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A Pilot Clinical Study in Acute STEMI

Award Information

Department of Health and Human Services
Award ID:
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
Solicitation Year:
Solicitation Topic Code:
Solicitation Number:
Small Business Information
51 Charles Lindbergh Blvd Uniondale, NY -
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
Phase 2
Fiscal Year: 2010
Title: A Pilot Clinical Study in Acute STEMI
Agency: HHS
Contract: 2R44HL091699-02A2
Award Amount: $2,914,839.00


DESCRIPTION (provided by applicant): Percutaneous coronary intervention (PCI) has become the mainstay for treatment of ST-segment elevation myocardial infarction (STEMI). Whereas early recanalization undoubtedly salvages myocardial tissue, reperfusion foll owing prolonged ischemia can also exacerbate injury. Infarct size needs to be limited, and the conditions favoring adaptive ventricular healing and remodeling optimized because in patients with acute myocardial infarction (AMI) who do not die of out-of-hos pital arrhythmias, long-term prognosis is dependent on the amount of myocardium that is lost, and the outcome of ventricular remodeling. Scatter factor / hepatocyte growth factor (SF/HGF) is an endogenous cell survival factor that exerts both acute and chr onic cardioprotective effects and can potentially be harnessed for salvaging the ischemic myocardium. The feasibility of SF/HGF as gene or protein therapy however is limited by issues relating to immune and inflammatory responses evoked by adenoviral prote ins, inherent instability of proteins in solution, their limited tissue half-life and the exorbitant costs associated with such therapy. Supported by the National Institutes of Health (NIH) Small Business Innovative Research (SBIR) and Rapid Access to Inte rventional Development (RAID) programs, we have identified and developed BB3, a novel small molecule SF/HGF mimetic. BB3 duplicates the bioactivities of the native protein in every assay tested to date. In single cardiocyte models simulating ischemia-reper fusion injury, BB3 attenuates apoptotic and necrotic death. In the isolated perfused heart, BB3 improves postischemic function and in in vivo experimental normothermic myocardial ischemia- reperfusion, systemic BB3 administration attenuates infarct size wh en administered 24 hours following onset of reperfusion. Of significant clinical interest is our finding that delayed BB3 administration also attenuates post-infarct ventricular dysfunction in both rat and pig. Furthermore, delayed BB3 administration confe rs functional and infarct-sparing benefit in renal, hepatic and cerebral models of ischemic and/or traumatic injury, preventing transition of these organs to failure. Supported by the SBIR program, a comprehensive panel of preclinical regulatory studies co mprising genotoxicology, in vivo toxicology and safety pharmacology studies for BB3 has been completed. Food and Drug Administration (FDA) approved an Investigational New Drug (IND) application for BB3 and a Phase I, Randomized, Single-Blind, Placebo-Contr olled, Single Dose, Dose- Escalating Study of BB3 Injected Intravenously in Healthy Subjects has been completed; no serious adverse events have been reported. The overall objective of this program is to evaluate clinical efficacy of BB3 in patients present ing with acute ST segment elevation myocardial infarction (A-STEMI) who undergo successful percutaneous reperfusion. PUBLIC HEALTH RELEVANCE: A small molecule organ protective agent has significant clinical potential in treatment of ST-segment eleva tion myocardial infarction (STEMI).

Principal Investigator:

Weizhong Cai

Business Contact:

Itxhak Dgoldberg
Small Business Information at Submission:


EIN/Tax ID: 111343007
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No