Mitochondrial medicine probably isn’t the last thing your family talked about over dinner, but it may be the key to dealing with some very difficult medical conditions. NeuroVive Pharmaceutical AB (OTCQX: NEVPF) is a niche biotech company that is working on novel solutions to serious medical conditions.
No one wants to be the victim of a traumatic brain injury (TBI). Not only is the initial TBI likely to cause ongoing problems, but the secondary effects of TBI can be devastating. None of this is pleasant to think about, especially because there is so little that modern medicine can do to help TBI victims recover.
NeuroSTAT is NeuroVive’s most advanced project. It is a potential preventative medicine for secondary injury in TBI victims, and it showed favorable properties in a phase II clinical study that investigated how the drug interacts with actual human victims of TBI.
NeuroVive is Working on Solutions
According to Dixie Fremont-Smith Coskie (http://nnw.fm/o8Fpx), the mother of a TBI survivor,
“…the reality is — unless you have experienced the loss, the heartache, and the ripple effects that brain injury can inflict — you cannot possibly understand the magnitude and the seriousness of the life-altering implications. The long-term impact that TBI imposes on the injured person, family members, and friends is unthinkable. The nightmare of TBI relives itself day after day, month after month, and year after year.”
We tend to focus on positive things in life, which is healthy. Unfortunately, some people have to deal with tremendous hardship because of terrible things that happen to innocent loved ones. When Fremont-Smith Coskie’s 13-year-old son, Paul, was hit by a car while riding a bike, she became one of those people.
Paul is a victim of TBI. Life, as they had known it at the Fremont-Smith Coskie home, ended in that moment. It is very easy to get lost in the numbers and forget that every statistic is a story. Some are easier to handle than others, and some will feel like your heart is being torn in two.
TBI is a Social Issue
Remember, sometimes numbers are people. There are some 50 million new cases of TBI reported every year. Not every case of TBI will be as severe as Paul’s, but the solutions that NeuroVive is working on are aimed at moderate to severe TBI, just like the one that Paul suffered.
“In the early stages of Paul’s injury, he was immobile and essentially in a vegetative state. We suddenly had to become his eyes, his ears, his voice. We needed to advocate for his every need,” says Fremont-Smith Coskie.
One of the biggest problems with TBI, besides the tremendous personal suffering of the victim and their loved ones, is the cost associated with caring for its long-lived effects.
Some estimates put the cost of care for TBI victims at more than $400 billion per year. TBI is not a one-time event. Instead, it takes hold of the life of its victims and ensures that the moment of impact will linger on for a lifetime.
The Long Road to Traditional TBI Recovery
It is difficult to estimate how much pain and suffering NeuroSTAT could eliminate. Of course, there would be massive cost savings to the health care system, but it could also save families like Paul’s from untold suffering.
As it stands today, recovery from TBI is a long, arduous and expensive process.
In some ways Paul’s family was lucky. They had access to a rehabilitation clinic that was only 20 minutes away by car. Although this isn’t a long distance, the family had to help Paul to access vital care for years, after they were able to nurse him through the initial vegetative state.
Paul’s mother isn’t a doctor, but she has direct experience with how TBI victims recover. She says, “A person’s outcome depends on the specific circumstances and severity of the injury, immediate and long-term medical care, rehabilitation services, and the individual patient and family. We also learned that many people with TBI plateau relatively soon after their injury, without making huge gains.”
There isn’t much information about TBI in the media. It isn’t a pleasant subject, and it certainly isn’t going to become clickbait anytime soon. TBI is painful, expensive and can seem hopeless. That is why NeuroSTAT is such an important project.
A Different World with NeuroSTAT
The NeuroSTAT program is developing a way to use cyclosporin (CsA) to keep mitochondria alive after a person sustains a TBI. Mitochondria are the power-plant of our bodies, so it should come as no surprise that when they die, we have big problems.
NeuroSTAT has been shown to help protect the brain in 20 independent, experimental studies, and it demonstrated that it can make a difference for TBI victims in a phase II study. While the research into how much NeuroSTAT can help is ongoing, the need for further advancements into mitochondrial medicine is clear.
In a way, TBI is a double blow to its victims. First, the impact that causes TBI does severe damage to the brain, but the secondary effects from the brain damage can be just as grievous, if not more so.
There is little that can be done to eliminate the initial impact that causes TBI from a medical point of view. Once the patient is in the hospital, the initial TBI has occurred.
NeuroSTAT enters the picture as soon as doctors know that they are dealing with a moderate to severe TBI and that mitochondrial death could be happening.
The goal of NeuroSTAT is to eliminate mitochondrial death to the greatest degree possible. The patient will still have to deal with the initial TBI, but NeuroVive hopes that its efforts will result in much lower recovery times, and far less overall damage from a TBI.
New Paths to Faster Recovery
It is impossible to know with absolute certainty whether or not NeuroSTAT would’ve helped Paul and his family. What we can be sure of is that cyclosporin does have a positive effect in the wake of TBI and that it warrants further development.
While TBI is a terrible thing, people can recover from it. After 10 years, Paul’s condition has improved tremendously, but it took an almost superhuman effort on the part of everyone involved, including the rehabilitation staff.
As Paul’s mother put it:
“Over time, my husband and I and our other seven children began to realize two things: the person we once knew might never be returned to us, and recovery would be lifelong. Because all of our lives had been put on hold for so long while we coped with such staggering changes, we started to nurture all of our family relationships.”
At the time she wrote that Paul was able to walk and talk again, and was even looking for a job. It is tremendous to see such strength in the face of unimaginable adversity, and it shows how brave people can be.
NeuroVive is working to help families like Paul’s so that, in the future, recovery times from TBI can be faster.
Keeping the mitochondria in the brain alive in the aftermath of TBI could also help people maintain a higher level of functionality, but it would be irresponsible to make any sort of definitive statements about specific medical outcomes.
NeuroVive Makes Progress on Tough Problems
NeuroVive has been around since the year 2000 and is working on some of the most challenging problems facing modern medicine.
The company focuses on how to best use mitochondrial medicine to address serious health care problems. So far, NeuroVive has developed NeuroSTAT, as well as a possible treatment for genetic mitochondrial diseases, called KL1333.
NeuroSTAT is further along than KL1333, though both are being used in trials on humans. KL1333 recently entered the second part of its ongoing clinical study, which is examining its safety profile, as well as the metabolic changes of KL1333 in healthy humans.
The Science Behind NeuroSTAT
NeuroSTAT has been the subject of 20 interdependent, experimental studies so far. One of those studies was a randomized, placebo-controlled, dose-escalation study of treatment with cyclosporin for patients with severe TBI.
Clearly, this is not a perfect situation for the patients.
The study included 40 patients in four dose cohorts who were treated within eight hours of their injuries. The study showed a dose-related improvement in favorable outcomes in the CsA-group at six months, which is hugely encouraging for the program.
Another randomized, placebo-controlled prospective study with 50 patients treated the patients within 12 hours of their injuries. It found microdialysis and cerebral hemodynamics with potential beneficial changes found following CsA administration. A safety and tolerability study also concluded that CsA is safe in TBI.
NeuroSTAT has been given Fast Track designation by the FDA and is also classified as an orphan drug in both the U.S. and EU. The Orphan Drug Designation (ODD) was created for drugs that address rare conditions, though, with 50 million new victims of TBI every year, the market for NeuroSTAT may be substantial.
Potential in Cellular Power
Mitochondria are like little power plants that give our cells the energy they need to survive. The mitochondrial die-off post-TBI is one example of how important mitochondria are for our health, but there are many others.
The study of mitochondria is leading to new breakthroughs in medical science, and NeuroVive isn’t alone in looking for new ways to treat diseases at an intra-cellular level. The Lewis Katz School of Medicine at Temple University (LKSOM) is looking into how mitochondria could play a role in how Alzheimer’s disease manifests in the body.
According to a recent study from LKSOM:
“Amyloid-beta deposition and tau pathology are considered the major contributors to Alzheimer’s disease and, as a result, they have been the main focus of therapeutic development.”
John W. Elrod, Ph.D., associate professor in the Center for Translational Medicine at LKSOM, went on to explain that, “Large clinical trials targeting these pathways have universally failed, however.”
Elrod added, “But up to now, no one has investigated the impact of altered calcium transport into and out of the mitochondria on the progression of Alzheimer’s disease… Our current study provides a missing link between these two hypotheses of Alzheimer’s pathogenesis.”
The importance of mitochondrial medicine is likely just starting to be understood. There have also been links drawn between the functioning of mitochondria, and the onset of Type 2 diabetes.
NeuroVive isn’t addressing any of these diseases directly, but, like many things in science, the value of specific research may only be understood as time goes on and minds come together for the public good.
For the moment, NeuroVive is advancing a drug that may have been able to help people like Dixie Fremont-Smith Coskie and her son, Paul. Today, Paul is back on his feet and living life again. With some luck and a lot of hard work, NeuroSTAT may be able to help multitudes of TBI victims do the same.
For more information, visit the company’s website at www.NeuroVive.com
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