Gel-forming Systems for Adhesion Prevention

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$726,047.00
Award Year:
2004
Program:
SBIR
Phase:
Phase II
Contract:
2R44GM063291-02A1
Award Id:
54545
Agency Tracking Number:
1R43GM063291-01
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
POLY-MED, INC., 6309 HWY 187, ANDERSON, SC, 29625
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
SHALABY SHALABY
(864) 646-8544
SHALABY@POLY-MED.COM
Business Contact:
JOANNE SHALABY
(864) 646-8544
SHALABY@POLY-MED.COM
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): Phase I study directed toward minimizing or preventing post-operative adhesion (POA) demonstrated that (1) a drug-free, gel-forming copolyester vehicle is more effective than hyaluronic acid (HA); (2) HA-based formulations are generally less effective than their non-aqueous copolyester, gel-forming counterparts; (3) antiangiogenic peptide and, in particular, the somatostatin analog (lanreotide acetate, LN) in a copolyester gel-forming vehicle are much more effective toward POA prevention than any other individual bioactive agent examined; and (4) certain anti-inflammatory drugs, and particularly, naproxen sodium (NP) have promising anti-adhesion properties. Phase 2 objectives are to (1) select an optimum gel-forming copolyester vehicle for the controlled release of an optimized, effective dose of NP and/or LN; (2) complete the development and scale-up studies of a selected formulation; and (3) initiate the safety study in collaboration with a marketing partner and complete commercialization plans for an anti-adhesion product in Phase II1. Accordingly, Phase II plans entail (1) optimizing the composition and volume of the non-aqueous, two-component, gel-forming copolyester gel-former (GF) to maximize its own ability to minimize POA, using a rat sidewall model (RT-SWM) and selecting one for testing the vehicle for the controlled release of naproxen sodium (NP) and/or LN; (2) optimizing the concentration of NP and LN in the selected GF composition to achieve maximum efficacy toward POA prevention using a RT-SWM; (3) determining the efficacy of selected combinations of NP and LN in GF using a RT-SWM; (4) conducting comparative studies of optimized NP, LN, and NP + LN formulations using a RT-SWM and a rabbit sidewall model (RB-SWM) and selecting one system for completing a study using a pig sidewall model (PG-SWM) for initiating additional studies as needed for regulatory approval; and (5) completing development and scale-up studies of the selected GF and its selected formulation.

* information listed above is at the time of submission.

Agency Micro-sites


SBA logo

Department of Agriculture logo

Department of Commerce logo

Department of Defense logo

Department of Education logo

Department of Energy logo

Department of Health and Human Services logo

Department of Homeland Security logo

Department of Transportation logo

Enviromental Protection Agency logo

National Aeronautics and Space Administration logo

National Science Foundation logo
US Flag An Official Website of the United States Government