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Home » HEMOSOL SELECTS THERAPEUTIC PROTEIN PRODUCT IGIV FOR DEVELOPMENT
HEMOSOL SELECTS THERAPEUTIC PROTEIN PRODUCT IGIV FOR DEVELOPMENT
July 13, 2005
Hemosol announced that it has chosen Immune Globulin Intravenous 10 percent (IGIV) as the first protein product that the company will advance through the clinical development and regulatory process in order to seek approval to commence commercial production. IGIV is comprised of naturally occurring antibodies that are normally produced in the human body, however, in some cases, patients cannot produce sufficient quantities of these antibodies and are required to receive IGIV infusions every three to four weeks to avoid infectious diseases.
The clinical development plan for Hemosol's IGIV protein product will begin with the FDA's acceptance of an investigational new drug application (IND), followed by a pivotal trial in patients diagnosed with Primary Immune Deficiency disease. Patients will be dosed for approximately 12 months and results will be compared to historical controls. A commercial product is expected to be available for launch in 2008.
IGIV is currently used to treat Primary Immune Deficiency, Idiopathic Thrombocytopenia Purpura, some forms of cancer, certain autoimmune diseases, pediatric AIDS and during organ transplants. Early-stage research has demonstrated that IGIV may also be of importance in the treatment of multiple sclerosis, rheumatoid arthritis and Alzheimer's disease.
Hemosol, an integrated biopharmaceutical developer and manufacturer of biologics, particularly blood-related protein based therapeutics, also intends to pursue regulatory approval for two other key therapeutic protein products: Alpha 1 Proteinase Inhibitor (A1PI), and von Willebrand Factor/Factor VIII. Hemosol expects to file INDs and commence pivotal trials for each of these additional drug candidates in 2006.
KEYWORDS Drug Pipeline Alert
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