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3BP may advance to clinical trials with NewGLAB Co.  

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Daniel
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11/09/2019 9:02 pm  

This website started as a result of my activity on Cancer Compass, on the 3BP related thread https://www.cancercompass.com/message-board/message/all,65701,511.htm?mid=759226#759226

And my first post on this website was on 3BP https://www.cancertreatmentsresearch.com/3-bromopyruvate/

I spent a lot of time researching this subject and how to convert it into a treatment option for us, and my wife used this often during our journey. We have seen good benefits from the drug and there was a lot of interest around the world, until one day in the summer of 2016 when a German clinic made a mistake and gave a very high dose of 3BP (4x to 7x higher) to their patients, leading to 3 deaths. That was such an unfortunate event for the patients involved but also for the name and progression of 3BP to clinical trials.

Fortunately, now there are recent news, indicating that on June 5 NewGLAB Co. has licensed 3BP rights from KoDiscovery LLC, that is Dr. Ko's company in US. (Dr. Ko is the scientist women who discovered the anti cancer effects of 3BP).

NewGLAB has incorporated its subsidiary NewG Lab Pharma Inc. in Maryland, the United States, to push forward its biotech business. NewGLAB Co. received the technologies for four diseases -- breast cancer, liver cancer, bladder cancer and melanoma, and submitted its clinical trial plans for potential anti-cancer candidate agent “NYH817100” to the Ministry of Food and Drug Safety in May 2019.

If NewGLAB Co. receives approval for the clinical test (expected around July and August), they plan to conduct the first clinical trials on 40 - 50 cancer patients at The Severance Hospital of Yonsei University starting with next year. (Ref.)


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Jcancom
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Jcancom
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12/09/2019 12:06 am  

Sorry, time was July 15, 2019 at 2:00 AM


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Jcancom
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12/09/2019 12:29 am  

Wow! Approaval granted by KDA and they're ready to start dosing next month? Are they kidding? 

https://www.cmocro.com/news_detail/Ministry+OKs+P1+Trial+Into+Haim+Bio%26%23039%3Bs+Metabolism+Antica/413309/index.html


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Daniel
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12/09/2019 12:31 am  

@jcancom

Yes J, thanks, now I remember. I just did not had time to react and now I saw the link on Cancer Compass and thought I should add the news here too. It's also good to know that the issue in Germany was the mistake of the doctor with the dose. This could now help 3BP to advance as it had nothing to do with its mode of action.


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Daniel
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12/09/2019 12:33 am  

@jcancom

Great finding! This is also an interesting statement: "Apart from the local trials, the company is working closely with Axcelead, a U.S. new drug development consulting firm, to receive a fast-track designation for phase 2 clinical trials"


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Jcancom
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12/09/2019 1:12 am  

D, this is what we have been waiting for all of these years! I thought it might never happen, but here we it is. We both know that they could see some very dramatic responses. If they do some selection with acetate PET, or perhaps some genotyping of circulating tumor samples, they could find the super responders. We know there must be a fair number of these super responders because we have at least 2 published patient reports in which there was massive responses. D, another thing I found interesting when I was looking around the Korean reports they mentioned that there have already been Korean 3-BP patients. I had not been able to find any English language reports so I was starting to take Korean lessons. Will be easier reading the English reports.  We will want to learn more about this NYH817100, what is the formulation. 

I greatly wish that they are fully aware of the power of 3-BP and have the appropriate medical interventions on hand. The liver patient, possibly the melanoma patients, the patients at Bracht probably others had fatal or near fatal responses to 3-BP. People need to be careful with 3-BP and properly manage the risk of TLS. For those patients that will have the most dramatic responses the risk would be especially large. If it were me, I would go in first with an acetate PET and see exactly where the MCT1s were open. This way you would  know before dosing how the tumor would likely respond. Going in blind would seem to me to be too dangerous.

This is such a great step for all those coping with cancer and for all our friends on this forum and elsewhere. As your article noted Korea appears to have fully embraced metabolic medicine as a pharmaceutical theme which is exactly what we have been talking about for the last while.

D, what happened to johan's avator? He had the best avatar of any with his Northern lights aura and now he's back to being Mr. Grumpy!  

 

 

 

 


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johan
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12/09/2019 2:29 am  
Posted by: @jcancom

 

"D, what happened to johan's avator? He had the best avatar of any with his Northern lights aura and now he's back to being Mr. Grumpy! "

 

LOL, who was I kidding J, I'm just a grumpy old man 🙂

 

 

 


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Jcancom
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12/09/2019 2:59 am  

johan, possibly so, though I have really embraced the Love as I have matured. I think D has played a considerable role in this transformation. We have focused our collective efforts through all these years and now after all of our prayers and dreams 3-BP is finally going to clinical trials! Yes! Yes! It is so amazing! We have all seen the melanoma's and liver's patient's report; 3-BP essentially rapidly completely shut down the metabolism of the entire tumor mass. We might only be days away from having another demonstration of this outcome.

Bring back the Love! Bring back the Love! Restore johan's avatar! We need more Love, we need more of that mystical connection to the universe that his avatar helped inspire! Less Grump, more light!

 


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johan
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12/09/2019 3:05 pm  

@jcancom

I'm back as pure light! 🙂

Have a great day!

 

 


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Jcancom
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13/09/2019 12:38 am  

johan, looking very fine. 3BP and the new avatar life is good, J


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Jcancom
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13/09/2019 12:51 am  

D, this is super exciting! We have been waiting years for this to move ahead. From what I can tell as soon as the Bracht verdict came down they moved forward (possibly even before). It would be difficult to say that Bracht was anything but very aggressive 3BP dosing. 

It will be uncomfortable for me to continue commenting on 3BP as it moves into clinical trials. The company is publicly traded and we have knowledge and insights that casual observers likely would not have. Things could happen fast and there could be substantial amounts of money floating around, probably best to stay quiet.

 

Any word on the formulation for NYH817100?   


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Daniel
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13/09/2019 1:32 am  

@jcancom

Hi J,

Yes, finally, after nearly 20 years from the discovery, and about 10 years from it's first application in humans with positive results, 3BP moves to a clinical trial.

I think we are allowed to comment anything about 3BP as long as we discuss mechanisms and it's application, and not politics. But I think we discuss so many of these aspects that we probably just don't have much to discuss. For me remains on of the drugs that contributed to the life and well being of my wife, while fighting cancer.

Today, while reading some literature I just came across this statement regarding adreno cortical cancer (the one we had to deal with): "1-year mortality rate for patients with metastases is 100%." http://www.discoverymedicine.com/Aymen-A-Elfiky/2019/08/diagnosis-and-management-of-advanced-adrenocortical-carcinoma/  or "those with stage IV disease (distant metastases) are unlikely to survive more than 1 year after the initial diagnosis." https://onlinelibrary.wiley.com/doi/full/10.1002/bjs.9743  

This remains me the contribution of the drugs we used to the life of my wife, that gave her 3 years, and 3BP had a major one. When she was feeling weak, she was asking for 3BP, and after she was feeling again full of energy. Only such effects and would be good enough to consider it as a drug for advanced cancer patients.

I would however not use it in early stage since we have many more things to learn about it.

Kind regards,
Daniel


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Jcancom
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13/09/2019 2:59 am  

D, I know I know! 3BP can and has induced massive responses. We have seen the published reports. And there has been 20 years of research to find all sorts of ways to amp it up. What would happen if there were a melanoma patient type response? That patient had enormous tumor burden and 3BP and paracetamol stopped it cold. They only provided supportive care; if they were to go full intensive care with a patient with a response like that, they might be able to pull them through even with such a massive tumor load. D, there could be a riot. There's social media, everyone's a reporter. This could unfold rapidly.  What if they were to open this up to compassionate use for very end stage patients? We have lacked a lot of the lab and diagnostic backup that would optimize treatment, what will happen now when medical infrastructure can be called upon?


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Jcancom
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14/09/2019 9:30 pm  

D, something that is also very exciting here is that an entire 3-BP universe can begin to emerge now. 3-BP is such a very strong lead product that almost anything would be a strong combination. Other companies could simply stay behind the block created by 3-BP. For example, something like a simple formulation of a GSH inhibitor that targets to tumors perhaps with chitosan etc. . There are so many of these out there. As soon as 3-BP reaches a certain point in development it would not be unexpected to find an entire pharmacy of such supporting treatments. As we have seen by themselves drugs such as paracetamol etc. might not be particularly powerful however in combination they can deliver very powerful results.


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Daniel
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14/09/2019 9:59 pm  

@jcancom

Hi J, you are right - and metabolic treatments may get more attention. Btw, do you know, are they going to treat the patients with systemic or local administration of 3BP? I am also curious to see what is the selection criteria for the patients joining the trial. It may be that they will select only patients with one blood type only.


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Jcancom
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14/09/2019 11:55 pm  

D, yes and from what I understand the company is positioning itself as the next wave of cancer treatment using metabolic approaches with other drugs. They would be on scene to see how patients might respond in combos. After all the years that we have talked about these different existing metabolic drugs we know how powerful that they can be in combination. It is still somewhat surprising how true that is. E.g., simply adding in a drug that in some places might even be OTC (paracetamol) with an extremely powerful treatment (3-BP) the entire tumor mass completely metabolically collapsed. Or as you noted recently possibly add in another GSH inhibitor namely FEN. Or E260. They treated with this very selective OXPHOS subunit 1 inhibitor, yet it was only when they added in ketogenic diet that there was a profound anti-cancer effect. It is fairly strange. The first drug might be only marginally successful (even something like 3-BP), though you add in a combo metabolic and you then see profound effects. We saw that with 3-BP that at Bracht there were a great many patients who apparently had very little benefit, yet at Dayspring where they add in other integrative treatments you see a string of successes.

This might be the trajectory for 3-BP, they might start off with monotherapy. Once it has cleared monotherapy they would then be able to use very powerful combos. Hopefully, not because that could take years and years.

D, it is frustrating because there is a substantial language barrier. There must be a great amount of information on the Korean language based internet, though it is not easy for me to understand. In some of the news reports there appeared to be mention of compassionate care patients that have already been treated and responded well. Any one out there with reach into these Korean sites please chime in!

Also with selection criteria, that is a very important issue. If this is going to be a slow and steady approach, then there might be no selection and probably not much response either. However, it is reasonable to expect that responder patients could be identified even before 3-BP treatment. Such selection is how many of the breakthough treatments have been advanced through trials (such as BRAF). With selection for 3-BP, you could start seeing the responses that have captivated us for all of these years. It really would not take too many patients who could be prospectively identified as a strong responder (e.g. melanoma patient) before  3-BP would essentially have to brought to patients on an emergency compassionate basis. People could become very freaked out by that. I would be very freaked out by that. The patient would essentially have a resurrection. I simply do not see how it would be possible to keep this contained if a 3-BP revival video went viral globally.

Not sure about the blood type angle; for me I would be thinking more about MCT-1 type, open MCT-1 is one of the only things that is needed. Yet, with neonc and POH perhaps even that is not needed.

D, this has been a hard struggle for you and all of our friends on the forum and elsewhere. Congratulations for all your efforts and devotions. Go team! 3-BP is such a strong drug that it might have happened on its own merits. Perhaps we are only flapping our wings and not having any influence. However, if I could turn back the clock, I would not have let the winds of chance guide this. I have the sense that all of our hopes and dreams and tragedies and prayers have contributed to finally seeing progress for metabolic medicine.   

Best Wishes, J

 

 

 

   

   

 

 

 

         


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Jcancom
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16/09/2019 3:04 pm  

critic on the compass forum has posted that NYH817100 is not actually 3BP; it is gossypol and phenformin. I had confused NYH817100 and 3-BP. This is a problem with the language barrier. Their formulation of 3-BP is on a somewhat slower timeline to start clinical trials.


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Daniel
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16/09/2019 7:43 pm  

@jcancom

Thanks for the update J! Here is teh pipeline with the status on the 3BP based drugs http://newglabpharma.com/rnd/clinical_development/ The best is to use this website in order to track the developments and the related news.


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Daniel
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16/09/2019 7:47 pm  

@jcancom

and here is the advisory board : ) http://newglabpharma.com/about_us/organization/

Given the people involved, it's possible that dr. Ko is (one of the) owners of this company.


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Jcancom
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17/09/2019 1:05 am  

Thank you D! I had not fully realized that Glab was the American subsidiary. The website describes all the ideas  that we have been discussing for the last number of years, so it is all quite familiar.

I had expected that the Korean component of the business would lead 3-BP into clinical trials. Now I am not so sure. Glab (America) has a list of cancer indications which are apparently preparing for trials labelled as KAT. Other clinical trials in Korea might or might not be run before those in States. Any idea what formulation KAT will be using?

    


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Daniel
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17/09/2019 1:21 am  

@jcancom

You are very welcome J. I think the answer to your question should be reflect by the patents of dr. Ko. I would expect anything they are going to do is already incorporated. But I haven't had the time to check if there is any new patent on 3BP from dr. Ko. If you find anything new, please let me know.


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dumbcritic
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07/01/2020 1:16 am  

Good to hear. Slightly off topic, but VDA-1102 is a PPI disrupter that allosterically binds to HKII, and causes it to dissociate from VDAC1 http://www.vidacpharma.com/pipeline/pipeline


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dumbcritic
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11/04/2020 2:43 am  

A new update: ''It has now been over a year since we have published an official KoDiscovery update for you, Dr. Ko’s supporters and followers. Some of you have contacted us to find out if any progress was being made and if Dr. Ko was still moving forward. The relative silence that we’ve had to maintain during 2019 has been to provide the time needed to bring together the various individuals with the skills, passion, resources and commitment to help facilitate her best path forward.  If you know anything about Dr. Ko, you can be certain that the reason for her lack of updates is NOT because she has been idle and waiting for something to happen. On the contrary, she has been busier than ever on multiple fronts to position KoDiscovery to take the next essential steps toward her ultimate goal, i.e., FDA clearance for her anticancer therapeutics.

While Dr. Ko is continuing her efforts to develop a new class of anticancer therapeutics by following FDA guidelines and regulations, she also has been working on a possible path to make her anticancer therapeutics available to cancer patients who are looking for additional treatment options. At this point, we are estimating that this alternative pathway will be feasible in the EU within this year in 2020!''

https://www.kodiscovery.org/so/fbN5bguQ_#/main


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