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Open letter to major chemical companies (BOL-148)

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G'mornin Jack and welcome to our community!

My, my...you did resurrect an old thread....it was started just a few months after our 4th annual patient conference in Portland in 2010...Bol-148 was the major topic and we were all very excited!!  Funding never came thru however and the compound is rarely discussed anymore!

I will message our founder and President, Mr Bob Wold and make him aware of your comment....curious as to the reason that CH has become personal to you?

Dallas Denny

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Jack,

As Denny says, a lot of us got our hopes way up for the availability of BOL through the company called Entheogen, which we were told year after year was on the verge of success, until it collapsed.  I won't do that again, but will wish you well if you want to give it a shot.  You expressions -- "quick, safe, reliable, affordable," etc. -- seem vastly optimistic to me, but maybe a smart, young, innovative, entrepreneurial fellow like yourself can make it happen.  

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13 hours ago, JF_RegenicaBio said:

 I'd love to continue the dialogue and see where I/we can be of assistance and get this drug in the hands of patients as quickly and efficiently as possible. Please email jfernandes@regenicabio.com if you're interested in discussing further. 

Strength and Optimism,

-Jack 

Hello Jack,
I will answer in email so we can discuss the situation and moving it forward.

To let everyone else in on what is currently happening, yes BOL-148 is again in the pipeline. What I learned long ago is that these pipelines run very slowly. It took psilocybin 17 years to get into a clinical trial.

As someone stated above regarding the report at our last conference, the patents are now in the hands of a new drug development company and negotiations are underway getting study approvals and FDA requirements on the steps they will require. (You can't just go to phase 3 clinical studies). 

Hope to have a better report on the status of BOL-148 at our conference coming up in Dallas in a few weeks.

Bob Wold

 

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4 hours ago, Dallas Denny said:

G'mornin Jack and welcome to our community!

My, my...you did resurrect an old thread....it was started just a few months after our 4th annual patient conference in Portland in 2010...Bol-148 was the major topic and we were all very excited!!  Funding never came thru however and the compound is rarely discussed anymore!

I will message our founder and President, Mr Bob Wold and make him aware of your comment....curious as to the reason that CH has become personal to you?

Dallas Denny

Thank you all for the responses and welcome. I am in touch with Bob and setting up a call to discuss the current status of the 2-Bromo-LSD program. At the very least, perhaps I can try and hold this new company accountable alongside you all and analyze things with you as they progress. 

There are a number of reasons why CH is personal to me and I'm happy to share more by pm. Broadly- I strive to be an advocate for those with debilitating disorders that have been abandoned by big pharma. My mother suffers from a serious disease with no adequate treatments, with a similar patient population to CH. 

2 hours ago, CHfather said:

Jack,

As Denny says, a lot of us got our hopes way up for the availability of BOL through the company called Entheogen, which we were told year after year was on the verge of success, until it collapsed.  I won't do that again, but will wish you well if you want to give it a shot.  You expressions -- "quick, safe, reliable, affordable," etc. -- seem vastly optimistic to me, but maybe a smart, young, innovative, entrepreneurial fellow like yourself can make it happen.  

I appreciate the kind words, but also can imagine and relate to your frustration. I have heard stories about Entheogen. I'm not here to bring false hope and have no clue if I can help. I'm just a patient advocate with a creative approach to drug development, a growing understanding of how the FDA works in practicality, and a team that is much smarter than I am. 

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4 hours ago, CHfather said:

I'm sure we all wish you the best, and appreciate that someone with your drive might be taking on the challenge. Bob W is the right guy to be talking to about the background and realistic prospects.  Thank you.

Thank you for that- I look forward to reading/learning more from the experiences that have been shared on this forum. 

I had the chance to speak by phone with Bob earlier today, and he seems like a great advocate (one with alot of insight and years of experience). He shared some really interesting stories with me. Some we laughed about, but others left me feeling really frustrated over the unique challenges faced by the CH community (like about those who lack access to sustainable prophylactic options and also score high on tests for PTSD, or elderly CH patients who struggle to access oxygen as a treatment).

Following our call, Bob told me he would put me in touch with the clinicians at Yale running a CH psilocybin study, and that he would introduce me to the individual out here in California who I think Bob said holds the BOL-148 patents and is trying to put things together for some preclin efforts.  I look forward to helping wherever I can and will post on the forum as things unfold. 

-J

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Bob is a hero to many of us.  And everyone who keeps it together while coping with CH is a hero to me, too.

There's no reason for me to be chiming in here, and absolutely no need for you to respond. I had a strong psychic investment in this (my daughter has CH) back then, and a financial investment in Entheogen (in the form of donations) that was not insignificant for me.  It's my understanding -- which could well be wrong in many places -- that there are two patents at issue. One is the patent for BOL-148 (2-bromo-LSD) itself, and one is the patent for using 2-bromo to treat CH. I know that John Halpern and Torsten Passie patented the latter around 2010, though I think maybe the patent holders are the institutions where they worked, Halpern at MacLean Hospital and Passie at a German hospital.  I think Harvard holds the BOL-148 patent because Albert Hoffman invented it there in the 1940s (but I know the patent for plain LSD was "assigned" to Sandoz).  

I have attached a little booklet that ClusterBusters put together a few years back.  Living with CH - 8.5x11 - 9-15-14.docx

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On 8/27/2019 at 7:05 PM, CHfather said:

I have attached a little booklet that ClusterBusters put together a few years back.  Living with CH - 8.5x11 - 9-15-14.docx

I have read the compilation and have shared with friends. Unbelievable and heartbreaking. Very grateful that you shared. 

I really hope we can figure out a way to facilitate some kind of access program to the 5ht2a drugs that seem to work in CH. Dealing with Sched-I is difficult but nothing is impossible. I reached out to the CEO of Savant HWP who presumably now holds the BOL Patents, and will hopefully hear back from him. 

In meantime- does anyone have experiences with the newly approved Alcanezumab-gnlm (Emgality)? I would love to hear. Hopefully it provides some with relief.

 

Edit: P.S. I am sorry to hear about Entheogen. It was irresponsible for them, in my opinion, to try and crowdfund a trial (if that is what happened). A full preclin program, necessary for BOL (multi species- ADME, GLP tox, CMC scale up, etc.) could cost millions before a single patient could be allowed to take a single dose in a trial. This is not to say there are not other ways to get the drug into the hands of patients, ASAP. 

 

 

 

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G'mornin Jack!

Thank you so much for your interest and desire to be of assistance to the clusterhead community!  Glad to see that you're in contact with our fearless leader and my personal hero!

I had the pleasure of meeting and visiting with Doc Halpern at our annual patient conference in Portland in 2010!  The thing that struck me most during those conversations was his compassion and desire to help all cluster headache patients....but he said he was driven most by the thought of sufferers in developing countries who had limited access to health care and medicine, no access to the internet.....folks who were destined to live their lives in agony with no chance of relief! 

As a man in his late 30's and early 40's, I lived that life for 7 years....reduced to rolling around on the floor at times, crying like a baby, begging my wife to blow my head off, enduring the exquisite pain that is clusters for an hour or more with each attack, and experiencing 4 or 5 individual attacks in a 24 hour time period!! 

Not a pretty picture and I'm so grateful that I found clusterbusters and alt meds......clusters now are more like an annoying inconvenience for me....and,  because I have this affliction, I've been blessed to meet and become friends with some of the kindest, most compassionate and caring folks on this planet!!

As to the efficacy of the CGRP meds like Emgality and Aimovig.....Eli Lilly has been a conference sponsor for several years so we've had a front row seat throughout the development and trials of Emgality......from what I've observed thus far in the online clusterhead support communities it is much like most other pharma meds for ch....works extremely well for some and poorly or not at all for others......but, it's progress and we'll take all of that we can get! 

Onward!!

Dallas Denny

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Denny, did you follow the Sewell vs. Halpern vs. Rick Doblin vs. bunches of other people saga that ensued when Halpern patented the application of BOL for CH?  Man, that was a juicy bunch of recriminations.  You almost had to pick sides, and I picked Sewell.  You can still find it on the internet, but I won't link to it.

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Yes, unfortunately I did Jerry!  TBH, my take from the whole deal was it was more about "bruised egos" than anything else!  Having met him, I was really quite fond of John and have the utmost respect for doc Sewell so I didn't take sides but was incredibly sorry to see dedicated cluster advocates at such odds with one another!

Dallas Denny

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8 hours ago, JF_RegenicaBio said:

It was irresponsible for them, in my opinion, to try and crowdfund a trial (if that is what happened).

Well, of course they were looking for major investors (which we were often told were just about to sign on), but they also did a crowdfunding thing, which a few friends of mine contributed to.  It did seem futile, even at the time.

You might know that people have found unscheduled substances that could be purchased "legally" and used to treat CH as psychedelics would treat it, but without the trip.  Perhaps not in the class of BOL in terms of efficacy, but very effective for a whole bunch of people (with the qualification that Denny mentioned -- a miracle for some; a bust for others). 5-MEO-Dalt was the big one, but the door got shut on that when companies stopped making/selling it. 

Just on a personal note, your work might have intersected with that of a friend of mine, Joe Moskal (of Naurex and Aptinyx), who has invented new compounds for treating brain and nervous system disorders, including rapastinel.  I played golf regularly with Joe over many, many years as the new molecule he invented for treating depression (no side effects, instant results) went through tens of million dollars in clinical trials.  Eventually sold to Allergan for a whole lot of money (which allowed Joe to join a country club and no longer have to play golf with a hacker like me), that substance "failed" some final trials and has been shelved. I'm directly aware of what it takes to bring pharma drugs to market. https://www.globenewswire.com/news-release/2019/07/12/1881976/0/en/Aptinyx-Salutes-Retiring-Chief-Scientific-Officer-and-NMDA-Receptor-Drug-Discovery-Pioneer-Joseph-Moskal.html 

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On 8/30/2019 at 5:25 AM, Dallas Denny said:

G'mornin Jack!

Thank you so much for your interest and desire to be of assistance to the clusterhead community!  Glad to see that you're in contact with our fearless leader and my personal hero!

Thank you for the welcome. I really hope to attend a CH conference in SoCal sometime soon. I have alot to learn as a rare disease advocate but can sense that the community here is really something- I hope take any lessons learned to other communities of those w/rare disorders who don't yet have infrastructure/unification. 

On 8/30/2019 at 8:02 AM, CHfather said:

Well, of course they were looking for major investors (which we were often told were just about to sign on), but they also did a crowdfunding thing, which a few friends of mine contributed to.  It did seem futile, even at the time.

Money is the top impediment to getting drugs to patients. It feels as if all I do is fundraise so I understand/empathize w/ the struggle. 

On 8/30/2019 at 8:02 AM, CHfather said:

Just on a personal note, your work might have intersected with that of a friend of mine, Joe Moskal (of Naurex and Aptinyx), who has invented new compounds for treating brain and nervous system disorders, including rapastinel.

Very promising NMDA partial agonist (like ketamine, without psychotomimetic effects). Replaced by Apimostinel which is under dev by same companies (Allergan+Naurex) as we speak. Not familiar w/Joe Moskal but sounds like an amazing connection and scientist. Would love to pick his brain. 

21 hours ago, Brain on fire said:

Hello Jack, just a quick thank you for your willingness to assist people like myself who have cluster headaches & people who care for someone who has them.

Thank you for the note- It's a pleasure to learn from you all and want to do anything I can to help. 

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3 hours ago, CJW said:

On the edge of my seat. waiting for this topic to continue.:unsure:

 

We must be on same wavelength- I was just about to post a small update.


Although I have no updates regarding BOL-148, I have gone back and forth with a company called Compass Pathways. 


There is an NDA in place, so can't disclose anything much. Will say that we are scheduled to chat more extensively on 9/18. I will also say that they have been developing psilocybin for use in treatment resistant depression and have enrolled a Phase IIb. I have heard psilocybin could be very promising for a certain group of patients. Will see what can be done. 

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@CJW thanks for sharing. Interesting Compass has not signed (sorry paste failed) 'The Statement on Open Science and Open....' Also interesting intellectual property was gained under non-profit status but transferred to their for profit. Appears there are a whole lot of snakes in the Compass Pathways pit.

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On 9/9/2019 at 4:04 AM, CJW said:

Read articles like those with a grain of salt- the journalists sometimes are the ones who are getting rich off of us (and our emotions). Also, here is how I see the money thing: As long as they bring us good medicines, we can work together to compensate the innovators. (And when a price gets too high, we can work together to get them lowered).


I don't know about the billionaire couple or any switch from non-profit to for-profit, but I do know that Compass seemed aboveboard when we spoke (although not too interested in Cluster). We planned to follow up in 3 months, but it does seem like they would only be open to a carve out if I put cash on the table, which is not typically how I do business with licenses+acquisitions (at this point in my career).  I still want to get access to BOL for you all but the person I was told holds the patents has no interest in collaboration or development. If anyone can put me in touch with the current company holding the BOL torch I really believe that I can conduct the preclin necessary to file an IND and get that into an expanded access program so you all can get it safely+legally (and quickly). I have contacts at Johns Hopkins and Yale and Cluster is really compelling- maybe they could initiate some studies if we were to submit a joint proposal to NIH or something. I just need more info on the current state of BOL. 

I'm heading to the U.K. on 11/9 to discuss collaborative research and development and to explore whether we can set up a small operation on behalf of my company in England. I'll meet with DSTL at Porton Down, the CEO of Salisbury NHS Trust, and Public Health England (PHE). If any of you have questions or concerns that I can reiterate on your behalf, please don't hesitate to shoot me an email (jfernandes@regenicabio.com). 

I'll then meet with BARDA and the FDA on 11/21, to discuss an antidote that we want to develop for children and agricultural workers who are poisoned by pesticides in the (mostly in the developing world). Again, if there are any small questions (these meetings are more specifically geared to antidotes) please let me know. 

I wish I had more resources to help. What I do have right now are great relationships, tenacity+persistence, and the desire to figure out some creative solutions for my friends, the clusterheads. 

Onward, 

-J

 

 

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Thank you again, Jack, for following up.  Your diligence is much appreciated.

I know nothing about patents. As I've said, I have thought that some part of Harvard holds the BOL patent.  Wouldn't Dr. Halpern or someone else associated with Entheogen know the answer to this? I see that there's a 2017 patent application for a method of creating 2-Bromo-LSD that doesn't involve using LSD to make the 2-Bromo. http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20180354940.PGNR.&OS=DN/20180354940&RS=DN/20180354940   But I have no idea whether the molecule itself is patented, or whether making it in this way circumvents the patent.

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There is a lot of banter about Compass.   They are seemingly trying to franchise and commodize the market promise of psychedelics.  The same thing is happening with ketamine in a more active way.  They can't patent psilocybin itself only a unique process to produce it.  We are seeing the same crap from insulin manufacturers right now.  These are money grubbing opportunistic folks like, but less useful, than toilet paper. 

 

The best models we have for psychedelic research and application are from MAPS and organizations like Beckley Foundation.  These forward looking organizations are a model for breaking down the barriers for bringing psychedelics to those who would benefit.  Proper training from places like the California Institute of Integral Studies help maintain the prudent education of therapists.  The whole psychedelic renaissance  with derail if the Timothy Leary approach repeats itself.  Folks will always be able to access psychedelic drugs if they are motivated but using them safely and properly is essential to effective intervention.  

 

Before I crap all over the Compass folks they do have some reputable souls working with them.  Bill Richards is an icon on par with Sewell and R Griffiths and he has helped with the "training of therapists" I would be shocked if his integrity were compromised.  That doesn't mean the front people aren't rats. It will be interesting to see how things transpire.

 

We all have to remember that even though in our hearts we "know" BOL, LSD, MM, psilocybin, 5-MEO DALT etc "work" to pacify  the demon we really don't know for sure which is why studies are so important.  I remain amazed the Yale study is still struggling to enroll.  The study is a model for anyone doing psychedelic research.

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