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Clinical Development of 4-Hydroperoxyifosfamide

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
60049
Program Year/Program:
2006 / SBIR
Agency Tracking Number:
CA094566
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
DEKK-TEC, INC.
725 TOPAZ STREET NEW ORLEANS, LA 70124-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2006
Title: Clinical Development of 4-Hydroperoxyifosfamide
Agency: HHS
Contract: 2R44CA094566-02A1
Award Amount: $539,124.00
 

Abstract:

DESCRIPTION (provided by applicant): 4-Hydroperoxyifosfamide (HOO-IFOS) is a stable, pre-activated form (peroxide) of 4-HO-IFOS, the initial metabolite of Ifosfamide (IFOS). Under physiological conditions HOO-IFOS under goes spontaneously ring opening and conversion to isophosphoramide mustard (IPM), the active cytotoxic metabolite of IFOS. The objective of the proposed research is to synthesize 4-hydroperoxyifosfamide (HOO-IFOS) in sufficient quantity to document and validate purity and stability. A lyophilized product will be prepared at The University of Iowa, Pharmaceutical Services under GLP/GMP guidelines for clinical use in patients with advanced cancer. GC/MS and HPLC assays will be validated for quantification of bulk and pharmaceutical grade drug. Toxicology studies using a 3-day dosing regime in mice and dogs will be conducted at a GLP facility using the final product. An assay to monitor plasma HOO-IFOS PK and acrolein/chloroacetaldehyde levels in dogs receiving HOO- IFOS will be finalized. An IND package will be prepared after all the above has been finalized and submitted to the FDA. In summary - HOO-IFOS had improved anticancer activities vs. human glioblastoma and breast cancer xenografts and CPA-resistant leukemia murine models. The goal of the SBIR application will be to develop a new pro-drug, 4-hydroperoxyifosfamide (HOO-IFOS) that will generate in vivo - isophosphoramide mustard (IPM) - with reduced formation of associated toxic - chloroacetaldehyde and acrolein - by-products, normally produced during IFOS.

Principal Investigator:

Lee R. Morgan
5045836135
lrm1579@aol.com

Business Contact:

Lee Morgan
5042885841
LRM1579@AOL.COM
Small Business Information at Submission:

DEKK-TEC, INC.
725 TOPAZ STREET NEW ORLEANS, LA 70124

EIN/Tax ID: 720976996
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No