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LIFOR® - THE NEED FOR A UNIVERSAL OXYGEN THERAPEUTIC
Background
Efforts to develop oxygen therapeutics for a variety of clinical applications remain intense. The potential benefits of an oxygen therapeutic include safety, universal compatibility, immediate availability, and long-term storage. Although the term “blood substitutes” has often been used to describe oxygen therapeutics, these products are not replacements for whole blood in terms of blood’s many components or the duration of the red blood cell’s oxygen carrying capacity. However, the development and approval of a safe and effective oxygen therapeutic product will benefit society and fill unmet medical needs. Potential indications for oxygen therapeutics are 1) local effects/regional perfusion, 2) perioperative indications, and 3) trauma.
Current Situation
World-wide demand for blood products (including red blood cells) increases annually and is a growing multi-billion dollar market. Despite the best efforts of blood collection and distribution agencies, general and type-specific shortages often occur, most frequently during the summer months and holiday periods. The short refrigerated shelf-life of red blood cells and the O- type-specific needs in emergency trauma exacerbates these shortages. Often the O- demand (universal red blood cell type) exceeds the collection ability of a blood center.
The safety and efficacy of the blood supply in developed countries such as the US are excellent due to modern testing methods, and errors and complications are rare. However, collected blood is not effectively screened for diseases such as hepatitis C, HIV, hepatitis B, and syphilis in many less developed countries. In many countries patients can have incompatibility and allosensitization reactions in addition to viral disease transmission. Also, outside of the US some countries still rely on paid donors for whole blood donations, which have been shown to be a less reliable source than unpaid, volunteer donors.
Competition
Currently, there are two broad categories of products being used or considered as blood substitutes or are being used for blood loss: volume expanders and oxygen therapeutics. Volume expanders are widely available and are used in both hospitals and first response blood loss situations by paramedics and emergency medical technicians despite their poor therapeutic characteristics and ability to provide oxygen due to red blood cell loss.
Two oxygen therapeutic class-based materials are being studied: fluorochemical- and hemoglobin-based. These materials have different mechanisms of action, and variants of both classes have been evaluated in clinical trials in the US and Europe to establish safety and efficacy. To date, known toxicological issues have not been overcome, and no oxygen therapeutic products are commercially available in the US for human use, nor is there a worldwide, regulatory approved “blood substitute.”.
LIFOR® ADVANTAGE
The Lifor® technology, utilizing oxygen carrying liposomal nano-particles, is a new, distinct class of potential oxygen therapeutic. Lifor® has the foundation to succeed as an oxygen therapeutic as demonstrated in various preliminary animal studies. See “Studies”.
Lifor® is sterile and animal component free, thus ensuring improved safety by removing the risk of infection and viral contamination. Lifor® has the potential to demonstrate universal compatibility, immediate availability, and excellent long-term storage.
Lifor® will never completely replace donated human red blood cells. However, it could fill an unmet medical need throughout the world to supplement the blood supply and could demonstrate important utility in cases of emergency medicine, disaster preparedness and battle field injury during severe trauma and blood loss. It could also offer a suitable alternative for people or countries that have cultural and religious objections to either receive or donate blood. Other potential indications for Lifor® as an oxygen therapeutic are local effects/regional perfusion and perioperative indications.
For more information on Lifor® as an Oxygen Therapeutic contact us.
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