The NERVGEN-291 miracle!

[NHE]

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

[NHE]

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

[NHE]

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]

[NHE]

Nervgen CEO Mike Kelly gave a presentation at the 2025 Bloom Burton & Co. Healthcare Investor Conference on May 5, 2025. He noted that the current phase 1b/2a clinical trial will have a readout of the chronic spinal cord injury (SCI) NVG-291 treatment arm in 5 weeks. He reported that patient recruitment for the subacute SCI arm of the trial is still ongoing. Mike Kelly also stated that NVG-291 had been approved for expanded access upon the request of one patient's doctor. Expanded access allows the patient to continue receiving NVG-291 after the patient had completed their participation in the trial. You can view the presentation at the following link.

https://event.summitcast.com/view/hG2Kh ... EE8LWSmtQV

[NHE]

NervGen Pharma to Present Topline Data for NVG-291 Phase 1b/2a Chronic Cohort Study at the American Spinal Injury Association Annual Scientific Meeting

May 21, 2025 7:30 AM EDT | Source: NervGen Pharma Corp.

https://www.newsfilecorp.com/release/252834

Vancouver, British Columbia--(Newsfile Corp. - May 21, 2025) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotechnology company dedicated to developing neuroreparative therapeutics, today announced that topline results from the chronic cohort of the ongoing Phase 1b/2a study of NVG-291 will be presented as an oral presentation at the 52nd American Spinal Injury Association Annual Scientific Meeting being held June 2-4, 2025 in Scottsdale, AZ.

"We are looking forward to completing the data analysis, unblinding the data, and presenting the first results from the chronic cohort in this initial proof-of-concept, double-blind, placebo-controlled clinical trial of NVG-291 in spinal cord injury ("SCI")," stated Daniel Mikol, MD, Ph.D., NervGen's Chief Medical Officer. "In this trial we have incorporated both clinical assessments as well as electrophysiological assessments of connectivity, as we feel this gives the highest probability of observing and characterizing an efficacy signal with NVG-291. We are hopeful that the results of the chronic cohort of our Phase 1b/2a trial may demonstrate, for the first time, the potential for NVG-291 to enable neural repair in individuals with SCI and will support further investigation of NVG-291 in SCI."

Presentation Details:

Presenting Author: Daniel Mikol MD, Ph.D., Chief Medical Officer, NervGen
Presentation Title: A 16-week Placebo-controlled Phase 1b/2a Study of NVG-291: Results for the Chronic Cohort
Session Name: General Session 6: Clinical Trial Updates: Clinical Trials: What's the Latest and When Will it Get Here?
Session Date: Tuesday, June 3, 2025
Session Time: 10:40 AM-11:40 AM MST
Location: Arizona Ballroom I, Grand Hyatt Scottsdale Resort, 7500 E. Doubletree Ranch Rd., Scottsdale, AZ