QUEBEC CITY, CANADA, October 10th 2019 – Today, Laboratoires Guertin announces that a campaign for funding has been launched to support a phase IIb-enabling pilot study with a tritherapy candidate (buspirone/L-DOPA/carbidopa)called Spinalon. This experimental oral pill has been shown to trigger short episodes of rhythmic leg activity in volunteers suffering chronically a severe spinal cord injury. In 2005, Spinalon was discovered as a pharmacological approach capable of eliciting, within minutes post-administration, spinal network activation and basic weight-bearing stepping on a treadmill for 30-45 minutes in completely paraplegic animals. In 2009, Nordic Life Science Pipeline signed an in-licensing agreement with Université Laval and Dr Pierre A. Guertin, the inventor, for the rights of testing SpinalonTM in a first-in-patient phase I/IIa study (NCT01484184). With support from the US Department of Defense (grant number W81XWH-11-1-08178) that first study was successfully completed in 2016 at the McGill University Health Center in Canada (Radhakrishna et al. Curr Pharm Des 23, 2017). Given that preliminary evidence of efficacy was found in completely paralyzed people, Laboratoires Guertin has decided to begin seeking funds for a pilot phase IIb enabling study in Belgium designed to demonstrate clinically-relevant efficacy on a treadmill in combination or not with medical devices such as muscle vibrators and exoskeletons. In parallel, Prof Dr Bloch, neurosurgeon in Switzerland (Centre Hospitalier Universitaire Vaudois), associate professor(Université de Lausanne), and co-founder of GTX Medical (Switzerland and The Netherlands) has announced, without authorization from Laboratoires Guertin and its founder, a clinical trial with buspirone/L-DOPA/carbidopa (SpinalonTM) in spinal cord-injured patients (NCT04052776).
Discovered at Université Laval (Canada) in 2005 by Dr Pierre A. Guertin (full professor at the faculty of medicine), this proprietary tritherapy candidate (WO2006026850) constitutes a novel class of treatment acting as a potent activator of the spinal locomotor network also known as the central pattern generator (CPG) for locomotion (Guertin, Ung, Rouleau Biotechnol J 5, 2010). It is composed of already known and regulatory approved molecules for patients with Parkinson’s disease or anxiety. This drug treatment candidate was shown in paraplegic animals when used regularly (e.g., 3-5 times weekly) in combination with pharmacologically-enabled treadmill training to prevent or reduce the secondary complications and co-morbid problems associated with chronic paralysis (cardiovascular, metabolic, musculoskeletal, hormonal, and psychological problems) Guertin, Ung, Rouleau, Steuer Neurorehabil Neural Repair 25, 2011; Ung, Rouleau, Guertin, Neurorehabil Neural Repair 26, 2012).
About Laboratoires Guertin
Founded by Dr Pierre A. Guertin, it is an emerging specialty company based in Quebec with subsidiary companies based in Canada and Europe that focuses on the development of clinically-relevant pharmaceutical and biocosmeceutical products as well as of specialized literature and services in the field of chronic secondary consequences and co-morbidities associated with paralysis, bowel and bladder problems, reproductive dysfunction, and aging diseases such as cancer and metabolic disorders.
About Biosynergis Canada It is a subsidiary company of Laboratoires Guertin with a branch in Luxembourg (Biosynergis International) which mission is to focus on North America-based and Europe-based research activities, respectively, as well as on commercialization and sales worldwide of products developed by Laboratoires Guertin.
does anyone know if this can help with male neurogenic bladder stemming from SCI?
Is there any planned use of this drug in applications in Australia ?
It is still in the testing stage. There are no marketing plans until the trial stages are all completed.
Do you have any idea when the trial stages are likely to be completed? And how long after that, will the drug be available to patients with SCI?
Overall, if funding is obtained in time, about 5 more years may be requires to get sales authorization.
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