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ORAL THERAPEUTICS FOR VIRAL MALIGNANCIES

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42CA081857-02
Agency Tracking Number: CA081857
Amount: $0.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 2002
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
GENE REGULATION LABORATORIES 45 BEAVER RD
WESTON, MA 02493
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 DOUGLAS FALLER
 (617) 638-4173
 DFALLER@BU.EDU
Business Contact
 SUSAN PERRINE
Phone: (617) 638-5639
Email: SPERRINE@GENEREGULATIONLABORATORIES.COM
Research Institution
N/A
Abstract

DESCRIPTION (provided by applicant): Epstein-Barr virus (EBV) is associated with a number of human lymphoid malignancies and carcinomas for which there are presently few effective treatments. Each year in the U.S., there are approximately 27,000 people afflicted with diseases caused by the Epstein-Barr virus, and an additional 107,000 people afflicted with malignancies associated with the Epstein-Barr virus. Worldwide, EBV-associated diseases are even more common, and current treatments are typically unsuccessful. Under FDA IND #47,529, we are currently testing Arginine Butyrate in combination with ganciclovir for treatment of these malignancies. Arginine Butyrate induces the latent EBV-enzyme thymidine kinase (TK), which, in turn, renders the EBV-positive malignant cells susceptible to killing by the anti-viral agent ganciclovir. This therapeutic strategy has been successful in early trials. Arginine butyrate, however, has drawbacks as a therapeutic, requiring constant, IV infusion to achieve detectable plasma levels. The development of new, oral agents will allow this therapy to be extended to a larger population of patients and a wider group of diseases. We already have proof-of principal that such orally-active agents can be developed. Our aims from the Phase I STTR were to identify new, long-lived, orally-bioavailable derivatives of our first, prototype drug, Arginine Butyrate, as therapeutics for the therapy of Epstein Barr virus (EBV)-associated malignancies. In this Phase II application, we propose to conduct formal preclinical development studies of a lead new compound, as required by the FDA, to obtain Investigational New Drug Status to begin Phase I clinical trials in humans. The aims of this proposal are: To prepare a medicinal formulation of the sodium salt of ST101, a synthetic SCFAD which ates EBV TK expression, to refine oral dosing-regimens for ST101, to prepare an Investigational New Drug (IND) Application for sodium ST101, and to evaluate additional SCFADs for activity in induction of EBV TK.

* Information listed above is at the time of submission. *

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