E7-12534. Government-Owned Inventions; Availability for Licensing

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

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: [phone]; fax: [phone]. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.

Orally Active Derivatives of 1,3,5(10)-estratriene

Description of Technology: The utility of estrogenic substances in the practice of medicine is well documented. Estrogens may be used for the replacement of the natural hormone estradiol in hypogonadism, and following the removal of the ovaries or cessation of ovarian activity during menopause. They are also widely employed as a component of oral contraceptives. However, orally-active synthetic estrogens are associated with a number of side effects, such as: Enhanced risk of endometrial carcinoma; induction of malignant carcinoma, especially in the cervix, breast, vagina and liver; promotion of gallbladder disease, thromboembolic and thrombotic diseases, myocardial infarction, hepatic adenoma, elevated blood pressure, and hypercalcemia; and reduced glucose tolerance.

The NIH announces a new family of novel, active estrogens that are nitrate esters of estradiol. These nitrate esters possess enhanced estrogenic activity following oral administration and lack a 17-ethynyl alcohol, which has been implicated in many side effects attributed to other synthetic estrogens. It is anticipated that these esters could be used in all instances where estrogen is prescribed as a treatment.

Applications: Hormone replacement therapies; Oral contraceptives.

Market: The hormone replacement market exceeds one billion dollars per year, and the oral contraceptive market is more than three billion dollars per year.

Development Status: Early stage.

Inventors: Hyun K. Kim et al. (NICHD).

Patent Status: U.S. Patent 5,554,603 issued 10 Sep 1996 (HHS Reference No. E-137-1993/0-US-01); Foreign counterparts in Australia, Canada, Japan, and Europe.

Licensing Status: Available for exclusive or non-exclusive licensing.

Licensing Contact: Tara L. Kirby, PhD; 301/435-4426; [e-mail].

Methods of Inducing Immune Tolerance Using Immunotoxins

Description of Invention: The invention concerns immunotoxins and methods of using the immunotoxins for the treatment of rejection response in a patient, including graft-versus-host disease and transplantation of organs, tissues and cells into a host. In a specific embodiment of the invention, the transplant involves pancreatic islet cells. The immunotoxins are targeted via an antibody that is specific to T cells. This allows the specific ablation of resting T cells, resulting in an accentuation of immune tolerizing responses and an increased tolerance to transplants and grafts. The toxin portion of the immunotoxin is genetically engineered to maintain bioactivity when recombinantly produced in Pichia pastoris. Data are available in transgenic animals expressing human CD3ε which supports the effects of the immunotoxin against T cells.

Applications: Use of immunotoxins decreases T cell population, allowing greater host immune tolerance of transplants and grafts; Specific method for increasing immune tolerance to pancreatic islet transplants.

Advantages: Specificity of the immunotoxin avoids the killing of other cells, reducing side-effects associated with other mechanisms of treatment (X-ray and cyclophosphamide) such as infection and induced malignancy; A GMP production process for the immunotoxin has already been successfully implemented.

Benefits: New methods and compositions with limited side-effects have the potential to revolutionize treatment of transplant/graft recipients; provides an opportunity to capture a significant market share for the millions of people who require transplants/grafts.

Inventors: David Neville et al. (NIMH).

Patent Status: U.S. Patent No. 5,167,956 issued 01 Dec 1992 (HHS Reference No. E-012-1991/0-US-01); U.S. Patent No. 5,762,927 issued 09 Jun 1998 (HHS Reference No. E-012-1991/4-US-02); U.S. Patent No. 6,103,235 issued 15 Aug 2000 (HHS Reference No. E-012-1991/7-US-01); U.S. Patent No. 7,125,553 issued 24 Oct 2006 (HHS Reference No. E-012-1991/7-US-02); U.S. Patent Application No. 09/810,999 filed 16 Mar 2001, which published as U.S. 2001/0024645 on 27 Sep 2001, Allowed (HHS Reference No. E-059-1998/0-US-02); International Patent Application No. PCT/US00/10253 filed 14 Apr 2000, which published as WO 00/61132 on 19 Oct 2000 (HHS Reference E-168-1999/0-PCT-02); U.S. Patent No. 6,632,928 issued 14 Oct 2003 (HHS Reference No. E-044-1997/0-US-07); U.S. Patent Application No. 10/435,567 filed 09 May 2003, which published as 2003/0185825 on 02 Oct 2003 (HHS Reference No. E-044-1997/0-US-08); U.S. Patent Application No. 10/296,085 filed 18 Nov 2002, which published as 2004/0127682 on 01 Jul 2004 (HHS Reference No. E-044-1997/1-US-06); Foreign rights are also available.

Licensing Status: Available for exclusive or non-exclusive licensing.

Licensing Contact: David A. Lambertson, PhD; 301/435-4632; [e-mail].

Collaborative Research Opportunity: The National Institute of Mental Health, Laboratory of Molecular Biology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize methods of using the immunotoxins for the treatment of rejection response in a patient. Please contact David Neville at [e-mail] for more information.

Dated: June 20, 2007.

Steven M. Ferguson,

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