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Camptothecin Analogs for Cancer Therapy

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
85409
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
CA125871
Solicitation Year:
N/A
Solicitation Topic Code:
NCI
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: 2010
Title: Camptothecin Analogs for Cancer Therapy
Agency: HHS
Contract: 2R44CA125871-02
Award Amount: $837,217.00
 

Abstract:

DESCRIPTION (provided by applicant): 7-Butyl-10-aminocamptothecin (BACPT), as a water-soluble dipeptide pro-drug - BACPTDP, is a novel camptothecin analog that has increased activity in hypoxic/acidic tumor tissues, characteristic of fast growing cancers t hat characteristically have deficient vasculature and outgrow their blood supply. Both in vitro and in vivo studies support the potential usefulness of BACPTDP in the treatment of pancreatic cancer. The significant responses seen with BACPTDP in the human PANC-1 xenograft model vs. other CPT controls are reviewed in support for the pre-clinical studies proposed in this application. The specific objectives of this Phase II study will be to: 1. Synthesize 7-butyl-10-aminocamptothecin dipeptide (BACPTDP) in 10 -20 g quantities - sufficient for preclinical studies and formulation studies. 2. Conduct mouse and dog toxicity and pharmacokinetic studies. 3. Formulate the drug as a lyophilized powder. Document stability and potential clinical usefulness. 4. Develop a nd assay tissue/blood biomarkers as indicators for BACPTDP absorption and efficacy (pharmacodynamics). 5. Prepare the IND for future Phase I studies. Upon completion of these studies an FDA IND submission will be made. PUBLIC HEALTH RELEVANCE: BACP TDP is a novel camptothecins that was originally designed at Duke University to be used in the treatment of hypoxic, poorly vascularized tumors that possessed acidic environments. Studies conducted in the Phase I grant in pancreas, colon, ovarian and lung cancer xenograft models and reviewed herein, support our decision to move the product forward and ready it for clinical trials. Subsequently, DEKK-TEC has partnered with Duke and Research Triangle Institute (RTI) to complete the pre-clinical development, p repare the IND and ready the products for a Phase 1 clinical trial. Prior to the latter, DEKK-TEC proposes conducting the necessary pre- clinical toxicity, pharmacokinetic, formulation and stability studies. The studies as described will fulfill the requir ements for a Phase I study to be designed.

Principal Investigator:

Lee R. Morgan
5045836135
LRM1579@AOL.COM

Business Contact:


lrm1579@aol.com
Small Business Information at Submission:

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

EIN/Tax ID: 172097699
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No