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Notice

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

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AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

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; baharm@mail.nih.gov. OTT will then e-mail you the date, time and number for the teleconference.

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Dated: June 26, 2008.

Richard U. Rodriguez,

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

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[FR Doc. E8-15182 Filed 7-2-08; 8:45 am]

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