GT Biopharma, Inc. 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 fully 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.
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 moved along expeditiously and that we have successfully completed enrollment. As we have communicated previously, we believe this drug could be particularly useful in elderly patients and, in case of positive results, potentially in other vestibular disorders which have significant unmet medical need.”
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.
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