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KannaLife Sciences – The Next Undiscovered Bio-Tech Play? - Part I
KannaLife is a late stage bio-pharmaceutical and phyto-medical company that specializes in the research and development (R&D) of pharmacological products derived from plants. The company announced in July of 2012, that it had signed an exclusive license agreement with the "National Institutes of Health - Office of Technology Transfer ("NIH-OTT") for the Commercialization of U.S. Patent 6,630,507, "Cannabinoids as Antioxidants and Neuroprotectants" (the "'507 Patent")" to focus on Hepatic Encephalopathy (HE) which is associated with reduced brain function due to various forms of liver toxicity.
The NIH-OTT website states that “The NIH Office of Technology Transfer evaluates, protects, markets, licenses, monitors, and manages the wide range of NIH and FDA discoveries, inventions, and other intellectual property as mandated by the Federal Technology Transfer Act and related legislation.” They further state that they “are committed to seeing that the public has ongoing access to newer and more effective health care products and procedures.” (Citation 1)
KannaLife is in a truly opportunistic position in that it has licensed from NIH-OTT on an exclusive basis the right to develop its intellectual property into a novel therapeutic treatment for HE with a market potential in the range of $500 million to $1 billion dollars. Kannalife’s proposed target drug candidate would be considered part of a new class of pharmaceuticals designed as neuroprotectants with additional potential therapeutic benefits in reducing oxidative stress.
Kannalife’s pre-clinical research being performed at the Pennsylvania Biotechnology Center located in Doylestown, PA. Kannalife’s R&D at Doylestown is focused on the use of Cannabidiol (CBD) and other potential cannabinoids analogs in selecting its target drug candidate for an Investigational New Drug Application (IND), and possibly an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (FDA).
Cannabidiol (CBD), used in Kannalife’s pre-clinical testing in Doylestown is, in its natural phyto emitting state, a compound which, aside from cannabis sativa and cannabis indica can be successfully derived from the industrial hemp plant seed and stalk. More can be found on CBD in my article Medical Marijuana Incs PhytoSPHERE Systems CBD - A Natural Evolution in Health.
Advancing the Research
In April of this year KannaLife signed a research and development agreements with Advanced Neural Dynamics, Inc. (AND) and IteraMed; both are collaborators with KannaLife located at the Pennsylvania Biotechnology Center in Doylestown.
Advanced Neural Dynamics is providing expertise in the pharmacology of small molecules and neuro-peptides focused on “novel small molecule neuroprotective therapeutics for the treatment of neurological diseases” and IteraMed “offers “value added” organic synthesis, medicinal chemistry consulting, and internal drug discovery” (Citation 2) according KannaLife’s press release. This is an impressive team that’s advancing the work of the government patent developers. Inventor’s of the patent is credited to the following doctors:
Dr. Aiden J. Hampson – National Institute of Mental Health (NIMH) Neuro-Pharmacologist
Dr. Julius Axelrod – Professor Emeritus, NIH Pharmacologist
Dr. Maurizio Grimaldi – Professor Neurology / Neuropsycopharmacology & Toxicology NIMH
Efficacy and Standardization
As KannaLife progresses its drug development, it is also taking steps to provide commercial and regulatory guidance and practices for producing and certifying organic botanical medicaments. Under Kannalife’s certification program it will seek to ensure it and others who subscribe and utilize Kannalife’s quality control (QC) and quality assurance (QA) protocols and processes does so to manufacture and sell quality products that can meet or exceed the standardization controls found in FDA’s Guidance for Industry Botanical Drug Products (June 2004). This guidance, in part, states:
“A traditional herbal preparation, which may have evolved over time, generally has the following characteristics:
• It meets official compendia or other published standards in terms of the botanical identity and plant part used for each botanical raw material.
• In the case of a multi-herb substance, it is composed of the same formulation as a historical formula, with the amount of each botanical ingredient falling within the range of traditional usage.
• It is prepared by the same processing methodology as traditionally used.
• It is used in the traditional manner in terms of therapeutic indication, route and schedule of administration, and quantities or doses.
See Part II to continue reading: