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Kannalife, Inc. Announces Completion of NIH-NIDA Phase 1 Grant and Results from Lewis Katz School of Medicine at Temple University for the Potential Use of KLS-13019 in the Treatment of CIPN

DOYLESTOWN, Pa., Feb. 11, 2020 (GLOBE NEWSWIRE) -- Kannalife, Inc. (KLFE) (“Kannalife” or the “Company”), a biopharmaceutical company specializing in the research and development of cannabinoid therapeutics, announced today that it has completed its phase 1 study funded by a grant (1R41DA044898-01) from the National Institutes of Health’s (NIH) National Institute on Drug Abuse (NIDA). The study was performed by Kannalife and the Lewis Katz School of Medicine at Temple University (LKSOM) to assess KLS-13019, the Company’s patented cannabidiol (CBD)-like molecule as a potential treatment of neuropathic pain and drug dependence.

The pre-clinical grant study was performed in an animal model to evaluate the potential use of KLS-13019 as a potent, non-opioid alternative in the prevention and reversal of chemotherapy-induced peripheral neuropathy (CIPN).

The animal model portion of the study was conducted by Sara Jane Ward, PhD, Assistant Professor of Pharmacology at LKSOM. Dr. Ward had independently begun the research focused on CBD for the potential treatment of CIPN in 2010 at LKSOM and published three papers on the subject prior to beginning the collaboration with Kannalife.

“I’m very excited about the results we have obtained with KLS-13019 to date. In our model, KLS-13019 is at least as effective as CBD to prevent neuropathic pain; however, KLS-13019 is also effective to reverse neuropathic pain as a consequence of cancer chemotherapy, whereas CBD was not effective under our test conditions. We will continue to explore the possibility that KLS-13019 could be even safer and more effective than CBD,” stated Dr. Ward.

Kannalife performed pharmacology studies on the mechanism of action of KLS-13019 and its effects on the sodium-calcium exchanger (mNCX-1), an important regulator of mitochondrial function. Results of the studies performed by Douglas Brenneman, PhD, for Kannalife, have been published in the Journal of Molecular Neuroscience in a paper titled, “Knockdown siRNA Targeting the Mitochondrial Sodium-Calcium Exchanger-1 Inhibits the Protective Effects of Two Cannabinoids Against Acute Paclitaxel Toxicity.”

“For KLS-13019 treatment of CIPN, significant progress has been made in identifying a molecular mechanism of protection from the complex effects of paclitaxel-induced damage of sensory nerve cells,” stated Dr. Brenneman.

The completed study could lead to a Phase 2 grant and further advances Kannalife’s belief that KLS-13019 could become a viable drug candidate, and an alternative to opioids, as a treatment for patients suffering from CIPN, and chronic pain management. CIPN is a disabling pain condition that afflicts between 30-40 percent of patients undergoing chemotherapy, for which there is no effective prevention strategy and treatment of established chronic CIPN is limited.1 Existing treatment options primarily include anticonvulsants and antidepressants, as well as opioids in more severe cases of CIPN.2

The global market for neuropathic pain was valued at more than $5 billion in 2015, and in 2016, CIPN accounted for more than 42 percent of market revenue. It’s estimated that by 2024, the total global neuropathic pain market will be worth more than $8.3 billion.3-4

The global opioids drug market was valued at $22.85 billion in 2017 and is expected to reach $32.6 billion by 2026, at a CAGR of 4.54% during a forecast period. Opioids are mainly used in cancer pain management and end-stage diseases in which painkilling care is required. The rising prevalence of cancer, high demand for pain therapeutics in the treatment of chronic pain, regulatory approvals and launches of innovative drug formulations, and increasing approval rate of abuse-deterrent formulations of opioid drugs are major driving factors of the global opioids drugs market. Extensive misuse of opioids, the growing incidence of death related to opioid overdose, and the rising number of lawsuits against opioid manufacturers are hindering the growth of the market. 5

A recently released animated video from Kannalife describes a Mechanism of Action (MOA) for KLS-13019. This video can be accessed on the Company’s website at www.kannalife.com and via Vimeo at https://vimeo.com/371214213.

Research reported in this press release was supported by the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) in the amount of $299,916 under award number 1R41DA044898-01.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Temple Health
Temple University Health System (TUHS) is a $2.2 billion academic health system dedicated to providing access to quality patient care and supporting excellence in medical education and research. The Health System consists of Temple University Hospital (TUH); TUH-Episcopal Campus; TUH-Jeanes Campus; TUH-Northeastern Campus; The Hospital of Fox Chase Cancer Center and Affiliates, an NCI-designated comprehensive cancer center; Temple Transport Team, a ground and air-ambulance company; Temple Physicians, Inc., a network of community-based specialty and primary-care physician practices; and Temple Faculty Practice Plan, Inc., TUHS’s physician practice plan comprised of more than 500 full-time and part-time academic physicians in 20 clinical departments. TUHS is affiliated with the Lewis Katz School of Medicine at Temple University.

Temple Health refers to the health, education and research activities carried out by the affiliates of Temple University Health System (TUHS) and by the Katz School of Medicine. TUHS neither provides nor controls the provision of health care. All health care is provided by its member organizations or independent health care providers affiliated with TUHS member organizations. Each TUHS member organization is owned and operated pursuant to its governing documents.

It is the policy of Temple University Health System that there shall be no exclusion from, or participation in, and no one denied the benefits of, the delivery of quality medical care on the basis of race, ethnicity, religion, sexual orientation, gender, gender identity/expression, disability, age, ancestry, color, national origin, physical ability, level of education, or source of payment.

About KLS-13019
KLS-13019 is Kannalife’s leading proprietary investigational CBD-like product for the potential treatment of a range of neurodegenerative and neuropathic pain disorders, beginning with chemotherapy-induced peripheral neuropathy (CIPN). KLS-13019 has not been reviewed or approved for patient use by the U.S. Food and Drug Administration (FDA) or any other healthcare authority in the world. Its safety and efficacy have not been confirmed by FDA-approved research.

About Kannalife, Inc.
Kannalife, Inc. is a biopharmaceutical company focused on the development of proprietary and patented cannabidiol (CBD) and CBD-like molecules for patients suffering from unmet medical needs of neurodegenerative disorders - including chemotherapy-induced peripheral neuropathy (CIPN), a chronic neuropathy caused by toxic chemotherapeutic agents; hepatic encephalopathy (HE), a neurotoxic brain-liver disorder caused by excessive concentrations of ammonia and ethanol in the brain; mild traumatic brain injury (mTBI), a disorder associated with single and repetitive impact injuries; and chronic traumatic encephalopathy (CTE), a disease associated with highly repetitive impact injuries in professional and amateur sports.

The Company’s family of proprietary molecules focuses on treating oxidative stress-related diseases such as HE, chronic pain from neuropathies like CIPN, and neurodegenerative diseases like CTE. Kannalife conducts its research and development efforts at the Pennsylvania Biotechnology Center of Bucks County in Doylestown, PA.

For more information about Kannalife, Inc., visit www.kannalife.com and visit the Company’s Twitter page at @Kannalife.

Forward-Looking Statements
This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and is subject to the Safe Harbor created by those sections. This press release contains statements about expected future events, the Company’s business plan, plan of operations, the viability of the Company’s drug candidates, and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements, by definition, involve risks and uncertainties. The Company does not sell or distribute any products that are in violation of the United States Controlled Substances Act.

References

  1. National Center for Biotechnology Information. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: a systematic review and meta-analysis. Accessed at https://www.ncbi.nlm.nih.gov/books/NBK291675/.
  2. Datamonitor Healthcare. Neuropathic Pain Market and Forecast Analysis to 2026. Accessed at https://pharmastore.informa.com/product/neuropathic-pain-market-forecast-analysis-2026/.
  3. BioSpace. Neuropathic Pain Market: lucrative opportunities and Fast Growth by 2026. Accessed at https://www.biospace.com/article/neuropathic-pain-market-lucrative-opportunities-and-fast-growth-by-2026/
  4. Research Reporting Insights. Neuropathic Pain Market. Accessed at https://www.researchreportinsights.com/report/sample/110114956/Neuropathic-Pain-Market.
  5. Marketwatch. Opioids Drugs Market Report 2019-2026: Market Size, Share, Dynamics and Analysis by Volume and Value. Accessed at: https://www.marketwatch.com/press-release/opioids-drugs-market-report-2019-2026-market-size-share-dynamics-and-analysis-by-volume-and-value-2019-11-12

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