HemoTech™ underwent foreign pre-clinical and human clinical testing in the late 1980s and early 1990s. Pre-clinical testing includes research performed by Texas Tech and its laboratories in Lubbock, Texas, and at ISI St. Antimo Laboratories in Naples, Italy, and a European IND study conducted at the Research Toxicology Center S.p.A (the “RTC”) in Rome, Italy. The research was based on in vivo animal studies and in vitro testing using various human cell lines.
The results generated from these tests support HemoTech™’s non-toxicity and biological activity.
A human clinical trial was performed at the Institute de la Recherché en Sciences de la Santé, Centre de l’ Anemie S. S. (Kinshasa, Zaire ) in 1990. The study involved nine children suffering from sickle cell anemia who received HemoTech™ in significant volumes (approximately 25% of total blood volume) over a two-hour period. The patients experienced significant improvement as well as overall improvement in their general condition. It was observed that the overall episodes of sickle cell anemia, where the sickle cells block the blood vessels, were reduced and pain was quickly relieved. The patients also showed better tissue oxygenation, better blood vessel dilation, and a significant erythropoietic response. These observations were made over a three-month period by closely monitoring the patients.
The significant results obtained from this trial are documented and published in the medical journal (Simoni J, Feola M, Angelillo R, Luhruma Z, Kabakele M, Manzombi M, Kaluila M : Clinical Trial of a Hemoglobin based blood substitute. Surgical Gynecology & Obstetrics,Surgery, Gynecology & Obstetrics – 174 : 379-386, 1992)
HemoBioTech, Inc. believes that HemoTech™’s limited Phase I equivalent clinical testing has produced data showing non-toxicity and biological activity in humans including erythropoiesis. In addition, the product has also established vasodilatory and anti-inflammatory activity. There have been no negative or adverse effects in the testing, although there can be no guarantee that this will be the case with additional testing. More than 80 abstracts have been documented in order to validate these results. A European Investigational New Drug (IND) application has also been filed which supports the preclinical results.