Since February, Health Rising has described the development of a new drug produced for chronic fatigue syndrome (ME/CFS) by a small pharmaceutical company named Cortene in three blogs:
- The Cortene Way: New Drug to Be Trialed in Chronic Fatigue Syndrome (ME/CFS) Soon – Pt. I
- Cortene II: A New Drug & A New Hypothesis For Chronic Fatigue Syndrome (ME/CFS)
- Cortene – A New Drug for Chronic Fatigue Syndrome (ME/CFS) Pt III: The Clinical Trial
Now it’s time to test the drug! Cortene’s trial has received the go-ahead from both the FDA and the Independent Review Board (IRB) and the trial will commence shortly, with Lucinda Bateman, MD, as the Principal Investigator, Suzanne Vernon, PhD, as Co-Investigator, and assisted by the experienced clinical trials team at the Bateman Horne Center.
A Different Path
Cortene’s path to testing a new drug for chronic fatigue syndrome (ME/CFS) has been different in several ways from past ME/CFS clinical trials.
Most research studies have sought to characterize ME/CFS by comparing biological samples across patients and healthy controls. Treatment-focused studies have generally used evidence from other disease groups, or had anecdotal evidence from within the ME/CFS population, and have tested whether approved drugs can improve symptoms or manipulate subsystems (e.g., Rituxan and Ampligen were both targeted at aspects of the immune system).
Cortene used a theoretical exercise to rethink how ME/CFS occurs to help them determine if their drug might be a good fit.
In contrast, Cortene was working with an experimental drug targeted at the stress system. They had no knowledge of ME/CFS, but following a chance encounter, engaged in an intensive theoretical exercise that sought to rethink every aspect of the disease. In particular, they tried to understand how a triggering event could cause relatively healthy individuals to develop dysfunction, often suddenly, in so many different systems (neuroendocrine, autonomic, immune, metabolic, thyroid, reproductive, etc.).
Cortene’s theoretical exercise made two important observations: First, that stress modulates all the systems impacted in ME/CFS; and second, that the stress response has an adaptive mechanism, which could conceivably allow the stress response system to “go off the rails” and chronically over-respond to minor stimuli.
These two observations led to Cortene’s hypothesis that ME/CFS results from a maladapted stress response in which the up-regulation of a single receptor causes an exaggerated, multi-systemic reaction to even minor stimuli. Cortene believes that this hypothesis is able to explain all of the many anomalies of ME/CFS (including gender disparity, genetic risk, diverse triggers, sudden/gradual onset, symptom variability, etc).
Cortene’s animal data, indicating that over-stimulating the suspect receptor in healthy rats induced ME/CFS-like symptoms, supported their hypothesis. The animal data showing that down-regulating the receptor stopped the production of ME/CFS-like symptoms, in turn, supported their proposed drug treatment regimen.
This has led to the first ever trial of a new drug specifically targeted at what is proposed to be the root cause of ME/CFS.
The fact that Cortene’s drug has not been approved in humans before meant a much more complex, expensive and time-consuming process was required to get approval to proceed with the trial. The investigational new drug application (IND) – which included the scientific rationale for the drug’s use, the animal efficacy, safety and toxicology studies, the plans to manufacture and formulate the drug, and the trial protocol – runs to hundreds of pages. Then there’s the all-important patent application, which has to be filed in advance of any publication, and is essential for raising the development capital that will ultimately be required to bring the drug to market—potentially $100 million.
Thus far, Cortene’s drug, a small protein called CT38, has been shown to be safe in a Phase 1 trial in healthy human volunteers. It is intended to down-regulate the receptor within hours, hopefully reversing the maladaptation and restoring patients to a pre-ME/CFS state. That is, if Cortene’s hypothesis is correct, and its experimental drug does what it appears to do in rats, the treatment is potentially curative.
Some manufacturing issues – not uncommon with new drugs, and now resolved – delayed the start of the trial a bit, but now the show is on.
The Clinical Trial
The study consists of a 4-week PRE-treatment period, a 2-week treatment period, and a 4-week POST-treatment period. Both the PRE- and POST-treatment periods will commence with a cardiopulmonary exercise test (CPET), where the investigators will record patient performance on a stationary bicycle.
The trial will test three groups (6 patients each) receiving either low, intermediate or high doses of the CT38 drug. Because the investigators did not want to expose patients to CPET without the potential for treatment benefit, the trial will not include a placebo arm. (Future trials, if they become necessary, will.) The trial will commence with the low dose that has been shown to be safe in humans and will only escalate the dose in the absence of concerning side effects.
During the treatment period, CT38 will be administered as a 3-hour infusion on 2 separate days.
The trial will assess exercise performance, functional ability (via Fitbit measurements of activity, heart rate, and sleep), cognitive function (via DANA mobile software testing), effects on vitals and orthostatic intolerance, patient-reported symptom scores and adverse events (among others), both pre- and post-treatment.
Is it possible that Cortene found a key to ME/CFS? Time will tell…
The trial seeks 18-60 year old patients who meet the Fukuda, Canadian and IOM criteria for ME/CFS, who have lived at an altitude between 3,500 and 5,500 feet above sea level for the past year, who have a relatively stable state of illness for the past 3 months, and who are willing to undergo CPET assessment.
People who have smoked (within 6 months), are pregnant or are breast feeding, have renal impairment or substance abuse issues, or have taken medications that interact with serotonin, norepinephrine, dopamine or cortisol in the 6 weeks prior to enrollment and throughout the duration of the study, are excluded. There are other requirements, but if you are interested in participating in the trial, the link to the screening form is the below.
The comprehensive hypothesis and promising animal data aside, Cortene continues to emphasize that caution is appropriate for any early stage drug trial such as this. That said, this development – a trial of a new drug intended specifically to reverse ME/CFS – has been a long time coming for a disease that has received such little interest from drug companies.
The fact that Cortene believes the drug could get at the heart of ME/CFS and even has the potential to quickly cure it, is a lot to take in. Could we be so lucky? Time, of course, will tell.
However the trial turns out, it’s encouraging to see a drug company targeting ME/CFS with a drug, let alone a new drug. It’s encouraging as well that Cortene has been able to privately raise the considerable funding needed to move forward with this initial trial. For me, I feel that Cortene has operated with integrity throughout and I think we’re in good hands.
Looking Forward
I asked Cortene what happens next if the trial is a success. They replied they would then have to demonstrate to the FDA:
- The drug’s effectiveness in a placebo-controlled trial
- Determination of the minimum effective dose (as opposed to maximum tolerated dose)
- The running of 2 large controlled trials (Phase III’s)
- The possible completion of some additional animal studies and finalization of drug production (and stability) before filing for drug approval.
One issue with getting FDA approval is the longstanding problem of finding the best endpoint to study ME/CFS. Today, CPET is a gold standard of sorts, but it is difficult for the patients, presents the potential for a crash, and requires that recovery time be built into the protocol – obviously not an optimal situation for the participants, the clinical trial team or Cortene.
Cortene is attempting to address this situation by examining many different endpoints (exercise performance, functional ability, cognitive function, effects on vitals and orthostatic intolerance, and patient-reported symptom scores), in hopes that a simpler measure of dysfunction and improvement, which could expedite clinical development, will be found. If such an endpoint is found, it will reduce the time to approval.
If the drug is successful in ME/CFS Cortene believes it may be helpful for other diseases such as fibromyalgia, GWS, etc.
The FDA has various incentive programs, including breakthrough therapy designation, fast-track designation, accelerated approval and priority review, which can expedite the approval of a drug for a disease with unmet needs. Breakthrough or fast-track designations would ensure extensive access to and guidance from the FDA, potentially enabling accelerated approval and the right to use a surrogate endpoint (albeit subject to providing subsequent proof that the surrogate is in fact a marker for clinical benefit). Priority review would reduce the time for FDA review. The FDA has already indicated that a drug that shows effect in ME/CFS would be eligible for these programs. Moreover, Cortene informs me that they feel the FDA has been very supportive, which demonstrated their commitment to ME/CFS.
All that said, getting a drug like CT38 FDA approval could take years, with the exact length of time dependent on how strong the results are and how quickly Cortene can demonstrate those results.
On the bright side, the fact that CT38 is hypothesized to be an acute or short-term treatment as opposed to a chronic treatment potentially eliminates the need for some long-term studies.
Beyond ME/CFS, Cortene postulates that the related diseases (Chronic Lyme Disease, Gulf War Syndrome, fibromyalgia, PTSD, multiple chemical sensitivities, etc.) result from similar maladaptations within the limbic system. CT38 could eventually be tested in these diseases as well.
As with any new drug, if the pilot study is successful, it will require considerable capital to move CT38 forward. In that event it’s likely, Cortene would seek funding from venture capitalists and big pharma to complete the larger studies needed, but, as Gilead’s recent Hep C drug showed, the market reacts extremely favorably to a CURE.
- Cortene I: Cortene to Trial New Drug for Chronic Fatigue Syndrome (ME/CFS)
- Cortene II: A New Drug & A New Hypothesis For Chronic Fatigue Syndrome (ME/CFS)
- Cortene III – A New Drug for Chronic Fatigue Syndrome (ME/CFS): The Clinical Trial
- Cortene IV – The Cortene Chronic Fatigue Syndrome (ME/CFS) Drug Trial Begins
- Cortene’s website
- Find the trial on the ClinicalTrials.gov site
I’m just beyond the age limit, or I’d have already volunteered. Praying for success in the clinical trial!
An actual Silver Bullet? This could be it. Let’s face it, there are very few hypotheses about the causation of this illness; this explanation seems to hang together and crucially explains symptoms and it’s vast variety of expressions.
Brilliant overview of the situation, as always Cort, thank you.
Thanks. We’ll see.
My hopes are always tempered by Ron Davis’s admonition of how complex the body is! Plus the recent fibromyalgia and Rituximab trial failures – they all had good Phase II trials and then bonked on the Phase III trials – weigh over me. I imagine it would be very unusual for a truly effective drug to come along so early in the drug development phase for a disease.
On the other hand, like you, I am impressed by the hypothesis and all it can explain. I was happy to hear Suzanne Vernon – one of the smartest people I know – say how uber smart Cortene crowd is and I’ve truly enjoyed interacting with them.
What a story it would make… Small drug company comes out of nowhere to cure or even just improve mystery disease (as all the big drug companies sit on their hands)
Could we really be so lucky? We’ll see.
Once again, HOPES ARE HIGH. But, I must say, this one sounds so fabulous. We all are in hopes. I can’t imagine such joy to feel normal after 32 years. WE MUST ALL THANK CORT FOR HIS DILIGENCE IN KEEPING UP. LOVE. JAVEN
MAYBE THIS TIME WE WILL BE LUCKY. MAYBE THIS TIME. MY HEART IS POUNDING WITH HOPE.
I sincerely hope it works. I have cfs/me fibryomayalgia systemic lupus and a skin desiese called HS .. all have no known cure. To rid my body of one off these illnesses would be heaven
Hi and thank you!!!!! this is great, i have been tracking my illness for several years as i address diet, exercise, rest, detox etc and i have reached the conclusion that its all to do with the stress response. so i’m really excited about this. I do wonder why the clinical trial subjects have to be living at 3.5-5.5 000 ft altitude? Did I miss something?
More importantly is any one conducting trials in the UK? It could take years till it reaches us otherwise!! x x x
J’ai consulté deux psychiatres avec lesquels nous avons recherché les causes possibles de la maladie. Les deux pensent qu’il s’agit d’un stress chronique qui a entraîné une dérégulation multisystémique. Je vis depuis 19 ans avec le sfc et c’est aussi mon hypothèse depuis longtemps. En ce qui me concerne. C’est une évidence mais la plupart des médecins refusent de reconnaître les effets délétères du stress sous toutes ses formes. Pas étonnant que les femmes soient plus souvent affectées par la maladie !
Any update on how this trial went and what Cortene are up to at the moment.?
I pray this gets funding and moves ahead in at a more quicker pace! Thanks Cort!
Why are those taking SSRI’s excluded?
Presumably because the SSRI’s effect some of the same systems that Cortene’s drug is effecting. They’re a confounding factor. If someone was testing an energy producing drug the participants wouldn’t be allowed to be taking CoQ10 for instance.
This is so exciting!!! I can’t even imagine if this disease could be reversed! I would be curious to know Ron Davis’s opinion on this.
I’m not terribly optimistic about the drug itself, but the trial looks to be well designed, Lucinda Bateman and Suzanne Vernon know what they are doing!
re-my last comment, keep in mind that this is just a feasibility study, not an efficacy study. So this study will not be used to claim that the treatment has effiacy. Hence the lack of a placebo control group. But assuming all goes well, they will then do a placebo controlled study based on the above design.
Cort, thank you for this! Using the obvious criteria, I cannot locate the study on clinicaltrials.gov. Am I missing something?
The clinicaltrials.gov posting is under review, should approved in 5-7 days.
You can now find the trial on the clinicaltrials.gov site here: https://clinicaltrials.gov/ct2/show/NCT03613129?term=NCT03613129&rank=1 – 🙂
Why do people have to be living at altitudes of 3500-5500 feet? That would seem to exclude a ton of folks who live in most of the US (including both coasts).
It’s because of the exercise testing. For technical reasons I don’t understand bringing people in from another elevation would affect the results of the exercise testing. Simply bringing them up to that elevation with apparently make a difference.
Hi Cort, people coming from a lower altitude will have increasing haemoglobin levels as they acclimatise which migh significantly affect the results of exercise testing. The converse applies to people from higher altitudes. When I went to China in 2002, I left from an altitude of 300 metres and haemoglobin of around 12.5, spent 3 weeks at altitued deom 3000 to 5000 metres and came back with a haemoglobin of around 15.5 and feeling wonderful. As haemoglobin levels came back to normal, so did CFS symptoms 🙁
They should open to all even below sea levels and note the differences as well in the exercise tests..
I was happy when I found out there would be a trial and now I’m mad. I cannot believe that the participants have to live between 3,500 – 5,500 feet above sea level! This is so disappointing it makes me sick. How many people will be left out because of this ridiculous requirement. The majority of the worlds population live at or near sea level, so why not test where the majority of people live?
I’m sure Cortene is not happy about this either. It makes it more difficult to get participants for the study. This is the first time that I’ve heard ever heard of an elevation requirement for a study as well! To me, though, it just demonstrates the rigor with which Cortene is working. It makes me think that their dotting all their i’s and crossing all their t’s. In that sense I actually appreciate the restriction.
This is only apparently because the testing is being done at Salt Lake City which is at an unusually high elevation (4200 ft)
If the first test is successful then the clinical trials locations will surely expand and elevation requirements won’t be a problem for the other sites (except that people at higher elevations won’t be able to go to lower elevation sites!). That is, if the CPET portion of the test is included.
Cort, do you have any updates? From what I understand south Florida hasn’t finished recruiting but Bateman’s seemed ahead of south Florida. Did this trial finish on schedule? When will we hear about any results? Thanks!
I think Cort already answered this. Bateman Horne Center is located in Salt Lake City and so they are probably trying to control for altitude changes that can affect exertion ability. For example, I like at about 7,500 ft, but do significantly better when at sea level. BHC will probably be able to recruit everyone that is needed for the study from their patient population. If this drug goes on to other trial arms, I would presume that they will work with other clinics and be able to loosen this criterion.
Yep, and it’s not like they need a lot of patients for this study (3 groups à 6 people = 18).
Better to have this first study done in an excellent medical center (for CFS) than to enable more possible candidates to apply.
It is just a small study. There are hundreds of thousands, maybe millions of people who live between the altitude limitations in the Western part of the USA.
Goodness gracious folks, calm down about the high altitude. There are millions of people who live at that altitude in the US, and a lot of them are also very ill with this horrible illness, just like in the rest of the country and the world. Including myself. Thank you for the information, Cort, and hope and prayers for a good outcome from this group and their study.
This is a tiny study, so I don’t think there’s any reason to be upset about the altitude limitations (in reply to Lynne). My concern is that this is an infusion treatment without a control group. Any sort of IV drip treatment would help a large number of ME/CFS patients, even without a drug in the IV, because of the extra hydration. So the trial may appear to show a positive result that will only be a result from extra hydration. That would be such a waste of effort and resources. I sincerely hope these experienced researchers have thought of a way to deal with this complication.
Cortene just informed me that the drug is not delivered by an IV infusion. It is delivered by subcutaneous infusion (under the skin, not in the vein) and the volumes are tiny (in the order of 1-4 milliliters) – hence it won’t provide any hydration benefits.
I’ll copy what I wrote in another blog:
…long term IV saline… …has shown promise before. It also has shown several times to potentially disrupt studies, like the rituximab one. The study failed. However, both rituximab (given as a medication via IV saline if I get it correct) and the IV saline “placebo” yielded good results. I’ll copy part of a former post I made here:
******
https://www.healthrising.org/blog/2017/04/15/saline-pots-chronic-fatigue-syndrome/
“At some point 50 of the participants reported no need for further infusions, except during times of stress, within six months of starting the infusions. ”
“So how did the authors believe that IV infusions every ten days or so which provided symptom relief for about three days translate into long-term relief? They didn’t know, but their best idea was that IV infusions gave the POTS patients a window to increase their activity levels and relieve the effects of deconditioning that often come with the disease. Ultimately, many didn’t feel the need to have more IV infusions at all.”
=> THE PLACEBO MAY NOT BE THE PLACEBO BUT (part of) THE WORKING INGREDIENT!
=> Few research is done on long term effect of regular IV saline, so doses and interval in the few trials might have been far less than optimal. Rituximab and Cyclophosphamide chemotherapy may provide better doses and intervals by chance.
=> If this could be true, optimal dosed IV saline may be cheaper, safer and would need no long test and approval faze.
******
Great! That’s good to know. Thanks, Cort.
My reading skills (comprehension and focus) are still off. I clearly did mis that Cortene set up his experiment in a clever way so that saline won’t interfere.
May all go well Cortene. Success and thanks for caring!
Actually I had it wrong and changed my reply; I thought it was a saline infusion – you were right on with your comment.
You said that a drug like this could take years for approval. If it actually worked, do you think they would fast track it to be ready in for the public within a year? What’s the usual time for a drug that works and an illness this serious?
There’s no getting around the fact that the drug approval process moves very slowly and probably more slowly in a drug that hasn’t been approved to treat a disease before. If the drug is successful it will take years to get it approved. How many? I don’t know but certainly more than two. Cortene would have to get many more investors lined up, they might have to do some more background studies, then they would have to do a phase II two placebo controlled trial and then two large phase III trials. It’s a lot of money to gather and a lot of logistical processes to put together.
If the trial were to go really well that would help the money come in…and that would surely be a big help.
Cortene was very happy with the FDA’s response. I got the impression that they felt that FDA was quite eager to help and didn’t throw up any roadblocks – on the contrary. That made me think that the FDA workshop on ME/CFS some years ago really did make a difference. So the good news is is that while the drug approval process is a long one it appears that the FDA will move the process along as quickly as it can.
How about the actions the President took recently to make experimental drugs available to the chronically ill? Would that help us to have access sooner? And is there any evidence that the MTHFR genes are involved? I show very high inflammation in my body on my labs.
I haven’t heard of that program but it certainly sounds like it could help.
There is definitely evidence that the MTHFR genes are involved in some people. A blog is coming up on that.
Any estimated timeframe when results will be released?
Mid-October would be the earliest. I would expect sometime later.
Great Overview! Read the previous blogs and am very excited the trial can now start. It’s definitely well designed and the background to this drug (they were searching for the ‘perfect’ disease for their drug, not vice versa) gives me a little hope.
So when can we expect the first (preliminary) results? Early ’19?
Earliest is sometime in October – after everyone is through the trial unless, I suppose, something unexpected happens and the ME/CFS patients react badly to the drug. That’s not expected. The drug produced few side effects in its initial testing but since since it’s has never been tested in ME/CFS it’s a possibility.
Thanks for the update Cort.
I’m excited about the possibility of this drug being helpful (dare I say ‘curative’?).
My own CFS was largely caused by preceding years of intense ‘life and death’ stress, PTSD, etc., totally damaging my HPA axis-hormone levels. I’m wondering if a subgroup of individuals with THIS causation would therefore respond better to Cortene than the CFS population in general. I hope they have a way to tease out this subgroup in their results and interpretation. I’d hate to think this drug might be very helpful for my subgroup, and yet not for perhaps the majority of CFS people, thus erroneously leading to a general conclusion that Cortene was not effective.
Your thoughts on this would be appreciated Cort. Thanks for all the great work you do.
The endocrine system is so darn complex that I would be hesitant to say anything but to this laymen it sounds like you might be a good candidate. That said, Cortene believes that a single intense infection could flip that switch. They propose both paths (infection, gradual onset) could end up with the same result and, in fact, started their hypothetical exercise with the idea of a person suddenly coming down with this illness after an infection.
I would think they’ll be looking closely at patient histories if some people respond and others don’t. I don’t know if they’re trying to get a variety of patient histories in the trial or not.
Great question 🙂
Thanks so much for your response. In my question, I mistakenly used ‘Cortene’ instead of CT38 as the name of the drug. I appreciate you deciphering my thoughts in spite of my mistake.
It seems Eimear (below) had a similar concern as mine; would you know Cort if there is a way without being annoying to suggest to Dr. Vernon and Dr. Bateman that it could be fruitful to specifically look at this subgroup (CFS developing in patients after acute and sustained stress, trauma, and in my case measurable disruptions in endocrine hormones) and their response to CT38? I noticed Dr. Vernon commenting on a post above. Perhaps I might reply to her post? or if there was a way to email her with my thoughts, do they have a way to be contacted? I so appreciate their good work! (and yours, thanks).
Also, If CT38 did show a higher beneficial response in this subgroup, that alone would tend to validate Cortene’s hypothesis of maladaptive stress response which would be huge. And of course it would be an indication for CT38 treatment for us (this subgroup). Obviously, I so hope all with CFS will respond, but if not, I would hate to have potentially beneficial treatment for this subgroup overlooked. Thanks again.
Thanks Thomas, Cortene is following the blogs and the comments so I’m sure that they’re aware of this issue. Thanks for bringing it up.
I am in the exact same boat as Thomas, I know I’ve a broken stress response and long term stress topped off with a viral infection flipped my switch literally overnight. If there is a sub group it works for, it would be devastating to miss them. Here’s hoping…
I would think you would be a great candidate for a future trial if gods willing (Battlestar Galactica reference) the first one pans out.
I think they will definitely measure intestinal permeability as a key parameter. That will tell a lot about the sub group of people in whom it will work.
Good point
I just finished posting on the previous blog (Honest Doctor) about my theory that a predisposing factor for ME/CFS might be that being an introvert is an added layer of stress (chronic). I observed 30 years ago when I became ill, that our local support group was overwhelming made up of introverts.
According to the Myers Briggs Type Indicator (MBTI), the U.S. population is approximately 75% Extraverts vs. 25% Introverts. Introverts (per MBTI) get their energy/recharge from pulling away from the “outer world” (outside their own heads)because we (Introverts) get drained from too much exposure to sensory input, people, etc. Extraverts on the other hand, get their energy from going to the “outer world.”
Introverts brains are also wired differently from what I’ve read. Maybe being an Introvert, in a population of mostly Extraverts is more stressful than anyone realizes. If you add in Type A personalities, then maybe the stage is set for ME/CFS. I’ve also read that for every emotion, there is a corresponding physical symptom expressed. Perhaps we are the physical manifestation of the body’s shut down mechanism that was intended to be protective, but went awry. Cortene seems to be aimed at the stress response, so maybe this will be our answer since nothing else has been effective. How many Introverts are reading this? Any thoughts?
Dear Tanya
You may be interested in the book, “The highly sensitive person” by Elaine Aron. She highlights some of your points about the brain being wired differently.
As for the time in getting a drug approved, well, surely this would be accelerated considering all the bed bound folks.
I’ve had a copy for many years and found it helpful.
Their theory on this is from what I understand, isn’t it basically the same thing that Annie Hopper and Ashok Gupta have been saying? that the stress response system in our body has been “stuck on” causing a disreglation in other systems in the body, so their approach is to heal the limbic system (Hopper’s DNRS) and or Heal the amygdala (Gupta’s amygdala retraining program)
yes i suppose doing an hour a day for 6 months or more is a big commitment..a lot more time consuming than a few infusions.
I do know a couple folks that have had good response to the DNRS training.
It’s all actually somewhat the same thing that many people are proposing in different guises with the exception that Cortene believes/hopes they may have nailed down the key physiological component at work.
Years ago Dr. Cheney yearned to put people with ME/CFS in a coma state to help them heal and several of his treatments (klonopin, doxepin elixir) attempted to calm down the nervous system. Jarred Younger believes the microglia in the brain are hypersensitive. MCAS proponents believe our mast cells are hyperactive. There’s documented central sensitization in fibromyalgia, low heart rate variability in ME/CFS and FM…However you approach it the wired and tired thing is everywhere.
Hopefully Cortene has found the key factor in this wired and tired mess. I would prefer a drug that turns it off! Ironically then I would probably get back to meditating 🙂
“I would prefer a drug that turns it off!”
I wouldn’t touch a medication that turns it off unless results are overwhelmingly positive. Adrenaline has saved my day quite some times before.
But I’m a rarity to that regard: I am an oddity who managed to improve under conditions of long lasting increased adrenaline. It’s nasty to have those surges and controlling them is harder than riding a bull. But for me at least adrenaline surges have some beneficial properties next to plenty of side effects.
IMO it might be interesting to look to opposing subgroups rather than mean. It may well be correlated with lack of breathing capacity.
I am the same way.. seems easier to get a drug to turn it off than spending 6 + months doing the DNRS practice.. it is more complex then meditating.. you actually go into positive feeling/memory times and live it out loud for as long as you can..then you project a future “memory” doing the same.. some folks are really good at telling the stories with positive good visual detail.
gupta’s is similar but different and I haven’t made it through the whole dvd set to know.
i dont think i would want to go into coma. that doesn’t sound like fun..but at lease he was willing to do something.
I’m an introvert and also fairly type A.
Interesting thought and something to think about.
Tanya – introvert type A here too.
Great reporting, Cort. I am hopeful.
Nice to see recognition of your efforts Cort in that they named the drug in your honour
Wasn’t that nice? And I didn’t even know them at the time…. Let’s hope it works! (All tongue in check except the last part.)
Thanks again Cort for great reporting. And Nice to see they named the drug after you.
🙂 🙂 🙂
I got ME/CFS through contracting glandular fever while at University couldn’t say that I was under immense stress or pressure at the time. Yes I was burning the candle and both ends but nothing out of the ordinary for a 18/ 19 yr old. Hope and pray for a treatment or cure
Yes I was University too – doing fine! Actually I was at a high point. Unusual stress not needed for me to get an apparently lifelong case of ME/CFS/FM.
I never experienced any stress so I’m guessing this wouldn’t work for me. It sounds too good to be true, in my opinion
Experiencing “stress” is not needed. A triggering event might be. I understand your feeling that it sounds like its good to be true. After 30 years with this disease I’ll certainly be pinching myself if it all works out. If I was really honest with myself, I probably mostly gave up on the dream of getting well long ago but honestly you never know. Something caused this disease and something will stop it.
Great article. Lets hope somethings comes of this trial
I live in hope to see my son get out of bed and have some quality of life!!
Can somebody explain to me (and I apologise I’m not very smart with these things) whether this drug is attempting fix a problem in the brain itself, eg like a brain chemical or whether the system that Cort noted above was in the body. I say this because there seems a strongly held view from some doctors that the issue with ME may be in the brain rather than a latent virus in the body or problem with the immune system
I believe the receptors Cortene is attempting to effect are found in the pituitary and other parts of the brain. That would make this a brain operation which is attempting to fix problems in the body as well.
I wonder if this is suggesting that the ME/CFS phenotype is similar to serontonin syndrom? What implications does this have for people on antidepressants?
Elizabeth, I’ve always wondered this since so many of my symptoms seem similar to serotonin overload. Flushing, muscles twitching, hyperthermia. I really think they are on to something. I’m also an introvert and was under extreme stress when I got a bad stomach virus and spiraled into 15 years of this dreadful way of life. Whenever I crash it is accompanied by flushing, fatigue, hyperthermia and brain fog. I’m confident that I would be perfect for this study but alas I live at 700 feet above sea level. Thank you Cort for keeping us informed.
Good question!
The fitbit’s EMF is adding a huge variable which could cause health effects falsely attributed to CT38. Some good links at the end of this article.
https://www.activistpost.com/2018/07/woman-claims-fitbit-alerted-her-to-medical-issues-decades-of-research-confirms-wifi-from-the-fitbit-could-have-caused-her-medical-issues.html
My concern is that the animals used in preclinical trials will not have been ill for 10 years or more,and therefore other switches in the body may now be permanently on/ off and affect the results. I think it would be interesting to see if this drug can a)be used very early in the illness to prevent chronicity developing or b) used in long-term chronic patients to prevent relapses caused by external stressors e.g. infections, hospital admissions.. I do hope the developers will think about it.
Thanks for mentioning that. The treatment is supposed to reset what’s broken – ME/CFS patient’s stress response systems – but as you note this drug has never been used in ME/CFS and we’ll just have to see what happens.
You brought up some really good questions. What if the drug helps for awhile and then needs to be reinfused – what then? I’m sure Cortene has thought about this. They did state that would mean more longer term testing and presumably considerably more money…
Thanks for the report Cort, well written and informative as usual. I also have concerns that the animal model is working on animals that have not lived with the condition for a long time. Anyone having ME/CFS for years if not decades will now also have other system impacts from the illness. And correcting one part may not show the improvements hoped for in those long term people. Do you know if they plan to look at length of time ill in the potential next stage as a factor if all goes well this time?
My only concern here is the weaknesses of CPET (not measuring the resultant PEM but only the percieved ability at the time) and also the Fitbit measurement of activity and functionality level – according to my fitbit my heart rate is healthy and I sleep within perfect range – but that does NOT depict the fact that I often have debilitating chest pains, can barely walk or stand for more than mere minutes, and I wake up completely unrefreshed every morning.
Surely these measuring tools could be more reputable?
I love the hypothesis, I am all in. The link to sign up for the study works, but then tells me that Bateman Horne does not have the capacity to take new patients. I am already a patient there from participating in Unumatz’s study. I will be calling on Monday to volunteer. The 2 CPETs are a little concerning, but I found that getting saline infusions afterward dramatically helped my recovery from the one I did in 2015 at Workwell. Hopefully, they will be offering that. It would also be interesting to see if my perceived improvement in my physical function actually show up in the pre Cortene CPET. One of the strongest appeals of this study is that there is no uncertainty about getting the drug VS a placebo. Really hope to get selected.
I just participated in an exercise study and found the same thing – a saline infusion REALLY helped. I hit the bed afterwards and was fine the next day.
Good luck getting in the trial.
How is ‘Cortene’ pronounced – like ‘keen’ or like ‘ken’ ?
I live at to low an elevation to be considered for this trial. I’m not interested in waiting 50 fucking years for this drug to make it through the approval pipeline so that I can try it. How do I set up an N of 1 clinical trial to gain access to Cortene NOW?
Sorry Jacob – impossible. Cortene has been granted approval to test this drug based on the specifications of the trial; who is doing, where it is being done, how it is being done, what is being tested. If they were diverge from these specifications they would conducting an illegal trial of a drug and they would presumably be history.
If the trial is successful, though, I imagine the testing sites will expand for the next one. There aren’t too many major cities at 4,000 ft. elevation.
Loving the hypothesis and the study. Hopeful but not too hopeful – we have been burnt before!
I am very optimistic about their theory, that said: i don’t believe this drug will be a panacea. That is really impossible with this heterogeneous disease. For a subgroup with autonomic dysfunction like over sympathetic activity it could help.
And how much will it cost ? The Hep C cure costs $80,000 – certainly beyond the reach of most of us.
And how much might it cost? The Hep C cure costs $80,000.
As long as it proves to be a cure, I’d personally sell everything I own just to purchase it.
No kidding!
Wary of any trial conducted by Suzanne Vernon, ex-CDC, ex-CAA and co-author of the fraudulent CDC Reeves “CFS” Criteria.
I have similar concerns due to her history, especially as Reeves’s sidekick.
But maybe she is now doing penance for her earlier missteps. I hope so.
Please check out Suzanne Vernon’s research record here:
https://www.ncbi.nlm.nih.gov/pubmed/?term=Vernon%20SD%5BAuthor%5D&cauthor=true&cauthor_uid=29741589
Justin you remind me of Steve Bannon – throwing weird conspiracy laden bombs unattached to the facts.
Suzanne Vernon has done nothing but promote and fund biological research into ME/cFS for decades. Please check out her research record here – https://www.ncbi.nlm.nih.gov/pubmed/?term=Vernon%20SD%5BAuthor%5D&cauthor=true&cauthor_uid=29741589
I would put this and the Griffith University (Australia) research as the most promising CFS research at this stage. What do you think Cort?
While Ron Davis’s work is interesting I am yet to be convinced by it.
I have yet to be convinced of anything to tell you the truth but I would go with Cortene – super smart people – and Ron and all the people he’s gathered around him.
But who knows how this is all going to turn out? It could be Griffiths or someone we don’t even know about. 🙂
Cortene Inc.’s blog essential says ME is a mental illness (“functional somatic syndrome or bodily distress syndrome”):
“ME/CFS is one of a group of etiologically unexplained diseases, including:
fibromyalgia syndrome;
chronic lyme disease;
Gulf War Illness;
post-traumatic stress disorder;
atypical depression;
irritable bowel syndrome; and
others
Collectively, these have been argued to represent one underlying common basic syndrome, sometimes referred to as functional somatic syndrome or bodily distress syndrome.”
http://corteneinc.com/mecfs
What’s Functional Somatic Syndrome?
From Biomedcentral.com:
Somatic manifestation of distress: functional somatic syndromes and somatic symptom disorders
Somatic complaints are often related to chronic stress-related illnesses, but the diagnoses are not obvious in all cases. In some cases, patients could be classified with functional somatic syndromes. The syndromes are defined as several related disease-conditions that are characterized more by symptoms, suffering, and disability than by structural or functional abnormality. Typically, the functional somatic syndromes include irritable bowel syndrome, tension type headache, chronic fatigue syndrome, and fibromyalgia, all of which are frequently observed in psychosomatic medicine clinics. Also, the somatic complaints which are not fully explained by a medical condition could be diagnosed as somatic symptom disorders from a view of psychiatry. According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the symptoms must cause clinically significant distress or impairment in social, occupational, or other area of functioning.
https://www.biomedcentral.com/collections/fss
Justin – Just because others refer to those diseases as FSS’s doesn’t mean they are mental disorders. Cortene is trying a biological treatment to reverse what they believe is a biological problem. Please read the blog more carefully and stop seeing demons where there are none.
Cort – thank you so much for covering this so thoroughly!
Fingers definitely crossed with this!
Cort, on the Cortene Inc. web site they have a flow chart that says they tried CT38 on healthy subjects. Did Cortene talk to you about how it affected this group of people? I’d be curious to know more about that if you are talking to Cortene again. Thanks.
i am 59 year old male in southern north dakota with severe cfs after 2 surgeries i was hoping more places would try this trial for more of us but still am hoping they are on to something big does boston with the fibro vaccine trial think cortene will help or do they think fibro vaccine is the one i guess time will tell which one will work for us with this disease mine is more cfs so i am excited for cortene but was hoping another clinic would open up and maybe if it proves true i hope more clinics will open fast for all of us is patients over 60 not included this time or will they next time?
I assume this drug is just being trial led by US residents.
If the drug worked and got its approval etc, would it be available in the UK and other parts of the world.
The US seems so much further ahead than us here I the UK un,Es I’m missing something ?
And, currently there is more awreness and debate in parliament as a result of Jen Brea’s UnRest film which is fabulous. And so much advocacy work to ‘get ‘ research, the. Things like this pop up!
I do not understand why there is not more cohesion between existing trials and studies worldwide! For,if there were, then maybe charities and advocacy groups could move on into supporting just the funding of these initiatives.
Like,you said Cort, this is a little firm coming up with a great idea and possible ‘cure’ or at its worst an idea that could improve the lives of ME/CFS patients.
So many projects on the go ( mainly in the US it seems) like Ron Davies group,at Stanford. If they could,somehow all,work together surely it would save time and money. Or, are they all working on different things? Even if they are, I’m sure duplication of experiments is taking place worldwide.
Any thoughts?
The field does seem to be cohering around some general topics a bit – metabolomics, energy production, autoimmunity, blood vessel problems and that helps – one group moves the field forward in one area and then another expands on that. I see little evidence that these groups are working together – far from it actually, unfortunately.
cort johnson you think they will have results soon on the treatment from salt lake utah and do you think it would be soon to see other places so many other people like me with chronic fatigue syndrome would get the help from cortene the drug company to see if it help so many of us how long before they will know what if the drug would cure or treat fast would that move this faster JR
Hi Cort!
I’ve had CFS/Me for about 7 years and now my daughter has it too. It’s hard to watch her at her young age being taken down by this debilitating Desease.
I’m wondering if besides treating extreme fatique, would Cortene also help with the other symptoms like nausea and IBS, cognitive, dizziness and headaches. My daughter and I both experience these symptoms daily from CFS/ ME with IBS.
Also, can you recommend a doctor in Los Angeles, Ca. that treats patients with CFS/ ME with IBS?
Hope to hear from you.
Thank you,so much for the work you’re doing. I’m so grateful!
Best wishes,
Joanna Dierck
So sorry to hear about your daughter, Joanna. If Cortene works I would hope that it would also help those other symptoms because the HPA axis Cortene is trying to effect affects so many symptoms in the body.
Dr. Chia or Dr. Holtorf – both in Torrance, Ca would surely treat both. If Murray Susser more in LA proper is still practicing he would and I’m sure there are quite a few other integrative type doctors in LA who would treat both.
Health Rising has links to several doctor databases that might be helpful – https://www.healthrising.org/forums/resources/large-databases-for-finding-me-cfs-and-fm-doctors.120/.
Good luck!
Wish I could go but 4 months in Utah away from my son here in the UK isn’t an option. Wish they’d do more trials in the uk. Fingers crossed it works.
I have my fingers crossed and am hoping like all the others here that this starts a new way of thinking. I am on a DX of FM for 11 years now and am off several drugs that weren’t working anymore. Nothing natural has worked as yet. I’m off the ssri’s and coq-10 so I’d be good, but Ill let the others with CFS get involved. I so want help for CFS, FM and the others. Ugga, it can be a painful ride with so many issues. All good thought going to Cortene (interesting on the site, your blogs and of course your name?)
i have had cfs and fibro for 6 years had stem cell therapy in my spinal fluid for headaches but not a cure but has helped i heard they have started the cortene trial is that true and how long before we hear anything about how it is going? any news yet if it is working or helping i hope this is a cure for all of us so hard to keep living but hoping this is a major breakthrough
Hi,
I’am from Czech republick. My illnes started near a year ago. There is no help here, i’m still considered as healthy man since there is not help for people like me (Us). Everything started when I was scared of dying last year, my stomach was unfunctional for weeks and I had to work with it…. suddenly one day headaches started and my body was weak… Now I have every day muscle pain, head pain, iam weak, need to sleep and so on… you know. I’am really happy that there are people who are trying to find a cure. Please, can you inform me by email about your future tests and successes? Really need help.
Thank you so much.
Dan
Hi
You don’t know how happiness you have brought to my life just with your theory
Regardless the efectiviness of the drug just your explanation makes sense to my last ten years of exasperation attempting to figure out what was happening to my health
I am wired and tired since 10 years ago I suffered from bacterial infections that don’t cure
In a few months unexpected new symptoms were adding without any clue. Right now I can feel lucky except for the insomnia because I can deal an almost normal life
However my body’s response to the stress is over excited preventing me from sleeping and increasing my autonomous system automatically. The thing I hate the most is that several times doctors misunderstood these symptoms with psychiatry illnessess
I expect all your efforts can be rewarded and most of us can get access to the drug as soon as it can be possible
Thanks and good luck
i am going on 6 years cfs and fibro i live in north dakota do you think cortene trial will soon branch out to other places soon if cortene proves to do you know much cort more information about the trial hard to find much out and if it is helping i heard they started in july and will know more in october is all i know do you know more thanks JR
Well done Cort Cortene and everyone else involved. Long time coming!! this drug has the capacity to change so many lives. Rock on!! i have been tracking my symptoms for several years and reached the same conclusion – its all about the stress response – but what its actually doing and why was still a mystery. This puts it into perspective. But please is there any hope for getting it in the UK, in the meantime? I’d gladly take part in a trial, if I could. However I do live by the sea, so ‘living at an altitude of 3.5-5.5 000 ft’ might make it tricky!. Did anyone get why this condition is there?
hi ambuka, i think that the trial is taking place at a higher altitude so your body has to be adjusted to living at that type of altitude. it takes a while to adjust. when i moved to tahoe it took me 3 weeks to adjust.
i have severe cfs for 6 years just past the 6 year mark any results cort you can share about cortene if it looks hopeful and if anyone is getting some relief from cortene trial i sure hope so thanks JR
Very hopeful we get positive results soon! Cort, thanks so much for reporting on this. I was also at a university 13 years ago when acquired CFS, and burning candle at both ends. May we forge ahead with hope!
High hopes on this one, thanks Cort for this amazing information. I was going to try Valtrex for my CFS, even if it worked for just a year, would be a year symptom free waiting for a real cure. Although I read that Valtrex stops working for most of the cases within sometime. I am afraid it would somehow change my organism in some way that would prevent me from being cured as nobody knows exactly how Valtrex operates on this mysterious disease. Does anybody thinks this is a danger and I should avoid Valtrex? Better to wait for a cure than spending 2 nice years and never be cured again! Good luck for everyone on this fight, hope is what keeps us going. Regards
i have severe cfs and fibro after 2 surgeries 6 years ago had neck surgery fine then had simple back surgery then everything went wrong stiff neck sore throat and terrible headaches and exhaustion tried many things guaifenisen has helped a lot and steroid shots in my neck but valtrex was on it for 2 years no better so i quite many doctors said it was was with a try but not for me still waiting for something better had stem cell therapy in my spinal fluid the first of august much better but very exspensive hope this helps still no cure that i have tried still hoping and praying
Any news on this trial? How is it going? How are the patients doing?
The trial hit a small hiccup, was briefly halted and should begin soon.
Cort are there any updates as of January 1, 2019? People are starting to adk again. When did they restart the trial after it was halted? Probably took a while to get it back to the FDA.
Cort, have you heard any preliminary results on this trial?
I wrote to them to ask and they replied:
“… We did send out a brief update to our mailing list a couple of weeks ago. As you will read (below) we cannot provide much information while the trial is still underway. We appreciate your interest and your patience. We assure you we will release more detailed information as soon as practical. …
We recognize that many of you are anxious to know the results of our clinical trial investigating the safety and efficacy of CT38 for treating ME/CFS. As much as patients and the broader community deserve to know, with the trial still on-going we are limited as to the information we can release without compromising the integrity of the study.
The study is being conducted by Dr. Lucinda Bateman of the Bateman Horne Center in Salt Lake City, Utah. We anticipate the study will be completed in the next few months and should be able to share some preliminary results in Q2-2019.
We would like to take this opportunity to thank you all for your support and wish you a happy and healthy New Year.
Regards,
Michael
—
Michael Corbett
CBO, Cortene Inc.”
Thanks Sara! Nice to know some updates as it delayed a bit
Year 2011? Or 2019?
Comment
We’re now in the 3 month period promised for the delivery of the results of the trials. Any idea when this will be released?
Just talked to Cortene. The last patient exited yesterday and they (Cortene) have begun the close-out process which involves verifying the database, analyzing the data and then doing a write-up which will take at least a couple of months.
They sent an email update:
“Dear Friends of Cortene,
We are writing to let you know we have just completed our clinical trail in ME/CFS earlier this week.
As you may already be aware, the trial was based upon our theory that a single receptor was up-regulated in the brains of ME/CFS patients. It proposed a novel therapeutic approach, in which a short exposure to a novel peptide (CT38) was intended to down-regulate the receptor, leading to symptom improvement. Our small (n=14) trial utilized 3 treatments of CT38, at 4 different dose-levels (no placebo).
While we understand you are anxious to hear about our observations, it would be premature to share these until the data has been thoroughly reviewed and analyzed. We anticipate it will take 1-2 months to complete our analysis and write up our findings.
That said, we have found the data encouraging and believe they support moving toward a randomized, double blind, placebo controlled trial. This will require significant funding and we are currently pursuing various channels to support continued development.
We look forward to sharing more details soon and thank you for your continued support and patience.
Regards,
Michael”
Do you know if there have been more updates since this?
Wondering if you know when you will be able to reports the results. It’s now over 3 months. Lawrence.
L’hypothèse d’un stress chronique m’a toujours paru évidente. Les deux
neuro- psychiatres que j’ai consultés ont conclu à la même chose. Cela expliquerait aussi une prévalence de la maladie chez les femmes {surcharge de travail, pression morale, perturbateurs endocriniens et autres agressions…) Merci pour ces précieuses informations !
Il y a une erreur de transcription : les psychiatres ont conclu à la même chose est la bonne version
Cortene has posted prelim info on page:
https://corteneinc.com/development/
interesting that symptoms monitored improved by 25+%
and that improvement was quick (within days) for
the dose level with best symptom improvement.