Clinical Development of 4-Hydroperoxyifosfamide

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$539,124.00
Award Year:
2006
Program:
SBIR
Phase:
Phase II
Contract:
2R44CA094566-02A1
Award Id:
60049
Agency Tracking Number:
CA094566
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
725 TOPAZ STREET, NEW ORLEANS, LA, 70124
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
LEE MORGAN
(504) 583-6135
lrm1579@aol.com
Business Contact:
LEE MORGAN
(504) 288-5841
LRM1579@AOL.COM
Research Institution:
n/a
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.

* information listed above is at the time of submission.

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