Read the Beforeitsnews.com story here. Advertise at Before It's News here.
Profile image
By ProactiveInvestors (Reporter)
Contributor profile | More stories
Story Views
Now:
Last hour:
Last 24 hours:
Total:

Algernon files meeting request with MHRA for use of DMT in Phase 1/2a human stroke study

% of readers think this story is Fact. Add your two cents.


Algernon Pharmaceuticals Inc said it has filed a scientific advice meeting request with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for a Phase 1/2a stroke study with its DMT-based drug candidate, AP-188. 

The company said the MHRA encourages companies to seek scientific advice before beginning clinical trials in the UK. These meetings are similar to the Pre-Investigational New Drug Application (Pre-IND) meetings offered by the US Food and Drug Administration. 

DMT, or N,N-dimethyltryptamine, is a known psychedelic compound that is part of the tryptamine family.

READ: Algernon Pharmaceuticals “very excited” by preclinical data on DMT candidate

Through the MHRA process, the company said it will confirm that its chemistry, manufacturing and controls information, pre-clinical data, and Phase 1/2a clinical plans are appropriate for submission of a Clinical Trial Authorisation (CTA) application for a study with DMT in the UK, which is planned for the fourth quarter of this year.

It said the Phase 1 portion will investigate the safety, dose, and pharmacokinetics of DMT, while the Phase 2a part will additionally examine the use of DMT as an adjunctive treatment to Constraint-Induced Movement Therapy for the treatment of upper-limb dysfunction in stroke patients.

During the Phase 1 study of DMT, it will also be able to evaluate if a sub hallucinogenic dose of DMT could be used for the treatment of hemorrhagic stroke patients in addition to patients who have suffered an ischemic stroke. This would be a significant discovery and could lead to a clinical trial to evaluate if patients would benefit from DMT shortly after their stroke has occurred, it added.

The company recently confirmed, in its own in vitro preclinical study, that DMT increased the growth of cortical neurons by 40% with statistical significance in one arm of the study, when compared to control. Algernon also reported that the increased growth was achieved with a sub hallucinogenic dose.

“We are pleased to initiate formal discussions of our clinical plans for DMT with the MHRA,” Algernon Pharmaceuticals CEO Christopher Moreau said in a statement. 

“The MHRA’s familiarity with DMT means the agency is well-positioned to advise the company on its clinical research program,” he added.

Algernon is a drug re-purposing company that investigates safe, already approved drugs for new disease applications, moving them into new human trials, developing new formulations and seeking new regulatory approvals in global markets.

Contact the author at [email protected]

Story by ProactiveInvestors


Source: https://www.proactiveinvestors.com/companies/news/963076/algernon-files-meeting-request-with-mhra-for-use-of-dmt-in-phase-12a-human-stroke-study-963076.html


Before It’s News® is a community of individuals who report on what’s going on around them, from all around the world.

Anyone can join.
Anyone can contribute.
Anyone can become informed about their world.

"United We Stand" Click Here To Create Your Personal Citizen Journalist Account Today, Be Sure To Invite Your Friends.

Please Help Support BeforeitsNews by trying our Natural Health Products below!


Order by Phone at 888-809-8385 or online at https://mitocopper.com M - F 9am to 5pm EST

Order by Phone at 866-388-7003 or online at https://www.herbanomic.com M - F 9am to 5pm EST

Order by Phone at 866-388-7003 or online at https://www.herbanomics.com M - F 9am to 5pm EST


Humic & Fulvic Trace Minerals Complex - Nature's most important supplement! Vivid Dreams again!

HNEX HydroNano EXtracellular Water - Improve immune system health and reduce inflammation.

Ultimate Clinical Potency Curcumin - Natural pain relief, reduce inflammation and so much more.

MitoCopper - Bioavailable Copper destroys pathogens and gives you more energy. (See Blood Video)

Oxy Powder - Natural Colon Cleanser!  Cleans out toxic buildup with oxygen!

Nascent Iodine - Promotes detoxification, mental focus and thyroid health.

Smart Meter Cover -  Reduces Smart Meter radiation by 96%! (See Video).

Report abuse

    Comments

    Your Comments
    Question   Razz  Sad   Evil  Exclaim  Smile  Redface  Biggrin  Surprised  Eek   Confused   Cool  LOL   Mad   Twisted  Rolleyes   Wink  Idea  Arrow  Neutral  Cry   Mr. Green

    MOST RECENT
    Load more ...

    SignUp

    Login

    Newsletter

    Email this story
    Email this story

    If you really want to ban this commenter, please write down the reason:

    If you really want to disable all recommended stories, click on OK button. After that, you will be redirect to your options page.