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Outpatient treatment for portal hypertension

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
96028
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
DK085754
Solicitation Year:
N/A
Solicitation Topic Code:
NIDDK
Solicitation Number:
N/A
Small Business Information
PHARMAIN CORPORATION
19805 N. Creek Pkwy, Suite 200 Bothell, WA -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2010
Title: Outpatient treatment for portal hypertension
Agency: HHS
Contract: 1R43DK085754-01
Award Amount: $223,422.00
 

Abstract:

DESCRIPTION (provided by applicant): Portal hypertension (increased pressure in the portal venous system) is one of the main consequences of cirrhosis. Although the reduction of portal hypertension is well documented to prevent the development of life-thre atening consequences, including bleeding esophageal varices and hepatorenal syndrome (HRS), pharmacological treatment options are severely limited. The synthetic peptide drug terlipressin has been used in Europe for the past twenty years as one of the safe st, most cost-effective and economical drugs to reduce portal hypertension and treat bleeding varices and hepatorenal syndrome. However, its short half life necessitates its administration by IV 4-6x daily, limiting its application to the acute care settin g. Our long term goal, in collaboration with our commercialization partner LAT-Pharma LLC, is to develop a long-acting formulation of terlipressin that can be ideally administered by sub-Q injection allowing for once daily administration for the management of portal-hypertension. The aims of the Phase I project are directed toward demonstrating that formulation of terlipressin with our proprietary nanocarrier affords an increase in half-life and a sustained release of the active agent with a prolonged pharm acological effect in vivo compatible with once-daily dosing. Terlipressin is currently not approved in the US and the envisioned drug candidate would have a significant market opportunity both in the acute care setting for life-threatening consequences of portal hypertension, and in the outpatient setting for the prophylactic treatment of portal hypertension. PUBLIC HEALTH RELEVANCE: The envisioned drug candidate is expected to be the first agent available that will allow cirrhotic patients and their physicians reduce portal hypertension in the outpatient setting, thereby avoiding emergency treatment of life-threatening bleeding variceal ruptures and Hepatorenal syndrome.

Principal Investigator:

Elijah M. Bolotin
2068606769
EBOLOTIN@PHARMAIN.COM

Business Contact:

Cherri Poe
ebolotin@pharmain.com
Small Business Information at Submission:

PHARMAIN CORPORATION
PHARMAIN CORPORATION 720 BROADWAY, STE 511 SEATTLE, WA 98122

EIN/Tax ID: 136435786
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No