USA flag logo/image

An Official Website of the United States Government

ANTI-STATHMIN BIFUNCTIONAL SMALL HAIRPIN RNA: PRECLINICAL DEVE

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
96599
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
N43CO201000108
Solicitation Year:
N/A
Solicitation Topic Code:
NCI
Solicitation Number:
N/A
Small Business Information
MUREX PHARMA
1717 MAIN STREET, 60TH FLOOR DALLAS, TX 75201-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2010
Title: ANTI-STATHMIN BIFUNCTIONAL SMALL HAIRPIN RNA: PRECLINICAL DEVE
Agency: HHS
Contract: N43CO201000108
Award Amount: $199,045.00
 

Abstract:

The three basic requirements for an effective RNA interference-based therapy are 1) identification of key genetic defect[s] that provide pivotal survival advantage(s) to the overall cancer cell population; 2) construction of a potent and durable target-specific therapeutic agent; and 3) deployment of a tumor selective, non-immunogenic, RES-stealthed delivery vehicle. Stathmin 1 (STMN1), a critical regulator of tubulin polymerization/depolymerization, is overexpressed in 86% of our patients. We have constructed a unique bi-functional shRNA (bi-sh) with enhanced siRNA and miRNA activities. Bi-shSTMN1 is packaged as a decorated, reversibly masked, bilamellar invaginated lipoplex shorn of impurities through the use of a novel SuperClean DNA process. Our technical objective is to integrate this proprietary SuperClean DNA technology to extend the systemic therapeutic window of bi-shSTMN1. We will manufacture GMP grade SuperClean bi-shSTMN1 plasmid DNA and establish the systemic maximum tolerated dose of this lipoplex. By incorporating treatment controls of similarly-prepared parental GMP plasmid DNA, we can also identify toxicity that may be attributed to bi-shSTMN1 expression. These findings, together with the completion of our dose escalation Phase I protocol, will culminate in a phase I/II clinical study to determine safety and efficacy of systemic targeted delivery of BIV-bi-shSTMN1 with docetaxel in advanced melanoma.

Principal Investigator:

Alex Tong

Business Contact:

Dave Shanahan
(214) 220-4303
Small Business Information at Submission:

MUREX PHARMA
1717 MAIN STREET, 60TH FLOOR DALLAS, TX 75201-

EIN/Tax ID: 201931144
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No