WASHINGTON, March 29, 2018 /PRNewswire/ --
GT Biopharma Inc. (OTCQB: GTBP) (Euronext Paris: GTBP.PA)
announced today that the Proof-of-Concept clinical trial with
GTP-011, a novel treatment for the symptoms of motion sickness,
that was initiated in late February
2018 is more than 50% enrolled. The study is a
single-blind, placebo-controlled, cross-over study. The
primary objective of the study will be to demonstrate
the anti-motion sickness efficacy of transdermal
GTP-011.
The cause of motion sickness is incompletely understood, but it
has been suggested that motion sickness may involve a sensory
conflict between the visual and the vestibular systems (Bestaven,
2016). The vestibular system is located in the brain stem and inner
ear and helps control balance and eye movements. It is believed
that more than 35% of US adults 40 years and older, or
approximately 69 million people, experience vestibular dysfunction
at some point in their lives and many of them go on to develop a
chronic vestibular disorder (Vestibular Disorders Association).
The prevalence of motion sickness varies as a function of the
type and severity of stimulus but is particularly common among
passengers on cruise ships in rough seas. It is also experienced by
individuals with air travel and when riding in automobiles. The
prevalence is generally higher in females.
Common symptoms of motion sickness, and certain vestibular
disorders, include vomiting preceded by nausea, malaise,
drowsiness, headache and sweating, among others. Certain vestibular
disorders such as vertigo are characterized by a feeling the person
or world is moving when it is not.
Currently, the scopolamine patch (Transderm Scop® from Novartis)
is viewed as a first-line medication for prevention of motion
sickness (Gil et al., 2012; Brainard and Gresham, 2014). However,
side effects can be of particular concern and include sedation
(Spinks et al., 2004), reduced memory for new information, impaired
attention, and lowered feelings of alertness (Parrott, 1989).
Mental confusion or delirium can occur after application of
scopolamine patch (Seo et al., 2009). Elderly people as well as
people with undetected incipient dementia or mild cognitive
impairment, or MCI, may be particularly prone to develop mental
confusion after applying the scopolamine patch (Seo et al.,
2009).
GTP-011 is a 72-hour, transdermal formulation that contains a
muscarinic receptor antagonist. Unlike scopolamine, however,
GTP-011's active ingredient has been reported not to affect memory
and cognition and has a low incidence of sedation (Kay et al.,
2012). GTP-011 may thus be a more favorable alternative, if
approved for marketing, to the scopolamine patch for the treatment
of motion sickness.
GTP-011 may also have utility in certain disorders of the
vestibular system which GT Biopharma expects to evaluate assuming
positive proof-of-concept data from the ongoing clinical trial. The
trial is sponsored by Cognitive Research Corporation.
GT Biopharma's President of the Neurology Division, Dr.
Kathleen Clarence-Smith, said "I am
pleased that the first trial with GTP-011 for
motion sickness has started. This drug could be particularly
useful in elderly patients. In case of positive results,
other vestibular disorders for which there is a major
medical need, will also be considered."
About Cognitive Research Corporation (CRC)
CRC is a privately held clinical research organization known for
expertise in evaluating the effects of medications, nutritional
supplements, and foods on cognitive functioning. CRC offers a
full range of services for Drug Development; Product Registration;
and Scientific/Medical Affairs. CRC is recognized for being a
leader in computer-based cognitive testing and use of driving
simulators in clinical trials. Additional information about
Cognitive Research Corporation can be found by visiting the
company's website at http://www.cogres.com .
About GT Biopharma, Inc.
GT Biopharma, Inc. is an immuno-oncology biotechnology company
focused on innovative treatments based on the company's proprietary
Tri and Tetra-specific Natural Killer Cell Engagers (TriKEs™ and
TetraKEs) and bispecific antibody-drug conjugate (ADC) platforms.
GT's lead oncology drug candidate, OXS-1550 (DT2219) is a novel
bispecific scFv recombinant fusion protein-drug conjugate composed
of the variable regions of the heavy and light chains of anti-CD19
and anti-CD22 antibodies and a modified form of diphtheria toxin as
its cytotoxic drug payload. OXS-1550 has demonstrated success in
early human clinical trials in patients with relapsed/refractory
B-cell lymphoma or leukemia. In addition, GT's TriKE platform will
address a number of cancer types. GT's nervous system platform is
focused on acquiring or discovering and patenting late-stage,
de-risked, and close-to-market improved treatments for nervous
system diseases (Neurology and Pain) and shepherding them through
the approval process to the NDA. GT Biopharma's neurology products
currently include PainBrake, as well as treatments for the symptoms
of myasthenia gravis, and motion sickness.
Except for historical information contained herein, the
statements in this release are forward-looking and made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements are inherently
unreliable and actual results may differ materially. Examples of
forward-looking statements in this news release include statements
regarding the effectiveness of the Company's products, the
potential outcome of clinical studies, the future success of
development activities and the future growth and operating and
financial performance of the Company. Factors which could cause
actual results to differ materially from these forward-looking
statements include such factors as the Company's ability to
accomplish its business initiatives, obtain regulatory approval and
protect its intellectual property; significant fluctuations in
marketing expenses and ability to achieve or grow revenue, or
recognize net income, from the sale of its products and services,
as well as the introduction of competing products, or management's
ability to attract and maintain qualified personnel necessary for
the development and commercialization of its planned products, and
other information that may be detailed from time to time in the
Company's filings with the United States Securities and Exchange
Commission. The Company undertakes no obligation to publicly update
or revise any forward-looking statements, whether as a result of
new information, future events or otherwise.
Contact:
Westwicke Partners
John Woolford
+1(443)213-0506
john.woolford@westwicke.com
SOURCE GT Biopharma Inc.