PharmaDrug Inc (CSE:BUZZ) (OTCPINK:LMLLF) announced Thursday it had filed an application with the US Food and Drug Administration to receive an orphan drug designation for the use of DMT in preventing kidney injuries in patients undergoing kidney transplants.
Ischemia reperfusion injury (IRI) is caused by a sudden temporary impairment of the blood flow to a particular organ and is associated with a robust inflammatory and oxidative stress response to hypoxia and reperfusion, which disturbs the organ function.
According to PharmaDrug, studies indicate that DMT, or N,N-Dimethyltryptamine, activates the sigma-1 receptor, an intracellular chaperone fulfilling an interface role between the endoplasmic reticulum (ER) and mitochondria in cells. The sigma-1 receptor ensures the correct transmission of ER stress into the nucleus resulting in the enhanced production of anti-stress and antioxidant proteins.
READ: PharmaDrug files Orphan Drug Designation application with the US Food and Drug Administration for use of N,N-Dimethyltryptamine (DMT) in the treatment of acute ischemic stroke patients
DMT has also been shown to have anti-inflammatory properties and potentially mitigates IRI injury caused by hypoxia, oxidative stress and inflammation in preclinical models of renal transplantation. The anti-inflammatory protective effects of DMT may provide a novel, more beneficial strategy to lessen the damage caused by ischemia and reperfusion during kidney transplantation.
"Although DMT is commonly associated with offering an intense psychedelic experience, the therapeutic potential of DMT is fascinating and remains underexplored,” PharmaDrug CEO Daniel Cohen said in a statement.
“We aim to unlock the potential of DMT in treating unmet medical needs beyond its potential utility in mental health disorders. Our orphan drug designation application for DMT in the prevention of kidney injury during transplant surgery fits with our psychedelic pharmaceutical strategy of creating a unique portfolio of DMT therapies targeting rare disorders while also focusing on foundational research with DMT to explore and evaluate its therapeutic potential both in the brain and other human organs."
PharmaDrug also told investors it had started efforts to expand its research activities in the pharmaceutical psychedelics space, with a particular focus on DMT. The Toronto-based firm plans to start preclinical and clinical development activities and broaden its intellectual property portfolio by creating unique DMT formulations.
Further differentiation in the space will be derived from the work that PharmaDrug will initiate around novel uses for DMT, it added, with the ultimate goal to fuse outstanding science and clinical translation.
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