TORONTO and TEL AVIV, Israel, June 22, 2023 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. ("NurExone" or the "Company") (TSXV: NRX) (FSE: J90) (NRX.V), is pleased to report positive imaging results from an internal preclinical study of its investigational drug ExoPTEN. The image analysis and measurements confirmed successful nerve regeneration following traumatic transection of the spinal cord in rats. These imaging results align with previous results showing a remarkable recovery of motor function in 75% of paralyzed rats suffering from spinal cord injuries and treated with the new therapy.
During a recent internal preclinical trial, the company's ExoPTEN drug caused 75% of rats to regain hind limb reflex, some motor function, and sensory control. Subsequently, the spinal cords of rats from the study were subjected to advanced Diffusion Tensor Imaging (DTI) to assess the structural integrity of the spinal cord. Our DTI analysis yielded representative observations for different rat groups as follows:
- Intranasal ExoPTEN with recovered motor function – Reinnervation, indicating a restoration of nerve supply to the spinal cord below the transection. (Fig.1A)
- Control group - Atrophied and de-innervated spinal cord below the transection (Fig.1A)
- A healthy spinal cord, without trauma, is included as a reference for comparison. (Fig.1A)
DTI was performed using conventional magnetic resonance imaging (MRI) and diffusion tensor imaging techniques. Furthermore, fractional anisotropy (FA) measurements were used for a quantitative assessment of tissue integrity. The results showed higher FA values indicating reduced tissue microstructural damage in the caudal region of the ExoPTEN-treated rats compared to the control SCI group (Fig. 1B). A range of healthy rat FA values from a separate experiment is included in Fig. 1B for reference. It is important to note that the nerves below the lesion site presented better survival and less degeneration, which is one of the common pathophysiological conditions after injury.
ExoPTEN is being developed to be a minimally invasive ExoTherapy for spinal cord injuries (SCI) administrated intranasally and yielding neuron regeneration and rewiring in traumatically damaged spinal cords. The drug is being developed using NurExone's proprietary ExoTherapy platform for producing and loading exosomes with pharmaceutical cargo targeting central nervous system injuries.
"We are delighted to receive promising results from this study, which demonstrated reinnervation as a result of our ExoPTEN product," said Dr. Lior Shaltiel, Chief Executive Officer. "Moreover, it validates the functional recovery we observed with non-invasive administration of our investigational ExoPTEN drug. We are eager to advance our research and clinical trials to translate these results to the millions of human patients in need."
Figs. 1A-B Diffusion Tensor Imaging and Measurements
Structural Integrity of the Caudal Spinal Cord
Figure Legend:
(A) To assess the structural integrity of the spinal cord, 9.4T conventional MRI and diffusion tensor imaging (DTI) was performed in control-treated (IN) SCI animals, ExoPTEN-treated (IN) SCI animals, and intact rats. In the control-treated SCI animals, caudal nerve tracts were completely severed at the epicenter indicated, leaving the caudal spinal cord de-innervated and atrophied. ExoPTEN promoted reinnervation and nourishment to the caudal spinal cord.
(B) Fractional anisotropy (FA) is a measure of tissue integrity. Thus, FA decreases with tissue microstructural damage. FA recordings caudal to the injury site were higher in ExoPTEN-treated rats compared to the control SCI group (B). The green area represents the range of healthy rats' FA values as obtained in a separate experiment. These DTI tractography images and measurements indicate re-innervation and nourishment to the caudal spinal cords in ExoPTEN rats treated intranasally.
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.
For additional information, please visit www.nurexone.com or follow NurExone on LinkedIn, Twitter, Facebook, or YouTube.
For further information, please contact:
Dr. Lior Shaltiel
Chief Executive Officer and Director
Phone: +972-52-4803034
Inbar Paz-Benayoun
Adv. Head of Communications and Investor Relations
Phone: +972-52-3966695
Email: info@nurexone.com
Investor Relations (Canada) Phone: +1 905-347-5569
Email: IR@nurexone.com
To download NurExone's Earnings Presentation, please visit:
https://nurexone.com/wp-content/uploads/2023/03/Nurexone-Q4-Full-Year-Fiscal-2022-Financial-Results-March-2023.pdf
FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" that reflect the Company's current expectations and projections about its future development. 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: our future plans and intellectual property; our scientific and development activities and the results of our internal pre-clinical trial; future scientific activities and the treatment of certain conditions; the therapeutic benefits, effectiveness, and safety of our product candidates; and the estimated growth of the market for acute spinal cord injuries.
In developing the forward-looking statements in this press release, we have applied several material assumptions, including that the internal pre-clinical trial represents reliable results, 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 29 to 36 of the Company's Annual Information Form dated March 30, 2023, 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.
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