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Cannabidiol - Kali-Extracts/PAO Group

Drug Profile

Cannabidiol - Kali-Extracts/PAO Group

Alternative Names: NCMB-1; RespRx

Latest Information Update: 28 Feb 2024

At a glance

  • Originator Kali-Extracts
  • Developer Kali-Extracts; PAO Group
  • Class Analgesics; Anti-inflammatories; Anti-ischaemics; Antiacnes; Antibacterials; Antiepileptic drugs; Antihyperglycaemics; Antihyperlipidaemics; Antineoplastics; Antiparkinsonians; Antipsoriatics; Antipsychotics; Antirheumatics; Antivirals; Anxiolytics; Behavioural disorder therapies; Cannabinoids; Cardiovascular therapies; Cyclohexenes; Drug withdrawal therapies; Heart failure therapies; Hepatoprotectants; Muscle relaxants; Neuroprotectants; Obesity therapies; Resorcinols; Skin disorder therapies; Small molecules
  • Mechanism of Action 5-HT1 serotonin receptor modulators; Cannabinoid receptor CB1 inverse agonists; Cannabinoid receptor CB2 inverse agonists; Transient receptor potential channel modulators; Virus internalisation inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Preclinical Lung cancer
  • No development reported Chronic obstructive pulmonary disease; COVID 2019 infections; Respiratory tract disorders

Most Recent Events

  • 28 Feb 2024 No recent reports of development identified for research development in Respiratory-tract-disorders in USA (PO, Liquid)
  • 28 Sep 2023 No recent reports of development identified for clinical-Phase-Unknown development in COVID-2019-infections in USA (PO, Liquid)
  • 28 Aug 2022 No recent reports of development identified for phase-I development in Chronic-obstructive-pulmonary-disease in USA (PO, Liquid)

Development Overview

Introduction

A liquid formulation of cannabidiol enriched extract (also known as NCMB1) is being developed by PAO Group, for the treatment of symptoms associated with chronic obstructive pulmonary disease (COPD), coronavirus infection, other respiratory conditions and lung cancer. Specifically for COVID-2019 infections, the two compounds, CBDA and CBGA, bind to spike proteins on the virus and block the spike protein from binding to sites in human host. The drug was originally developed by Kali Extracts, and later acquired by PAO Group. Kali Extracts used a patented cannabis extraction process of NCM Biotech for extraction of cannabinoid extract. Clinical development for the treatment of chronic obstructive pulmonary disease and symptoms associated with COVID-2019 infections is underway in the US. Preclinical development for the treatment of lung cancer is underway in the US. Early research for the treatment of respiratory conditions is ongoing in the US.

In 2018, Kali-Extracts acquired NCM Biotech [1] .

As at August 2022, no recent reports of development had been identified for phase-I development in Chronic-obstructive-pulmonary-disease in USA (PO, Liquid).

As at September 2023, no recent reports of development had been identified for clinical-Phase-Unknown development in COVID-2019-infections in USA (PO, Liquid).

As at February 2024, no recent reports of development had been identified for research development in Respiratory-tract-disorders in USA (PO, Liquid).

Company Agreements

In July 2020, PAO Group Inc entered into a purchase agreement with Kali-Extracts Inc for acquiring cannabidiol (RexpRx) from the latter. PAO purchased the drug from Kali in an all stock deal for common stock. PAO is undergoing negotiations with Kali for the potential comprehensive acquisition of the underlying patent from which the cannabidiol formula was derived. [2]

Key Development Milestones

In October 2021, PAO Group reported that cannabidiol (RespRx) in non-clinical trials demonstrated efficacy in treatment of lung cancer [3] .

In August 2020, PAO Group announced that it intends to submit IND application for cannabidiol (RexpRx) to US FDA for the treatment of chronic obstructive pulmonary disease [4] .

As of August 2020, PAO Group completed a clinical trial of cannabidiol in 25 patients with symptoms associated with COVID-2019 infections. Based on positive results from this trial, the company also plans to make Coronavirus Treatment Acceleration Program (CTAP) application, in collaboration with a CRO [4] .

As at July 2019, liquid formulation of cannabidiol was in a phase I development for the treatment of chronic obstructive pulmonary disease [1] .

In in vitro studies, liquid formulation of cannabidiol down-regulated genes responsible for inflammation and demonstrated improvement in airway function in non-human primates model of with chronic pulmonary fibrosis [5] [6] [7] .

Research from a cannabidiol study indicated that cannabidiol impacted hyper-immune responses which potentially develop into a cytokine storm which in-turn impacts COVID-19 patients. Cannabidiol also positively stimulated immune responses countering bad cells. Results from a tetrahydrocannabinol-based study showcased its ability relieve pain, but also indicated immune response manipulation capabilities to include anti-inflammatory reactions, along with stimulation of immune responses to fight bad cells. Both studies were conducted to investigate and explain the therapeutic potential of RexpRx [8] .

Patent Information

As of October 2021,USPTO granted patent to PAOG associated with a patented cannabis extraction method encloses U.S. Patent No. 9 199 960 entitled methods and apparatus for processing herbaceous plant materials including the cannabis plant [9] .

In January 2020, Kali-Extracts filed a patent application for cannabidiol formulation for the treatment of symptoms associated with chronic obstructive pulmonary disease (COPD) and other respiratory conditions [10] .

In December 2015, the US PTO issued a patent number US 9 199 960 B2 entitled "Method and apparatus for processing herbaceous plant materials including the cannabis plant". The US patent provides protection to method to increase the yield of cannabinoids, particularly cannabidiol from Cannabis plant material [11] .

Drug Properties & Chemical Synopsis

  • Route of administration PO
  • Formulation Liquid, unspecified
  • Class Analgesics, Anti-inflammatories, Anti-ischaemics, Antiacnes, Antibacterials, Antiepileptic drugs, Antihyperglycaemics, Antihyperlipidaemics, Antineoplastics, Antiparkinsonians, Antipsoriatics, Antipsychotics, Antirheumatics, Antivirals, Anxiolytics, Behavioural disorder therapies, Cannabinoids, Cardiovascular therapies, Cyclohexenes, Drug withdrawal therapies, Heart failure therapies, Hepatoprotectants, Muscle relaxants, Neuroprotectants, Obesity therapies, Resorcinols, Skin disorder therapies, Small molecules
  • Target 5-HT1 serotonin receptor; Cannabinoid receptor CB1; Cannabinoid receptor CB1 inverse; Cannabinoid receptor CB2; Cannabinoid receptor CB2 inverse; Transient receptor potential channel; Virus internalisation
  • Mechanism of Action 5-HT1 serotonin receptor modulators; Cannabinoid receptor CB1 inverse agonists; Cannabinoid receptor CB2 inverse agonists; Transient receptor potential channel modulators; Virus internalisation inhibitors
  • WHO ATC code

    L01 (Antineoplastic Agents)

    N03A-X24 (Cannabidiol)

    R (Respiratory System)

    R03 (Drugs for Obstructive Airway Diseases)

  • EPhMRA code

    L1 (Antineoplastics)

    R (Respiratory System)

    R3 (Anti-Asthma and COPD Products)

    V (Various)

  • Chemical name 2-[(1R,6R)-3-methyl-6-prop-1-en-2-ylcyclohex-2-en-1-yl]-5-pentylbenzene-1,3-diol
  • Molecular formula C21 H30 O2
  • CAS Registry Number 3556-78-3

Biomarkers Sourced From Trials

Indication Biomarker Function Biomarker Name Number of Trials

absence epilepsy

Eligibility Criteria

FSH

1

adenocarcinoma

Eligibility Criteria

PSA

1

adenocarcinoma

Outcome Measure

Testosterone

PSA

1

1

arthralgia

Outcome Measure

Estradiol-17beta 3-sulfate

1

autistic disorder

Outcome Measure

N-Acetyl-L-aspartic acid

L-Glutamine

1

1

cardiovascular disorders

Detailed Description

Tumor necrosis factor alpha (TNF-alpha)

Interleukin-6 (IL-6)

Interleukin-10 (IL-10)

Interleukin 1 Beta (IL-1β)

Ferritin

D-dimer

Cardiac Troponin I

C-reactive protein (CRP)

BNP

1

1

1

1

1

1

1

1

1

cerebral ischaemia

Brief Summary

carboxylesterase 1

1

cerebral ischaemia

Brief Title

carboxylesterase 1

1

cerebral ischaemia

Official Title

carboxylesterase 1

1

DiGeorge syndrome

Eligibility Criteria

MDD1 (Major depressive disorder)

1

Dravet syndrome

Outcome Measure

CLYBL

1

Dravet syndrome

Brief Title

carboxylesterase 1

1

Dravet syndrome

Arm Group Description

Sucralose

1

Dravet syndrome

Official Title

carboxylesterase 1

1

Dravet syndrome

Brief Summary

Estradiol-17beta 3-sulfate

carboxylesterase 1

1

1

drug dependence

Outcome Measure

Hydrocortisone

1

dyslipidaemias

Eligibility Criteria

Insulin

1

dyslipidaemias

Outcome Measure

Insulin

Fructosamine

C-peptide

Apolipoprotein B (AOPB)

1

1

1

1

early breast cancer

Arm Group Label

9-cis-Retinoic acid

13-cis-Retinoic acid

1

1

early breast cancer

Outcome Measure

pregnancy specific beta-1-glycoprotein 2

Cytokeratin 5

CEA

carcinoembryonic antigen related cell adhesion molecule 3

CA 15-3

9-cis-Retinoic acid

1

1

1

1

1

1

early breast cancer

Brief Title

9-cis-Retinoic acid

1

early breast cancer

Arm Group Description

9-cis-Retinoic acid

13-cis-Retinoic acid

1

1

early breast cancer

Detailed Description

Cytokeratin 5

1

early breast cancer

Eligibility Criteria

pregnancy specific beta-1-glycoprotein 2

CEA

carcinoembryonic antigen related cell adhesion molecule 3

1

1

1

early breast cancer

Official Title

9-cis-Retinoic acid

1

early breast cancer

Brief Summary

PGR

Estrogen receptor alpha (ER alpha)

Cytokeratin 5

9-cis-Retinoic acid

1

1

1

1

epilepsy

Brief Summary

Estradiol-17beta 3-sulfate

carboxylesterase 1

1

1

epilepsy

Brief Title

Valproic acid glucuronide

carboxylesterase 1

1

1

epilepsy

Official Title

Valproic acid glucuronide

carboxylesterase 1

1

1

epilepsy

Outcome Measure

CLYBL

1

fibromyalgia

Outcome Measure

Hydrocortisone

1

fragile X syndrome

Eligibility Criteria

FRAXA

FMR1 intronic transcript 1

FMR1

2

2

2

fragile X syndrome

Outcome Measure

FRAXA

FMR1 intronic transcript 1

FMR1

ATP-binding cassette, sub-family A (ABC1), member 3

1

1

1

1

generalised epilepsy

Eligibility Criteria

FSH

1

glioblastoma

Eligibility Criteria

MGMT

1

glioblastoma

Official Title

MGMT

1

Heroin-related disorders

Brief Summary

carboxylesterase 1

1

Heroin-related disorders

Brief Title

carboxylesterase 1

1

Heroin-related disorders

Official Title

carboxylesterase 1

1

infantile spasms

Brief Summary

carboxylesterase 1

1

infantile spasms

Brief Title

carboxylesterase 1

1

infantile spasms

Official Title

carboxylesterase 1

1

Lennox-Gastaut syndrome

Brief Summary

Estradiol-17beta 3-sulfate

carboxylesterase 1

1

1

Lennox-Gastaut syndrome

Brief Title

carboxylesterase 1

1

Lennox-Gastaut syndrome

Official Title

carboxylesterase 1

1

major depressive disorder

Detailed Description

Thyroid stimulating hormone beta (TSH)

matrilin 1, cartilage matrix protein

GATA3

Cytidine monophosphate

CD59 molecule, complement regulatory protein

1

1

1

1

1

multiple sclerosis

Arm Group Description

Piperine

1

myocarditis

Detailed Description

Cardiac Troponin I

BNP

1

1

myocarditis

Eligibility Criteria

Cardiac Troponin I

1

myocarditis

Outcome Measure

Tumor necrosis factor alpha (TNF-alpha)

Interleukin-6 (IL-6)

Interleukin-10 (IL-10)

Interleukin 1 Beta (IL-1β)

Ferritin

Cardiac Troponin I

C-reactive protein (CRP)

BNP

1

1

1

1

1

1

1

1

myoclonic epilepsies

Brief Title

Valproic acid glucuronide

1

myoclonic epilepsies

Official Title

Valproic acid glucuronide

1

Opioid-related disorders

Outcome Measure

Retinoyl b-glucuronide

Anandamide

2-Arachidonylglycerol

1

1

1

Opioid-related disorders

Brief Title

carboxylesterase 1

1

Opioid-related disorders

Detailed Description

Anandamide

2-Arachidonylglycerol

1

1

Opioid-related disorders

Eligibility Criteria

Thyroxine (T4)

Prolactin

Luteinizing hormone (LH)

Estradiol-17beta 3-sulfate

Bilirubin

1

1

1

1

1

Opioid-related disorders

Official Title

carboxylesterase 1

1

Opioid-related disorders

Brief Summary

carboxylesterase 1

1

pain

Eligibility Criteria

CYP2C9

1

pain

Outcome Measure

Hydrocortisone

1

Parkinson's disease

Brief Title

carboxylesterase 1

1

Parkinson's disease

Arm Group Description

Sucralose

1

Parkinson's disease

Eligibility Criteria

protein tyrosine phosphatase, receptor type F

1

Parkinson's disease

Official Title

carboxylesterase 1

1

Parkinson's disease

Brief Summary

carboxylesterase 1

1

pervasive child development disorders

Outcome Measure

N-Acetyl-L-aspartic acid

L-Glutamine

1

1

postoperative pain

Outcome Measure

Interleukin-6 (IL-6)

1

prostate cancer

Eligibility Criteria

PSA

1

prostate cancer

Outcome Measure

Testosterone

PSA

1

1

Rett syndrome

Outcome Measure

IGF1

1

Rett syndrome

Brief Title

carboxylesterase 1

1

Rett syndrome

Eligibility Criteria

MECP2

L-Aspartic acid

ALT

1

1

1

Rett syndrome

Official Title

carboxylesterase 1

1

Rett syndrome

Brief Summary

carboxylesterase 1

1

schizophrenia

Arm Group Label

Insulin

E1A binding protein p300

1

1

schizophrenia

Brief Title

carboxylesterase 1

1

schizophrenia

Arm Group Description

Insulin

fatty acid amide hydrolase

E1A binding protein p300

1

1

1

schizophrenia

Official Title

carboxylesterase 1

1

schizophrenia

Brief Summary

carboxylesterase 1

1

seizures

Eligibility Criteria

FSH

1

seizures

Outcome Measure

IGF1

1

substance-related disorders

Eligibility Criteria

UDP glucuronosyltransferase family 1 member A complex locus

T-cell surface antigen CD4

solute carrier family 35 (UDP-galactose transporter), member A2

1

1

1

substance-related disorders

Outcome Measure

Hydrocortisone

Anandamide

1

1

tonic-clonic epilepsy

Eligibility Criteria

FSH

1

tremor

Arm Group Description

Sucralose

1

tremor

Eligibility Criteria

protein tyrosine phosphatase, receptor type F

1

tuberous sclerosis

Brief Summary

carboxylesterase 1

1

tuberous sclerosis

Brief Title

carboxylesterase 1

1

tuberous sclerosis

Official Title

carboxylesterase 1

1

tuberous sclerosis

Outcome Measure

IGF1

1

type 2 diabetes mellitus

Eligibility Criteria

Insulin

1

type 2 diabetes mellitus

Outcome Measure

Insulin

Fructosamine

C-peptide

Apolipoprotein B (AOPB)

1

1

1

1

ulcerative colitis

Detailed Description

Calprotectin

C-reactive protein (CRP)

1

1

ulcerative colitis

Outcome Measure

Calprotectin

1

Biomarker

Drug Name Biomarker Name Biomarker Function
Cannabidiol - Kali-Extracts/PAO Group Anandamide Outcome Measure
BDNF Outcome Measure
BPI fold containing family A member 2 Outcome Measure
C-reactive protein (CRP) Outcome Measure
calcineurin binding protein 1 Arm Group Description
microseminoprotein, beta- Outcome Measure
persephin Outcome Measure
phosphoserine phosphatase Outcome Measure
Prolactin Outcome Measure
regenerating family member 1 alpha Outcome Measure
RIDA Outcome Measure
syntaxin binding protein 3 Outcome Measure
Valproic acid glucuronide Arm Group Description
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections For symptoms associated with COVID-2019-infections - No development reported (Clinical) USA PO / Liquid PAO Group 28 Sep 2023
Chronic obstructive pulmonary disease Foe symptoms associated with COPD - No development reported (I) USA PO / Liquid Kali-Extracts 28 Aug 2022
Lung cancer - - Preclinical USA PO / unspecified PAO Group 15 Oct 2021
Respiratory tract disorders - - No development reported (Research) USA PO / Liquid Kali-Extracts 28 Feb 2024

Commercial Information

Involved Organisations

Organisation Involvement Countries
Kali-Extracts Originator USA
PAO Group Owner USA
University of Kentucky Collaborator USA

Brand Names

Brand Name Organisations Indications Countries
RespRx Kali-Extracts Chronic obstructive pulmonary disease USA

Scientific Summary

Pharmacodynamics

Summary

In nonhuman primates with chronic pulmonary fibrosis, 5-fold dilution of liquid cannabidiol formulation increased airway flow rate by 82%, respiration rate by 55%, airway flow rate by 82%, inspiratory airway flow velocity by 149%, and tidal volume by 38% compared with own control values after two weeks treatment. Improvement in pulmonary function in these primates also accompanied with increases in resting minute ventilation. Undiluted of liquid cannabidiol formulation also increased inspiratory flow rate by 49% and tidal volume by 24% after 2 weeks of treatment. Respiration rate was unchanged from pretreatment values. 25-fold dilution of liquid cannabidiol formulation did not showed any marked improvement on airway or lung functions. The data suggest potential of cannabidiol formulation for the treatment of chronic obstructive airway diseases that restrict inspiratory air flow [6] [7] .

In in vitro studies, cannabinoids extract alone demonstrated up- or down-regulating genes responsible for inflammation and healing by as much as 200-fold in human small airway epithelial cells (HSAEpC) [5] .

Future Events

Expected Date Event Type Description Updated
31 Dec 2021 Regulatory Status PAOG plans to launch cannabidiol in fourth quarter of 2021 [9] 13 Oct 2021

Development History

Event Date Update Type Comment
28 Feb 2024 Phase Change - No development reported No recent reports of development identified for research development in Respiratory-tract-disorders in USA (PO, Liquid) Updated 28 Feb 2024
28 Sep 2023 Phase Change - No development reported No recent reports of development identified for clinical-Phase-Unknown development in COVID-2019-infections in USA (PO, Liquid) Updated 28 Sep 2023
28 Aug 2022 Phase Change - No development reported No recent reports of development identified for phase-I development in Chronic-obstructive-pulmonary-disease in USA (PO, Liquid) Updated 28 Aug 2022
15 Oct 2021 Phase Change - Preclinical Preclinical trials in Lung cancer in USA (PO) [3] Updated 19 Oct 2021
11 Oct 2021 Patent Information PAO Group has patent protection for Cannabidiol in USA by October 2021 [9] Updated 13 Oct 2021
11 Oct 2021 Regulatory Status PAOG plans to launch cannabidiol in fourth quarter of 2021 [9] Updated 13 Oct 2021
02 Jul 2021 Biomarker Update Biomarkers information updated Updated 02 Oct 2021
06 Oct 2020 Trial Update 9304490 - created HE missed from MR 9300394; added results of study in KDM as discussed with SME Updated 06 Oct 2020
11 Aug 2020 Trial Update PAO Group plans clinical development in Chronic obstructive pulmonary disease in USA (PO) [4] Updated 06 Oct 2020
11 Aug 2020 Phase Change - Clinical Clinical trials in COVID-2019 infections in USA (PO) before August 2020 [4] Updated 18 Aug 2020
11 Aug 2020 Regulatory Status PAO Group announces intention to submit Coronavirus Treatment Acceleration Program application to regulatory authorities for COVID-2019 infections [4] Updated 18 Aug 2020
11 Aug 2020 Regulatory Status PAO Group announces intention to submit IND to US FDA for Chronic obstructive pulmonary disease [4] Updated 18 Aug 2020
30 Jul 2020 Licensing Status PAO Group acquires Cannabidiol from Kali-Extracts [2] Updated 18 Aug 2020
28 Jan 2020 Patent Information Kali-Extracts files for patent protection for cannabidiol formulation for treatment of chronic obstructive pulmonary disease and other respiratory conditions [10] Updated 11 Feb 2020
28 Jan 2020 Phase Change Early research in COVID-2019-infections in USA (PO) [10] Updated 30 Jan 2020
28 Jan 2020 Phase Change Early research in Respiratory tract disorders in USA (PO) [10] Updated 30 Jan 2020
09 Jul 2019 Phase Change - I Phase-I clinical trials in Chronic obstructive pulmonary disease in USA before July 2019 (PO) [1] Updated 30 Jan 2020
01 Feb 2019 Phase Change - Preclinical Preclinical trials in Chronic obstructive pulmonary disease in USA (PO) before February 2019 [6] Updated 30 Jan 2020
01 Feb 2019 Scientific Update Pharmacodynamics data from preclinical studies in Chronic obstructive pulmonary disease released by Kali-Extracts [6] [7] Updated 30 Jan 2020
19 Dec 2018 Scientific Update Pharmacodynamics data from in vitro studies in Chronic obstructive pulmonary disease released by Kali-Extracts [5] Updated 30 Jan 2020
01 Dec 2015 Patent Information kali-extracts has patent protection for extraction method of cannabinoids in USA [11] Updated 30 Jan 2020

References

  1. KALY Adds New CBD Extraction Contract Worth $10 Million in Annual Revenue.

    Media Release
  2. PAOG Announces Acquisition of Resprx Entering 200B Biopharma Market.

    Media Release
  3. PAOG Cites New British Medical Journal Case Report On CBD Lung Cancer And COPD Treatment As Validation Of PAOG Ongoing RespRx Drug Research.

    Media Release
  4. PAOG Cannabis Pharma Initiative Stands to Benefit From Senator Marco Rubio and Congresswoman Jenniffer Gonzlez Coln New Bill.

    Media Release
  5. Kali-Extracts, Inc. Releases Preclinical Research Study Results on Therapy for Respiratory Disease Driving $11 Billion Treatment Market.

    Media Release
  6. KALY - Kali-Extracts, Inc. Announces Cannabis Extract COPD Primate Treatment Study Research Report Preview.

    Media Release
  7. KALY - Kali-Extracts, Inc. Previews Pending Report On Cannabis Treatment For Lung Disease Study.

    Media Release
  8. PAOG Announces New Engagement To Prepare For Investigational New Drug Application With FDA.

    Media Release
  9. PAOG Set To Realize First CBD Nutraceutical Sales In Q4 With Rapid Revenue Growth Expected To Follow.

    Media Release
  10. KALY-Kali-Extracts RespRx Could Offer Treatment for Coronavirus Symptoms.

    Media Release
  11. Method and apparatus for processing herbaceous plant materials including the cannabis plant - Patent. Internet-Doc 2020;.

    Available from: URL: https://patents.google.com/patent/US9199960B2/en?oq=9%2c199%2c960
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