Betterhumans Aims to Run Senolytic Trials
Some of you may remember Betterhumans as one of a number of transhumanist community websites from years back, providing news and advocacy in service of efforts to improve the human condition. Extending healthy lifespan by engineering practical rejuvenation therapies has always been a core transhumanist goal. In one of the more interesting second acts in our community, the Betterhumans name is now hanging on the door of a medical research and development non-profit. This organization runs a supercentenarian study, and is now working on trials of senolytic therapies, starting with the dasatinib and quercetin combination that was first used in mice a few years ago. This is something that I would definitely like to see more of in our community. All of the pieces of the puzzle exist for people who want to work at assembling responsible, transparent, small human trials for the first candidate senolytic drugs. The drugs cost little, the animal studies are compelling, so why wait?
Betterhumans has a long history in the field of transhumanism. It was started as an educational website in mid-2001 and evolved to become a popular website presenting ideas and news about exponential technologies. It ceased operating as a website around late 2008, when h+ Magazine took over its functions. This new iteration of Betterhumans is the most aggressive yet. We will shortly be putting out new information about how ordinary people can modify their diet and lifestyle to take advantage of some of the latest findings in scientific research. Our research team is focused on bringing cutting-edge scientific discoveries from the lab to the clinic, so that humanity can take advantage of these breakthroughs in a safe and inexpensive manner, as quickly as possible.
Operating as a Florida non-profit corporation, the short-term goals of Betterhumans are extending healthy maximum human lifespan and greatly reducing the risk of disease. All discoveries will be offered under a Creative Commons Public Patent License, or equivalent. In 2015, Betterhumans received funding from the Methuselah Foundation to carry out stem cell research and gene-editing experiments, with the express intention of delaying aging and rejuvenating vital organs.
We intend to pursue many small scale human pilot studies to test the safety and efficacy of various FDA-approved drugs and therapies thought to have anti-aging effects. We will publish all results so that other researchers, physicians, and patients can have information which may aid their efforts. The question seeking to be answered by this Phase 0 pilot study is whether the senolytic compounds dasatinib and quercetin will significantly eliminate senescent cells contained in the muscle and fat tissue of elderly individuals who have metabolic syndrome and/or osteoarthritis, and will reduce levels of systemic inflammation, insulin resistance, improve their immunological responses, and in those having osteoarthritis, reverse the progression of this disease.
Good to see, James is a personal friend of mine so I am happy to see more movement in this direction.
Good to see people aren't waiting for the FDA to green light these things. I'm also very glad that the data from these studies will be shared. Those of us that are the early adopters will benefit from this.
That being said, I think the FDA is starting to come into the 21st century.
https://endpts.com/scott-gottlieb-vows-to-shake-up-the-fda-backing-a-trend-toward-faster-drug-development/
https://blogs.fda.gov/fdavoice/index.php/2017/09/fdas-plan-to-engage-the-public-in-the-agencys-new-effort-to-strengthen-and-modernize-fdas-regulatory-framework/
https://www.cnbc.com/2017/09/06/fda-seeking-digital-health-entrepreneur-in-residence.html
Japan is already moving ahead with bold regulatory moves. I expect the rest of the world will catch up soon enough as legacy costs outstrip the tax base. In fact, I'm seeing some things here in Canada that are very encouraging. The cost of aging is very real.
For example, there is a big kerfuffle going on right now as Canada starts to tax Corporations and Higher income earners.
http://www.cbc.ca/news/canada/british-columbia/2017-bc-budget-update-1.4284778
http://www.cbc.ca/news/politics/trudeau-media-avai-kelowna-1.4279456
The middle class is tapped out, so the only way we can make ends meet is by going after higher earners. They will and are fighting back. We'll see how it goes.
But I digress.
Once we know proper dosages, side effects and costs, count me in on the medical tourism train until the "Very Smart People" figure this out. Hopefully, it won't be too long.
And the fearless guys over at longecity already ordered a group buy of FOXO4-DRI. I guess we'll see some more anecdotal evidence there soon. It's a shame they don't have the contacts to make it a useful trial.
Why are they bothering to do this if Unity will soon be testing the same compounds in phase 1 trial?
These small community organised phase 0 trials raise a few interesting questions. Why are they only beginning now in 2017? What are the enabling factors? Is it some basic scientific results in the lab that give people the confidence to self experiment? Or is it the falling cost of carrying out these experiments? I find the second possibility interesting.
How is this related to the biohacking movement? That community seems like a bunch of people who at the moment just put genes in bacteria to make them grow. But could the falling cost and growing ease of the surrounding technology mean that this area is about to explode and intersect with the self experimentation movement? Here is a funny interview with Josiah Zayner who created http://www.the-odin.com/
The FA! blog speculated a few years back on whether someone could start producing their own myostatin antibodies: https://www.fightaging.org/archives/2016/10/how-to-go-about-using-myostatin-antibodies-to-grow-muscle-today/
But that involved finding a lab to produce the antibodies, which is a complex and difficult step that a biohacker probably couldn't manage. But another technology, siRNA delivered via Chad Mirkin's spherical nucleic acids, could be used to knock down myostatin in muscles, and apparently it is easier to make spherical nucleic acids (although being a layperson I don't know this for sure).
Does anyone else have any clearer thoughts on why this is only occurring in 2017?
Jim
Before Unity doses their first patient, assuming they are done all their in-vitro pharmacology and animal models, they still need to go through analytical assays in multiple species, dosing formulation development, PK studies, ADME studies, Cytochrome P450 studies, hERG / purkinje fiber studies, safety pharmacology studies, dose ranging studies, 14 day repeat dose tox studies, 3 month repeat dose tox studies, genetic tox studies, and even some minor CARC work
It's not "soon"
Because Unity isn't going to be soon it will be 3-5 years at least due to the complexity of clinical trials. So what James is doing is using the things we have available now to give those waiting and especially those who are older a fighting chance. D&Q might be a rough therapy against senescent cells but frankly, it is probably better than nothing.
I'm involved in the Longecity group buy, getting 50ml of FOXO4-DRI around November. If anyone has recommendations for methods of testing aging biomarkers and such I'd be interested to hear and implement.
@gheme: see some thoughts here: https://www.fightaging.org/archives/2017/05/planning-a-single-person-trial-of-senolytic-drug-candidates/
Also: https://www.fightaging.org/archives/2017/07/zymo-research-launches-a-publicly-available-dna-methylation-test/
While, yes, I support self-experimentation and would agree that there is no good framework for anti-aging studies yet, we still need to be careful. We will need to get more aggressive with human studies at some point (e.g. micro-dosing and safety testing on human volunteers who give informed consent)
However, anyone partaking in such "studies" now has to realize that both the risks and benefits are high. I worry that the first fatality due to something stupid and expected like tumor lysis syndrome, will be misportrayed in the media and will harm future senolytic trials.
Those who do not work in aging research won't understand that the potential benefits of anti-aging therapies may outweigh even enormous safety concerns. As long as informed consent was given, it is ethically acceptable, but regulators and doctors will think more along the lines of primum non nocere.
The solution to that would be to get the high benefits (36.000.000 lifes safed for every year you can take out of the of the official trial system) without the high risks by running those "studies" professionally. This shouldn't be too difficult because self-experimentation with senolytics run by layman didn't cause any casualties yet. With appropriate safety precautions there shouldn't be any either.
If that is what you need to do to get media attention please start ASAP. The naysayers in the press will be proven wrong.
I would be an interested candidate for self-experimentation with senolytics, but I would like to feel there would be appropriate safety precautions in place.
My husband and I are aged 92 and 88 and at present in reasonable health for our age, however I feel time is running out and we need to do something soon if we want real longevity. I have always supported the SENS idea of disposing of unwanted dead cells and feel at the moment it is the right way to go.
Jean Purcell: Did you signed for cryonics?
I would like to know more about your trial on senolytic drugs. I am a cancer survivor (non Hodgkin's) but I am left with long term effects from chemo and radiation. I suffer fatigue,chemo brain osteoporosis and diabetes. I am not old,but cancer chemo and radiation have made me old. I am only 51 and disabled. I would like to be considered to participate in your trial.
Thank you
Cindy