NanaBis™ (NanoCelle® CBD/THC) for management of intractable pain in advanced cancer patients

Cannabis
ANZCTR: ACTRN12617001480370
Date Started: 2018-06-06
Progress - FIH Safety & Efficacy - Completed

test

Study Site:

Royal North Shore Hospital

FORMULATION:

NanaBis™ is an investigative new product containing 1:1 ratio of Cannabidiol (CBD) and delta-9-trethydrocannabinol (THC), in a sub-micron spray applied to the oro-buccal membrane.

About trial:

The aim of this project was to conduct a safety, tolerability and exploratory end-point pilot study assessing the administration of a cannabis extract, NanaBis™ as an adjunct to opioid analgesia for the management of intractable pain in patients with a positive diagnosis of advanced cancer.

NanaBis™ is a non-ARTG product currently in clinical trials and available under SAS. SAS application can be made either manually via the appropriate application forms or on-line via https://sas.tga.gov.au. More info can be found at How to access Medicinal Cannabis

Inadequate control of chronic pain is a major contributor to disease burden in approximately half of cancer patients. This trial demonstrated that NanaBis™ provided adequate bioavailability of THC and CBD and is safe & tolerable in people with cancer and uncontrolled pain with preliminary evidence of analgesic efficacy. 

Trial Progression:

  • SAD/MAD Trial, Royal North Shore Hospital - COMPLETED

    Clarke S BB, McLachlan AJ, Henson JD, Rutolo D, Hall S, Vitetta L. Pilot Clinical and Pharmacokinetic Study of Δ9-Tetrahydrocannabinol (THC) / Cannabidiol (CBD) Nanoparticle Oro-Buccal Spray in Patients with Advanced Cancer Experiencing Uncontrolled Pain. Cancers. 2020;UNDER REVIEW.
     
  • OBS Study, multiple AU sites - underway
  • M/C Phase 3 - in development

HREC Date:

2017-06-16

HREC ID:

HREC/16/HAWKE/496

CTN:

CT-2017-CTN-02369-1 v3

PUBLICATIONS OR CONFERENCES ASSOCIATED WITH THE PROGRAM

An oro-buccal nanoparticle delivered cannabis medicine for pain management in cancer: A clinical trial in progress.

American Society of Clinical Oncology (ASCO), Virtual Conference

Date:          2020-05-29

Understanding the Trial NanaBis™

Clinical Trial for Advanced Cancer Pain Seminar Melbourne

Date:          2018-03-06

Authors:   Hall S

Potentiating new Neurological pain drugs from cannabis (CBD/THC)

14th World Congress on Healthcare and Technologies, London UK

Date:          2019-07-22

Authors:   Sean Hall

Innovating Humanity - Opioids to Covid-19, Learnings and Health Needs for Our Future

23rd International Conference on Multidisciplinary Studies: Resilience for Survival (ICMS XXIII), Cambridge University

Date:          2020-07-30

Authors:   Dr Sean Hall

International Precision Medicine Conference 2021

Dr. Sean Hall presents at the International Precision Medicine Conference 2021 in Orlando USA. The presentation titled: The Pain: an opioid epidemic requiring a non-opioid alternative

Date:          2021-04-21


PARTNER'S ASSOCIATED WITH THE PROGRAM

Royal North Shore Hospital

Royal North Shore Hospital

Established in 1885, Royal North Shore Hospital (RNSH) and its associated health services meet the health needs of four local government areas - Mosman, Willoughby, Lane Cove and North Sydney.

 

RNSH is a principal tertiary referral centre as well as a NSW Trauma Centre. The state-wide services provided by RNSH are severe burns injury, spinal cord injury, neonatal intensive care and interventional neuroradiology.

 

For more information about Royal North Shore Hospital visit https://www.nslhd.health.nsw.gov.au/Hospitals/RNSH/

Agilex Biolabs

Agilex are experts in bio analytical excellence. Medlab’s Human Analytics (ASSAY) are developed in conjunction with Agilex Biolabs Pty Ltd with ongoing commercial relationships that pay royalty to Medlab from all 3rd parties.

Extractas Biosciences

NanaBis™ is manufactured by Extractas Biosciences (Formally Tasmanian Alkaloids) exclusively for Medlab. Extractas Biosciences are a global leader in the extraction and purification of high-value plant-derived products for the pharmaceutical industry have added Medicinal Cannabis products and services to their portfolio including; cultivation, manufacturing, formulation, analytical and release for supply. Extractas Biosciences hold all applicable/necessary Office of Drug Control (ODC) and Therapeutic Goods Administration (TGA) licences required for these activities. 

Nitto Avecia Pharma Services

Nitto Avecia offers outstanding GMP analytical testing to Medlab on a contracted basis. Nitto operates an FDA approved facility in California, USA.