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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MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
Sign up for “The Mission Report” at www.MissionIR.com
