CTO of Scythian
Biosciences Corp. (TSXV: $SCYB.V) Talks about Drug Development and
Commercialization and Potential of #Cannabinoids
Former VP of Celgene
(NASDAQ: $CELG) Talks about Scythian’s Potential Treatment for Concussion
and/or TBI
September 25, 2017 – Investorideas.com, a global news source
and investor resource covering cannabis and biotech stocks releases an
exclusive Q&A interview with Maghsoud Dariani, CTO of Scythian Biosciences
Corp. (TSXV: SCYB).
Scythian Biosciences
Corp. (TSXV: SCYB) reported September 13th that Maghsoud Dariani has become the
Chief Scientific Officer of the Company. Mr. Dariani was previously on the
Company's advisory board and has over 35 years of experience in the development
and commercialization of products in the pharmaceutical industry. Mr. Dariani's
experience includes, among other things, management positions at Semorex, Focus
Pharmaceuticals, Celgene (NASDAQ:
CELG) and Chiral Pharmaceuticals.
Q&A Interview:
Q: Investorideas.com
Congratulations on your recent appointment as Chief
Scientific Officer of Scythian Biosciences. Can you talk about your new role
and based on the current stage of development of the company’s drug treatment for
concussions and traumatic brain injury with its proprietary Cannabinoid combination,
what you see as the next steps?
A: Maghsoud Dariani,
Chief Scientific Officer
Thank you! I am excited to join Scythian Biosciences and
look forward to working with the team to manage the development of our
proprietary Cannabinoid combination drug for the treatment of concussion and
traumatic brain injury (TBI). We are
extremely fortunate to be collaborating with the University of Miami, a premier
research center on concussion and TBI to develop an effective drug treatment
for this disorder. TBI, which can result in long-term negative and life altering
symptoms affects more than 2 million; mostly young people in the US alone and
there is no standard drug treatment, making this a significant unmet need.
We are currently conducting pre-clinical studies in accepted
rodent models to establish the efficacy of our combination drug for TBI and to
determine effective dosing. Upon
completion of this stage, we will embark on IND enabling studies, Toxicology,
Pharmacokinetics, Pharmacodynamics, ADME (absorption, distribution, metabolism,
and excretion), and CMC (chemistry, manufacturing, and control). We are working with a premier FDA consulting
company who will ensure that our pre-clinical and IND enabling studies are in
line with FDA requirements and will assist us in preparing our IND package for
submission to the FDA. Upon FDA
acceptance of our IND, we will initiate our human clinical trials in
collaboration with the University of Miami and possibly other TBI centers of
excellence.
Q: Investorideas.com
Can you talk about your 35 years of experience in
development and commercialization of products in the pharmaceutical industry?
A: Maghsoud Dariani, Chief Scientific Officer
Excellent question.
What I have learned during my drug development and commercialization
journey is that success requires i) being meticulous and completely thorough
during pre-clinical evaluation of drugs under development and ii) paying
attention to what the data is telling you during early stages of clinical
trials. Pre-clinical pharmacodynamics is
relatively inexpensive and can save a lot of money by preventing the wrong
compounds from going forward. The
compounds should be evaluated in as many validated models as possible to ensure
both efficacy and safety. Rushing
through this stage and cutting corners can result in costly future failures.
Once the compounds have successfully passed through pre-clinical development, careful
attention to and thorough analyses of the outcomes from phase I and II clinical
trials are critical. Often, companies
and people are under pressure to move compounds to phase III pivotal trials,
which are very costly and time consuming.
Failure to do adequate early analyses and ignoring what the data is
saying results in disappointing and very costly failures in meeting phase III
clinical end points.
Q: Investorideas.com
Do you see taking a
different path or strategy for a smaller
company like Scythian Biosciences
versus working with a larger
company like Celgene Corporation (NASDAQ: CELG) ?
A: Maghsoud Dariani,
Chief Scientific Officer
Fundamentally speaking, NO.
Drug development has distinct stages which have to be followed whether
you are a small company or a large one.
The only differences that I see, is that smaller companies are much less
bureaucratic and there are a lot less layers.
This simply translates to faster decisions and a somewhat shorter
timeline to commercialization.
Q: Investorideas.com
Can you talk about what is unique about the company’s drug
(s) in development?
A: Maghsoud Dariani,
Chief Scientific Officer
There is currently no approved drug for mild traumatic brain
injury and concussion which afflicts more than 2 million mostly young people in
the US. Trauma causes inflammation
followed by immune response (gliosis) that can damage nerve cells. Depending on the severity of the trauma, the
resulting symptoms can last for several months or stay with injured people for
the rest of their lives. Early and successful drug intervention to reduce
inflammation and reduce gliosis is urgently needed. Our drug under development is a combination
of two compounds that attack neuronal inflammation and gliosis through two
different pathways. This is a unique and
proprietary approach that has not been tried before.
Q: Investorideas.com
How do you see Cannabinoids playing a role in the future of
pharma and biotech?
A: Maghsoud Dariani,
Chief Scientific Officer
The cannabinoid system is present throughout the central
nervous system and is crucial for controlling a range neurophysiological
processes such as pain, appetite, learning and memory. The cannabinoid receptors, CB1 and CB2 in the
central nervous system are also targets for cannabinoids isolated from the
cannabis plant (marijuana) as well as their synthetic analogues. The
cannabinoid system has emerged as a key regulator of neuronal cell fate and is
seen as capable of conferring neuroprotection.
Many neurological diseases have neurodegenerative components that result
from neuroinflammation, oxidative stress and excitotoxicity. Natural and synthetic cannabinoids represent
a class of compounds that are attractive for the development of
neurodegenerative diseases such as epilepsy, Tourette’s syndrome, multiple
sclerosis, pain, schizophrenia, Alzheimer's disease and cerebral ischemia.
Q: Investorideas.com
In closing on a personal note, what motivated and inspired
you to come on board as Chief Scientific Officer of Scythian?
A: Maghsoud Dariani,
Chief Scientific Officer
I love challenges and developing a potential treatment for
concussion and/or mild traumatic brain injury is a big challenge! It is a condition with unmet need that
afflicts significant number of people. I
also have an excellent track record in overseeing and managing R&D, and
when Jonathan asked me to join his team, it was a great fit and I accepted it
with enthusiasm.
About Mr. Dariani
Mr. Dariani has over 35 years of diverse and progressive
management experience in the development and commercialization of products in
the pharmaceutical industry. Mr. Dariani has a successful record of business
management, strategic planning, acquisition and divestiture, project
management, production management, R&D management, economic evaluations,
competitor analyses, and development and administration of multi-million dollar
budgets. Mr. Dariani is an entrepreneurial business leader with a sound grasp
of successful business strategies, an excellent foundation in science and
engineering, and a strong background in product development and commercialization.
He is currently the CEO of Semorex Inc. – a privately held company focused on
the discovery and development of novel therapeutics for cancer. Mr. Dariani
also leads Myos Rens' science and technology efforts and has overall
responsibilities for manufacturing, basic science, pre-clinical and clinical
studies. Prior to joining Semorex Inc., Mr. Dariani was President of Focus
Pharmaceuticals, Inc ("Focus") where he managed the development and
approval of drug products, achieving one FDA approval and bringing another to
the clinical evaluation stage. Prior to joining Focus, Mr. Dariani was Vice
President of the chiral pharmaceutical business unit at Celgene Corporation
("Celgene"). During his twelve years at Celgene, Mr. Dariani developed
and implemented Celgene's manufacturing strategy, managed and successfully sold
Celgene's chiral intermediates business unit, and formulated a strategic plan
for leveraging Celgene's expertise in chiral technologies towards the
development of chirally pure drug products. Mr. Dariani was responsible for the
successful development and FDA approval of the chirally pure versions of
Ritalin, which are currently marketed by Novartis under the Focalin and Focalin
XR trade names. Prior to Celgene, Mr. Dariani held progressively more
responsible engineering and development positions at Celanese Corporation. Mr.
Dariani holds a Bachelor of Science from The City College of New York and a
Master of Science from University of Massachusetts in Chemical Engineering. Mr.
Dariani is a member of Board of Directors at Semorex Inc. and Mesa
Therapeutics.
Maghsoud Dariani,
Chief Scientific Officer Scythian Biosciences Corp. (TSXV: SCYB)
Scythian is a research and development company committed to
finding a solution for the prevention and treatment of concussions and
traumatic brain injury with its proprietary Cannabinoid combination.
Scythian's mission is to be the first accepted drug regimen
for concussive treatment. Scythian has recently formed a collaboration with the
University of Miami and its world renowned neuroscientific team to conduct
pre-clinical and clinical trials of its drug regimen. The University of Miami
believes that Scythian's scientific approach shows significant promise and
differs from previous approaches to treat this growing problem. The
collaboration with the University of Miami allows access to their extensive
knowledge base in the fields of traumatic brain injury and concussions and
allows for Scythian's clinical studies to be undertaken at their world-class
facilities
Gillian A. Hotz, PhD, is leading Scythian's program at the
University of Miami. Dr. Hotz is a nationally recognized behavioral
neuroscientist and expert in neurotrauma, concussion management, and
neurorehabilitation. She has extensive experience in neurocognitive testing.
Dr. Hotz has been the co-director of University of Miami Miller School of
Medicine's Concussion Program since 1995.
Scythian is also endorsed by Pro Football Legends and the
World Boxing Association on its mission.
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