NetworkNewsWire Editorial Coverage: America is in an opioid
epidemic. On an average day, 91 Americans will die from an
opioid-related overdose. That’s according to the CDC, which also
reports that the number of prescription opioids sold in the U.S.
has nearly quadrupled since 1999 despite no overall change in the
amount of pain reported. The result is more than half a million
deaths by opioid overdose from 2000 to 2015. These sobering figures
reveal the desperate need for opioid substitutes, and
cannabis-based therapies for pain treatment are emerging as viable
alternatives. The potential rewards are significant for companies
that can develop these therapies, and among those growing in
recognition are India Globalization Capital, Inc.
(IGC) (IGC
Profile), Vitality Biopharma, Inc.
(VBIO), Cara Therapeutics, Inc. (CARA),
Zynerba Pharmaceuticals, Inc. (ZYNE) and
AXIM Biotechnologies, Inc. (AXIM).
According to a 2016 report published by Transparency Market
Research, analysts surmise that almost 20 percent of the world’s
population currently suffers from chronic pain (1). As
such, the global pain management therapeutics market is expected to
exhibit a 3.7 percent CAGR through 2024, with market valuation
increasing to US $83.0 billion by the same year.
A closer look at chronic pain explains this growth. Terminal
illness, for one, is frequently accompanied by pain so agonizing,
severe, and difficult to treat that death can seem like a
preferable option to the patient. A key disadvantage of currently
available drug therapies for chronic severe pain is that
opioid-based drugs can create various side effects, including
hallucinations, sedation, nausea, respiratory depression,
constipation and dysphoria. Pain treatment also poses a significant
challenge to health care professionals because it frequently
debilitates patients in ways that hamper their day-to-day
functionality, which, by extension, poses a huge productivity
problem among U.S. citizens. In 2012, the annual cost of pain in
the United States was estimated at between $560 billion and $635
billion—eclipsing the costs of national priority health
conditions.
In light of this information, imagine for a moment the
inconceivable potential of a cannabis-based combination therapy
that could effectively address a large market indication. An
achievement of this sort would propel an undiscovered stock
straight into the spotlight. Such is the case and possibility with
India
Globalization Capital (IGC).
IGC aims to formulate and commercialize cannabinoid compounds as
an alternative to addictive long-term opioid treatments,
endeavoring to do so through a focus on combination therapy. The
company is developing a portfolio of phytocannabinoid-based
therapies to treat a broad range of therapeutic indications,
including neuropathic and cancer pain. IGC has applied for a U.S.
patent to treat pain based on a novel therapy that utilizes
cannabinoid extracts. This therapy employs a cream that is applied
through the use of various delivery technologies and has
indications in both humans and other mammals, including dogs and
cats. The company plans to conduct metabolic profiling and to run
trials in the near term. IGC’s patent filing (IGC-501) is a
cannabis-based formulation that addresses neuropathic and arthritic
pain via various delivery techniques.
IGC’s innovative and exciting strategy is to leverage its “first
mover” position to become a leader within the
phytocannabinoid-based combination therapy specialty pharmaceutical
sector. Developing cannabis-based combination therapies represents
a huge and unique opportunity in this emerging specialty
pharmaceutical sector. Obtaining FDA approval for combination
therapy is typically significantly quicker and less costly than new
drug applications, which means IGC can potentially bring its
cannabis-based pharmaceutical products to market in a timely and
thus cost-effective manner. With a market cap of approximately
$11.0 million, a fraction of that of its peer group, IGC is poised
to explode once its cannabis-based pain therapies obtain approval
and can be brought to the market.
Another company taking aim at bringing cannabis-based therapies
to market is Vitality Biopharma (VBIO), which has
a market cap of approximately $51.7 million. A cure development
company, Vitality Biopharma is focused on utilizing cannabinoid
“prodrugs” to treat serious neurological and inflammatory disorders
and to provide targeted therapies with the potential to offer
long-term or durable relief and possibly help patients recover lost
function.
Prodrugs are compounds or medications that, upon administration,
are converted inside the body into a pharmacologically active drug
that may already have a lengthy history of clinical investigation
and use. As reference drugs may already have independent
verification of their safety and effectiveness, some prodrugs can
potentially be quickly approved by demonstrating comparable
bioavailability or bioequivalence. A prodrug can simultaneously be
much more marketable because of its ability to eradicate
undesirable side effects or commercial aspects.
As public interest in medical marijuana applications continues
to increase, clinical trials sponsored by academic investigators
for using cannabinoids in the treatment of profitable, large-market
disease indications is also increasing. Vitality Biopharma’s
ability to quickly create proprietary prodrug versions of CBD, THC,
CBVD and others positions the company to benefit from emerging data
and increasing medical community recognition of the potential pain
relief and anti-inflammatory effects of cannabinoids. It has become
a well-established fact that cannabis has the potential to provide
relief of pain and inflammation in certain disease indications, and
Vitality Biopharma’s prodrugs have the potential to exert the same
positive therapeutic effects as current therapies, with noteworthy
improvements. Vitality Biopharma has filed intellectual property
applications and is seeking global patent protection through 2035
with strong composition matter claims for prodrugs of THC, CBD and
CBDV, as well as for the company’s proprietary prodrug biosynthesis
platform that utilizes enzymatic glycosylation.
Another company applying the medical properties of cannabis for
the treatment of pain is Cara Therapeutics (CARA),
with a market cap of approximately $539.6 million. Cara
Therapeutics is a clinical-stage biotechnology company focused on
developing and commercializing new chemical entities, which are
designed to lessen pain and pruritus by selectively targeting
peripheral kappa opioid receptors. The company is developing a
novel and proprietary class of product candidates designed to
target the peripheral nervous system of the body and that have
shown initial efficacy in patients suffering with
moderate-to-severe pain. This has been demonstrated without
creating many of the unwanted side effects that are normally
associated with current pain therapeutics.
Studies conducted to assess the effects of cannabis have led to
a recent discovery of an endogenous system of ligands within humans
that are involved in various physiological processes, including
pain and inflammation. The primary naturally occurring ligands for
this system activate numerous cannabinoid receptors, including CB1
and CB2 receptors. CB1 receptors and associated ligands are
primarily localized in the brain, while CB2 receptors are chiefly
found in peripheral tissues—in particular immune cells like
leukocytes and mast cells, which have been shown to have
involvement in pain and inflammatory responses. Cara Therapeutics
is developing lead molecules that selectively modulate peripheral
CB receptors without targeting CNS cannabinoid receptors. The
company will initially develop peripheral CB receptor modulators as
a novel therapeutic approach for neuropathic pain. CR701, the
company’s most advanced CB compound, is currently in preclinical
development.
Zynerba Pharmaceuticals (ZYNE), with a market
cap of approximately $255.8 million, is also seeking to treat a
variety of severe health conditions, including peripheral
neuropathic pain—in this case by applying synthetic cannabinoid
therapeutics that are formulated for transdermal delivery. A
clinical-stage pharmaceutical company, Zynerba Pharmaceuticals
currently has two lead product candidates in its development
pipeline: ZYN002 and ZYN001. These product candidates are being
evaluated in five therapeutic indications. ZYN002 is the first and,
currently, the only synthetic CBD, which is a non-psychoactive
cannabinoid. It has been formulated as a patent-protected
permeation-enhanced gel for transdermal delivery through the skin
into the body’s circulatory system and is in phase 2 clinical
development. ZYN001 is a prodrug of THC that facilitates
transdermal delivery through the skin and into the circulatory
system through a patch. A phase 1 clinical trial of ZYN001 is
planned to commence in 2017.
AXIM Biotechnologies (AXIM), with a market cap
of approximately $410.5 million, is focused on the research,
development and production of cannabinoid-based pharmaceutical
products and supplements. The company owns the patent for the use
of chewing gum as a cannabinoid delivery method, and its MedChew RX
gum will soon commence phase 3 clinical trials for the treatment of
pain and spasticity related to multiple sclerosis. This
pharmaceutical, functional chewing gum contains equal portions of
THC and CBD. Thanks to the company’s proprietary technology,
various problems related to the water insolubility of cannabinoids
have been addressed and resolved. Based on AXIM’s proprietary
intellectual property, a new direct and controlled slow-release
nano-technology delivery method is planned to be investigated.
Various other R&D projects are also being considered that
involve AXIM’s proprietary intellectual property.
There is no denying the power and potential of cannabis-based
therapies for pain management, and investors have the opportunity
to scout the playing field of this market to identify the most
promising companies. This growing segment of the health care field
increasingly demonstrates favorability by addressing key health
issues that affect people in the United States and around the
world.
Sources:
(1) Transparency Market Research http://nnw.fm/uL54B
For more information on India Globalization Capital visit
India
Globalization Capital (IGC)
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