The NERVGEN-291 miracle!

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Re: The NERVGEN-291 miracle!

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DIM wrote: Sun Jun 30, 2024 8:15 am It isn't a lifetime therapy, just until someone achieves mobility then will stop it?
With spinal cord injury I think it should be a one time treatment. Once the nerves have regrown, I don't see why you would need to continue the treatment. Though I don't know how long it would take for full restoration of function. MS may be a different situation though unless we stop the degeneration first.
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Re: The NERVGEN-291 miracle!

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200.000$ per year for lifetime therapy is intended for very few people in the globe...
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Re: The NERVGEN-291 miracle!

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I hope this trial commences once their current spinal cord injury trial finishes.

NervGen Brings Advanced Imaging to Planned NVG-291 Trials

September 29, 2021

https://multiplesclerosisnewstoday.com/ ... -trial-ms/

A partnership will allow NervGen to use Imeka‘s proprietary biomarker imaging technology to precisely measure changes in the brain and spinal cord in its upcoming clinical trials, including a study of NVG-291 in people with multiple sclerosis (MS)

NervGen plans to initiate Phase 1b/2 trials into its lead candidate for neural repair in MS patients, and in people with spinal cord injury, next year. A Phase 1/2a trial is also planned for Alzheimer’s disease.

“We are very excited to apply Imeka’s advanced imaging technology to assess the biological activity of NVG-291 in clinical trials,” Daniel Mikol, MD, PhD, chief medical officer of NervGen, said in a press release.

NVG-291 is an investigational peptide, or a small protein, designed to stimulate nerve regeneration by modulating the activity of the protein tyrosine phosphatase (PTP) sigma, a receptor of nerve cells that blocks nerve regeneration following tissue damage.

PTP sigma receptors have been shown to halt the repair of nerve cells following an injury, either caused by a disease like MS or as a result of trauma, such as in spinal cord injury.

The compound has shown promising preclinical results in animal models of MS, promoting the regeneration of damaged nerves and boosting remyelination — the restoration of the fatty myelin coating surrounding nerve fibers, which is lost in MS.

“In animal studies, NVG-291 has shown a multi-modal mechanism of action, including enhancement of axonal regeneration, neuroplasticity and remyelination, reflecting its ability to repair the damaged nervous system,” Mikol said.

A Phase 1 clinical trial, taking place in Australia, is currently investigating the safety and pharmacokinetics (movement into, through, and out of the body) of NVG-291 in a group of healthy volunteers.

Participants are receiving one of six ascending doses of the therapy to determine NVG-291’s best therapeutic dose. Top-line data are expected by year’s end on this phase, at which point NervGen anticipates advancing into the study’s multiple ascending dose part.

Should the Phase 1 data be positive, the company plans to launch two Phase 1b/2 clinical trials — one in people with MS and another in those with spinal cord injury — as well as a trial in Alzheimer’s patients. All will apply Imeka’s imaging technology to assess the effectiveness of NVG-291.

“We are very excited to be part of the development of NervGen’s drug, whose novel mechanism of action suggests it could make an enormous difference for patients who have experienced nervous system damage,” said Jean-René Belanger, CEO of Imeka.

Imeka’s technology combines artificial intelligence and free-water diffusion imaging to obtain detailed images of the brain’s white matter, where most of myelin is located and which is the prime target of immune system attacks in MS. This technology allows clinicians to determine the degree of myelin loss.

“Imeka’s imaging technology … allows the very precise measurement of changes to the brain and spinal cord to detect precisely where and how a therapeutic is having its effect,” said Paul Brennan, president and CEO of NervGen.

“Incorporating Imeka’s imaging technology in our clinical trials will nicely complement other outcome measures, including changes in clinical function and fluid biomarkers, to strengthen the evidence supporting that NVG-291 can also repair nervous system damage in humans,” Mikol added.

The two Canadian companies are also submitting research grants to combine their technologies in preclinical and clinical studies into nervous system conditions.

“Recently, we have also worked closely together on several grant applications to various agencies, including the U.S. Department of Defense. We are immensely impressed with the Imeka team and their technology and believe that this partnership will result in a robust and data rich clinical trial program,” Brennan said.
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Re: The NERVGEN-291 miracle!

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Nervgen Pharma presented at the Canaccord Genuity conference August 13, 2024.

https://wsw.com/webcast/canaccord98/ngenf/2645170

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Re: The NERVGEN-291 miracle!

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No news, good news? Nothing about MS...
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Re: The NERVGEN-291 miracle!

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DIM wrote: Sat Aug 17, 2024 11:49 pm No news, good news? Nothing about MS...
What surprised me is that there were no questions from the audience. Maybe they were all in disbelief?

Anyways, they had previously mentioned that results of their phase 1b/2a spinal cord injury trial would be out during Q3. Now it looks like we might have to wait until Q1 2025.
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Re: The NERVGEN-291 miracle!

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NervGen Pharma to present at the 63rd International Spinal Cord Society Annual Scientific Meeting, very promising for those with MS and spinal cord issues:
https://nervgen.com/nervgen-pharma-to-p ... c-meeting/
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Re: The NERVGEN-291 miracle!

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NERVGEN 291 for SCI reddit conversation

https://www.reddit.com/r/NervGen_NerveRepair/
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Re: The NERVGEN-291 miracle!

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The Peptide Promise With NervGen Pharma's Mike Kelly

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Re: The NERVGEN-291 miracle!

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NervGen Completes Dosing Another Group With MS Candidate NVG-291


https://multiplesclerosisnewstoday.com/ ... e-nvg-291/
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Re: The NERVGEN-291 miracle!

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NervGen Pharma: Proof that NVG-291 works?


https://stockhouse.com/opinion/independ ... -291-works
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Re: The NERVGEN-291 miracle!

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NervGen Completes Dosing of First Subject in Subacute Cohort of its Phase 1b/2a Clinical Trial of NVG-291 in Spinal Cord Injury

February 06, 2025 7:30 AM EST | Source: NervGen Pharma Corp.

https://www.newsfilecorp.com/release/239818

Vancouver, British Columbia--(Newsfile Corp. - February 6, 2025) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company dedicated to developing neurorestorative therapeutics, today announced that the first subject has been enrolled and dosed in the subacute cohort of its Phase 1b/2a proof-of-concept, double-blind, randomized placebo-controlled clinical trial (NCT05965700) evaluating its lead candidate, NVG-291, in individuals with spinal cord injury (SCI). The company previously reported the completion of enrollment of the chronic cohort and announced that results for the chronic cohort are expected in Q2 2025.

Recently, the company received IRB approval for an amendment focused on the subacute cohort of its Phase 1b/2a clinical trial. Key changes to the protocol were implemented to facilitate enrollment, for example, revising the timing of subacute SCI to 20 to 90 days post-injury, and to decrease the burden on study participants by reducing the number of visits and assessments.

"The efficacy of NVG-291 is being evaluated in two separate cohorts of individuals with cervical spinal cord injury, chronic and subacute, given the demonstrated efficacy in preclinical models of both chronic and acute SCI," said Daniel Mikol, MD, Ph.D., NervGen's Chief Medical Officer. "We are pleased to report that the first subject in the subacute cohort of our Phase 1b/2a clinical trial in traumatic SCI has been enrolled and dosed. We believe that the protocol amendment will enhance enrollment and result in a better overall experience for participants, particularly by reducing burden as individuals enrolled in this cohort are close to the time of their injury and will still be receiving standard of care rehabilitation."

"As we begin the year, our team is on track to report data on the chronic cohort in the second quarter and to advance the enrollment in the subacute cohort throughout 2025," said Mike Kelly, NervGen's President & CEO. "We truly believe that this will be a pivotal year for NervGen and we look forward to further advancing NVG-291 towards our end goal of helping individuals with SCI."

[Continued]
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Re: The NERVGEN-291 miracle!

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Neevgen CEO Mike Kelly is interviewed for the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 11, 2025.

https://wsw.com/webcast/oppenheimer39/ngenf/2991280

Note: If you're prompted to register to listen to the interview, then you don't need to provide real information. I successfully used name@company.com.
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