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PharmaDrug Inc. (CSE:BUZZ) (OTC: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.
A piece of legislation meant to promote research on the therapeutic potential of certain psychedelic substances has been approved by the House Public Health Committee in Texas.
The bill, introduced in February by Rep. Alex Dominguez, would direct the Department of State Health Services and the Texas Medical Board to study psilocybin, MDMA and ketamine in the treatment of post-traumatic stress disorder.
The committee included an amendment that limits state-funded research to be done on military veterans with PTSD, as opposed to a larger range of disorders proposed by the original bill, reported Marijuana Moment.
Numinus Wellness (Pink: LKYSF) (TSXV:NUMI) announced the launch of a new Phase I clinical trial in partnership with KGK Science that will test the company’s naturally derived psilocybin formulation on human subjects.
“The formulation is not just psilocybin, but a full spectrum extract that has been developed at Numinus Bioscience,” Sharan Sidhu, Numinus science officer and general manager, told Benzinga.
The trial will enroll 14 healthy volunteers and assess the safety and psychoactive properties of a Psilocybe mushroom formulation extracted at the Numinus lab in British Columbia.
“We believe there are several likely advantages to naturally occurring Psilocybin therapeutics that will make them attractive for researchers and consumers alike,” said Sidhu.
The company holds a license to cultivate and extract magic mushrooms in Canada.
As opposed to most psilocybin clinical trials today, Numinus’ study uses a derivative of natural mushrooms instead of a synthesized version of the drug.
“We are confident that this trial will document that natural Psilocybin extractions meet health regulator requirements for safety, efficacy and quality, and ultimately enable the establishment of better access to this medicine,” she added.
MindMed (NASDAQ:MMED) completed its Nasdaq uplisting on April 27.
The company’s stock on Toronto’s NEO exchange skyrocketed after the announcement to uplist, climbing 118% from CA$2.67 ($2.17) to CA$5.84 over a three-day period.
The actual Nasdaq debut proved negative on its price action, with the stock on the NEO exchange dropping to CA$4.78 at market close on April 30, with its Nasdaq stock closing the week at $3.91.
Nonetheless, the overall positive results were met with gratitude by the company at its bell-ringing ceremony at Nasdaq headquarters on Thursday.
“I’m proud to be an investor in MindMed, leading the charge to look at these very important studies, to see if we can solve some of society’s biggest problems: drug addiction, depression and many others,” said Kevin O’Leary, an early investor in the company.
CEO J.R. Rahn told Benzinga: “There is a very passionate shareholder base that is looking for returns but also wants to change mental health. This is really the advent of conscious capital.”
The company expects trading to commence during the week of May 10.
