VIDEO: Recce Pharmaceuticals (ASX:RCE) granted US patent, page-9

I don't think phase 1 will give any indication other than safety and tolerability. As I said, I don't really know what the effects would be in a septic patient. Lipopolysaccharides are a lipid layer that protects the bacteria but the shedding also produces the immune septic shock response. They are also known as LPS. Recce327 breaking open the bacterial cell might not cause a higher shedding of lipopolysaccharides however, it is possible it may.

I did find this journal below which states LPS does rise with cell lysis. Again, we will not know how sick the patient will initially be but the rapid action of RCE327 might be a concern. The correct dosage could be the key to success. and may involve an initial small dose followed by subsequent higher doses.

We really cannot know until phase 2 trials.

Review: Biomaterial-associated thrombosis: roles of coagulation factors, complement, platelets and leukocytes

Maud B.Gorbet,Michael V.Sefton, inThe Biomaterials: Silver Jubilee Compendium, 2004

6.2Endotoxin

Endotoxins, also called LPS, are the component of theouter membraneofgram-negative bacteriaand are released into the circulation upon disruption of the intact bacteria (death, cell lysis) [231]. Endotoxin is commonly found everywhere in our environment and it is the most significant pyrogen in parenteral drugs and medical devices. Endotoxins are also present in the digestive system. Their presence in the blood stream may cause septic reactions with a variety of symptoms such as fever, hypotension, nausea, shivering and shock [232]. High concentrations can lead to serious complications such asdisseminated intravascular coagulation(DIC), endotoxin shock and adult respiratory distress syndrome (ARDS). Endotoxins are known to activate complement, thekininsystem,leukocytes, platelets and endothelial cells [231,232] and are the “enemy” of both in vitro andin vivo studyof blood–material interactions. In vivo, they may lead to the complications mentioned above, while in vitro, the presence of this contaminant may affect the results and compromise the conclusions.