Nexien BioPharma to File Pre-IND Meeting Request with the FDA
February 26, 2019
— Encouraging clinical observations and patient questionnaire results
indicate that specific cannabinoid formulations are supportive in the
treatment of patients suffering from myotonic dystrophy —
DENVER–(BUSINESS WIRE)–Nexien BioPharma, Inc. (“Nexien” or the “Company”) (OTCQB: NXEN), a next
generation biopharmaceutical company focused on research, development
and commercialization of novel FDA-compliant cannabinoid pharmaceuticals
and related drug delivery systems, today announced encouraging results
of clinical observations of patient groups consisting of patients
suffering from non-dystrophic myotonia and myotonic dystrophies (DM)
type 1 and 2, indicating that specific cannabinoid formulations are
supportive in relief of myotonia and DM symptoms. Nexien intends to
proceed with related clinical studies in accordance with U.S. Food and
Drug Administration (FDA) protocols, commencing with the filing of a
Pre-IND meeting request.
Parallel to ongoing clinical observations, Dr. Benedikt Schoser at the
University of Munich, a Nexien scientific advisor and leading myotonic
dystrophy expert, and The Myotonic Dystrophy Foundation in the United
States each conducted questionnaires with patients suffering from DM
type 1 and DM type 2. The purpose of the questionnaires was to determine
patient perspectives on the effects of naturally occurring cannabinoids
and whether these specific effects resulted in symptom relief. The
results of both questionnaires in the United States and Germany were
positive and suggested further exploration is warranted. Dr. Schoser´s
team, along with DM organizations in the United States and Germany,
published the results of this preliminary questionnaire in the Journal
of Neurology: “Cannabis use in myotonic dystrophy patients in Germany
and USA: a pilot survey.”1
Concurrently, based on ongoing clinical observations in DM1 and DM2
patients, as well as the results of the questionnaires, Nexien and Dr.
Schoser are preparing protocols to commence pre-clinical and clinical
studies.
Alex Wasyl, Nexien’s Chief Executive Officer, stated, “The results of
the clinical observations reinforced by the patient questionnaires
support the use of specific cannabinoid formulations in the treatment of
myotonia, and DM1 and DM2 symptoms. Based on these outcomes and
significant anecdotal evidence, Nexien will work toward filing a Pre-IND
Meeting Request with the FDA to commence pre-clinical and clinical
studies.”
1https://link.springer.com/article/10.1007%2Fs00415-018-9159-2
About Myotonia and Myotonic Dystrophies (DM)
Myotonia refers to a neuromuscular condition in which the relaxation of
a muscle is impaired and can affect any muscle group of the body.
Because a repeated effort is required to relax the muscle, individuals
with myotonia may have massive trouble with normal daily activities
including releasing their grip on objects (e.g., knife, fork and spoon),
and having difficulty rising from a seated position, or beginning to
walk. Patients suffering from myotonia often walk with a stiff, slow and
awkward gait.
DM is an autosomal dominant transmitted genetic disorder that affects
all parts of the human body, but predominantly affects muscular
function. Symptoms include gradually increased muscle loss and weakness.
There is currently no cure for DM and various drugs are often prescribed
to manage symptoms without great success. An estimated 31.5 in 100,000
people are affected by DM1 in the United States alone.
About Dr. Benedikt Schoser
Dr. Benedikt Schoser is the senior consultant neurologist and co-chair
of the Friedrich-Baur Institute, Germany’s major national referral
center for rare neuromuscular diseases. His clinical and research
interests are in the field of multisystemic neuromuscular diseases and
metabolic and myotonic myopathies. Dr. Schoser is an Associate Professor
of Neurology at the Ludwig Maximilians University in Munich, Germany.
Since 2010, he has been the head of the Interdisciplinary Center for
Neuromuscular Disorders at the University’s Munich campus. Dr. Schoser
has authored and co-authored more than 220 articles in peer-reviewed
journals and contributed more than 20 chapters to books on neurology and
muscle pathology.
About Nexien BioPharma, Inc.
Nexien BioPharma is a US-based pharmaceutical company engaged in the
formulation, development and commercialization of cannabinoid-based
pharmaceuticals in accordance with U.S. Food and Drug Administration
(“FDA”) pre-clinical and clinical pathways, to address a broad range of
medical conditions and disorders. Nexien BioPharma website: www.nexienbiopharma.com.
Forward Looking Statements
Nexien Disclosure Notice: This press release may contain
“forward-looking statements, which are deemed to be any statements made
by or on behalf of Nexien BioPharma that are not statements of
historical facts. These statements reflect current beliefs, and a number
of important factors could cause actual results to differ materially
from those expressed in this release, including the factors set forth in
“Risk Factors” in our most recent Form 10-K filed with the Securities
and Exchange Commission (SEC) and subsequent filings with the SEC.
Readers are cautioned not to place reliance on these forward-looking
statements, which are valid only as of the date they were made. Nexien
BioPharma undertakes no obligation to update or revise any
forward-looking statements to reflect new information or the occurrence
of unanticipated events or otherwise, except as expressly required by
law.
Contacts
Nexien BioPharma, Inc.
info@nexienbiopharma.com
The Equity Group
Kalle Ahl, CFA
(212) 836-9614
kahl@equityny.com
Devin Sullivan
(212) 836-9608
dsullivan@equityny.com