Ecofibre Limited (ASX:EOF), a leading international provider of hemp products has announced the commencement of a Phase II clinical trial using hemp-derived CBD products from subsidiary Ananda Health.
The study, which will be undertaken by the Philadelphia-based Lankenau Institute for Medical Research, aims to assess the efficacy of a hemp-based cannabidiol (CBD) product, Ananda Health Spectrum gelcaps, on the severity and duration of chemotherapy-induced peripheral neuropathy (CIPN) among breast, colon, and ovarian cancer patients who received common types of neurotoxic chemotherapy.
The debilitating condition, CIPN, is often chronic, compromising patients’ quality of life and limiting their ability to complete a full course of potentially life-saving treatments. Currently, there are no safe and effective medications to treat or prevent CIPN, but research in animals using CBD offers hope as a new treatment.
The Coala-T-CBD Study is the first clinical trial positioned to translate this success to humans and is led by oncologist Dr. Marisa Weiss, the founder and chief medical officer of www.Breastcancer.org and Director of Breast Radiation Oncology and Breast Health Outreach at Lankenau Medical Center.
“We are proud to be the first in the United States to study the impact of hemp-derived full spectrum CBD on CIPN, a condition that affects approximately 25-50% of pediatric and adult cancer patients undergoing neurotoxic chemotherapy,” Weiss states.
“To our knowledge, this is the first phase II clinical trial using full-spectrum hemp extract for the treatment of CIPN to receive an FDA IND. This level of research is necessary to answer the global call from the medical community, patients, and regulatory bodies seeking effective treatment of this difficult, common chemotherapy side effec,” says Weiss.
Among other milestones, the Coala-T-CBD StudyTM received an IND (investigational new drug) by the Food and Drug Administration (FDA) and will use Ananda softgels in the study protocol. The IND allows for Weiss’ team to conduct the highest-quality research using a randomized, double-blind, placebo-controlled clinical trial.
The FDA has publicly requested data on hemp-derived CBD regarding tolerability, drug interactions, toxicity, and dosing and Ecofibre responded early by investing an additional USD1.8 million in research across several studies.
In 2019, the company published a peer-reviewed study3 regarding the effects of low-dose CBD in chronic pain patients. The results demonstrated that low-dose CBD was well tolerated and improved pain, sleep, mood and opioid use.
The Coala-T-CBD Study will contribute to Ecofibre’s growing clinical research portfolio of CBD use across age groups, populations, disease states, and doses. Importantly, the new trial will offer critical insights on the use of higher-dose CBD.
In addition to its clinical trials in the U.S., Ecofibre will be supporting research on low-dose full spectrum CBD later this year in Australia.
Alex Capano, Ecofibre’s Chief Science Officer commented, “These studies will provide solutions for patients and contribute valuable data on the safety and efficacy of hemp CBD products. We understand the critical need for more sophisticated, rigorous research and are dedicated to closing those gaps.”
Ecofibre CEO, Eric Wang adds, “A core foundation for Ananda Health has been to support quality research for patient and practitioner education. Whilst the recent pandemic has created market uncertainty, the Company remains highly committed to its long-term investment to support our customers and the FDA in creating the knowledge base to inform better decisions for our industry.”
Source | EcoFibre