EGF/Gastrin for Islet Regeneration

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$1,543,646.00
Award Year:
2013
Program:
SBIR
Phase:
Phase II
Contract:
2R44DK084724-03A1
Award Id:
n/a
Agency Tracking Number:
R44DK084724
Solicitation Year:
2013
Solicitation Topic Code:
NIDDK
Solicitation Number:
PA12-088
Small Business Information
19805 N. Creek Pkwy, Suite 200, Bothell, WA, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
167580682
Principal Investigator:
GERARDO CASTILLO
(206) 568-1499
gcastillo@pharmain.com
Business Contact:
MALISSA KILCUP
(206) 451-7105
gms@pharmain.com
Research Institution:
Stub




Abstract
DESCRIPTION (provided by applicant): New therapies are desperately needed to relieve patients with Type 1 diabetes from the neuropathy, nephropathy and retinopathy associated with the current standard of treatment, injected insulin. Transplantation of pancreatic islet -cells, in combination with immunosuppressant to avoid immune rejection, is restricted to a subgroup of diabetics and is limited by the shortage in availability of donor islets. Combination treatment using Epidermal Growth Factor Receptor Agonist (EGFRA) and Gastrin (G17) results in an increase in -cell mass and reverses hyperglycemia in diabetic mice and rats. Because of short half-life (minutes) of both G17 and EGFRA, these were administered by infusion (rats) or frequent daily injection (mice) and a clinical trial of this treatment combination suffered from limited efficacy. Results from Phase 1 SBIR demonstrated the proof of concept that the experimental diabetes treatment using a combination of EGFRA and G17 can be improved significantlyby the use of EGFRA with Protected-graft-copolymer (PGC) excipient (PGC-EGFRA). The PGC protects and stabilizes EGFRA in the blood (10- fold stabilization) in combination with Omeprazole (OPZ), an over the counter proton pump inhibitor for the treatment ofstomach hyperacidity. The OPZ in this combination provides sustained elevation (up to 1000 fold over the baseline) of blood G17 level (over 24hr versus few minutes from G17 injection) without the associated hyperacidity of the stomach. The aims of the Phase 2 SBIR are to 1) produce well characterized PGC formulations, 2) find the maximum tolerable dose (MTD) of the formulations and the most effective dosing regimen for the treatment of STZ-diabetic mice, and 3) find the most effective dosing regimen for each formulation with or without Anti-CD3 for the treatment of NOD mice to achieve a cure rate of higher than 60%, and 4) to evaluate stability and safety of each formulation. At the end of Phase 2, we will have a single treatment regimen which we will use to collect data for an IND filing. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: This Phase 2 application will be a full pre-clinical development and optimization of the treatment regimen effective in preserving and enhancing islet -cell function in diabetic mice. This treatment will alleviate suffering of people with diabetes and will be a cost saving treatment that will reduce the economic burden to society. The eventual goal is the filing of an IND application with the FDA.

* information listed above is at the time of submission.

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