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SOURCE Prolong Pharmaceuticals LLC
DATA PRESENTED AT JOINT IFAO/JSAO MEETING SHOWS SANGUINATE TO BE SAFE AND WELL TOLERATED IN HEALTHY SUBJECTS
SOUTH PLAINFIELD, N.J., Oct. 3, 2013 /PRNewswire/ -- Prolong Pharmaceuticals LLC, a biopharmaceutical company developing products to treat several diseases and their debilitating comorbidities presented Phase I results of its lead product, SANGUINATE™ at the Joint Conference of the International Federation of Artificial Organs and the Japan Society of Artificial Organs. The IFAO/JSAO took place in Yokohama, Japan, September 27-29.
SANGUINATE (PEGylated carboxyhemoglobin bovine) is an intravenous therapeutic that combines the beneficial functions of a carbon monoxide releasing molecule (CORM) with an oxygen transfer agent (OTA) as well as acting as a plasma expander/flow enhancer. Results from animal studies indicate that low dose release of carbon monoxide promotes anti-inflammatory and anti-vasoconstriction effects, while oxygen is actively delivered to regions of low oxygen concentration (ischemia).
The Phase I study was a single center, single-blind, placebo-controlled, single dose study of the safety, tolerability and pharmacokinetics of SANGUINATE in healthy subjects. Three dose levels of SANGUINATE (80 mg/kg, 120 mg/kg, and 160 mg/kg) were administered by intravenous infusion to 3 groups. Each group included 8 subjects: 6 subjects who received active treatment (SANGUINATE) and 2 subjects who received placebo comparator (saline).
Overall, SANGUINATE was found to be well tolerated. There were no serious adverse events in this study and there were no discontinuations due to adverse events. Full results from this study are pending publication.
"We are very pleased that the results from SANGUINATE's Phase I trial found the product to be safe and well tolerated. The safety data we have observed is superior to previously studied HBOCs (Hemoglobin- Based Oxygen Carriers). These results mean that SANGUINATE can advance into patients. We are now moving forward into Phase II trials in patients with sickle cell disease, who suffer from painful vaso-occlusive crises," stated Hemant Misra, Ph.D., Vice President -- Clinical Development.
Patients with sickle cell disease (SCD) have an inherited defect in their hemoglobin molecules which leads to the devastating development of numerous comorbidities. Comorbidity is the presence of one or more disorders in addition to a primary disease. Severe, debilitating pain is the most common comorbidity of SCD. However, the disease affects virtually every organ system, leading to cardiovascular, renal, respiratory, musculoskeletal and nervous system complications.
These comorbidities are due to a combination of severe oxygen deprivation and the toxicity of the patient's own hemoglobin released from their abnormally fragile red blood cells. These processes cause a cascade of events resulting in cell death, tissue damage and organ dysfunction. It is hoped that SANGUINATE will interfere with these events early on so that these comorbidities are reduced or prevented.
"SANGUINATE is designed to offer a multipronged approach to treating ischemic / hemolytic disorders such as sickle cell disease," stated Misra.
SANGUINATE is an investigational biopharmaceutical product that has a multiple mechanisms of action designed to release therapeutic carbon monoxide and actively transfer oxygen to hypoxic tissue. SANGUINATE has completed Phase I safety trials and Prolong Pharmaceuticals is preparing to launch Phase II trials in SCD patients.
About Prolong Pharmaceuticals:
Headquartered in South Plainfield, New Jersey, Prolong Pharmaceuticals, LLC is developing products to treat several diseases and their associated debilitating comorbidities which cause reduced quality of life, increased medical cost and significant mortality. The company's lead product, SANGUINATE™, is in clinical testing, focused on treating the comorbidities of sickle cell disease and other disorders where oxygen deprivation due to hemolysis and/or ischemia occurs. The company's senior management team includes inventors of the most successful drug delivery technology in pharmaceutical history, PEGylation, approved in the United States and around the world and now responsible for more than $30 billion in drug sales worldwide. For more information visit: www.prolongpharma.com
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