NurExone Biologic Reports Additional Positive Preclinical Trial Outcomes with ExoPTEN: 75% of Paralyzed Rats Show Recovery after Acute Spinal Cord Injury Study
Figure 1: Stress levels in treated rats (as indicated by self-harm)
TORONTO and TEL AVIV, Israel, March 20, 2023 (GLOBE NEWSWIRE) — Toronto and Tel Aviv, March 20, 2023 – Biopharmaceutical firm NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V) (“NurExone” or the “Company”), disclosed today additional results from an internal preclinical study of its investigational drug ExoPTEN demonstrating effective treatment of 75% of paralyzed rats suffering from spinal cord injuries.
The Company’s most recent preclinical trials, that have taken place over 10 weeks in NurExone’s labs in Israel, have proven that its experimental drug ExoPTEN caused 75% of rat subjects in the study to regain hind limb reflex, some motor function, and sensory control. These rats, who regained function, also showed no signs of self-harm, an indicator of stress. (Fig. 1)
ExoPTEN is being developed to be a minimally invasive ExoTherapy for spinal cord injuries (SCI), yielding neuron regeneration and rewiring in traumatically damaged spinal cords. It has shown promising results in laboratory studies for reversing paralysis in rats.
The drug has been developed using NurExone’s proprietary ExoTherapy platform for producing and loading exosomes with pharmaceutical cargo targeting spinal cord injuries intranasally. NurExone’s ExoTherapy platform is being developed to find a safe, effective, non-invasive treatment for acute spinal cord injuries, which affect millions of people worldwide and can lead to permanent paralysis.
The study showed that:
- In the ExoPTEN-treated group comprising four rats that received intranasal administration of ExoPTEN, 75% of the rats responded to treatment and recovered hind limb reflex, rehabilitated some motor function, demonstrated no sign of self-harm (an indicator of stress) and recovered sensory control.
- In the exosome-only and therapeutic PTEN siRNA molecule-only treated groups, each with four rats, 25% of the subjects experienced recovery of hind limb reflex, motor function, and sensory control, while also showing no signs of stress-related self-harm.
- In a control group of six rats treated with a non-therapeutic saline solution, none exhibited any sensory, reflex recovery, or motor rehabilitation. All rats in this group displayed self-harm behavior, indicating a higher level of stress.
The results of the preclinical study will be presented this week by NurExone’s Director of R&D, Dr. Lyora Aharonov at the “Extracellular Vesicles: Friends and Foes II” meeting at the Weizmann Institute of Sciences in Israel in a session focusing on exosomes in health and disease.
Dr. Aharonov stated that “these results further validate the early positive scoring for functional and sensory recovery and add positive indications regarding the well-being of the rats. It is extremely encouraging and we look forward to advancing our research and clinical trials to bring this therapy to patients in need.”
A 5.2 billion USD market and a patent
According to the National Spinal Cord Injury Statistical Center of the United States and taking into account the current U.S. population of 333 million, recent estimates suggest that the annual incidence of spinal cord injury (SCI) is about 54 cases per million people in the United States. This amounts to more than 18,000 new SCI cases each year.
NurExone’s ExoTherapy platform has the potential to revolutionize spinal cord injury treatment and significantly enhance patient outcomes. The projected global market of the industry is $5.2 billion by 2027, with $2.9 billion for acute spinal cord injury and $2.3 billion for Exosome-based technology (Diagnostic and Therapeutic). As comparable therapies are presently unavailable, the Company is dedicated to prioritizing the spinal cord injury community and providing them with this innovative technology.
About NurExone Biologic Inc.
NurExone Biologic Inc. is a TSX Venture Exchange listed pharmaceutical company that is developing a platform for biologically-guided ExoTherapy to be delivered, non-invasively, to patients who suffered traumatic spinal cord injuries. ExoTherapy was conceptually demonstrated in animal studies at the Technion, Israel Institute of Technology. NurExone is translating the treatment to humans, and the Company holds an exclusive worldwide license from the Technion and Tel Aviv University for the development and commercialization of the technology.
Nurexone Biologic Inc.’s management team, led by CEO Dr. Lior Shaltiel, boasts a wealth of experience and a history of success within the pharmaceutical industry. The Company’s scientific advisory board comprises renowned experts in drug delivery and CNS therapeutics, including Prof. Shulamit Levenberg, a recipient of numerous accolades such as the Wolf Foundation’s Krill Prize for excellence in scientific research. Prof. Levenberg has also been recognized as a “Research Leader” in tissue engineering by Scientific American for her groundbreaking work on engineered tissue vascularization.
Additionally, the board features Prof. Nahshon Knoller, MD, the former head of the neurosurgery department at Israel’s largest hospital, who has led three clinical spinal cord injury studies.
To download Nurexone’s Company Presentation, please visit: www.nurexone.com/investors
For more information on NurExone Biologic Inc., ExoPTEN and the ExoTherapy platform, please visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.
For more information, please contact:
Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Investor Relations (Canada)
Phone: +1 905-347-5569
Email: IR@nurexone.com
FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking statements” that reflect the Company’s current expectations and projections about its future results. When used in this press release, forward-looking statements can be identified by the use of words such as “may,” or by such words as “will,” “intend,” “believe,” “estimate,” “consider,” “expect,” “anticipate,” and “objective” and similar expressions or variations of such words. Forward-looking statements are, by their nature, not guarantees of the Company’s future operational or financial performance and are subject to risks and uncertainties and other factors that could cause the Company’s actual results, performance, prospects, or opportunities to differ materially from those expressed in, or implied by, these forward-looking statements. No representation or warranty is intended with respect to anticipated future results, or that estimates, or projections will be sustained.
Forward-looking statements are necessarily based on estimates and assumptions made by us in light of our experience and perception of historical trends, current conditions, and expected future developments, as well as the factors we believe are appropriate. Forward-looking statements in this press release include, but are not limited to, statements relating to: the inferences made from our internal and preclinical study of ExoPTEN treatments, including the potential development of treatments for humans; our goal to conduct ExoPTEN clinical trials and develop a treatment for spinal cord injuries; the estimated size and growth of the market for the treatment of spinal cord injuries; and the therapeutic benefits, effectiveness, and safety of our product candidates.
In developing the forward-looking statements in this press release, we have applied several material assumptions, including that our the interim results are indicative of results that may be seen in future studies, third party sources of industry data represent reasonable estimates, our ability to retain key personnel, our ability to continue investing in research and development, our ability to secure available funding and to continue as a going concern, the general business and economic conditions of the industries and countries in which we operate, and our ability to execute on our business strategy.
Many risks, uncertainties, and other factors could cause the actual results of the Company to differ materially from the results, performance, achievements, or developments expressed or implied by such forward-looking statements. These risks, uncertainties, and other factors include, but are not limited to, the following: those risk factors identified under the heading “Risk Factors” on pages 62 to 69 of the Company’s Filing Statement dated May 12, 2022, a copy of which is available under the Company’s SEDAR profile at www.sedar.com; risks related to the Company’s early stage of development; lack of revenues to date; government regulation; market acceptance for our products; rapid technological change; dependence on key personnel; protection of our intellectual property; dependence on our strategic partners; overall economic conditions; competitive pressures; network restrictions; and other similar factors that may cause the actual results, performance or achievements to differ materially from those expressed or implied in these forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of the press release or as of the date otherwise specifically indicated herein. Due to risks and uncertainties, events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required pursuant to applicable securities law. All forward-looking statements contained in the press release are expressly qualified in their entirety by this cautionary statement.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Figure 1: Stress levels in treated rats (as indicated by self-harm)
An indicator of stress in laboratory rats is a propensity for self-harm. The stress level of the rats was found to be correlated with functional recovery, i.e. recovered rats did not exhibit self-harm.
Preclinical Research results poster:
https://nurexone.com/wp-content/uploads/2023/03/Friends-and-foes2-Reduced.pdf
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/63fb354c-d6e6-466a-aaab-4963330c9f3e
