Interview NervGen Pharma: "We have a drug with the potential to treat Alzheimer's, MS, spinal cord injury and stroke".

All the indications you listed have one thing in common: they involve damage of the central nervous system.

That is a very important point! Our drug, NVG-291, simply turns the nervous system’s natural self-healing mechanisms back on. This leads to dramatic outcomes for many indications. For example, studies with mice that were paralyzed showed that they can move their legs with great dexterity again after treatment with our drug.

The original discovery was made by Dr. Jerry Silver back in the 1990s. Dr Silver is our founding scientist and an important advisor to the company. Specifically, damage to the nervous system, whether due to injury or disease, causes a scar to build around the site of trauma. The primary purpose of the scar is to protect the area from further damage. Unfortunately, the scar tissue contains a molecule that interacts with the nerves and ultimately brings naturally healing to a halt. Our drug essentially modulates that molecule’s activity, allowing healing to naturally happen. One important way that the nervous system heals itself is by increasing plasticity, i.e. growth of new nerve connections. Another process is called remyelination which is the rebuilding of the protective coating around the nerves, which is known as myelin. In studies of animals with stroke, we have even observed stem cells moving into the affected nerve areas, which also has the potential to contribute to healing. In summary, there are many different healing processes that make us very confident that our drug has the ability to help many millions of people with a wide variety of causes of nervous system damage.

Another critical point! I, myself, have spoken to people with a spinal cord injury who have told me that they have long since come to terms with being in a wheelchair and could live well with this condition if only their lost bladder function were restored. Also, in paralyzed people, the diaphragm is often impaired, making breathing difficult, and they may also lose sexual function.

Success restoring any of these other important functions would greatly improve quality of life and could make our drug a blockbuster. In one animal study, at the highest dose levels studied, 100% of the mice had improved bladder control, some partially, some completely. The same is true for Alzheimer's - while we believe our drug may restore memory function, even if we could only repair damage in other areas that effect Alzheimer’s patients, such as motor control or coordination, our drug would be a sensation.

It should be noted that Dr. Jerry Silver is a world renowned, award-winning spinal cord injury and regenerative medicine researcher and Professor of Neurosciences at Case Western Reserve University (CWRU) in Cleveland, Ohio.

His approach is now gaining the respect of the scientific community and has been widely covered in the medical and mainstream media, including the New York Times. But when Dr. Silver made the discovery more than 20 years ago, it was different. He had to swim against the tide for a long time. His discovery challenged a prevailing scientific paradigm.
Only gradually has further research validated his ground-breaking research. The time is ripe for Dr. Silver's discoveries to help people, and we plan to present the first tangible evidence in patients next year.

First of all, I must clarify that our approach is unique compared to other drug development efforts. Many drug development programs are only trying to reduce damage, or slow down progression of a disease which takes a long period of time for the effect to be observed. The approach with our drug, NVG-291, is to allow the central nervous system to repair itself. Repair can happen dramatically and relatively quickly so we expect significant improvement in patients much quicker than if we were trying to slow progression of disease, and possibly as quickly as 3-6 months. Our previous studies in animals have generated remarkable results within weeks of administering our drug. This gives us the ability to produce final read out data in 12-18 months time as opposed to the numerous years that most drugs take.

Our clinical trials will initially focus on Alzheimer's disease, spinal cord injury and multiple sclerosis. Dr. Silver’s work has always focused on spinal cord injury where he has built a tremendous body of data that supports the potential for significant improvements in these patients. We intend to begin our clinical trial on both recently injured and chronically injured patients. Studying a pharmaceutical in patients that have been injured for more than 1 year is rare, but we have remarkable data that suggests that our drug may successfully help restore function even in these patients. We anticipate having results from these trials as early as next year which is really exciting.

There is a solid body of evidence to support the rationale for proceeding with a clinical trial examining efficacy in Alzheimer’s disease patients. We plan to initiate this study by the end of this year. With Alzheimer's disease we also see scarring around the plaques that accumulate in the brain, and believe that these play an important role in inhibiting repair. If that is correct, then the repair mechanisms we have observed with NVG-291 in other models, such as plasticity, regeneration, autophagy and microglial shifting, should play a role in repairing cognitive function in the Alzheimer’s disease patient. Just imagine the large number of people in the prime of their lives who are confronted with this incurable disease every year. To take the horror out of this disease would be a medical breakthrough. At NervGen Pharma, we believe we may have a significant treatment for these patients to help them regain functionality.

We also plan to start a Phase II study in multiple sclerosis in the first half of 2023. By doing this, we are targeting another shocking disease, in addition to spinal cord injury and Alzheimer's disease.

We are extremely proud of our three scientific and clinical advisory boards that are comprised of world leading experts in the fields of Alzheimer’s, spinal cord injury and multiple sclerosis. We asked the top global thought-leaders to join our team and were pleasantly surprised with the response. There was a strong interest by almost everyone we approached. This is important for two reasons; it helps validate that the technology is of interest to the scientific and clinical leaders in the field and ensures that we have the highest-level input possible as we design our clinical trial programs. In addition, our research is known to many experts around the globe especially in the spinal cord injury community, as for years, Dr. Jerry Silver has been a name that stands for both the quality of his research and the hope it gives. While I am confident that the scientific community will continue to understand our potential, we now are focused on ensuring the financial community has the same appreciation.

We now have data to tell our story to the outside world. Our Phase 1 clinical trials have shown that our drug is well-tolerated at a dose level that exceeded the equivalent highest dose used in preclinical efficacy studies. That essentially means we believe we have a drug that we can take to Phase 2 clinical trials, which is a turning point in the eyes of biotech investors. While we believe that this dose can already be effective, we will continue to increase the dose levels in our Phase 1 to give us greater flexibility in dosing as we proceed to patients.

We are currently listed in Canada on the TSX.V, in the US on the OTCQX and in Germany. Later this year, we are also aiming for a listing on Nasdaq. There are many biotech investors who are not yet familiar with our company or may not invest until we are also listed on Nasdaq. Our expectation is that the start of our Phase II trials later this year will help to propel our share price. We believe we have a compound with great potential that is very different from existing drugs. This is true both in terms of the scientific foundation and the anticipated efficacy and desired outcome for patients. As biotech investors are looking to break new ground, especially around Alzheimer's, as well as other diseases and physical traumas that are associated with damage to the central nervous system, I am confident that NervGen will soon enjoy the recognition in the capital markets that it already has within the scientific community.