Abuchowski A.,Prolong Pharmaceuticals
Advances in Experimental Medicine and Biology | Year: 2016
Oxygen transfer agents have long been sought as a means to treat hypoxia caused by congenital or acquired conditions. Hemoglobin-based oxygen carriers were in clinical development as blood substitutes, but development was halted due to the finding of significant vasoactivity. Rather than develop a blood substitute, a product for indications characterized by hypoxia is in development. PEGylated bovine carboxyhemoglobin (SANGUINATE™) is both a carbon monoxide releasing molecule and an oxygen transfer agent. It is comprised of three functional components that act to inhibit vasoconstriction, reduce inflammation and optimize the delivery of oxygen. SANGUINATE has the potential to reduce or prevent the effects of ischemia by inhibiting vasoconstriction and re-oxygenating tissue. Phase 1 safety trials in healthy volunteers were completed in 2013. SANGUINATE was shown to be safe and well tolerated with no serious adverse effects. Phase Ib studies have been completed in stable patients with Sickle Cell Disease. SANGUINATE has also been administered to two patients under emergency use protocols. Both patients exhibited improved status following treatment with SANGUINATE. © Springer Science+Business Media, New York 2016. Source
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 166.30K | Year: 2008
DESCRIPTION (provided by applicant): Hemorrhage is the leading cause of death from combat trauma and the second leading cause of civilian death. Trauma is mainly treated with intravenous liquids, such as isotonic crystalloid solutions. Although volume expa nsion is desirable, none of these solutions is capable of overcoming tissue oxygen deficits (ischemia). Proper use of transfused blood can assist in resuscitation; however there are significant problems with its use, including storage restraints, availabil ity, typing, risk of disease transmission and immune suppression. These issues make the routine use of stored human blood for use outside the hospital impractical. In an attempt to overcome many of these issues, efforts have been made to develop hemoglobin based oxygen carrier (HBOCs) blood substitutes which have advantages such as decreased chance of disease transmission, lack of a need for typing, and most importantly improved availability with decreased storage demands. Prolong Pharmaceuticals has develo ped a unique HBOC product for the treatment of severe hemorrhagic shock consisting of a combination of PEGylated bovine hemoglobin (PEG-Hb) and hypertonic saline (HS). It is specifically designed to increase the oxygen carrying capacity of blood as well as to enhance the delivery of oxygen to tissues by keeping the vasculature open through its hypertonic-oncotic actions. We have found this product to be capable of rapidly restoring tissue oxygenation and repaying oxygen debt in an animal model of severe tra umatic shock. In this Fast- Track SBIR grant, we will conduct the preclinical studies needed to support an IND to conduct clinical testing of the product. In the phase I component, we will conduct pharmacokinetic analysis of PEG-Hb/HS to define optimal dos ing for follow up efficacy and toxicology assessment and to establish dosing parameters for future clinical studies. In the phase II SBIR component we will conduct additional efficacy studies to determine the extent of survival that PEG-Hb/HS induces in ou r animal model of trauma and will also perform toxicology assessment to support the future use of this product in the treatment of trauma. PUBLIC HEALTH RELEVANCE: The studies proposed in this grant are designed to further the development of PEG- Hb/HS as a hemoglobin based oxygen carrier to treat traumatic shock. We have shown that this product can reverse oxygen debt in an animal model of severe hemorrhagic shock and studies proposed in this grant will move forward the preclinical development of this prod uct including additional efficacy studies and IND supporting pharmacokinetic and toxicology studies.
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 101.34K | Year: 2008
Hemorrhage is a leading cause of death from severe trauma. Hemoglobin blood substitutes (HBOC) have a number of advantages in treating hemorrhage including improved availabilty with decreased storage demands. Prolong Pharmaceuticals has developed a PEGylated bovine hemoglobin (PEG-Hb) that is designed to enhance the delivery of oxygen to tissues. In the Phase l component of this Fast-Track SBIR contract we will begin to optimize the production of this material as a starting point for large scale production of PEG-Hb in the Phase II SBIR contract. In this phase II component of the Fast-Track SBIR contract, we will develop and implement the scale-up production of PEG-Hb developed in the phase I SBIR. This wil involve three parallel tasks including the large scale purification of bovine hemoglobin and synthesis of PEG-Hb in its appropriate formulation
Prolong Pharmaceuticals | Date: 2015-09-04
Prolong Pharmaceuticals | Date: 2014-07-23
pharmaceuticals used for stimulating white blood cell production.