Algernon’s Pre Clinical Research Plan
The Company will be conducting a number of pre-clinical research experiments to guide the Company as it advances towards its planned clinical trials. Studies will include:
- Potency of multiple new forms of DMT
- Toxicology
- Treatment timing and duration
- DMT in combination with CIMT
The Company has identified several of countries that allow research with tryptamines as well as Contract Research Organization’s (CRO’s) with experience in this area of research which have the required approvals to work with controlled substances.
Algernon’s DMT Clinical Research Plan
Ischemic Stroke
Each year there are approximately 15M strokes that occur globally with 700,00 strokes occurring in the U.S. alone. Approximately 85% of all strokes are ischemic strokes, which occur when a blood clot blocks blood flow to the brain.
Currently, medication treatments for ischemic stroke are primarily limited to Tissue Plasminogen Activator (“TPA”) or blood thinners. However, these treatments are stroke type specific and cannot be given until the patient has received a CT scan to determine if the stroke is ischemic or haemorrhagic. Patients being treated with TPA must receive the drug within 3 hours of the injury. As a result, only 5% of stroke patients receive TPA.
Additional treatment options involve surgical intervention such as catheter embolectomy and decompressive craniotomy.
Based on its preclinical data research, Algernon plans to test DMT in the clinic in patients as soon as possible after the stroke injury occurs. If it is established in the Company’s preclinical research phase that DMT can be used to treat both haemorrhagic and ischemic stroke, the patient will not have to wait for a CT scan and treatment can begin immediately, possibly while being transported to the hospital.
Algernon’s preclinical research is designed to help establish the optimal treatment period duration for DMT as well as the clinically effective sub-hallucinogenic dose.
Post-Stroke Rehabilitation
Eighty five percent of stroke survivors will end up with from some form of disability after having suffered a stroke. Intensive physical rehabilitation has been shown by researchers to improve function and reduce long-term disability.
While Algernon will investigate DMT to treat a patient as quickly as possible after the stroke occurs, it will also investigate the potential of the drug as a treatment during the rehabilitative process. Rehabilitation therapy, which includes motor-skill exercises, mobility training and range-of-motion therapy, and can begin as soon as 24 to 48 hours after the stroke has occurred.
One specific type of rehabilitation therapy, previously referenced, is called CIMT. It is focused on improving upper extremity function in stroke patients and involves intensive training of the weaker arm while restricting the use of the stronger arm.
Algernon will investigate DMT in preclinical animal models of CIMT for the promotion of neurogenesis and structural and functional neural plasticity during various time periods after the stroke has occurred. If the final data is positive, the Company will move DMT into a separate clinical trial to test for its efficacy as a post stroke rehabilitation adjunctive treatment.
of New Drugs Fail in the Pre-Clinical Stage
of Phase II trials Succeed*
*Source: PhRMA