tootalljones
5 meses hace
It all depends on the strength of the results and the number of patients, and of course, the FDA will have access to the OLE program. If the earthlings have anywhere close to the success of the mice, who were tested and measured in a half dozen preclinical studies (or mice trials), then this could move shockingly fast. And by that I mean 2 years from now. For instance, they have a category called "breakthrough" designation, which can move things up substantially. Personally, I would view the mice as candidates for breakthrough status by the FDA, but then again, they are just mice. If the humans in any way remotely approach the mice data, things could move very fast. There will be a deluge of patient volunteers in this regard as well, and the ramifications would be staggering. Even small improvements would be heralded. And I am betting we get significant or meaningful, functional improvements, a logical position to take based on the preclinicals. I am not expecting patients to regain the sort of lower limb function the mice did, but then again, I am a pessimist, but who knows. It was a wise choice to give the patients stronger doses than were given to the mice. And I just read an informed post on stocktwits, where the poster said, because of the size of the human spinal cord vs. a mouse's, that he thinks that while the drug might be effective very soon in the dozing process, the ultimate benefits (the learning curve), may not peak for 9 or more months....Remember the company says the mice had not reached their ultimate functionality when the preclinical studies were generally stopped. This suggests, if true, that while the current patients are getting almost 3 months of daily shots,.....their progress upward might top out until another 6 months of the drug, or who knows, even longer, ...but this is all just speculation. Plus the ramification of the drug for other central nervous system diseases is incalculable. Time will tell.
tootalljones
5 meses hace
thanks, but with full enrollment in Q3, which we are now just starting, let's say by August 15th, the mid point, that would result in a very nice jolt to the stock price higher in late August, or early to mid Sept. Even getting the last patient enrolled in a trial such as this is big deal. Then the protocol requires 84 continuous daily shots to that last (new) patient, let's call it 3 months for that last one, so we are then at Dec. 15th of this year. I would expect actually 2 PR's, one of the preliminary data, which should be a blockbuster NR sometime in January 2025, with the full data release perhaps 2-3 months later. But the first PR will rock the world.
The stock will be ascending the rest of this year.....in anticipation. The market cap now is miniscule.
They will be analyzing all of the DATA which has already rolled in (I would think) as each patient or couple of patients graduate (actually while the daily dosing is taking place every once in a while), and we have already had quite a few already graduate from the trial regimen, for patients who have been in the trial since September 2023. through Q1 of this year. So I think it won't take long to finish up the data for the last few patients, as they will already have a near full data bank.. Which means we get a PR within 30 days or so of mid to late Dec of this year.
We will also get a PR at some point this year surely of the OLE "trial" being opened for the placebo patients, so they too will get the real drug certainly any time now soon (the first enrollees) and the already graduated patients who got the drug, so I would think this merits a very meaningful PR. They won't make these volunteers wait till the full trial is finished. We also should have something on the the new compound getting started this year (another PR), and remember, putting alzheimers's aside, the worldwide spinal cord market, both subgroups, is massive, a billion dollar annual market, and the MS market, (my quick google search, speaks of it being a 22 billion dollar annual market.....
but here is what has me genuinely excited. Check this clip from Dec 2023. Remember, the drug is supposed to show signs of working in a matter of weeks, per Dr. Silver (I would think within a month to 6 weeks +/....if not days?
But here is the clip that tells me they are getting a signal already from the patients already enrolled, it is her tone of voice which is soaring with enthusiasm, and the words she used. Preliminary for sure, but still....
check it out around the 42 minute mark. '
Also impressed by the people involved in this trial and the quality of management of the company....etc.
https://blinkofaneye.podbean.com/e/194-season-finale-nervegen-with-meghan-morrow/
Grey_Ghost
5 meses hace
Good article overall, but there's one significant omission.
The author quotes the September 25, 2023 PR which states:
Given there are approximately 300,000 people with SCI living in the United States alone, the limited number of clinical trials in this area and the tremendous anticipation for this trial within the SCI community, recruitment for the chronic cohort (1-10 years post injury) is anticipated to happen relatively quickly with results expected by mid-2024.
He goes on to reiterate this timeline in his own narrative, stating, The news release said it expected to provide positive results “next summer.” So if you are looking for a driver for this company’s shares, we may be approaching a significant timeframe now.
However, NervGen's May 16, 2024 operational update offers the following guidance:
Recruitment in our Phase 1b/2a clinical study of NVG-291 for individuals with spinal cord injury (SCI) has gone well, however, it has been slower than originally anticipated during Q2 due to challenges in finding, screening, and onboarding individuals that meet our very specific and rigorous inclusion and exclusion study criteria,” said Mike Kelly, NervGen’s President & CEO. “Given the heterogeneous nature of spinal cord injuries and our efforts, through the novel design of our study, to recruit as homogeneous a SCI population as possible, the current study protocol and our single trial site location have limited the number of subjects that both qualify and can travel to Shirley Ryan AbilityLab in Chicago. While we have undertaken additional initiatives and operational directives that should help us in fully recruiting the study, we believe full enrollment of the chronic cohort is now more likely in Q3 of this year.
So, based on NervGen's own guidance, a readout from 1b/2a will not take place this summer as they have yet to achieve full enrollment. Instead, it seems more likely readout will take place mid-to-late Q4.
Schekin
10 meses hace
https://www.newsfilecorp.com/release/198043/NervGen-Pharma-on-Track-to-Complete-Enrollment-Deliver-Data-Readout-in-Phase-1b2a-Clinical-Trial-for-NVG291-in-Spinal-Cord-Injury?k=
NervGen Pharma on Track to Complete Enrollment, Deliver Data Readout in Phase 1b/2a Clinical Trial for NVG-291 in Spinal Cord Injury
February 15, 2024 8:47 AM EST | Source: NervGen Pharma Corp.
On track to complete enrollment of the chronic cohort in Q2 2024
Data readout from chronic cohort expected in Q3 2024
Planning underway to make NVG-291 available to placebo-treated subjects following cohort completion
Vancouver, British Columbia--(Newsfile Corp. - February 15, 2024) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQX: NGENF), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, today announced that it is on track to complete enrollment in Q2 2024 and deliver the data readout in Q3 2024 of the chronic cohort in the Company's Phase 1b/2a proof-of-concept, double blind, randomized placebo-controlled clinical trial for its proprietary investigational lead compound, NVG-291, in individuals with spinal cord injury (SCI). Preclinical studies of NVG-291 demonstrated functional improvement in both acute and chronic spinal cord injury models of SCI. The Shirley Ryan AbilityLab in Chicago, a global leader in physical medicine and rehabilitation for adults and children with the most severe and complex conditions and a pioneer in the use of objective, quantitative electrophysiological based motor connectivity assessments, is the single center for this clinical study.
Additionally, NervGen is developing plans to initiate a new study in which subjects completing the current trial who received placebo would have the option to receive open-label NVG-291 under a separate protocol. NervGen plans to initiate this open-label study, provided that an efficacy signal is observed in the chronic cohort, when the cohort is unblinded in the third quarter of 2024 and is contingent upon protocol approval by the U.S. Food and Drug Administration (FDA) as well as the study's Institutional Review Board.
"We are pleased with the pace of enrollment and smooth execution of this landmark clinical study in spinal cord injury," said NervGen's Chief Medical Officer, Dan Mikol, MD, PhD. "We believe the results of this study - once the study data are unblinded - will be a key enabling step that may bring us closer to the first approved therapy for spinal cord injury, and we look forward to the prospect of delivering positive results later this year. We are also very excited about our plans to offer open-label NVG-291 to those placebo-treated subjects who committed their time and energy in the current trial."
"Our dedicated team at Shirley Ryan AbilityLab is thrilled to be well underway with this important clinical research trial in individuals with spinal cord injury, and is encouraged by the many inquiries we've received from willing research subjects," stated Monica A. Perez, PT, PhD, Scientific Chair of the Arms + Hands Lab at Shirley Ryan AbilityLab; Professor of Physical Medicine & Rehabilitation at Northwestern University; Research Scientist at the Edward Hines Jr. VA Hospital; and the principal investigator of this trial. "This trial employs a cutting-edge design that incorporates electrophysiology both as part of the inclusion criteria of participants and to monitor motor recovery. A wealth of information about connectivity and function is being collected from each subject throughout the study, and we look forward to analyzing these results in order to fully assess the efficacy of NVG-291."
Those interested in participation in this trial are invited to call 855-559-6902.
About the NVG-291 Phase 1b/2a Trial
The double blind, placebo-controlled proof-of-concept trial (NCT05965700) will evaluate the efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (10-49 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI imaging measures and blood biomarkers that together will provide comprehensive information about the extent of recovery of function, with a focus on improvements in motor function. Specifically, the primary objective is to assess the change in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment based on changes in motor evoked potential amplitudes. Secondary objectives are to evaluate changes in a number of clinical outcome assessments focusing on motor function, upper extremity dexterity and grasping and mobility, as well as changes in additional electrophysiological measurements. Each cohort will be evaluated independently as the data becomes available. The trial is being partially funded by a grant from Wings for Life, which is being provided in several milestone-based payments that will offset a portion of the direct costs of this clinical trial.
About Shirley Ryan AbilityLab
Shirley Ryan AbilityLab, formerly the Rehabilitation Institute of Chicago (RIC), is the global leader in physical medicine and rehabilitation for adults and children with the most severe, complex conditions - from traumatic brain and spinal cord injury to stroke, amputation and cancer-related impairment. The organization expands and accelerates leadership in the field that began at RIC in 1953. The quality of its care has led to the designation of "No. 1 Rehabilitation Hospital in America" by U.S. News & World Report every year since 1991. Upon opening in 2017, the $550 million, 1.2-million-square-foot Shirley Ryan AbilityLab became the first-ever "translational" research hospital in which clinicians, scientists, innovators and technologists work together in the same space, surrounding patients, discovering new approaches and applying (or "translating") research real time. This unique model enables patients to have 24/7 access to the brightest minds, the latest research and the best opportunity for recovery. Shirley Ryan AbilityLab is a 501 (c)(3) non-profit organization. For more information, go to www.sralab.org.
About Wings for Life Accelerated Translational Program
Even with very promising discoveries, the translation from scientific discovery to applied therapeutics is a long and difficult road due to regulatory burdens, complexities of clinical trial design, patient recruitment and retention barriers, and the high cost of cutting-edge research. The Wings for Life Accelerated Translational Program (ATP) has been specifically designed to be able to accommodate obstacles to efficient clinical translation.
The ATP strives to assist applicants to find the best way forward in clinical translation of high caliber, promising therapies. The ATP is supported by a network of clinicians, scientists, and other professionals with expertise in all aspects of clinical trials. Select members of the ATP Support Network will be called upon, as required, to assist in ensuring that treatments with auspicious potential are translated in the most scientifically rigorous and efficient way possible.
About NVG-291
NervGen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic peptide targeting mechanisms that interfere with nervous system repair. NVG-291 is derived from the intracellular wedge domain of the receptor type protein tyrosine phosphatase sigma (PTPs). NVG-291-R, a rodent analog of NVG-291, has been shown to promote nervous system repair and functional recovery in animal models of spinal cord injury (acute and chronic intervention), peripheral nerve injury, multiple sclerosis and stroke, through enhanced plasticity, axonal regeneration, and remyelination. NVG-291 has received Fast Track Designation from the FDA.
About NervGen
NervGen (TSXV: NGEN) (OTCQX: NGENF) is a clinical stage biotech company dedicated to developing innovative treatments that enable the nervous system to repair itself following damage, whether due to injury or disease. NervGen's lead drug candidate, NVG-291, is being evaluated in a Phase 1b/2a clinical trial. The Company's initial target indication is spinal cord injury. For more information, go to www.nervgen.com and follow NervGen on Twitter, LinkedIn, and Facebook for the latest news on the Company.
Contacts
Huitt Tracey, Corporate Communications
htracey@nervgen.com
604.537.2094
Bill Adams, Chief Financial Officer
info@nervgen.com
778.731.1711
Schekin
10 meses hace
Is this stunning "evidence" that NervGen has the goods?
https://stockhouse.com/opinion/contributors/2024/02/01/is-this-stunning-evidence-that-nervgen-has-goods
This could be the signal that tiny NervGen Pharma Corp. (TSX-V: NGEN; OTCQX: NGENF) is destined to be one of the top performing biotech startup stocks this year.
It came in a seemingly innocuous podcast interview about the company’s ongoing Phase 1b/2a “proof of concept” human trials. In online investment chat groups, they’re saying that the podcast offered up a bombshell revelation – that extraordinary therapeutic improvements are apparently being achieved by paralyzed trial volunteers.
Simply stated, at least a couple of trial participants may apparently be regaining the use of their limbs – albeit incrementally.
This sneak peek inside this randomized double-blind, placebo-controlled trial has major implications.
Something quite remarkable appears to be happening at Chicago’s Shirley Ryan AbilityLab – a global leader in physical rehabilitation for patients with severe nerve damage. This is where at least one of the initial trial patients – mindful that there are only a handful of trial volunteers in total so far – is apparently regaining some function of his extremities, even though he suffers from chronic spinal paralysis.
This stunning revelation was shared by a globally-renowned podcaster called Louise Phipps Senft, who runs a non-profit advocacy/support organization for spinal cord injury victims called Blink of An Eye, which is based in Baltimore. She said in a December 20th podcast(minutes 42.10-42.41) that one of NervGen’s trial volunteers — who enrolled with the support of her organization – began to experience noticeable improvements after only a few once-a-day injections.
This volunteer has been administered NervGen’s experimental peptide called NVG-291 as part of a 12-week trial program that officially got underway late last year. It’s the first of its kind for humans. And that’s why the trial is being so closely watched by the medical community and investors alike.
Any suggestion that trial volunteers are getting remarkable results within weeks, rather than months, would not come a surprise to NervGen’s scientists. In the past, they have successfully used NVG-291 in numerous preclinical trials to achieve substantial and unprecedented recovery of functionality of laboratory rodents that had sustained severe spinal cord damage.
They also proved that NVG-291 is not toxic to these animals, even in high doses. This is one of the official reasons why this drug candidate has recently been fast-tracked by the FDA in human trials. Unofficially, it might be because FDA medical scientists have become aware that NVG-291 appears to be working already. Either way, this fast-tracking by the regulators represents another key signal to investors that the company’s share price may be getting primed for a sustained rally in 2024.
“Proof of Concept” Trial: Where there is smoke, is there fire?
Admittedly, it’s a big leap to hope for comparable results in humans to laboratory animals. But this seems to be what’s happening already with at least one of the trial’s first patients. This is mindful of the fact that he doesn’t know whether he’s being injected with the trial drug candidate or a placebo.
Importantly, these volunteers have a “chronic” injury that is between one and 5 years old. Apparently, there are no records of humans having significant recovery beyond 12-18 months post-injury. It would be almost miraculous if a patient getting the placebo experienced any noticeable improvement.
However, if a patient becomes able to move his digits during the trial, this represents a huge breakthrough for NervGen.
Consider the fact that the trial’s researchers set out with far more modest aspirations, which was to use electrical stimuli to detect subtle improvements in muscle functionality and limb mobility. Even the tiniest of improvements in that regard would be considered something of a success. But if patients can exhibit observable movement in response to the treatment, that’s by far a best-case scenario – one that appears to be playing out.
For anyone interested in the technical explanation of how trial results are measured, here it is: The primary endpoint is to show improvement of the body’s “electrophysiology”, or natural electrical impulses, according to NervGen’s trial scientists.
Functional improvements are secondary (even more desirable) endpoints. So if a volunteer is experiencing improved functionality, this means that the primary endpoint of increased electrical impulses has been successfully achieved, pointing to a successful trial.
Of course, no official comment can be expected from NervGen or from Shirley Ryan AbilityLab until much later this year after all the trial data readouts have been fully assessed. So the countdown has started to a pending trial outcome announcement that will surely have a major impact on NervGen’s share price. As of now, NervGen may then be just a few months away from a serious stock re-rating.
Here’s Why NVG-291 has “Blockbuster” Drug Potential
In terms of the Big Picture, NervGen believes that NVG-291 has the potential to be a revolutionary “blockbuster” treatment for all kinds of nerve and neuron damage, not just spinal cord injuries. This is mindful of the fact that no drugs have ever before been approved anywhere in the world for nerve regeneration and for improving plasticity in damaged nerves.
NervGen is also hoping to treat other conditions like MS and stroke, thanks to an extraordinarily strong collection of animal data. This means that NVG-291 might also be able to treat conditions as devastating to society as Alzheimer’s disease — an affliction involving 6 million Americans, which costs the US $350 billion a year to manage.
NervGen should complete the Phase 1b/2a trial later this year, which includes a post-trial evaluation. The trial will involve 20 people, who each receive a once-a-day injection for 12 weeks. Half receive the drug candidate and the other half receive a placebo.
It’s statistically significant that more than just the one trial volunteer is making what is being referred to as exciting progress by Meghan Morrow, who is the project manager for NervGen’s trial.
This was Morrow’s assessment when she was being interviewed last December on Louise Phipps Senft’s podcast about NervGen. And even though Morrow is professionally obliged to keep her cards close to her chest about the trial’s progress, she did offer the following tantalizing insight as to its possible outcome.
“It is a double-blind trial. So no one knows anything, except the pharmacist…But I will say that obviously there is speculation when we see individuals making gains. And then we get really excited…”
Key Investment Takeaways
A few savvy investors were quick to digest the implications of this podcast’s revelations, and the share price shot up accordingly on heavy volume soon after it aired. But now the stock is settling down again on normal volume, forming a new, higher price base ahead of its next anticipated up-leg. Whether that happens before or after the announcement of Phase 1b/2a trial results remains to be seen.
For now, NervGen continues to remain under the radar for most investors due to the company’s low-key public profile. The stock is accordingly still undervalued considering how far NervGen has come in validating the efficacy of NVG-291. And the prospect of continued success in human trials would surely send the company’s share price surging to new multiples.
It’s also worth remembering that the US federal government is encouraging NervGen’s progress too with its recent awarding of a Fast Track designation for trials. But this may not be such a surprise development to NVG-291’s co-inventor, Dr. Jerry Silver. He was quoted on a different podcast in late November, 2023 as saying that he expects human trial volunteers to respond as quickly to treatment as the animals did, which produced remarkable results within just a few weeks.
Click to enlarge
Dr. Jerry Silver, co-inventor of NVG-291. Image credit: NervGen
“Now when we give the peptide or the enzyme, those connections that are smothered wake up very rapidly. Do you remember when you asked me how long it would take for people to get better? And I said it would happen very quickly within weeks. That’s what we’ve seen,” Dr. Silver said.
The following few months promise to be last chance for investors to see NervGen remain undervalued and largely overlooked by most risk-tolerant investors. But if paralyzed trial volunteers keep improving, the announcement of such stunning results later this year would surely thrust NervGen in the investment limelight – setting the stage for a remarkable performance.
Disclosure:
The author of this article or members of his household or family, do not own shares in NervGen at this time. However, he may from time to time buy or sell shares in companies that are profiled in his various investment articles. Additionally, he is not compensated by the company directly or indirectly. His commentary is therefore based solely on his personal research and understanding of the life sciences sector. It is not intended as investment advice.
The material provided in this article is for information only and should not be treated as investment advice. For full disclaimer information, please click here.
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Schekin
10 meses hace
https://nervgen.com/nervgen-pharma-reports-q3-2023-financial-results-and-operational-updates/
NervGen Pharma Reports Q3 2023 Financial Results And Operational Updates
Phase 1a/2b clinical trial of NVG-291 underway with dosing of individuals with spinal cord injury; results from chronic cohort expected in mid-2024
Fast Track designation granted by U.S. Food and Drug Administration (FDA) for NVG-291 in spinal cord injury
Seasoned financial industry executive, John Ruffolo, appointed to Board
Vancouver, Canada. November 9, 2023 – NervGen Pharma Corp. (TSX-V: NGEN; OTCQX: NGENF) (“NervGen” or the “Company”), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, today reported its financial and operational results for the third quarter ended September 30, 2023.
“We’ve made great progress recently starting with the dosing of subjects in our landmark Phase 1a/2b clinical study of NVG-291 for individuals with spinal cord injury, followed by receiving Fast Track designation from the FDA for NVG-291 in spinal cord injury,” said Mike Kelly, NervGen’s President & CEO. “Additionally, we are very fortunate to have John Ruffolo join our Board. John brings substantial expertise in the finance and capital arena along with his personal experience and passion to advance therapies in spinal cord injury and we look forward to benefiting from his substantial expertise.”
“The FDA’s decision to grant Fast Track designation for NVG-291 is a big step forward for our development program and it underscores the significance and severity of the unmet medical need that exists for individuals living with spinal cord injury and their caregivers,” continued Mr. Kelly. “Our clinical trial is an important proof-of-concept study aimed at demonstrating the potential NVG-291 may have in enabling repair of nervous system damage in individuals with spinal cord injury, which has never been achieved before.”
Operational Highlights for Q3 2023
We advanced the clinical development of NVG-291.
In August, we received Institutional Review Board approval of our landmark Phase 1b/2a proof-of-concept clinical trial of NVG-291, in individuals with spinal cord injury (SCI) and in September we announced that the first subject was dosed in this trial.
Subsequent to the quarter-end, we announced that the FDA has granted Fast Track designation for NVG-291 in individuals with spinal cord injury. FDA’s Fast Track program is designed to facilitate the development of drugs intended to treat serious conditions and fill unmet medical needs as part of the FDA’s goal to get important new drugs to patients earlier. Fast Track designation also provides eligibility for both Priority Review, which can shorten the New Drug Application review process, and for Accelerated Approval, which can allow for an earlier or faster approval based on a surrogate or intermediate clinical endpoint.
We expanded the expertise of our Board with the following addition.
Subsequent to the quarter-end, we announced the appointment of John Ruffolo, Founder and Managing Partner of Maverix Private Equity, to the Company’s Board of Directors. Mr. Ruffolo previously founded OMERS Ventures, the venture capital arm of the large Ontario pension fund, and championed Canada’s technology industry as a co-founder of the Council of Canadian Innovators. Mr. Ruffolo brings substantial expertise in finance and developing leading-edge technologies to our Board, and he also brings the very unfortunate experience of surviving a tragic accident, which resulted in severe injuries including a spinal cord injury.
We improved our cash position with equity proceeds and grant funding to support our ongoing clinical and preclinical activities.
During the nine months ended September 30, 2023, we received $767,211 from the exercise of stock options and Common Share Purchase Warrants.
On June 27, 2023, we announced that we had been awarded a grant of up to US$3.18 million from Wings for Life, a not-for-profit spinal cord injury research foundation, under the foundation’s Accelerated Translational Program. The funding is being provided in several milestone-based payments and will offset a portion of the direct costs of our Phase 1b/2a proof-of-concept clinical trial for NVG-291. As at September 30, 2023, we have achieved three of the five milestones in the grant, and received US$1.92 million.
Financial Highlights
Cash and Investments: NervGen had cash and investments of $14.8 million as of September 30, 2023, compared to $22.5 million as of December 31, 2022. The net cash burn for Q3 2023 from operating and investing activities was approximately $1.6 million. This was offset by approximately $0.1 million in proceeds from the exercise of options and warrants during the quarter.
R&D Expenses: Research and development expenses net of grant funding received were $0.8 million for the three months ended September 30, 2023, compared to $3.2 million in the same period in 2022. The decrease in Q3 2023 was primarily due to the receipt of grant funding from Wings for Life which offset the startup costs for our Phase 1b/2a proof-of-concept clinical trial, chemistry, manufacturing and control work pertaining to the manufacture of NVG-291 required for chronic toxicology studies and clinical trials conducted in the previous period, as well as a decrease in clinical and regulatory costs as we completed our Phase 1 clinical study.
G&A Expenses: General and administrative expenses were $2.6 million for the three months ended September 30, 2023, compared to $1.7 million for the same period in 2022. The increase in Q3 2023 was primarily due to non-cash stock-based compensation expense related to option and retention security grants to our new President & CEO, other employees and consultants, and the timing of the related vesting, partially offset by a decrease in employee salaries related to severance payments to our previous President & CEO in the prior period.
Net Loss: For the three months ended September 30, 2023, net loss, which included $2.8 million of non-cash expenses, was $4.3 million, or $0.07 per basic and diluted common share. For the three months ended September 30, 2022, net loss, which included $1.2 million of non-cash expenses, was $3.5 million, or $0.06 per basic and diluted common share.
About NVG-291
NervGen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic peptide targeting mechanisms that interfere with nervous system repair. NVG-291 is derived from the intracellular wedge domain of the receptor type protein tyrosine phosphatase sigma (PTPs). NVG-291-R, a rodent analog of NVG-291, has been shown to promote nervous system repair and functional recovery in preclinical models of spinal cord injury (acute and chronic intervention), peripheral nerve injury, multiple sclerosis and stroke, through enhanced plasticity, axonal regeneration, and remyelination. NervGen has initiated a Phase 1b/2a placebo-controlled proof-of-concept trial (NCT05965700) to evaluate the efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (10-49 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. Initial results for the chronic cohort are expected in mid-2024.
About NervGen
NervGen (TSX-V: NGEN, OTCQX: NGENF) is a clinical stage biotech company dedicated to developing innovative treatments that enable the nervous system to repair itself following damage, whether due to injury or disease. NervGen’s lead drug candidate, NVG-291, is to be evaluated in a Phase 1b/2a clinical trial. The Company’s initial target indication is spinal cord injury. For more information, go to www.nervgen.com and follow NervGen on Twitter, LinkedIn, and Facebook for the latest news on the Company.
Contacts
Huitt Tracey, Corporate Communications
htracey@nervgen.com
604.537.2094
Nancy Thompson, Vorticom Public Relations
nancyt@vorticom.com
212.532.2208
Schekin
10 meses hace
https://nervgen.com/nervgen-pharma-receives-fast-track-designation-for-nvg-291-for-the-treatment-of-individuals-with-spinal-cord-injury/
NervGen Pharma Receives Fast Track Designation For NVG-291 For The Treatment Of Individuals With Spinal Cord Injury
– Designation Facilitates and Expedites Development of Drugs for Patients with Serious Unmet Medical Needs
– Enrollment Progressing in NVG-291 Phase 1b/2a Clinical Trial, with Initial Cohort Data Expected in Mid-2024
Vancouver, Canada, October 23, 2023 – NervGen Pharma Corp. (TSX-V: NGEN; OTCQX: NGENF), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI). FDA’s Fast Track program is designed to facilitate the development of drugs intended to treat serious conditions and fill unmet medical needs as part of the FDA’s goal to get important new drugs to patients earlier. Fast Track also provides eligibility for both Priority Review, which can shorten the New Drug Development (NDA) review process, and for Accelerated Approval, which can allow for an earlier or faster approval based on a surrogate or intermediate clinical endpoint.
“The FDA’s decision to grant Fast Track designation for NVG-291 underscores the significance and severity of the unmet medical need that exists for individuals living with spinal cord injury and their caregivers,” said Mike Kelly, NervGen’s President & CEO. “We believe that NVG-291 has the potential to be the first approved treatment indicated to enable neurological/functional recovery following spinal cord injury, and we look forward to working closely with the FDA in the clinical development process with the goal of obtaining approval to market NVG-291 as soon as possible.”
About Fast Track Designation
Fast Track designation is intended to facilitate development and expedite review of drugs to treat serious or life-threatening conditions so that a product can reach the market expeditiously. A drug that is intended to treat a serious or life-threatening condition that demonstrates the potential to address an unmet medical need may qualify for Fast Track designation. Features of this designation include opportunities for frequent interactions with the review team. These include meetings with the FDA to discuss items such as study design, extent of safety data required to support approval, dose-response concerns, accelerated approval, the structure and content of an NDA, and other critical issues. In addition, such a product could be eligible for priority review if supported by clinical data at the time of NDA.
About NVG-291
NervGen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic peptide targeting mechanisms that interfere with nervous system repair. NVG-291 is derived from the intracellular wedge domain of the receptor type protein tyrosine phosphatase sigma (PTPs). NVG-291-R, a rodent analog of NVG-291, has been shown to promote nervous system repair and functional recovery in animal models of spinal cord injury (acute and chronic intervention), peripheral nerve injury, multiple sclerosis and stroke, through enhanced plasticity, axonal regeneration, and remyelination. NervGen has initiated a Phase 1b/2a placebo-controlled proof-of-concept trial (NCT05965700) to evaluate the efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (10-49 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. Initial results are expected in mid-2024.
About NervGen
NervGen (TSX-V: NGEN, OTCQX: NGENF) is a clinical stage biotech company dedicated to developing innovative treatments that enable the nervous system to repair itself following damage, whether due to injury or disease. NervGen’s lead drug candidate, NVG-291, is being evaluated in a Phase 1b/2a clinical trial. The Company’s initial target indication is spinal cord injury. For more information, go to www.nervgen.com and follow NervGen on Twitter, LinkedIn, and Facebook for the latest news on the Company.
Schekin
10 meses hace
https://nervgen.com/nervgen-pharma-announces-first-subject-dosed-in-landmark-phase-1b-2a-clinical-trial-for-nvg-291-in-spinal-cord-injury/
Chronic spinal cord injury cohort results expected in mid-2024
Subacute spinal cord injury cohort results expected in late 2024/early 2025
Vancouver, Canada, September 25, 2023 – NervGen Pharma Corp. (TSX-V: NGEN; OTCQX: NGENF), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, today announced the first subject has been dosed in the Company’s landmark Phase 1b/2a proof-of-concept placebo-controlled clinical trial for its proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI).
“This is a significant milestone for NervGen and also an exciting day for individuals with spinal cord injury as we progress this first-in-kind product candidate into clinical studies,” said Mike Kelly, NervGen’s President & CEO. “This unique trial design will allow us to evaluate NVG-291’s efficacy independently for each cohort of subjects – subacute and chronic. We believe the results of this research study will be a key enabling step that may bring us closer to the first approved therapy for spinal cord injury, and we look forward to the prospect of delivering positive results next summer.”
Given there are approximately 300,000 people with SCI living in the United States alone, the limited number of clinical trials in this area and the tremendous anticipation for this trial within the SCI community, recruitment for the chronic cohort (1-10 years post injury) is anticipated to happen relatively quickly with results expected by mid-2024. Results from the subacute cohort (10-49 days post-injury) are expected in late 2024/early 2025. The trial is being conducted at Shirley Ryan AbilityLab in Chicago, a global leader in physical medicine and rehabilitation for adults and children with the most severe and complex conditions.
“Our team at Shirley Ryan AbilityLab is excited to have begun investigational treatment in this important clinical research trial in individuals with spinal cord injury,” stated Monica A. Perez, PT, PhD, Scientific Chair of the Arms + Hands Lab at Shirley Ryan AbilityLab; Professor of Physical Medicine & Rehabilitation at Northwestern University; Research Scientist at the Edward Hines Jr. VA Hospital; and the principal investigator of this trial. “We look forward to fully recruiting this study and executing upon this innovative trial, which has the potential to change how we design and implement SCI clinical studies in the future.”
About the NVG-291 Phase 1b/2a Trial
The placebo-controlled proof-of-concept trial (NCT05965700) will evaluate the efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (10-49 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI imaging measures and blood biomarkers that together will provide comprehensive information about the extent of recovery of function, with a focus on improvements in motor function. Specifically, the primary objective is to assess the change in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment based on changes in motor evoked potential amplitudes. Secondary objectives are to evaluate changes in a number of clinical outcome assessments focusing on motor function, upper extremity dexterity and grasping and mobility, as well as changes in additional electrophysiological measurements. Each cohort will be evaluated independently as the data becomes available. The trial is being partially funded by a grant from Wings for Life, which is to be provided in several milestone-based payments and will offset a portion of the direct costs of this clinical trial.
About Shirley Ryan AbilityLab
Shirley Ryan AbilityLab, formerly the Rehabilitation Institute of Chicago (RIC), is the global leader in physical medicine and rehabilitation for adults and children with the most severe, complex conditions – from traumatic brain and spinal cord injury to stroke, amputation and cancer-related impairment. The organization expands and accelerates leadership in the field that began at RIC in 1953. The quality of its care has led to the designation of “No. 1 Rehabilitation Hospital in America” by U.S. News & World Report every year since 1991. Upon opening in 2017, the $550 million, 1.2-million-square-foot Shirley Ryan AbilityLab became the first-ever “translational” research hospital in which clinicians, scientists, innovators and technologists work together in the same space, surrounding patients, discovering new approaches and applying (or “translating”) research real time. This unique model enables patients to have 24/7 access to the brightest minds, the latest research and the best opportunity for recovery. Shirley Ryan AbilityLab is a 501 (c)(3) non-profit organization. For more information, go to www.sralab.org.
About Wings for Life Accelerated Translational Program
Even with very promising discoveries, the translation from scientific discovery to applied therapeutics is a long and difficult road due to regulatory burdens, complexities of clinical trial design, patient recruitment and retention barriers, and the high cost of cutting-edge research. The Wings for Life Accelerated Translational Program (ATP) has been specifically designed to be able to accommodate obstacles to efficient clinical translation.
The ATP strives to assist applicants to find the best way forward in clinical translation of high caliber, promising therapies. The ATP is supported by a network of clinicians, scientists, and other professionals with expertise in all aspects of clinical trials. Select members of the ATP Support Network will be called upon, as required, to assist in ensuring that treatments with auspicious potential are translated in the most scientifically rigorous and efficient way possible.
About NVG-291
NervGen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic peptide targeting mechanisms that interfere with nervous system repair. NVG-291 is derived from the intracellular wedge domain of the receptor type protein tyrosine phosphatase sigma (PTPs). NVG-291-R, a rodent analog of NVG-291, has been shown to promote nervous system repair and functional recovery in animal models of spinal cord injury (acute and chronic intervention), peripheral nerve injury, multiple sclerosis and stroke, through enhanced plasticity, axonal regeneration, and remyelination.
About NervGen
NervGen (TSX-V: NGEN, OTCQX: NGENF) is a clinical stage biotech company dedicated to developing innovative treatments that enable the nervous system to repair itself following damage, whether due to injury or disease. NervGen’s lead drug candidate, NVG-291, is being evaluated in a Phase 1b/2a clinical trial. The Company’s initial target indication is spinal cord injury. For more information, go to www.nervgen.com and follow NervGen on Twitter, LinkedIn, and Facebook for the latest news on the Company.
Contacts
Huitt Tracey, Corporate Communications
htracey@nervgen.com
604.537.2094
Nancy Thompson, Vorticom Public Relations
nancyt@vorticom.com
212.532.2208
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Cautionary Note Regarding Forward-Looking Statements
This news release may contain “forward-looking information” and “forward-looking statements” within the meaning of applicable Canadian and United States securities legislation. Such forward-looking statements and information herein include, but are not limited to, the Company’s current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, or any other future events or developments constitute forward-looking statements, and the words “may”, “will”, “would”, “should”, “could”, “expect”, “plan”, “intend”, “trend”, “indication”, “anticipate”, “believe”, “estimate”, “predict”, “likely” or “potential”, or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements include, without limitation, statements relating to: the objectives, timing, rate of subject recruitment and study design of the clinical development of NVG-291 including the planned single site Phase 1b/2a clinical trial in SCI with Shirley Ryan AbilityLab; our belief that the results of the Phase 1b/2a clinical trial will enable us to evaluate NVG-291’s efficacy independently for each cohort of subjects and advance our clinical pathway to approval; the innovative aspect of the trial having the potential to change the design of SCI clinical trials in the future; the receipt of the milestone-based grant payments and the potential assistance from ATP; the belief that targeting mechanisms that interfere with nervous system repair is a promising target for reducing the clinical effects of nervous system damage through multiple mechanisms; and the creation of innovative treatments of nervous system damage due to trauma or disease.
Forward-looking statements are based on estimates and assumptions made by the Company in light of management’s experience and perception of historical trends, current conditions and expected future developments, as well as other factors that we believe are appropriate and reasonable in the circumstances. In making forward-looking statements, the Company has relied on various assumptions, including, but not limited to: the Company’s ability to manage the effects of the COVID-19 pandemic; the accuracy of the Company’s financial projections; the Company obtaining positive results in its clinical and other trials; the Company obtaining necessary regulatory approvals; and general business, market and economic conditions.
Many factors could cause our actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements, including without limitation, a lack of revenue, insufficient funding, the impact of the COVID-19 pandemic, reliance upon key personnel, the uncertainty of the clinical development process, competition, and other factors set forth in the “Risk Factors” section of the Company’s Annual Information Form, Short Form Base Shelf Prospectus, financial statements and Management Discussion and Analysis which can be found on SEDARplus.ca. All clinical development plans are subject to additional funding.
Readers should not place undue reliance on forward-looking statements made in this news release. Furthermore, unless otherwise stated, the forward-looking statements contained in this news release are made as of the date of this news release, and we have no intention and undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement.
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