Bioviva and Telocyte

BioViva would like to thank Dr Michael Fossel for this blog spot and in recognizing the importance of our work. BioViva will be using FDA standards and an IRB in all of our clinical trials. Bioviva is choosing to do them offshore so that we can spend less money and create treatments that people can afford. This offshore method is used by many of the biggest pharmaceutical companies as well.

Michael explains why there is a difference in the approach of the two companies but importantly why there is room for both methods. It is not about being first, being first is irrelevant, it's about developing therapies that could ultimately save lives! 

You can read Michael's blog post here

Alzheimer's Cure

Reversing Alzheimer's by Lengthening Telomeres

There are telomere lengthening compounds available right now for use in research labs. They are not currently available for human use. A group of scientists wants to test these compounds on aging humans now to see if the telomere lengthening effects will induce meaningful age reversal effects.

Telomeres in our cells shorten as we grow older and create cellular havoc that predisposes us to multiple age-related pathologies. These experimental enzymes promote telomere lengthening and in the process offer an intriguing opportunity to circumvent biological aging processes.

Alzheimer's disease has no cure and evidence points at microglial epigenetic changes being the cause of the inability to remove misfolded proteins in neurons. This proposed study will evaluate the effect the use of hTERT (human telomerase reverse transcriptase) to reverse biomarkers and symptomatology of aging with special target of the microglia cells in Alzheimer's patients. Misfolded beta amyloids can be effectively cleared by healthy microglia. This could represent a clinical breakthrough in Alzheimer's treatment that would be immediately available in the clinical setting.

Dr Michael Fossel a leading expert in the field of telomere biology and ageing has kindly written the following article for us which explains why Telomerase activation could be a very powerful weapon in the fight against Alzheimer's disease. 

How Alzheimer's Can Be Prevented and Cured…

by Michael Fossel, MD, PhD

As I said in my medical textbook on aging, "If age is a thief, then the greatest treasure we lose is ourselves."

We fear Alzheimer's not simply because it takes away our health, but because it steals our souls.

Once, we thought it was simply "old age" that gradually killed the cells that carry information and memory. These are brain cells that make us who we are and define our consciousness.

Only in the past two decades, have we gradually come to realize that it's not the neurons, which are merely the innocent bystanders in the tragedy, but the microglial cells that cause the disease. It's our microglia, not our neurons that steal our very souls.

Alzheimer's disease begins in our glial cells. These cells together form 90% of our brains, while neurons are only a small minority in the nervous system. One set of these glial cells, the microglia, have the critical job of protecting the neurons and supporting them metabolically. These are the cells that, among dozens of other functions, are responsible for clearing metabolic waste products and recycling the extracellular proteins that surround the neurons.

Unfortunately, as we age, the microglial cells not only fail to divide, but gradually lose telomere length. By itself, telomere loss is unimportant, but this loss begins a cascade of crucial changes in our cells.

As these telomeres shorten, they trigger a gradual shift in gene expression throughout the entire microglial cell. While the genes remain unchanged, the "tune they play" i.e. the epigenetic pattern of gene expression becomes a sinister song. Proteins that are critical to DNA repair, to making our mitochondria work, to holding free radical damage to a minimum, begin to become scant. Where once, a young microglial cell would recycle proteins quickly and efficiently-- including beta amyloid proteins -- as the cell ages, the rate of turnover slows to a crawl.

The problem is much like many other things in life. If cell phones were replaced not every two years, but every twenty years, few of them would work. If a garden is weeded not every week, but once every two years, it would be engulfed in weeds. If we showered not once a day, but once every year, few of us would have friends.

Cells are no different: if we recycle proteins quickly, there is little damage, but if we recycle proteins slowly, then the damage begins to become obvious. Our cells don't age because they are damaged; rather our cells permit damage to accumulate because they age. Shorter telomeres cause changes in gene expression, slower cell recycling, with the end results being old, damaged cells.

In Alzheimer's disease, the microglia is the earliest change, the key change that begins the entire cascade of pathology to dementia. As our microglial cells slow down, they no longer keep up with the damage around them and the result is a gradual accumulation of damaged and denatured proteins.

The disaster begins...

At first, only trivial amounts of beta amyloid begin to accumulate in small aggregates, but then they grow larger, gathering into huge amyloid plaques. Where once they could barely be seen, they now become visible under a microscope. But the problem is not simply these plaques themselves, but their effect on the neurons. Beta amyloid protein is critical to cell function, but only in small amounts, not in the vast plaques that now surround the besieged neuron. These growing plaques are toxic to neurons, making it harder and harder for these cells to survive, let alone function normally.

Tau proteins likewise begin to form tangles and the neurons can no longer maintain themselves. At first, they begin to lose the ability to transmit nerve impulses, then they become more and more damaged internally, until the neurons die, first only a few, then in larger populations, leaving only scars, inflammation, and empty space. One-by-one our neurons are snuffed out, submerged under the rising effects of beta amyloid and tau proteins, and all of this, the plaques, the tangles, and the dying neurons characteristic of Alzheimer’s can be traced back to the failing microglial cells.

As I write this, there have been more than 1,300 clinical Alzheimer's trials looking at potential interventions. Many deal only with nursing care, but of those that try to intervene in the actual pathology, most have amyloid as their target, and a few target tau proteins. Small wonder then, that none of these trials has ever been able to slow, let alone stop, or even reverse the disease. Every one of them is aimed at the wrong target. Instead of trying to reverse the primary problem (the changes within the aging microglial cell) they aim at what are merely symptoms and results rather than causes. Imagine what would happen if we tried to cure bacterial infections by aiming merely at fevers, rather than aiming at the bacteria themselves. Current clinical trials are much the same: instead of aiming at the cause, they aim at the result.

Can we do better?

Almost certainly, we can. We know that the changes in gene expression that define aging in our cells are controlled by the changing telomere lengths as these cells divide.

We also know that if we reset the telomere to the original length, we not only reset gene expression, but end up with a cell that looks and acts like a young cell.

We have even done this not only in human tissues, in the lab, but in animals such as mice and rats. When we reset telomere lengths in the aging rodent brain, the animals begin to act normally again and we see the brains returning toward normal volume and function.

Can we do the same for human patients? Can we cure Alzheimer's disease? We almost certainly can. We now not only understand how the disease works, and we not only have been able to show we can manage to intervene in animals, but we already have the tools we need to cure Alzheimer's disease in those we love.

Telomeres can be reset using telomerase, and enzymes comprising hTERT and hTERC. hTERT stands for human telomerase reverse transcriptase and hTERC stands for human telomerase RNA component Both of these telomere length extending enzymes can be delivered into the human brain, using either liposomes or viral vectors, much as has already been done in animal trials.

Once we can reverse the disease, once we can cure Alzheimer's, it will change from the most frightening of illnesses to one we can deal with: easily prevented, easily cured, and (much as it once erased our personal memories) a forgotten thing of the past.

There are at least two biotech projects currently aimed at human trials, one via standard FDA-sponsored research (Telocyte), the other using a faster and less formal, "offshore" approach (BioViva). We support both approaches, wanting an effective therapy for Alzheimer's that is both safe and rapidly available to all.

BioViva is seeking funding to initiate the use of these kinds of microglial telomere lengthening therapies in human test subjects immediately. If successful, we might not just eradicate Alzheimer’s disease, but also the cognitive impairment that strikes all people as they age past 30.

Maximum Life Foundation is raising $250,000 to give a grant to BioViva to test these therapies on human volunteers. 100% of donations earmarked for this study will be sent to BioViva with nothing subtracted for overhead. The grant would cover this initial phase of the study and more.

To learn more and to see how you can help please visit or sponsor at www.MaxLife.org 


You can learn more about telomerase and telomeres in Dr Fossels new book "The Telomerase Revolution" here. This is an excellent book aimed at the layman and explains in detail how telomere biology applies to the aging process and why it may be a suitable intervention point.

First patient treated with gene therapy for aging

BioViva Treats First Patient with Gene Therapy to Reverse Aging

SEATTLE, WA (PRWEB) SEPTEMBER 30, 2015

BioViva USA, Inc. has become the first company to treat a person with gene therapy to reverse biological aging, using a combination of two therapies developed and applied outside the United States of America. Testing and research on these therapies is continuing in BioViva’s affiliated labs worldwide.

BioViva CEO Elizabeth Parrish announced that the subject is doing well and has resumed regular activities. Preliminary results will be evaluated at 5 and 8 months with full outcome expected at 12 months. The patient will then be monitored every year for 8 years.

Gene therapy allows doctors to treat disease at the cellular level by inserting a gene into a patient’s cells instead of using the regular modalities of oral drugs or surgery. BioViva is testing several approaches to age reversal, including using gene therapy to introduce genes into the body.

Although not generally considered a disease, cellular aging is the leading cause of death in the developed world. Side effects like muscle wasting (sarcopenia), grey hair and memory loss are the well-known hallmarks.

And the aging cell is also responsible for the diseases of aging, including Alzheimer’s disease, heart disease and cancer. BioViva is leading the charge to treat the aging cell and reverse aging. “The aging cell is a key factor that has been overlooked for too long. Companies have put millions of dollars into treating the diseases of aging, such as dementia, frailty, kidney failure and Parkinson’s disease, and we still do not have a cure,” says Parrish.

Until now, no company had tried multiple gene therapies in one person. When asked why BioViva has done so, Parrish says, “Aging involves multiple pathways. We wanted to target more than one for a better outcome.

There was an AMA on Reddit October 11th at 6pm UTC or 11am PDT if you want to have a look at some of the excellent questions people had they can be found here.

The Telomeres-P53-PGC aging axis

This 2011 paper by Dr DePinho builds on previous papers and his theory of the "telomere-p53-PGC axis". This is a big reason along with the work of Dr Michael Fossel I believe telomerase therapy is probably the best chance of radical life extension in the near future. This is one of a number of papers that implicate dysfunctional telomeres in a cascade that causes mitochondrial dysfunction and various other aging consequences.

ABSTRACT Telomere dysfunction activates p53-mediated cellular growth arrest, senescence and apoptosis to drive progressive atrophy and functional decline in high-turnover tissues. The broader adverse impact of telomere dysfunction across many tissues including more quiescent systems prompted transcriptomic network analyses to identify common mechanisms operative in haematopoietic stem cells, heart and liver. These unbiased studies revealed profound repression of peroxisome proliferator-activated receptor gamma, coactivator 1 alpha and beta (PGC-1α and PGC-1β, also known as Ppargc1a and Ppargc1b, respectively) and the downstream network in mice null for either telomerase reverse transcriptase (Tert) or telomerase RNA component (Terc) genes. Consistent with PGCs as master regulators of mitochondrial physiology and metabolism, telomere dysfunction is associated with impaired mitochondrial biogenesis and function, decreased gluconeogenesis, cardiomyopathy, and increased reactive oxygen species. In the setting of telomere dysfunction, enforced Tert or PGC-1α expression or germline deletion of p53 (also known as Trp53) substantially restores PGC network expression, mitochondrial respiration, cardiac function and gluconeogenesis. We demonstrate that telomere dysfunction activates p53 which in turn binds and represses PGC-1α and PGC-1β promoters, thereby forging a direct link between telomere and mitochondrial biology. We propose that this telomere-p53-PGC axis contributes to organ and metabolic failure and to diminishing organismal fitness in the setting of telomere dysfunction. 

http://www.researchgate.net/publication/49823573_Telomere_dysfunction_induces_metabolic_and_mitochondrial_compromise.

Gene therapy is the future

 

BioViva - Gene Therapy to Treat Aging
Written by Sven Bulterijs, & Avi Roy

BioViva, an ambitious biotech startup, aims to cure diseases using gene therapy. It is the first company to recognize aging as a disease and tackle it at the genetic level. New insights in research and medicine point to cellular degeneration or aging as the root cause of most of the chronic disease associated deaths. Treating aging itself, rather than one disease at a time, gives us the opportunity to radically extend healthy lifespan (see figure below; Source: R. A. Miller/University of Michigan). Prof. R. A. Miller’s re- search shows that if we were to cure cancer today we would only increase lifespan by another 10 or 15 years as people would die from other diseases of aging. While if we were able to slow down aging we could add conservatively add 30 to 40 healthy years to our lives.

As the population ages and most people live longer than 80 years the cost of medical care for the elderly is becoming overwhelming. According to the Whitehouse Council of Economic Advisers the health care spending will skyrocket from more than 15% of the national budget today to over 40% of the budget by 2040 (see figure below). These are catastrophic projections for our economy and even an expensive cure to the dis- eases of old age would save us a lot of money. BioViva’s CEO Liz Parrish says, “we can not continue to treat the symptoms of aging such as Cancer, Alzheimer’s and Heart Disease in hopes to solve them independently, they are all symptoms of aging cells, we have thrown enough money at trying to achieve this and it hasn’t worked. It is now time to get to the essence of why these diseases happen and treat the real problem, the aging cell.”

BioViva was formed to cure the acquired and congenital diseases of childhood. It was through looking at these disease models that the eureka moment of curing aging was formed. Progeria is a childhood disease that has all the characteristics of accelerated aging. There are many speculative accelerated aging effects in other childhood dis- eases as well. BioViva decided to fight the first “old mans war” on aging diseases to bring cures to kids. “The information we will gather treating aging as a disease impacts childhood diseases directly,” says Parrish.

BioViva is not against chronological aging, they want you to get older by years. Its good to accumulate wisdom and experience. As a matter of fact they want you to get really old, without looking old. How are they going to do that? BioViva’s gene therapies are targeting the decay of aging cells themselves. Older people have the same cells as young people, the cells just perform differently. BioViva is changing the amounts of proteins created by the DNA in the cells to make them act young again. If you don’t look younger then the therapy has not worked. Aging is the most visible disease on the planet, the common signs are wrinkles, muscle wasting, obesity, loss of vision and stamina, and grey hair but look inside and it goes even further and includes plaques in arteries, frail bones and aging organs. Reversing visual aging is an excellent biological marker of success.

What is Normal?

For most of human existence our average life expectancy rarely went beyond 25 years of age, and up until about 300 years ago this was considered normal. In 1665 up to 90% of deaths occurred due to infectious diseases, while only 1% died of aging. Indeed
death from aging was so rare that the great philosopher of the time Montaigne wrote “To die of old age is a death rare, extraordinary, and singular, and, therefore, so much less natural than the others;”

Fast forward to the present time and we see the advent of antibiotics and immunizations were big game changers. Only approximately 3% of the U.S. population died of infectious disease in 2010, it is now deemed an abnormal way to die, it makes headlines. Today most people in industrialized nations die from the diseases attributed to aging cells. The public at large considers dying from aging the normal way to die but the people behind BioViva say the normal thing for science to do is to change that. BioViva mainly works as a catalyst to help bring therapies developed by many different companies and research institutes to the patients who need them "We bring therapies to patients with no other alternative” states Dr Williams BioViva’s CMO.

What does BioViva Offer?

The entire human genome was decoded in 2003 and this data has been the catalyst for precision and personalized medicine revolution. We are getting a better understanding about which proteins are responsible for which processes. We are understanding the difference between a cancer cells and a healthy cell. We know more about what youthful cells create and what old cells lack. Thousands of people are dying everyday that could benefit from our increasing understanding of the genome. BioViva aims to fix this problem.

BioViva aims to harness our understanding of the human genome to create gene thera- pies that would cure diseases and extend our health and well-being. Bioviva touts one of the strongest scientific advisory boards in longevity research. The likes of Bill An-
drews, Michael Fossel, George Church and more. Each one of these names is willing to take the plunge into new territory and affect change. Each understands the potential of gene therapy and the need for new treatments to change the paradigm of death.

BioViva’s first treatments are aimed at Atherosclerosis and Alzheimer’s. They target youthful cellular behavior to obtain results. Gene therapy is a delivered via a shot and not a pill that you will have to take for a lifetime. It is less polluting to the environment and uses your own cells to create the proteins you need. Bioviva wants to create a form of well being never seen in the human body before, a balance that keeps us from bio- logically aging in the first place.

BioViva is embarking with a therapy that is in phase 2 clinical trials in the USA, with a different organization, so it has passed safety and efficacy. BioViva is using this therapy to treat a different disease, atherosclerosis. Atherosclerosis is the accumulation of plaques in the arteries. About 80% of the population in the U.S. can be diagnosed with this by the age of 30 years old. Plaques can be found forming in young children. Atherosclerotic plaques lead to heart attacks and heart disease. Approximately 30% of the population dies of heart problems directly associated with these plaques. If BioViva is right this therapy could knock this disease off the national statistics.

BioViva is also pioneering therapies to help with Alzheimers now. Alzheimers has no cure and is a debilitating disease to both those who have it and those who are care- givers. With their new therapy BioViva hopes to stop the disease in its tracks, reverse beta amyloid buildup and potentially reverse aging. What? Yes, BioViva is using the only gene therapy that has ever been proven to not only reverse aging in animal model but to also reverse aging in every cell it has been used on in human cell studies.

BioViva and Stevia First have joined forces to treat Diabetes Type 2 and Obesity. Stevia First is an agricultural biotechnology company that is enabling dramatically healthier food and nutrition products. Stevia First has worked on mapping geroprotectors for in- formation on how to extend lifespan, information that BioViva can use to fortify its work. “We were already working with a gene therapy that increases insulin sensitivity and helps defeat obesity, so this collaboration made sense,” states Dr Williams.

There are several more therapies in the works.  Bioviva has a potential patent for Diabetes Type 1 under review. This could alleviate the use of insulin and its hazards for hundreds of thousands of people worldwide. BioViva will move forward into Immune boosting therapies to treat such diseases such as HIV and autoimmune diseases.  Will immune boosting therapies protect against cancer? “It is a real possibility” states Dr William's.

BioViva believes it is time to become pioneers again. People used to sail the sea thinking the earth was flat, they climbed a mountain to see what was on the other side. Now, we must pioneer health to ensure our worst fear of our past pioneering efforts doesn’t come true… eventual death by aging.

Liz Parrish, CEO states "If pharmaceuticals were enough, the USA would not have the most medicated people on the planet and a society that is still dying of the very dis- eases that they treat"

Treatment will start in the old and work back to the young with public support and trust. The idea is to have people take their gene therapies in advance of disease. Before you show symptoms,,gene therapy will nip the potential time bomb in the bud. You would receive a few injections early in life  instead of having open heart surgery later. You will receive a few shots instead of getting Alzheimers or organ failure. Liz Parrish states  "If pharmaceuticals were enough, the USA would not have the most medicated people on the planet and a society that is still dying of the very diseases that they treat." With the U.S.  taking over 50% of the pharmaceuticals and being only 5% of the worlds population the numbers are staggering.

Enhancement or preventative medicine?

The long term goal of the company is to have a real preventive and regenerative medicine regime that works for the world at large.There will be a big debate if this is in fact enhancement or preventative medicine. Antibiotics were the first regenerative medicine, meaning you returned to a state of health, immunizations were our first preventative medicine meaning you did not get the illness if inoculated properly against it. Gene therapy has the ability to be both, It can restore healthy function and keep you from get- ting sick to begin with. In 1600, both antibiotics and immunizations would have appeared to be enhancement, today they are common place. Public education is crucial, Hollywood hype has been misleading to the negative potential of these sciences.

BioViva believes people should have a right to change and repair their genome. They feel that people in the near future will harness this technology to improve their lives. There has been a lot of debate around this science but the ability to access the tools to see what public opinion is has not been offered before. Liz Parrish states, “we want to make you smarter, stronger, faster and more visually accurate, and I think that is a good thing.”

BioViva aims to harness our understanding of the human genome to create gene therapies that would cure diseases and extend our health and well-being. Bioviva touts one of the strongest scientific advisory boards in longevity research. The likes of Bill Andrews, Michael Fossel, George Church and more. Each one of these names is willing to take the plunge into new territory and affect change. Each understands the potential of gene therapy and the need for new treatments to change the paradigm of death.

BioViva’s first treatments are aimed at Atherosclerosis and Alzheimer’s. They target youthful cellular behavior to obtain results. Gene therapy is a delivered via a shot and not a pill that you will have to take for a lifetime. It is less polluting to the environment and uses your own cells to create the proteins you need. Bioviva wants to create a form of well being never seen in the human body before, a balance that keeps us from bio- logically aging in the first place.

BioViva is embarking with a therapy that is in phase 2 clinical trials in the USA, with a different organization, so it has passed safety and efficacy. BioViva is using this therapy to treat a different disease, atherosclerosis. Atherosclerosis is the accumulation of plaques in the arteries. About 80% of the population in the U.S. can be diagnosed with this by the age of 30 years old. Plaques can be found forming in young children. Atherosclerotic plaques lead to heart attacks and heart disease. Approximately 30% of the population dies of heart problems directly associated with these plaques. If BioViva is right this therapy could knock this disease off the national statistics.

BioViva is also pioneering therapies to help with Alzheimers now. Alzheimers has no cure and is a debilitating disease to both those who have it and those who are care- givers. With their new therapy BioViva hopes to stop the disease in its tracks, reverse beta amyloid buildup and potentially reverse aging. What? Yes, BioViva is using the only gene therapy that has ever been proven to not only reverse aging in animal model but to also reverse aging in every cell it has been used on in human cell studies.

BioViva and Stevia First have joined forces to treat Diabetes Type 2 and Obesity. Stevia First is an agricultural biotechnology company that is enabling dramatically healthier food and nutrition products. Stevia First has worked on mapping geroprotectors for information on how to extend lifespan, information that BioViva can use to fortify its work. “We were already working with a gene therapy that increases insulin sensitivity and helps defeat obesity, so this collaboration made sense,” states Dr Williams.

There are several more therapies in the works.  Bioviva has a potential patent for Diabetes Type 1 under review. This could alleviate the use of insulin and its hazards for hundreds of thousands of people worldwide. BioViva will move forward into Immune boosting therapies to treat such diseases such as HIV and autoimmune diseases.  Will immune boosting therapies protect against cancer? “It is a real possibility” states Dr William's.

BioViva believes it is time to become pioneers again. People used to sail the sea thinking the earth was flat, they climbed a mountain to see what was on the other side. Now, we must pioneer health to ensure our worst fear of our past pioneering efforts doesn’t come true… eventual death by aging.

Liz Parrish, CEO states "If pharmaceuticals were enough, the USA would not have the most medicated people on the planet and a society that is still dying of the very dis- eases that they treat"

Treatment will start in the old and work back to the young with public support and trust. The idea is to have people take their gene therapies in advance of disease. Before you show symptoms,,gene therapy will nip the potential time bomb in the bud. You would receive a few injections early in life  instead of having open heart surgery later. You will receive a few shots instead of getting Alzheimers or organ failure. Liz Parrish states  "If pharmaceuticals were enough, the USA would not have the most medicated people on the planet and a society that is still dying of the very diseases that they treat." With the U.S.  taking over 50% of the pharmaceuticals and being only 5% of the worlds population the numbers are staggering.