5. Documented our Hemopurifier® effectively captures the current pandemic strain of the H1N1 Swine Flu Virus. During invitro studies, the Hemopurifier® removed 68% of H1N1 virus from blood plasma in 30 minutes, 80% of the virus in two hours, and a 96% reduction of H1N1 was observed at six hours. The studies were performed by third party researchers approved by the United States Department of Health and Human Services (HHS) to house and conduct research with pandemic strains of H1N1 virus. Beyond the H1N1 Swine Flu Virus data, third party researchers have now validated the ability of our Hemopurifier® to capture Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection. In addition to being the first-in-class medical device to selectively capture infectious viruses, the breadth of our collected data reinforces my belief that our Hemopurifier® is the leading and perhaps only true broad-spectrum countermeasure against drug resistant bioterror and pandemic threats.
6. Reported compelling human clinical outcomes against Hepatitis-C virus (HCV) infection; then disclosed a data supported strategy to improve HCV cure rates; and subsequently discovered a clinical validation by Asahi Kasei Kuraray Medical (Asahi) that confirms moderate levels of viral filtration at the outset of standard of care (SOC) therapy can dramatically impact HCV cure rates. Asahi reported 71.4% cure rates in patients who previously failed SOC, by applying their V-RAD filtration system (Click Here for V-RAD Website) once daily for three consecutive days at the outset of the 48-week SOC drug regimen. Cure rates of HCV patients who previously fail and then reinitiate SOC are generally reported below 20%. Viral load reductions of 26.1% were documented during each V-RAD treatment period, which averaged 3 1/4 hours in duration. These results do not bode well for drug candidates vying to become a component of SOC therapy. Especially if viral filtration achieves such results without needing to be administered during the remaining 47-weeks of SOC therapy and without stacking additional drug toxicity on top of the known toxicity of SOC therapy. However, this is good news for 180 million individuals infected with HCV worldwide. Regardless, we believe the viral filtration capabilities of our Hemopurifier® will provide even better treatment outcomes. This sentiment is reflected in the following paragraph extracted from my December 8th shareholder letter:
On October 30th, we reported HCV treatment outcomes at the 42nd Annual American Society of Nephrology (ASN) Conference. When analyzing Hemopurifier® treatment data from all of our HCV human studies, we documented average per-treatment viral load reductions of 29-42%. While the length of each Hemopurifier® treatment was similar in duration to V-RAD, the Hemopurifier® did not benefit from SOC associated viral load reductions as our results were achieved in the absence of SOC therapy. We acknowledge and appreciate that V-RAD has indeed documented that viral filtration improves HCV treatment outcomes. However, we believe the Hemopurifier® delivers the necessary capabilities to establish broad-market acceptance of a medical device in infectious disease care. Foremost of these capabilities is our ability to selectively capture infectious viruses and immunosuppressive proteins not addressed by V-RAD. The selective capture of deleterious agents from circulation establishes an environment that permits continuous or aggressive intermittent treatment strategies that can truly optimize patient outcomes. Whereas historic therapeutic filtration approaches, including V-RAD, are restricted in scope as they indiscriminately remove particles from blood by molecule size. As a result, the safe application of such treatments remains limited as beneficial blood components required for health are removed along with the deleterious target.
7. Initiated a relationship with Kentucky Bioprocessing LLC (KBP) to establish the processes necessary to support large-scale production of the active affinity agents we immobilize inside our Hemopurifier®. Such affinity agents allow our Hemopurifier® to selectively capture viruses and immunosuppressive proteins from blood and other fluids. The KBP relationship represents an important step towards establishing the long-term commercial feasibility of our Hemopurifier® in the marketplace.
8. Executed a non-exclusive agreement with NextPharma Technologies (Click Here for Website) to establish manufacturing of our Hemopurifier® under good manufacturing practice (GMP) requirements set forth in quality system (QS) regulations for medical device commercialization. As the result of a lengthy and dedicated effort, we established our GMP manufacturing processes and initiated our first Hemopurifier® production run. Consequently, we are primed to initiate commercialization in India and have established a manufacturing standard that exceeds the requirements for human clinical studies in the United States and the European Union. For a complete news summary of our activities in 2009, please "click here".
6. Reported compelling human clinical outcomes against Hepatitis-C virus (HCV) infection; then disclosed a data supported strategy to improve HCV cure rates; and subsequently discovered a clinical validation by Asahi Kasei Kuraray Medical (Asahi) that confirms moderate levels of viral filtration at the outset of standard of care (SOC) therapy can dramatically impact HCV cure rates. Asahi reported 71.4% cure rates in patients who previously failed SOC, by applying their V-RAD filtration system (Click Here for V-RAD Website) once daily for three consecutive days at the outset of the 48-week SOC drug regimen. Cure rates of HCV patients who previously fail and then reinitiate SOC are generally reported below 20%. Viral load reductions of 26.1% were documented during each V-RAD treatment period, which averaged 3 1/4 hours in duration. These results do not bode well for drug candidates vying to become a component of SOC therapy. Especially if viral filtration achieves such results without needing to be administered during the remaining 47-weeks of SOC therapy and without stacking additional drug toxicity on top of the known toxicity of SOC therapy. However, this is good news for 180 million individuals infected with HCV worldwide. Regardless, we believe the viral filtration capabilities of our Hemopurifier® will provide even better treatment outcomes. This sentiment is reflected in the following paragraph extracted from my December 8th shareholder letter:
On October 30th, we reported HCV treatment outcomes at the 42nd Annual American Society of Nephrology (ASN) Conference. When analyzing Hemopurifier® treatment data from all of our HCV human studies, we documented average per-treatment viral load reductions of 29-42%. While the length of each Hemopurifier® treatment was similar in duration to V-RAD, the Hemopurifier® did not benefit from SOC associated viral load reductions as our results were achieved in the absence of SOC therapy. We acknowledge and appreciate that V-RAD has indeed documented that viral filtration improves HCV treatment outcomes. However, we believe the Hemopurifier® delivers the necessary capabilities to establish broad-market acceptance of a medical device in infectious disease care. Foremost of these capabilities is our ability to selectively capture infectious viruses and immunosuppressive proteins not addressed by V-RAD. The selective capture of deleterious agents from circulation establishes an environment that permits continuous or aggressive intermittent treatment strategies that can truly optimize patient outcomes. Whereas historic therapeutic filtration approaches, including V-RAD, are restricted in scope as they indiscriminately remove particles from blood by molecule size. As a result, the safe application of such treatments remains limited as beneficial blood components required for health are removed along with the deleterious target.
7. Initiated a relationship with Kentucky Bioprocessing LLC (KBP) to establish the processes necessary to support large-scale production of the active affinity agents we immobilize inside our Hemopurifier®. Such affinity agents allow our Hemopurifier® to selectively capture viruses and immunosuppressive proteins from blood and other fluids. The KBP relationship represents an important step towards establishing the long-term commercial feasibility of our Hemopurifier® in the marketplace.
8. Executed a non-exclusive agreement with NextPharma Technologies (Click Here for Website) to establish manufacturing of our Hemopurifier® under good manufacturing practice (GMP) requirements set forth in quality system (QS) regulations for medical device commercialization. As the result of a lengthy and dedicated effort, we established our GMP manufacturing processes and initiated our first Hemopurifier® production run. Consequently, we are primed to initiate commercialization in India and have established a manufacturing standard that exceeds the requirements for human clinical studies in the United States and the European Union. For a complete news summary of our activities in 2009, please "click here".
