Pneumedoreductive Surfacant - New Therapy for Emphysema

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$95,000.00
Award Year:
2004
Program:
SBIR
Phase:
Phase I
Contract:
1R43HL077961-01
Award Id:
71003
Agency Tracking Number:
HL077961
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
AERIS THERAPEUTICS, INC., 10-A ROESSLER RD, WOBURN, MA, 01801
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
EDWARD INGENITO
(617) 732-7420
EINGENITO@PARTNERS.ORG
Business Contact:
DAVID DOVE
(781) 937-0110
DOVE@BISTECHINC.COM
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): This Phase I SBIR application is presented by Bistech, Inc. of Woburn, MA. It will test the feasibility of using a new inhaled pharmaceutical agent, pneumoreductive surfactant (PRS), to treat pulmonary emphysema, a progressive and disabling disease that affects millions of individuals throughout the world. Existing medical therapies for emphysema, such as bronchodilators and anti-inflammatory drugs, are of limited benefit since they do not address the fundamental physiological defect in this disease: loss of elastic recoil caused by destruction of the collagen and elastin fibers of the lung. Two factors determine lung elastic recoil: 1) stretching of the tissue fiber network and 2) surface tension generated by the surface film at the alveolar air-liquid interface. In, theory, elastic recoil could be restored in emphysema either by repairing the tissue fiber network or by increasing surface tension. While medical therapies cannot readily accomplish the former, they may be able to accomplish the latter. Prototype formulations of pneumoreductive surfactant have been developed by Bistech. In preliminary in vitro testing and short term in vivo testing, these formulations appear to increase recoil effectively and safely. The studies proposed here will extend these preliminary observations, and examine whether PRS can be developed for clinical testing. The specific aim of this proposal is to evaluate short and long term physiological and biological responses to PRS administration in an experimental model of emphysema that accurately represents the disease as it presents in humans. The studies are designed to provide detailed information about the effects of PRS on lung function in vivo, and to identify any potential toxic effects of prolonged PRS exposure. If Phase I proves successful, a Phase II application will be filed to complete preclinical animal testing and product formulation, initiate pharmacology-toxicology studies, develop a manufacturing plan, and begin the planning of a Phase 1 clinical trial in human patients.

* information listed above is at the time of submission.

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