Why clinical development’s next AI bottleneck is not the model, but the system around it.
|Articles|July 27, 2007
HemoBioTech Engages CRO to Facilitate Clinical Study in India of its Human Blood Substitute, HemoTech
HemoBioTech Engages CRO to Facilitate Clinical Study in India of its Human Blood Substitute, HemoTech
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DALLAS, TX, June 21, 2007-HemoBioTech (OTCBB: HMBT.OB) announced today that it has engaged Paragon Biomedical (www.parabio.com) to provide regulatory and clinical services in India related to the Company’s proposed human blood substitute, HemoTech. Paragon will submit preclinical data regarding HemoTech studies that were part of a European IND and clinical data related to the HemoTech human study in Zaire to the Indian regulatory agency for review. The goal is to receive permission to commence clinical studies of HemoTech in India.
A limited clinical study of HemoTech was performed in 1991 at the Institute de la Recherche en Sciences de la Sante, Centre de l’Anemie S.S. in Zaire. Nine sickle cell anemia patients were infused with amounts of HemoTech representing 25% of patients’ total blood volume. This limited clinical trial resulted in significant patient improvement and suggested that HemoTech: 1) can work as a physiological oxygen carrier in humans; 2) is non-toxic; 3) is vasodilatory and anti-inflammatory; and 4) induces red blood cell production (erythropoiesis). Peripheral blood reticulocytes increased from 4% to 49%.
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