PURIFICATION OF A BACTERIAL PROTEASE INHIBITOR

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$500,000.00
Award Year:
1985
Program:
SBIR
Phase:
Phase II
Contract:
n/a
Award Id:
1516
Agency Tracking Number:
1516
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
3115 E 40th Ave, Denver, CO, 80205
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
John C. Cheronis
Director
() -
Business Contact:
() -
Research Institution:
n/a
Abstract
THIS PROJECT IS INTENDED TO DEVELOP A PROTEASE INHIBITOR THAT CAN BE SAFELY ADMINISTERED TO PATIENTS WHO HAVE ONGOING ELASTIN DESTRUCTION AS A MAJOR FEATURE OF THEIR DISEASE. SUCH DISEASES INCLUDE THOSE IN WHICH PHAGOCYTE ACTION (INFLAMMATION) HAS OCCURRED IN CONJUNCTION WITH CONNECTIVE TISSUE TARGETS. PROMINENT AMONG THESE DISEASES ARE PULMONARY EMPHYSEMA, PNEUMONIAS, ADULT RESPIRATORY DISTRESS SYNDROME, DERMATOLOGIC IN FLAMMATORY PROCESSES AND INFECTIONS, VASCULITITIS, AND AUTOIMMUNE DISORDERS. WE HAVE ALREADY DEMONSTRATED A UNIQUE INHIBITOR OF HUMAN NEUTROPHIL ELASTASE IN SEVERAL BACTERIAL SPECIES. WE HAVE PERFORMED PRELIMINARY PURIFICATION AND CHARCTERIZATION OF ONE OF THESE INHIBITORS. WE MUST NOW DOCUMENT THAT THIS INHIBITOR IS CAPABLE OF PREVENTING SOME OF THE DISEASES MENTIONED, IN LABORATORY ANIMAL STUDIES AND, AT THE SAME TIME, DOCUMENT THE SAFETY OF ADMINISTRATION OF THIS INHIBITOR. AFTER THE EFFICACY AND SAFETY OF THIS PRODUCT IS DOCUMENTED IN ANIMAL STUDIES, APPLICATION WILL BE MADE TO BEGIN HUMAN STUDIES. DURING PHASE I, WE HOPE TO BEGIN AND COMPLETE THE SUBSTANTIAL PORTION OF OUR ANIMAL STUDIES USING RABBIT AND RAT EXPERIMENTAL MODELS OF DISEASE. PRIMARILY, WE WILL STUDY THE ABILITY OF THIS INHIBITOR TO PREVENT EXPERIMENTALLY INDUCED EMPHYSEMA AND TO MITIGATE AGAINST THE PERMEABILITY CHANGES IN ANIMAL MODELS OF THE ADULT RESPIRATORY DISTRESS SYNDROME. DURING PHASE II, FURTHER ANIMAL STUDIES WILL BE ADDED AND HUMAN STUDIES WILL BEGIN. IF ALL THE POTENTIAL OF THIS PRODUCT IS REALIZED, THEN THIS MEDICATION MAY BECOME THE MAINSTAY OF THERAPY IN MANY CHRONIC AND ACUTE DISEASES THAT EFFECT TENS OF MILLIONS OF INDIVIDUALS IN THIS COUNTRY AND AROUND THE WORLD, SEVERAL OF WHICH HAVE NO EFFECTIVE THERAPY.

* information listed above is at the time of submission.

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