UPDATE: ECOFIBRE LIMITED – Ananda Health products used in first clinical trial on hemp-derived CBD to treat chemotherapy-induced peripheral neuropathy
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Georgetown, Kentucky, July 23, 2020 (GLOBE NEWSWIRE) — Ecofibre Limited (Ecofibre, Company) (ASX:EOF, OTC-NASDAQ Intl Designation: EOFBF) is pleased to announce that the Lankenau Institute for Medical Research (LIMR), Wynnewood, Pa., has begun patient enrollment in a phase II clinical trial using Ananda Health hemp-derived cannabidiol (CBD).
The purpose of this study is to assess the efficacy of a hemp-based 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.
Ecofibre and Ananda demonstrate their commitment to advancing the science of CBD with the launch of the Coala-T-CBD study™ (ClinicalTrials.gov Identifier: NCT04398446). The phase II clinical trial began enrolling patients at LIMR in June.
CIPN is a debilitating condition that 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 treated with CBD offers hope.
The Coala-T-CBD StudyTM is the first clinical trial positioned to translate this success to humans and is led by oncologist Marisa Weiss, MD, the founder and chief medical officer of www.Breastcancer.org and Director of Breast Radiation Oncology and Breast Health Outreach at Lankenau Medical Center, Wynnewood, Pa
“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% to 50% of pediatric and adult cancer patients undergoing neurotoxic chemotherapy,” Weiss states.
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. “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 effect,” says Weiss.
The IND allows for Weiss’ team to conduct the highest-quality research using a randomized, double-blind, placebo-controlled clinical trial.
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The FDA has publicly requested data on hemp-derived CBD regarding tolerability, drug interactions, toxicity, and dosing. Ecofibre responded early by investing an additional USD $1.8 million in research across several studies.
10.1080/00325481.2019.1685298) 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. ” data-reactid=”39″ type=”text”>In 2019, the company published a peer-reviewed study (DOI: 10.1080/00325481.2019.1685298) 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 StudyTM contributes to Ecofibre’s growing clinical research portfolio examining CBD use across age groups, populations, disease states, and doses. Importantly, the Coala-T-CBD StudyTM will offer critical insights on the use of higher-dose CBD.
Ecofibre’s second phase II clinical trial (ClinicalTrials.gov Identifier: NCT04436081) will evaluate moderate-dose CBD on agitation, sleep, and mood in dementia patients. The moderate-dose study is currently pursuing its own FDA IND and expects patient enrollment in August in with a group of neurology and gerontology specialists in Virginia.
The Coala-T-CBD StudyTM includes comprehensive physician and laboratory analyses to determine the safety of moderate- and high-dose CBD.
In addition to its clinical trials in the U.S., Ecofibre will support research on low-dose full-spectrum CBD later this year in Australia.
Alex Capano, Ecofibre’s Chief Science Officer, states, “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.
“We are pleased to work with such a high-quality group of researchers and physicians at LIMR,” Wang continues “The Coala-T-CBD StudyTM will provide ongoing updates, and we anticipate completion in 2022.”
www.ecofibre.com.” data-reactid=”51″ type=”text”>For more information on Ecofibre Limited, visit www.ecofibre.com.
For more information on the Coala-T-CBD™ Study, visit www.mainlinehealth.org/research/clinical-trials/
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Company Secretary, Ecofibre Limited
Ecofibre is a provider of hemp products in the United States and Australia.
In the United States, the Company produces nutraceutical products for human and pet consumption, as well as topical creams and salves. See www.anandahemp.com and www.anandaprofessional.com.
In Australia, the Company produces 100% Australian-grown and -processed hemp food products including protein powders, de-hulled hemp seed, and hemp oil. See www.anandafood.com.
The Company is also developing innovative hemp-based products in textiles and composite materials in partnership with TexInnovate in the United States. See www.hempblack.com.
The Company owns or controls key parts of the value chain in each business, from breeding, growing, and production to sales and marketing. Our value proposition to customers is built on strong brands and quality products.
About Lankenau Institute for Medical Research (LIMR)
limr.org.” data-reactid=”67″ type=”text”>LIMR is a nonprofit biomedical research institute located on the campus of Lankenau Medical Center, Wynnewood, Pa., and is the research division of Main Line Health. Founded in 1927, LIMR’s mission is to improve human health and well-being. Faculty and staff are devoted to advancing innovative new approaches to formidable medical challenges, including cancer, cardiovascular disease, gastrointestinal disorders, autoimmune diseases, and regenerative medicine, as well as population health. LIMR’s principal investigators conduct basic, preclinical, clinical, and translational research, using their findings to explore ways to improve disease detection, diagnosis, treatment, and prevention. They are committed to extending the boundaries of human health through technology transfer and training of the next generation of scientists and physicians. For more information, visit limr.org.
CONTACT: Jonathan Brown Ecofibre [email protected]