Altemia™ Our Solution for Sickle Cell Anemia

ALTEMIA is our proprietary product candidate that is being developed for the treatment of sickle cell disease. ALTEMIA consists of a complex proprietary mixture of fatty acid ethyl esters formulated using Advanced Lipid Technologies® (ALT®) specifically to address the treatment of SCA. The drug is encapsulated in a small soft gelatin capsule and intended to be taken once daily. As early as 1991, it was suggested that certain fatty acids decrease the destruction of red blood cells in mammals. It also has been found that sickle cell patients have abnormal blood fatty acids in red blood cells, white blood cells, platelets and plasma. These findings led to the hypothesis that certain fatty acids might be useful in the treatment of SCA. In 2001, a small human clinical trial showed that certain fatty acids could reduce pain episodes in sickle cell patients, perhaps by reducing activity that leads to obstructive blood clotting. Other studies have shown that certain fatty acids can increase hemoglobin levels and reduce pain episodes, VOC episodes, anemia, organ damage and other disease complications in sickle cell patients.

ALTEMIA is designed to replenish the specific fatty acids destroyed by HbS. Based on research performed by Sancilio & Company, Inc. (SCI) and others, the specific fatty acids contained in ALTEMIA, may restore balance and fluidity to red blood cells and other cells impacted by the disease. We believe that ALTEMIA will treat sickle cell disease by decreasing blood cell adhesion, chronic inflammation and red blood cell hemolysis, the factors that lead to reduction in pain episodes, VOC crises and organ damage. Based on its formulation and mechanism of action, we believe that ALTEMIA is well-positioned to deliver a narrow, therapeutic dose of certain fatty acids directly to the membrane of red blood cells of sickle cell patients. The combination of ALT® drug delivery technology and highly purified fatty acid esters may reduce VOC significantly. We also believe that ALTEMIA has the potential to address the inflammatory symptoms (e.g., pain and fatigue) of SCA and to assist in reducing sickle cell events in general. We believe that by consistently and reliably delivering ALTEMIA into a patient’s bloodstream, the impacted membrane of a sickle cell patient will become more fluid, preventing the cascade of events that create VOCs and organ damage in general. By minimizing damage, ALTEMIA may be able to reduce sickle cell crisis events and related mortality.

ALTEMIA has been recognized by the US FDA as an orphan drug and has qualified for the pediatric voucher program.