Not Available

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$1,002,558.00
Award Year:
2010
Program:
SBIR
Phase:
Phase II
Contract:
N44CO201000100
Award Id:
94156
Agency Tracking Number:
N43CO0800065
Solicitation Year:
n/a
Solicitation Topic Code:
NCI
Solicitation Number:
n/a
Small Business Information
2814 WILD PLUM CT., COLUMBIA, MO, 65201-
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
787875579
Principal Investigator:
WYNN VOLKERT
Business Contact:
(573) 639-2615
Research Institution:
n/a
Abstract

As part of the SBIR Phase I effort, Nanoparticle Biochem Inc has successfully completed detailed therapeutic efficacy studies of NBI-29 (GA-198AuNP; GA = gum arabic) in prostate tumor bearing mice and toxicity studies of the non radioactive surrogate of NBI 29 in pigs. In order to clinically translate NBI-29 for treating prostate tumor human patients, the objectives of this SBIR Phase II proposal will involve: (i) development of quality control methods for the optimized final formulation of NBI-29 to meet the standards of safety, identity, strength, quality and purity required for investigational drugs; (ii) determination of the biodistribution and radiation dose delivered to normal organs from NBI-29 released from the prostate gland in normal dogs; (iii) determination of diffusion and retention of NBI-29 in prostate gland in dogs; (iv) development of intra-prostate CT-guided multi-injection protocol to maximize the homogeneity of the radiation dose delivered throughout the prostate gland in normal dogs; and (v) evaluation of therapeutic efficacy in prostate tumor bearing dogs. The completion of toxicity/therapeutic efficacy in dogs, as envisaged in the SBIR Phase II effort, will allow filing of an IND application with the US FDA to commence Phase I clinical trials in human prostate cancer patients.

* information listed above is at the time of submission.

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