NurExone Moves Forward Towards Human Clinical Trials, Completes Pre-IND Meeting with the FDA for Proprietary ExoPTEN Drug
13 9월 2023 - 9:30PM
NurExone Biologic Inc. (TSXV: NRX) (FSE: J90) (NRX.V) (the
“
Company” or “
NurExone”), a
biopharmaceutical company developing biologically-guided exosome
therapy (“
ExoTherapy”) for patients with traumatic
spinal cord injuries, is pleased to announce that the Company has
completed a Pre-Investigational New Drug
(“
Pre-IND”) meeting with the U.S. Food and Drug
Administration (“
FDA”) in connection with the
manufacturing, preclinical and clinical development plan of
ExoPTEN, NurExone’s first ExoTherapy product, after receiving a
written response from the FDA on August 29, 2023.
A Pre-IND meeting offers open communication
between applicants and the FDA, enabling the applicants to receive
information regarding the preparation of an IND application and
guidance for the clinical studies of the Company’s ExoPTEN drug.
The FDA provided clear and valuable guidance on the chemistry
manufacturing and controls and agreed that our proposed ExoPTEN
release testing strategy would be expected to adequately control
for safety of the ExoPTEN product for use in the planned
first-in-human clinical trial. The FDA’s response to the Company
indicated that the planned toxicity study strategy is acceptable
under FDA guidelines and large-scale animal studies will not be
required. Based on the FDA’s feedback, the Company plans to submit
an IND application regarding the development of ExoPTEN by Q4,
2024, and expects to initiate Phase 1/2 human clinical studies in
2025.
“We are pleased to have completed a Pre-IND
meeting with the FDA in connection with the development of ExoPTEN
and are optimistic that this will help expedite our progress to the
clinical stage,” said Dr. Lior Shaltiel, CEO of NurExone. “This
meeting is part of our continued commitment to advance our FDA
regulatory approval strategy to launch ExoPTEN into the U.S.
market, where we see a high demand for acute spinal cord injury
treatments.”
ExoPTEN is being developed to be a minimally
invasive ExoTherapy for spinal cord injuries 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.
About NurExone Biologic Inc.
NurExone Biologic Inc. is a TSXV 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 more information, please contact:
Dr. Lior ShaltielChief Executive Officer and DirectorPhone:
+972-52-4803034Email: info@nurexone.com
Investor RelationsPhone: +1 905-347-5569Email:
IR@nurexone.com
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 Company’s ExoTherapy drug, ExoPTEN, the planned toxicity
study strategy with the FDA, potential first-in-human clinical
trial for ExoPTEN, the completion of an IND application regarding
the development of ExoPTEN, and the potential launch of a product
into the U.S. market upon completion of applicable regulatory
phases. 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 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, our ability to execute on our
business strategy, that there will be certain amount of demand for
the Company’s potential product, inflation will remain stable, and
that the results of our studies reflect results that can be
extrapolated.
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 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.
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.
NurExone Biologic (TG:J90)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
NurExone Biologic (TG:J90)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024