[Federal Register Volume 68, Number 216 (Friday, November 7, 2003)]
[Notices]
[Pages 63113-63114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28056]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

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

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is 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 
application 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 application.

Cytotoxic Indeno- and Isoindenoisoquinoline Compounds

Yves G. Pommier (NCI).
U.S. Provisional Patent Application No. 60/469,718 filed 12 May 2003 
(DHHS Reference No. E-253-2003/0-US-01).
Licensing Contact: George Pipia; 301/435-5560; [email protected].

    The present invention is directed to novel indeno- and 
isoindenoisoquinoline compounds, their derivatives and their 
pharmaceutical formulations having anticancer activity, as well as 
methods of treating cancer. The invention is also directed to methods 
of preparing these novel compounds. These compounds have been tested 
against 55 tumor cell lines and have been found to have a strong 
activity against a wide variety of tumor cell lines, including lung, 
colon, central nervous system, melanoma, ovarian, renal, prostate and 
breast cancers, compared with 2-methoxy estradiols. Some of these 
compounds target topoisomerase I and remain active in camptothecin-
resistant cancer cells. It is expected that these compounds will be 
very useful in the treatment of a wide variety of cancers.

Identification of Novel Birt-Hogg-Dub[eacute] (BHD) Gene

Laura S. Schmidt (NCI).
PCT Application No. PCT/US03/17227 filed 30 May 2003 (DHHS Reference 
No. E-190-2002/2-PCT-01).
Licensing Contact: George Pipia; 301/435-5560; [email protected].

    Birt-Hogg-Dub[eacute] (BHD) syndrome is an inherited autosomal 
dominant neoplasia syndrome characterized by benign hair follicle 
tumors and is associated with a higher risk for developing renal 
cancer, spontaneous pneumothorax and/or lung cysts.
    The present invention describes identification of the BHD syndrome 
associated germline mutations in a novel human gene, herein called BHD 
gene. This gene encodes for the protein, folliculin, functions of which 
remain currently unknown.
    This discovery makes possible the development of a diagnostic 
method for BHD syndrome using a simple blood test. The test is 
particularly useful in detecting BHD mutations in asymptomatic carriers 
within BHD families.
    Patients with kidney tumors can be evaluated for BHD gene mutations 
using a similar genetic diagnostic test, which will allow for a more 
accurate diagnosis of a kidney cancer and improved patient prognosis. 
The BHD encoding sequence is the third gene found to be responsible for 
inherited kidney cancer, and mutation testing allows for a correct 
diagnosis and initiation of the proper treatment, which is different 
for each of the types of kidney cancer caused by the three genes.
    Methods of using BHD encoding sequence also allows for a 
differential genetic diagnosis of spontaneous pneumothorax, or 
collapsed lung. Since collapsed lung can be caused by several factors, 
a BHD diagnostic test allows a physician to determine predisposition to 
and possible recurrence of additional spontaneous pneumothoraces due to 
mutation(s) in the BHD gene.

[[Page 63114]]

    The discovery should also lead to the development of novel 
pharmaceutical products and methods for treating BHD skin lesions using 
creams containing the BHD gene product, folliculin. Such products and 
methods of treatment are expected to reduce the size and appearance of 
the benign hair follicle tumors.
    The disclosed technology will provide new and exciting 
methodologies to correctly diagnose BHD syndrome and should lead to the 
development of novel pharmaceutical reagents for treatment of BHD skin 
lesions as well as other skin diseases.
    This research is also described in: Nickerson et al., Cancer Cell 
2: 157, 2002; Zbar et al., Cancer Epidem. Bio. Prev. 11: 393, 2002; 
Schmidt et al., Am. J. Hum. Genet. 69: 876, 2001; Toro et al., Arch. 
Dermatol. 135: 1195, 1999.

    Dated: October 27, 2003.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 03-28056 Filed 11-6-03; 8:45 am]
BILLING CODE 4140-01-P