Stem Cell Therapeutics Announces Joint-Venture Agreement With Reneu Inc. and Nexgen Medical Systems, Inc
Novel Combination of Neural Stem Cell Technology & Direct-to-Brain Administration of Therapeutics via an FDA-Cleared Neurocatheter
Press Release: JOINT VENTURES – 38 minutes ago
TORONTO, ONTARIO--(Marketwire - Feb. 19, 2013) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS) ("SCT" or the "Corporation") a life sciences company developing stem cell-related technologies, today 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. "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.
About Stem Cell Therapeutics Corp.:
Stem Cell Therapeutics Corp. develops stem cell-based therapeutics through partnerships with research institutions and technology transfer organizations. SCT's objectives include the sourcing and acquisition of additional stem cell-related development opportunities, and securing capital for the advancement of its licensed or acquired products. SCT is currently conducting a Phase II clinical trial in traumatic brain injury with NTx(R)-428 designed to characterize the ability of hCG followed by EPO to promote neurological and functional recovery of the brain following moderate-to-serious acute cortical (white matter) injury to the brain. For more information visit: www.StemCellThera.com.
About ReNeu Inc.:
ReNeu Inc. is a biotechnology company developing novel therapies for the treatment of central nervous system disorders. Our proprietary approach is to enhance brain remodeling and plasticity by administering neurogenesis-promoting drugs directly into the brains of patients. Our lead product, UnDo™, aims to improve brain and motor function in victims of stroke. For more information visit: www.ReNeuInc.com.
About NexGen Medical Systems, Inc.:
NexGen Medical Systems, Inc. is a private, development-stage Florida-based company that is developing catheter-based medical device products for therapeutic interventions in radiology, vascular surgery, and neurosurgery. The Company is commercializing an integrated medical device product line for removal of blood clots from head, neck, and peripheral vessels. The Company also develops access devices and technologies for the treatment of neurological diseases and disorders. NexGen is incorporated in Delaware and commenced operations in 2005. For more information visit: www.NexgenMedsystem.com.
Caution Regarding Forward-Looking Information:
This press release may contain forward-looking statements, which reflect SCT's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, SCT's ability to obtain financing in connection with the proposed arrangement; uncertainties as to the timing of the arrangement; the satisfaction of the conditions precedent to the completion of the arrangement; changing market conditions; the successful and timely completion of pre-clinical and clinical studies; the establishment of corporate alliances; the impact of competitive products and pricing; new product development risks; uncertainties related to the regulatory approval process or the ability to obtain drug product in sufficient quantity or at standards acceptable to health regulatory authorities to complete clinical trials or to meet commercia or otherwisel demand; and other risks detailed from time to time in SCT's ongoing quarterly and annual reporting. Except as required by applicable securities laws, SCT undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events.