[Federal Register Volume 73, Number 129 (Thursday, July 3, 2008)]
[Notices]
[Page 38233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-15182]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Public Teleconference Regarding Licensing and Collaborative 
Research Opportunities for: Methods and Compositions Relating to 
Detecting Dihydropyrimidine Dehydrogenase (DPD)

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

ACTION: Notice.

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Technology Summary

    This technology relates to a method of detecting DPD Splicing 
Mutations.

Technology Description

    Scientists at the National Cancer Institute have discovered a 
method detecting DPD Splicing Mutations. This method can identify 
patients with such mutations, and thereby alert the health care 
provider that the patient will have an adverse reaction to the 
chemotherapeutic agent, 5-Fluorouracil.
    The invention relates to methods and compositions that are useful 
for detecting deficiencies in DPD levels in mammals including humans. 
Cancer patients having a DPD deficiency are at risk of a severe toxic 
reaction to the commonly used anticancer agent 5-fluorouracil (5-FU). 
The technology encompasses DPD genes from human and pig, methods for 
detecting the level of nucleic acids that encode DPD in a patient, and 
nucleic acids that are useful as probes for this purpose.
    Novel applications of the methods include:
     Screening of patients prior to the administration of the 
chemotherapeutic agent, 5-Fluorouracil.
     Diminishing and potentially eliminating the severe side 
effects of 5-Fluorauracil in patients.

Competitive Advantage of Our Technology

    5-Fluorouracil (5-FU) is a therapeutic for the treatment of 
multiple cancers, including breast and colon cancers. In the United 
States, approximately 275,000 cancer patients receive 5-FU annually. It 
is estimated that three percent (3%) of those patients develop some 
degree of toxic reaction. Patients suffering toxic reactions are 
difficult and expensive to treat further. Approximately, 15% of those 
developing toxic reaction, will die as a result of exposure to 5-FU. 
Death is typically caused by cardiotoxicity. More than 1,300 patients 
in the United States die each year as a result of 5-FU toxicity. These 
deaths are all potentially avoidable if patients that are likely to get 
adverse reaction with 5-FU treatment are detected prior to treatment.

Patent Estate

    This technology consists of the following patents and patent 
applications:
    I. United States Patent Number 5,856,454 entitled ``cDNA for Human 
and Pig Dihydropyrimidine Dehydrogenase,'' issued January 5, 1999 (HHS 
Ref. No. E-157-1994/0-US-01);
    II. United States Patent Number 6,015,673 entitled ``Cloning and 
Expression of cDNA for Human Dihydropyrimidine Dehydrogenase,'' issued 
January 18, 2000 (HHS Ref. No. E-157-1994/0-US-03);
    III. United States Patent Number 6,787,306 entitled ``Methods and 
Compositions for Detecting Dihydropyrimidine Dehydrogenase Splicing 
Mutations,'' issued September 7, 2004 (HHS Ref. No. E-157-1994/1-US-
01);
    IV. United States Pre-Grant Publication number 2005/0136433A1 
corresponding to application serial number 10/911237 entitled ``Methods 
and Compositions for Detecting Dihydropyrimidine Dehydrogenase Splicing 
Mutations,'' published June 23, 2005 (HHS Ref. No. E-157-1994/1-US-19) 
and all issued and pending counterparts in Europe, Canada, and 
Australia.

Next Step: Teleconference

    There will be a teleconference where the principal investigator 
will explain this technology. Licensing and collaborative research 
opportunities will also be discussed. If you are interested in 
participating in this teleconference please call or e-mail Mojdeh 
Bahar; (301) 435-2950; [email protected]. OTT will then e-mail you 
the date, time and number for the teleconference.

    Dated: June 26, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer. National Institutes of Health.
[FR Doc. E8-15182 Filed 7-2-08; 8:45 am]
BILLING CODE 4140-01-P