VistaGen
Therapeutics stands at the forefront today of the rapidly developing world of
stem cell technology, with a tight portfolio of IP that cuts hard and fast
across multiple, critical applications in the areas of drug rescue and
regenerative medicine. The company’s Human Clinical Trials in a Test Tube™
platform fuses together proprietary technologies for controlled
development/differentiation of human pluripotent (having the potential to
differentiate into almost any cell) stem cells into many types of mature,
functional adult cells and the utilization thereof.
This incredible
capacity to produce large quantities of functional adult cells has thus far led
to two 3D “micro-organ” bioassay system applications for drug rescue,
CardioSafe 3D™ and LiverSafe 3D™. Using stem cell-derived, functional heart and
liver cells (respectively) to create mock-up 3D cell networks and tissue
structures, which accurately model the actual organs in the body, presents the
multibillion dollar pharma development space with a safer small molecule Drug
Rescue Variant™ solution pathway. This salvage opportunity technology is able to
help drug developers recoup the massive capital outlays associated with
creating once-promising new drug candidates that got dropped due to bad drug
interactions and/or toxicity concerns, in essence offering drug developers a
way to hit the reset switch and come away with a safer, more effective product
instead of lost capital. Moreover, CardioSafe 3D and LiverSafe 3D offer pharma
developers a drug metabolism and toxicity screening solution that ably
surmounts one of the major causes of the high failure rates among otherwise
promising drug candidates, the persistent limitations of preclinical drug
testing.
VistaGen is also
developing a novel, orally available small molecule prodrug candidate known as
AV-101, which has shown solid results in Phase 1 clinical development for
neuropathic pain in the U.S., under an active Investigational New Drug
application with the FDA. With apparent traction in depression and epilepsy, as
well as potentially in other neurological conditions, including Parkinson’s,
AV-101 is of particular interest in that it acts as a synthetic analog for a
naturally-occurring regulatory compound in the central nervous system,
kynurenic acid (AV-101 converts into the analog, 7-chlorokynurenic acid, inside
the brain). High oral bioavailability, excellent blood-brain barrier transport
dynamics and preferential conversion to synthetic kynurenic acid at sites of
neural damage, all reinforce the $8.8M in funding VSTA has received from the
NIH for AV-101′s development.
Advancements in the
broader stem cell space, like the recent announcement that Japanese researchers
at the RIKEN Center for Life Science Technologies have identified how CCL2 (a
chemokine that plays a role in immune response) functions as a pluripotency
enhancer in human induced pluripotent stem cells, makes VSTA’s portfolio start
to look more and more interesting. The potential for modeling drug interactions
in vitro with high-fidelity in vivo results guidance (long before substantial
development costs start to add up), as well as the potential to salvage
otherwise deprecated, yet promising drug candidates, combined with an eventual
ability to re-grow various tissues and break through to new horizons in
regenerative medicine, makes VSTA an exciting company for its size and market
cap. Inducing the body to take up cultured stem cells and re-grow blood, bones,
cartilage and other tissues, even heart, liver and pancreatic tissue, is
serious blue sky potential that may even dwarf the value of chemical variant
salvaging on drug candidates for pharmaceutical and biotech customers.
With recent patent
expansions in both the U.S. and Canada this year for their stem cell technology
platform, VistaGen is feeling supremely confident about the company’s
performance. CEO of VSTA, Shawn K. Singh, JD, even noted how the Canadian
patent allowance in particular expands the company’s core IP in a key target
market the company has been after for years now. This particular patent, under
exclusive license from the Icahn School of Medicine, Mount Sinai, New York,
covers pluripotent stem cell culture systems which produce endoderm lineage
cells, including liver, lung, pancreas, parathyroid, and thyroid cells. The
equivalent U.S. patent expansion covers three patents under similar license and
roundly reinforces the company’s already strong LiverSafe 3D position, while
also opening up collaboration potential in the area of liver biology and drug
metabolism assay, as well as regenerative therapy for diabetes using pancreatic
beta-islet cells.
The recent (July 2)
announcement that University at Buffalo researchers have identified the “master
switch” which triggers myelination in the brain, a process where fatty layering
(a sign of healthy central nervous system functionality) accumulates on the
neuronal axon (or main shaft), allowing the brain cell to transmit data quickly
and reliably (enabling more complex brain activity to take place), should give
investors some idea of where this sector is heading. The identification of this
“master switch,” a transcription factor in human brain cells known as SOX10,
puts multiple sclerosis for instance directly in the crosshairs for development
of an efficient treatment. An MS treatment based on transplantation of
myelin-generating progenitor cells that doesn’t take a year or more, says it
all about the potential of the stem cell space really. In this particular case
the potential exists for a small molecule drug candidate that could switch on
SOX10 as well.
The immense
potential of stem cell technology for fundamentally transforming several areas
of medicine is fully inherent in companies like VistaGen Therapeutics, whether
we are talking small molecule drug development or regenerative stem cell
therapies and organ modeling.
More data on
VistaGen Therapeutics is available at: www.vistagen.com
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