January 10, 2006.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

    Dated: March 8, 2006.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
 [FR Doc. E6-3764 Filed 3-15-06; 8:45 am]
BILLING CODE 4140-01-P