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Arginine deiminase as an Anti-Cancer Therapy

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
55570
Program Year/Program:
2001 / SBIR
Agency Tracking Number:
2R44CA078028-02A1
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
PHOENIX PHARMACOLOGICS, INC.
PHOENIX PHARMACOLOGICS, INC. ASTECC FACILITY #A-217 LEXINGTON, KY 40506
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2001
Title: Arginine deiminase as an Anti-Cancer Therapy
Agency: HHS
Contract: N/A
Award Amount: $0.00
 

Abstract:

DESCRIPTION: The distinctive arginine requirement of hepatocellular carcinomas and malignant melanomas provides the basis for a new potential chemotherapy. Just as acute lymphocytic leukemia cells require asparagine and E. coli asparaginase enzyme can be used to effect a cure for this disease, we propose using a mycoplasma derived arginine deiminase (ADI) to treat hepatocellular carcinoma and malignant melanomas. As a result of Phase I funding we have discovered a method where by ADI can be formulated with polyethylene glycol (PEG) such that it has a much longer circulating half-life in mice and is less immunogenic. When ADI formulated with PEG is injected into mice it selectively reduces the plasma levels of arginine and starves human melanomas and hepatocellular carcinomas implanted into these animals. This treatment is also being tested in dogs with spontaneous melanoma (under an INAD received from the FDA) and is quickly being proven to be an effective means of treating spontaneous melanoma with very few, if any, side effects. We have requested and received an Orphan Drug Designation for this project and in a Pre-IND meeting with the FDA and the Orphan drug Office, delineated the experiments needed to file a Phase I IND to permit human testing of this drug. The studies proposed in this grant reflect the FDA requirements and when completed will allow for the testing of ADI formulated with PEG in humans. The studies proposed include the validation of the process used to make (under GMP conditions) 3 lots of ADI-PEG, characterize these lots with validated procedures, obtain pharmacodynamic and pharmacokinetic data that will allow allometric modeling of the predicted human dosing and perform the necessary immunological and toxicological testing needed for this project to progress into human clinical testing. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

Principal Investigator:

Mike A. Clark

Business Contact:


8592579027
MACLARL@POP.UKY.EDU
Small Business Information at Submission:

PHOENIX PHARMACOLOGICS
ASTECC FACILITY #A-217 UNIVERSITY OF KENTUCKY LEXINGTON, KY 40506

EIN/Tax ID: 232927291
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No