USA flag logo/image

An Official Website of the United States Government

TUMOR IMMUNOTHERAPY WITH BIODEGRADABLE MICROSPHERES

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
65283
Program Year/Program:
2003 / SBIR
Agency Tracking Number:
CA085097
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
THERAPYX, INC.
138 FARBER HALL 3435 MAIN STREET BUFFALO, NY 14214
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2003
Title: TUMOR IMMUNOTHERAPY WITH BIODEGRADABLE MICROSPHERES
Agency: HHS
Contract: 2R44CA085097-02
Award Amount: $2,555,134.00
 

Abstract:

DESCRIPTION (provided by applicant): Proof of principle for the feasibility of our proprietary tumor vaccination strategy involving the use of Interleukin-12-encapsulated microspheres has been demonstrated in Phase I studies. A single intra-tumoral injection of Interleukin-12-encapsulated biodegradable microspheres induces the complete regression of small primary tumors, promotes the development of long-term systemic anti-tumor immunity and results in the eradication of established disseminated disease in murine tumor models. In this Phase II application, we propose to perform extensive product development work, complete the toxicology/pharmacology studies and develop a clinical treatment protocol in preparation for IND filing. To this end, in Aims 1, 2 and 3, we will focus on product development studies including analytical assay development (Aim 1), process development for scale-up and stability analysis (Aim 2) and formulation development work to improve product stability (Aim 3). Pharmacokinetic and toxicological characterization of the product will be performed in Aim 4. In Aim 5, the optimized formulation will be used to evaluate the effect of dose, treatment schedule and booster vaccinations on long-term cure of disseminated disease in a pre-clinical routine tumor model. The optimal treatment strategy identified in Aim 5 will provide the blueprint for a Phase I clinical trial protocol. These studies are expected to generate the data that is necessary for IND approval.

Principal Investigator:

Nejat K. Egilmez
5028524030
NEJAT.EGILMEZ@LOUISVILLE.EDU

Business Contact:


7168292701
Small Business Information at Submission:

THERAPYX, INC.
THERAPYX, INC. 138 FARBER HALL BUFFALO, NY 14214

EIN/Tax ID: 161613097
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No