This Is MS Multiple Sclerosis Knowledge & Support Community

DIM wrote: ↑Mon Nov 25, 2024 1:00 pm NervGen Completes Dosing Another Group With MS Candidate NVG-291

https://multiplesclerosisnewstoday.com/ ... e-nvg-291/

This phase 1 trial appears to have been misidentified by Multiple Sclerosis News Today. This article's title states...

NervGen Completes Dosing Another Group With MS Candidate NVG-291

NVG-291 is an investigational therapy for MS and other nervous system disorders
Patricia Valerio, PhD avatar

by Patricia Valerio, PhD | November 18, 2022

However, the study description at ClinicalTrials.gov clearly states that it was a phase 1 trial for spinal cord injury.

https://clinicaltrials.gov/study/NCT05308953

On March 13, 2025 Nervgen participated in the Virtual Life Sciences Investor Forum. Nervgen CEO Mike Kelly's presentation can be found at the following link.

Note, registration is required, but real info is optional.

https://www.virtualinvestorconferences. ... 325LSIFVIC

NervGen Initiates Expanded Access Policy

March 31, 2025 7:30 AM EDT

https://www.newsfilecorp.com/release/246658

• The U.S. Food and Drug Administration (FDA) informed the company that an expanded access protocol for NVG-291 may proceed.

Vancouver, British Columbia--(Newsfile Corp. - March 31, 2025) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company dedicated to developing neurorestorative therapeutics, today announced the company has initiated an expanded access policy to allow treatment use of the investigational product NVG-291 for those individuals with spinal cord injury (SCI) who have participated in NervGen clinical trials and meet specific eligibility criteria. The company received a request from a physician for expanded access to NVG-291 for a subject who participated in the chronic cohort of the Phase 1b/2a clinical trial. After the company submitted an expanded access protocol for NVG-291 to the FDA, the FDA informed the company that the study could proceed.

NVG-291 is an investigational drug in clinical development that has not been approved by regulatory authorities for marketed use. It is unknown whether it is effective for the treatment of individuals with SCI, and there may be unknown risks associated with its use. Expanded Access programs allow patients who have unmet medical needs with serious or life-threatening conditions to access investigational products that are not yet approved by the FDA outside of a clinical trial.

"NervGen is committed to the continued clinical development and evaluation of NVG-291 as a potential novel treatment approach in spinal cord injury," said Daniel Mikol, M.D. Ph.D., NervGen's Chief Medical Officer. "As we announce this expanded access policy for specific participants, we continue to enroll the subacute cohort of the Phase 1b/2a study in SCI as we prepare to unblind the efficacy and safety results from the chronic cohort of this study in early June 2025."

The company's expanded access policy provides a potential opportunity for individuals living with SCI who have participated in NervGen clinical trials to continue access to NVG-291 for treatment. The company's decision to change its expanded access policy was based, in part, upon a special circumstance related to a physician request for access to NVG-291.

For information about NervGen's expanded access policy for NVG-291 and the process to submit a request, please refer to the company's policy.

[Continued]