Leading Contract Research Organization to carry out pharmacological studies, part of planned FDA Investigational New Drug (IND) application
TORONTO and HAIFA, Israel, March 22, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company, developing regenerative medicine therapies, is proud to announce a strategic service agreement with Vivox Ltd. (“Vivox”), a leading provider of animal testing and services in Israel to biotech and pharmaceutical companies. This large-scale animal testing represents a significant step towards filing an Investigational New Drug (IND) application in the US for NurExone’s ExoPTEN therapy for spinal cord injury (SCI).
Under the terms of the agreement, Vivox will provide Contract Research Organization (CRO) services to NurExone, as a prerequisite to commencing Human Trials under the planned IND. The scope of the services to be provided includes the carrying out of experiments by Vivox on a total of 100 rats, divided into 5 different experiments. Every experiment involves comprehensive care and monitoring of the rats. In the experiments, some of the test subjects will receive the ExoPTEN active ingredient and a second group will receive a placebo and/or naïve exosomes (without the PTEN active ingredient). The typical treatment period is approximately 2 months. The aim of this series of tests is to evaluate the optimal dosage of ExoPTEN in various pharmacologically relevant rodent models of spinal cord. The agreement underscores both companies' commitment to accelerating innovative therapies for SCI.
"We are pleased to commission Vivox to conduct a series of closely monitored experiments on a large group of laboratory animals as part of the ExoPTEN IND enabling studies. The testing will encompass mobility, behavior, motor and sensory recovery of rats following Spinal Cord Injury and treatment with ExoPTEN," said Dr. Lior Shaltiel, CEO of NurExone. "We anticipate that this independent and detailed analysis will corroborate and expand upon the encouraging results observed in numerous laboratory experiments."
NurExone believes that the ExoPTEN therapy holds significant promise as a potential treatment for SCI. Preclinical studies have demonstrated its ability to promote neural regeneration and functional recovery in animal models. By collaborating with Vivox, NurExone aims to accelerate the development and regulatory path of ExoPTEN, to bring this potentially transformative treatment to patients in need.
About Vivox Ltd.
Vivox is a leading CRO in Israel, specializing in in-vivo and in-vitro preclinical services for pharmaceutical, biotech, and medical device companies. Established in 2018, Vivox has conducted numerous successful experiments and operates a state-of-the-art facility in Yokne’am-Illit. With a focus on accuracy and efficiency, Vivox offers a range of services including toxicology expertise, disease models, surgical services, and analytics. The company is dedicated to helping pharmaceutical firms develop innovative medicines through tailored studies conducted under strict safety measures for high-quality results.
About NurExone Biologic Inc.
NurExone Biologic Inc. is a TSXV listed pharmaceutical company that is developing a platform for biologically-guided exosome-based therapies to be delivered, non-invasively, to patients who have suffered Central Nervous System injuries. The Company’s first product, ExoPTEN for acute spinal cord injury, was proven to recover motor function in 75% of laboratory rats when administered intranasally. ExoPTEN has been granted Orphan Drug Designation by the FDA. The NurExone platform technology is expected to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.
For additional information, 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
Email: info@nurexone.com
Thesis Capital Inc.
Investment Relation - Canada
Phone: +1 905-347-5569
Email: IR@nurexone.com
Dr. Eva Reuter
Investment Relation - Germany
Phone: +49-69-1532-5857
Email: e.reuter@dr-reuter.eu
Cautionary Statement Regarding Forward-Looking Statements
This press release contains certain "forward-looking information" within the meaning of applicable Canadian securities legislation. Such forward-looking information and forward-looking statements are not representative of historical facts or information or current condition, but instead represent only the Company's beliefs regarding future events, plans or objectives, many of which, by their nature, are inherently uncertain and outside of the Company's control. Often, but not always, forward-looking statements and information can be identified by the use of words such as "plans", "expects" or "does not expect", "is expected", "estimates", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved.
Forward-looking statements in this news release include statements relating to: the benefits, terms, and scope of the strategic agreement, including the stated nature, goals, and manner of which experiments will be conducted; the ongoing commitment of the Company to further therapies for SCI; the anticipation that an independent and detailed analysis will corroborate and expand upon the encouraging results observed in numerous laboratory experiments; ExoPTEN therapy holding significant promise as a potential treatment for SCI; the Company’s stated goals for accelerating the development and regulatory path of ExoPTEN; and the expectation of the NurExone platform technology will offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.
Forward-looking information in this press release are based on certain assumptions and expected future events, namely: the Company’s ability to realize upon the benefits, terms, and scope of the strategic agreement; the Company’s ability to keep its ongoing commitment of the Company to further therapies for SCI; that an independent and detailed analysis will corroborate and expand upon the encouraging results observed in numerous laboratory experiments; the ExoPTEN therapy has the ability to be a significant promise as a potential treatment for SCI; the Company’s ability to realize upon the stated goals for accelerating the development and regulatory path of ExoPTEN; and the Company’s ability to realize upon its expectation of the NurExone platform technology to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.
These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the Company’s inability to realize upon the benefits, terms, and scope of the strategic agreement; the Company’s inability to keep its ongoing commitment of the Company to further therapies for SCI; that an independent and detailed analysis will not corroborate and expand upon the encouraging results observed in numerous laboratory experiments; the ExoPTEN therapy will not be a significant promise as a potential treatment for SCI; the Company’s inability to realize upon the stated goals for accelerating the development and regulatory path of ExoPTEN; and the Company’s inability to realize upon its expectation of the NurExone platform technology to offer novel solutions to drug companies interested in noninvasive targeted drug delivery for other indications.
Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
Although the Company believes that the assumptions and factors used in preparing, and the expectations contained in, the forward-looking information and statements are reasonable, undue reliance should not be placed on such information and statements, and no assurance or guarantee can be given that such forward-looking information and statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information and statements.
The forward-looking information and forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake to update any forward-looking information and/or forward-looking statements that are contained or referenced herein, except in accordance with applicable securities laws.
Neither TSX-V nor its Regulation Services Provider (as that term is defined in the policies of the TSX-V) accepts responsibility for the adequacy or accuracy of this release.
