PharmaDrug Inc. (CSE: BUZZ) (Pink: LMLLF) announced an FDA-granted Orphan Drug Designation to its wholly owned subsidiary Sairiyo Therapeutics Inc., for the use of DMT in organ transplantations.
When patients undergo an organ transplant, there's a high risk of ischemia-reperfusion injury, a type of injury that can occur when blood rapidly returns to the organ after being restricted by a long period. This can lead to the organ being rejected by the body, as well as other injuries to the patient.
Preclinical models of kidney transplantation showed that DMT can be used to mitigate injury caused by ischemia-reperfusion. The treatment still needs to undergo extensive clinical research.
“We are the first and only company in the world to receive FDA orphan drug designation for DMT,” said Daniel Cohen, CEO of PharmaDrug.
In this case, the DMT molecule would not be used for its psychedelic effects, but for its therapeutic potential in treating transplant-related pathologies.
Orphan drug status is granted to products that can treat or prevent rare diseases that affect less than 200,000 people in the United States. This status allows novel treatments to qualify for benefits and financial incentives, in order to incentivize research that may be unprofitable due to a low patient population.
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