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CLINICAL TRIALS

& RESEARCH OF

PSYCHEDELICS

The Future Of Psychedelic Assisted Natural Medicine Therapy

Cube Accelerated Treatment Technology (CATT)

Cube Psytech team has identified psilocybin-assisted psychotherapy and clinical studies that can demonstrate potential disease- modifying therapeutics, Cancer-Related Psychiatric Distress, Addiction, Treatment-Resistant Depression, Obsessive- Compulsive Disorder, Cluster Headaches, Neuroscience and Pharmacology.

Process of solutions includes:

  • Licencing Application For Clinical Studies

    License application for the permission of psilocybin assisted clinical studies has been submitted 

  • Psilocybin Assisted Addiction Therapy

    Our first clinical trial for the psilocybin assisted addiction therapy is a randomized placebo-controlled study ofrepeated micro-dosing. The objective of the study is tounderstand the proactive impact of psilocybin on opioid addiction through micro-dosing.

  • Toxicological Studies

    Dose optimization to understand the efficacy, adverse effects, toxicity of psilocybin will be designed to understand the impact and efficacy of various genetics. 

  • Pharmacology and Efficacy Study

    Cube Psytech is partnered with world leaders

    in clinical research who have developed and designed more than 50 leading naturally derived drug molecules.

Mental Health issues are a global challenge and providing preventive solutions is dependant on the early detection of symptoms. Cube Tech is a specially designed global AI platform that enables us to assess and identify the deviations from optimized healthy lifestyle data.

  • Artificial Intelligence (AI)

    The AI assisted therapy provides pre-determined data to health professionals and helps reduce the time taken to assess symptoms. This data driven technology can be used in any coroner of the world. Pre-determined dataoriented solutions will provide options to help coordinatewith health professionals. Our innovative AI assisted Cube

    Accelerated Treatment Technology (CATT) will contribute to the betterment of global mental health.

A New Solution

For PAIN MANAGEMENT & AddIctIon

Pain is one of the critical underlying issues in contributing to addiction, and serves as a gateway contributor into the opioid epidemic. An estimated 125 million adult Americans suffer from either acute or chronic pain. Pain remains the most common reason worldwide, specifically in North America, to seek medical care. Opioids represent one of the most widely prescribed drug classes in Canada and the United States to manage moderate to severe pain.


Opioids are used more in North America than anywhere else in the world. This "opioid epidemic" leads to dramatic increases in the use and abuse of prescription and illicit opioids, which has resulted in a staggering number of opioid-related fatalities and addiction based quality of life decline. Increasing demand for opioids is due to the lack of awareness and the abundant availability of cheap and synthetic opioids from the illicit market.


Cube Psytech is devising protocols and strategies for individuals in need of pain management that can provide tools for patients to manage their illness without the use of opioids.

Addiction

The problem

Cube Psytech aims to support and provide cost-effective and reliable solutions for people suffering from mental disorders and addictions.

A 2017 World Mental Health data report estimated 792 million people live with mental health disorders.


United Nations World Drug Report estimated more than 271 million people globally suffer from drug use disorder. Opioid addiction has been estimated to have accounted for over 53 million.


Our mission as a company will be the development of psilocybin based compounds to treat addiction. We are exploring psilocybin as an innovative treatment approach to addiction and pain management through a preclinical trial. We are developing the first psilocybin-based drug candidates targeting addiction in opioids for pain management.

Our Process

The Solution

Our team has identified psilocybin-assisted psychotherapy and clinical studies that can demonstrate potential disease- modifying therapeutics, Cancer-Related Psychiatric Distress, Addiction, Treatment-Resistant Depression, Obsessive- Compulsive Disorder, Cluster Headaches, Neuroscience and Pharmacology.

Patent Accessibility for the innovative psychedelic technologies include:

  • Neurobiology patents that can be used to further psilocybin and psilocin molecules interactions with brain receptors.
  • Use of nano technology in psilocybin as a drug molecule to treat chronic stress generated by cancer.
  • Patentented technology to optimize controlled environment to modify the efficiency of eucaryotic cells which includes fungus / mycelium.

01

New Formula Discovery 

Submit research to the office of clinical trials

02

Human Clinical Trials

Conduct clinical trails with pre-existing network of patients

03

Proprietary Drug Formulation

Patented drug formulations and delivery methodology

Introduction

PSILOCYBIN BASED TREATMENT FoR ADDICTION

Phase I (Microdosing)


Our first clinical trial will be the study of psilocybin stability and in vivo research and development for addictive disorders with the randomized placebo-controlled trial of repeated micro-dosing for addiction.


This study is a randomized, participant and investigator masked, placebocontrolled trial to understand the effects of micro-dosing with 100 participants. Subjects will be visiting the assessment site where MRP will assess the condition and decide inclusion, exclusion, dosage per subject, and the duration. The selection and the assessment criteria will be explained to the subjects clearly. The maximum dosage per subject depending on the severity is 8mg and the lowest dose per subject is 3mg. The first study conducted will be between 6 (six) months to 1 (one) year.

Objective Of Trial

OBSERVATIONS OF OUR CLINICAL TRIAL

 1) Understanding the stability of psilocybin in various environmental conditions.


2) Understanding the proactive impact of psilocybin on opioid addiction by micro-dosing (oral).


Srinivasa Reddy (Founder & COO) (Expert in medicinal compounds and molecular biology/ cancer research) will be conducting the trial with assistance from Dr. Jagdeep Gupta (Medical Degree in Chronic Pain Management) and Dr. Julia Raudzus - Clinical Assistant Professor Programs: Consultation Liaison Psychiatry, Eating Disorders.


The study will evaluate the effect of psilocybin on patients suffering from chronic pain and addiction. All of the study protocols and research adhere to the rules and regulations as set forth by Health Canada and the Office of Clinical Trials.

The Team

The Science Team

Health Canada License

Cube Psytech has applied for both the Exemption 56J Licence (request for clinical trials with psylocibin) and a Dealer’s License with Health Canada. Both licences are in the review period. Once approved these licences will allow Cube Psytech to conduct advanced research, control studies, cultivate, manufacture and distribute pharmaceutical grade psylocibin products.

Controlled Substance Exemption License for Psilocybin

A brief outline of the 4-step application process

01

Application for Exemption Licence for Psilocybin

  • Develop Research Protocols
  • Identify patients for trial
  • Identify patient centre for analysis and observation
  • Develop psylocibin compound
  • Security storage plan

Complete

02

Submit application to the Office of Clinical Trials

Once the office of clinical trails has confirmed the application is complete the application goes into a 45 day review process. A No Objection letter is required before the application can be submitted to Health Canada. 

Complete

03

Submit application and No

Objection Letter from OTC

To Health Canada

Health Canada will review all exemption licence applications to use psylocibin for scientific purposes for 45 Days. Research licences exemption is approved for 100mg of psilocybin and psilocin. 

Complete

04

Approved Exemption

Licence from Health Canada

Through our research partnerships, Cube Psytech has immediate access to a large, and legal, patient base to run clinical trials. Cube Psytech plans to take a cost-effective strategic position in psilocybin stage 2 & 3 clinical trials.

Patents Accessibility for Innovative Technologies

Neurobiology Patents that can be used further using Psilocybin and Psilocin molecules for brain

receptors:

1. Biomarker for diagnosing toxicity of nanoparticles and method for evaluating toxicity of nanoparticles using the same. (United States patent and Trademark Office (USPTO), Co-inventor; Patent number: 9689019, Date of Patent: June 27, 2017).


2. Nano-neurotoxicity bio-marker composition based on intracellular aggregates which are biomarkers of degenerative brain diseases (United States patent and Trademark Office (USPTO), Co-inventor; Patent number: 20190194715, Date of Patent: June 27, 2019).

Controlled environment and grow condition Patents – in Plants but it can be modified to any eukaryotic organisms (Fungus/Mycelium):

1. Effect of intensity and wavelength of red, blue, amber lights on quality and quantity of lettuce plants (United States patent and Trademark Office (USPTO), Co-inventor).


2. Light effect on enhancing the quality and quantity of lettuce ((United States patent and Trademark Office (USPTO), Inventor.

The Future

Pharmaceutical Grade Psilocybin Products

Pharmaceutical Patents

Future Patents related to works:

Psilocybin-assisted psychotherapy and clinical studies that can demonstrate potential disease- modifying therapeutics, Cancer- Related Psychiatric Distress, Addiction, Treatment-Resistant Depression, Obsessive- Compulsive Disorder, Cluster Headaches, Neuroscience and Pharmacology, Clinical trials for cancer- related anxiety and depressive disorders.

Near Future Focus

  • Optimize commercial cultivation processes
  • Improve strain quality & yield
  • Improve extraction efficiencies
  • Fungi extract innovation
  • Product development
  • Innovation in human delivery mechanisms
  • Synthetic and non-synthetic compound exploration
  • Active compound investigation
  • Pharmaceutical development & new drug formulation research

The Future of Psychedelic Medicine

Investor Deck PDF
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