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Monday, September 25, 2017

CTO of Scythian Biosciences Corp. (TSXV: $SCYB.V) Talks about Drug Development and Commercialization and Potential of #Cannabinoids

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 –, 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:

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.

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.

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.

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.   

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.

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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