PURE FACTOR IX FOR TREATMENT OF HEMOPHILIA B

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 7318
Amount: $50,000.00
Phase: Phase I
Program: SBIR
Awards Year: 1987
Solitcitation Year: N/A
Solitcitation Topic Code: N/A
Solitcitation Number: N/A
Small Business Information
Cbr Laboratories Inc
800 Huntington Avenue, Boston, MA, 02115
Duns: N/A
Hubzone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 DAVID H BING PHD
 (617) 741-6470
Business Contact
Phone: () -
Research Institution
N/A
Abstract
HEMOPHILIA B IS A SEVERE BLEEDING DISORDER CHARACTERIZED BY A FUNCTIONAL DEFICIENCY IN THE BLOOD COAGULATION PROTEIN FACTOR IX (OR CHRISTMAS FACTOR). THERAPY FOR BLEEDING EPISODES IN THESE PATIENTS REQUIRES THE INTRAVENOUS REPLACEMENT OF FACTOR IX GIVEN AS FRESH FROZEN PLASMA OR WITH COMMERCIALLY AVAILABLE CONCENTRATES OF FACTOR IX IN WHICH THE PROTEIN IS ONLY PARTIALLY PURIFIED. ALTHOUGH THESE COMMERCIAL MATERIALS HAVE PROVEN TO BE EFFECTIVE IN TREATING THIS DISEASE, THEY CONTAIN MANY IMPURITIES, ARE OFTEN CONTAMINATED WITH A VIRUS, AND ARE ASSOCIATED WITH SIGNIFICANT MORBIDITY. THE GOAL OF THIS PROJECT IS THE DEVELOPMENT OF A HIGHLY PURIFIED FORM OF FACTOR IX. FACTOR IX WILL BE OBTAINED BY USING A RECENTLY DESCRIBED INVENTION THAT EMPLOYS CONFORMATION-SPECIFIC ANTIBODIES AGAINST HUMAN FACTOR IX TO PURIFY THIS PROTEIN. THIS FACTOR IX WILL BE HOMOGENEOUS AND THUS SUITABLE FOR INTRAVENOUS THERAPY. PUBLISHED STUDIES OF FACTOR IX PURIFIED BY THIS METHODOLOGY INDICATE THAT IT IS FREE OF THE CONTAMINANTS AND INFECTIOUS AGENTS RESPONSIBLE FOR COMPLICATIONS ASSOCIATED WITH THE CURRENTLY COMMERCIALLY AVAILABLE CONCENTRATES. IN THIS PHASE I STUDY, SUFFICIENT FACTOR IX WILL BE PURIFIED TO ACCOMPLISH STUDIES OF ACUTE TOXICITY IN RABBITS AND THE ABILITY TO CORRECT THE BLEEDING DEFICIENCY IN HEMOPHILIAC DOGS.

* information listed above is at the time of submission.

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