TORONTO and HAIFA, Israel, Aug. 01, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX), (OTCQB: NRXBF), (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company, is thrilled to announce an important milestone in its regenerative medicine efforts. The Company has successfully transferred the manufacturing of the small interfering RNA (“siRNA”) sequence for its flagship ExoPTEN nanodrug to a German producer with Good Manufacturing Practice (“GMP”) capabilities. A move to a GMP-grade manufacturer is essential for producing a drug for clinical trials and commercial sale.
The siRNA sequence was validated at the new GMP partner, solidifying the Company’s commitment to advancing regenerative medicine therapies and strengthening its confidence in meeting future clinical manufacturing demands.
NurExone reports that the siRNA from the new vendor achieved an approximately 80% reduction in expression of PTEN (Phosphatase and Tensin Homolog), demonstrating potency and effectiveness that is comparable to the siRNA from the Company’s previous, research-grade producer. NurExone’s ExoPTEN nanodrug, that is still under development, uses PTEN inhibition to facilitate nerve growth and regeneration after injury or damage. Figure 1 below shows that both the research-grade and the new GMP vendor’s siRNA effectively downregulate PTEN mRNA in a neuroblastoma cell line with comparable efficacy.
Dr. Lior Shaltiel, CEO of NurExone, stated: “The tech transfer to a new GMP-compliant vendor for our siRNA sequence is a significant achievement, establishing the foundation for future GMP manufacture of a potent and patented product. Achieving production that meets the strict quality and regulatory standards necessary for clinical trials is a critical step in the development of our ExoPTEN nanodrug."
GMP is a system of regulations, guidelines, and procedures intended to ensure that products are produced and controlled according to quality standards.
Figure 1
Figure 1 illustrates the downregulation of PTEN mRNA in a neuroblastoma cell line following transfection with siRNA targeting PTEN from two different manufacturers: a research-grade producer and a new GMP-grade producer. The relative expression levels of PTEN mRNA are shown on the y-axis, with three experimental conditions depicted on the x-axis: control (untreated cells), research-grade producer, and new GMP-grade producer.
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.
Dr. Lior Shaltiel Chief Executive Officer and Director Phone: +972-52-4803034 Email: [email protected]
Thesis Capital Inc. Investment Relation - Canada Phone: +1 905-347-5569 Email: [email protected]
Dr. Eva Reuter Investment Relation - Germany Phone: +49-69-1532-5857 Email: [email protected]
FORWARD-LOOKING STATEMENTS
This press release contains certain “forward-looking statements”, that reflect the Company’s current expectations and projections about its future results. Wherever possible, words such as “may”, “will”, “should”, “could”, “expect”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict” or “potential” or the negative or other variations of these words, or similar words or phrases, have been used to identify these forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements relating to the success of the partnership with the GMP partner in Germany; the Company making progress with the new GMP partner’s latest tests achieving a reduction in expression of PTEN; the technology transfer to the new GMP compliant partner establishing the foundation for future GMP manufacture of a potent and patented product; and the partnership with the GMP partner helping NurExone to continue its development of its ExoPTEN nanodrug, which it hopes to use to treat central nervous system injuries.
These statements reflect management’s current beliefs and are based on information currently available to management as at the date hereof. In developing the forward-looking statements in this press release, we have applied several material assumptions, including the general business and economic conditions of the industries and countries in which we operate; the general market conditions; the ability to secure additional funding; the partnership with the GMP manufacturer having the intended impact on the Company and its business; the patents safeguarding NurExone’s technology; the Company’s drug products will have their intended benefits and effects; the Company will make progress using its new partnerships and technologies to move to commercialization of their products; the Company’s intellectual property and technology being novel and inventive; the intellectual property having the intended impact on the Company and its business; and the NurExone platform technology will offer novel solutions to drug companies.
Forward-looking statements involve significant risk, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to differ materially from the results discussed or implied in the forward-looking statements. These risks and uncertainties include, but are not limited to risks related to the Company’s early stage of development; lack of revenues to date; government regulation; market acceptance for its products; rapid technological change; dependence on key personnel; protection of the Company’s intellectual property; dependence on the Company’s strategic partners; the fact that preclinical drug development is uncertain, and the drug product candidates of the Company may never advance to clinical trials; the fact that results of preclinical studies and early-stage clinical trials may not be predictive of the results of later stage clinical trials; the uncertain outcome, cost, and timing of product development activities, preclinical studies and clinical trials of the Company; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; the potential inability to obtain or maintain regulatory approval of the drug product candidates of the Company; the introduction of competing drugs that are safer, more effective or less expensive than, or otherwise superior to, the drug product candidates of the Company; the initiation, conduct, and completion of preclinical studies and clinical trials may be delayed, adversely affected or impacted by unforeseen issues; the potential inability to obtain adequate financing; the potential inability to obtain or maintain intellectual property protection for the drug product candidates of the Company; the NurExone platform technology being unable to offer novel solutions to drug companies; risk that the Company will not pay the registration fees prior to the deadline or at all; risks that the Company’s intellectual property and technology won’t have the intended impact on the Company and/or its business; the Company’s inability to realize upon with the new GMP partner in Germany; and the risks discussed 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.sedarplus.ca. These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update or revise them to reflect new events or circumstances, except as required by law.
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