Stem Cell Therapeutics Corp. has announced a joint-venture agreement with ReNeu Inc. of Calgary, AB, Canada, ("ReNeu") and NexGen Medical Systems, Inc. of Melbourne, FL, USA ("NexGen").
ReNeu is a company formed to commercialize drug-based therapies to treat central nervous system disorders in combination with devices and processes for direct-to-brain administration.
Subject to the definitive agreement, SCT and NexGen will license their respective technologies to ReNeu under world-wide, royalty-free licenses for the use of NexGen's FDA-cleared EViTAR™ line of proprietary intracranial delivery systems and SCT's NTx-265, -428 and -488 covering the proprietary use of drugs for the regeneration of endogenous neural stem cells.
To the knowledge of the Corporation the EViTAR™ intracranial delivery system is the only FDA-cleared Class II medical device currently indicated for the injection of material into the brain during intracranial procedures.
It is designed for site-specific, low-volume, high-concentration delivery of drugs to target tissues in the brain of patients suffering from stroke, neurodegenerative disease, and tumors.
SCT's NTx-265 is a therapeutic regimen of approved and clinically well-defined drugs that include human Chorionic Gonadotropin ("hCG") and erythropoietin ("EPO") for the regeneration of neural stem cells in patients following stroke, traumatic brain injury and other neurological conditions.
"ReNeu's perceptive innovation that the combination of SCT's award-winning, proprietary discoveries by Dr. Sam Weiss, Director of the Hotchkiss Brain Institute, if administered in a direct-to-brain process, holds the promise of delivering the regenerative results that Dr. Weiss' discovery originally proposed. NexGen's EViTAR family would appear to be an ideal vehicle for the clinical expansion of the SCT products and we are enthusiastic about its prospects," said David Allan, Executive Chairman of SCT.
Under the Letter of Agreement SCT will own 50% of the joint-venture for which the definitive agreement is anticipated within 60 days, subject to final due-diligence and usual conditions being met.
"The breakthrough benefit to patients that could be expected to result from a positive clinical demonstration from the combination of these two critical elements for the treatment of neurologically degenerative diseases could be of significant importance for the treatment of patients with stroke and other neurological conditions," said Dr. Joseph Tucker, founding CEO of ReNeu.
Dr. Tucker continued, "The most effective preclinical treatments from Dr. Weiss' work licensed to SCT were the direct-to-brain approaches, which clearly indicated the prospect of important benefit to patients when developed clinically. At the time, SCT proceeded in its clinical development with systemic rather than site-specific administration because of the absence of availability of a direct-to-brain approach, with the consequence that only limited amounts of SCT's drug combination reached the brain and equivocal clinical outcomes were achieved. We have high expectations that this fortuitous combination of these two novel approaches could have an importantly different and positive outcome."
"NexGen is very excited about this collaboration with SCT and ReNeu," said John Kucharczyk, CEO of NexGen Medical Systems.
"The novel treatment methods have the potential to introduce entirely new therapies for several neurological diseases and disorders. NexGen's proprietary EViTAR™ neurocatheters are designed for delivery of therapeutic agents directly to target tissues in the brain and spinal cord, which is expected to significantly reduce side-effects associated with systemic delivery of drugs," Kucharczyk added.
ReNeu's initial board will be composed of David Allan, Executive Chairman of Stem Cell Therapeutics, Dr. John Kucharczyk, CEO of NexGen Medical Systems, Dr. Brad Thompson, Chairman & CEO of Oncolytics Biotech and Dr. Joseph Tucker, founding CEO of ReNeu.
The Company intends to vigorously pursue regulatory approval to move the combined technologies into clinical trials with a target of clinical initiation in 2014.
SCT will retain all rights to its endogenous stem cell-stimulating technology other than direct-to-brain administration.