DOYLESTOWN, Pa., June 30, 2020 (GLOBE NEWSWIRE) — Kannalife, Inc. (“Kannalife” or the “Company”) (OTCQB: KLFE), a biopharmaceutical and medchem company specializing in the research and development of potent novel monotherapeutics, announced today that the Company has been issued patents in Switzerland (CH), Germany (DE), France (FR), United Kingdom (GB), Ireland (IE), Italy (IT), Spain (ES), Belgium (BE), Sweden (SE), Turkey (TR), the Netherlands (NL), and Denmark (DK) for its patent known as WO2015/106108A2 and titled, “Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy” (the “PCT Patent”).
With the PCT Patent, along with Kannalife’s novel lead drug candidate KLS-13019 and its other novel therapeutic agents like Atopidine™, Kannalife now has near-global coverage in the top pharmaceutical markets in the world.
In 2018, Europe was responsible for 23.2 percent of the world’s pharmaceutical sales.1 The size of the market in the European Union Five is expected to grow by 25 percent between 2017-2022,2 with experts predicting the market will reach over $226 billion in total from pharmaceutical market sales.3
“We have a very live and viable leading drug candidate in KLS-13019, which is a non-opioid based solution to treating neuropathic pain. The remarkable capabilities behind the science of KLS-13019 and its sister compounds are their ability to effectively break the blood-barrier and their strong neuroprotective and anti-inflammatory properties,” said Dean Petkanas, CEO of Kannalife. “These key pharmacological benefits open the door to a host of other peripheral and central nervous system diseases and disorders as well.”
KLS-13019 leads Kannalife’s intellectual property portfolio of novel monotherapeutic molecules (“KLS Family”), which have been proven capable of acting as neuroprotective agents and have the potential to treat a range of diseases, including nervous system, oxidative stress, and neurodegenerative disorders. KLS-13019 is the Company’s leading candidate to treat chemotherapy-induced peripheral neuropathy (CIPN), a disorder that currently has no FDA approved drugs for treatment. Current off-label prescription of opioids, a leading agitator of overdose deaths and addiction, is the model of treatment.
The PCT Patent grants mark the nineteenth (19th) patent that Kannalife has received to date worldwide. Of the nineteen (19) patents issued to Kannalife, two (2) are U.S. patents, and seventeen (17) are foreign patents. The two (2) U.S. patents are:
- U.S. Patent 9,611,213 “Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy”
- U.S. Patent 10,004,722 “Method for treating hepatic encephalopathy or a disease associated with free radical mediate stress and oxidative stress with novel functionalized 1,3-benzene diols”
The seventeen (17) foreign patents claim priority to Kannalife’s original 2014 U.S. filing through international application PCT/US2015/010827, which was published as WO2015/106108A2 titled, “Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy.”
Of the seventeen (17) foreign patents, twelve (12) of them are granted for the PCT Patent in the European territories of BE, CH, DE, DK, ES, FR, GB, IE, IT, NL, SE and TR. The remaining five foreign patents are:
- Japanese Patent JP6486950B2 “Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy”
- Russian Patent RU2676475C2 “Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy”
- Chinese Patent CN106456573B “Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy”
- Australian Patent AU2015204609B2 “Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy,” and
- European Patent EP3094318B1 “Novel Functionalized 1,3-Benzene Diols and their Method of Use for the Treatment of Hepatic Encephalopathy.”
The Company recently completed a STTR phase 1 study funded by a grant from the National Institutes of Health’s National Institute on Drug Abuse. The study was performed in an animal model to evaluate the potential use of KLS-13019 as a potent, non-opioid alternative monotherapeutic in the prevention and reversal of CIPN.
Kannalife also has national phase patent applications based on the PCT Patent application pending in Canada, Brazil and India.
About Kannalife, Inc.
Kannalife, Inc. is a biopharmaceutical medchem company focused on the development of proprietary and patented novel, monotherapeutic 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.
Atopidine™ is Kannalife’s novel, patented small molecule that has been shown to have protective and anti-inflammatory properties in pre-clinical testing. The same studies show that it has also outperformed cannabidiol (CBD) in preventing inflammatory responses relevant to UVB-radiation, including cytokines, TNF-a, IL-1b, and IL-6.
KLS-13019 is Kannalife’s leading patented, investigational, novel, monotherapeutic product for the potential treatment of a range of neurodegenerative and neuropathic pain disorders, beginning with chemotherapy-induced peripheral neuropathy (CIPN). Neither KLS-13019 or Atopidine™ have been reviewed or approved for patient use by the U.S. Food and Drug Administration (FDA) or any other healthcare authority in the world. Their safety and efficacy have not been confirmed by FDA-approved research.
The Company’s KLS 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.
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.
- European Federation of Pharmaceutical Industries and Associations. The Pharmaceutical Industry in Figures
- Evaluate. European Pharma Market Outlook to 2022
- Statista. Total pharmaceutical market sales forecast in Europe from 2012 to 2022
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Scott Gordon, Managing Director of CORE IR