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Post by peppy on Jun 12, 2017 11:53:43 GMT -5
Although Afrezza may qualify as the most potentially disruptive innovation for the treatment of diabetes to come along in 20 years, I suspect that there have been many other innovative drug treatments that have faced the same resistance and, perhaps, have disappeared from the market. My favorite candidate for that is the BCG vaccine as Type 1 cure. There is some evidence that the BCG vaccine resets the immune system and even a phase 1 trial but funding the phase 2 trial has been a struggle. Hopefully that will change since they just presented their interim Phase 2 results at the ADA. This is the link to the Phase 2 trial and to an article in the Boston Business Journal. Needless to say this treatment is wildly unpopular with all the pharma sector (and probably the JDRF) since it costs almost nothing and cures all the Type 1 diabetics who are a huge profit center for them. MGH study shows vaccine could permanently reverse type 1 diabetes www.bizjournals.com/boston/news/2017/06/10/mgh-study-shows-vaccine-could-permanently-reverse.html
Two years after beginning a groundbreaking phase II clinical trial in reversing type 1 diabetes, researchers from Massachusetts General Hospital have discovered that a vaccine could permanently reverse the disease.
The five-year long, mid-stage clinical trial is looking at the bacillus Calmette-Guerin vaccine, an inexpensive and already generic vaccine that is used around the world to prevent tuberculosis.
Dr. Denise Faustman, director of the Massachusetts General Hospital immunobiology laboratory and principal investigator of the trial, said interim results show that unlike other vaccines that irritate white blood cells to prompt an immune response, the BCG vaccine affects white blood cells at the genetic level, regulating which genes are expressed and which are not. The body consequently stops producing the abnormal white blood cells responsible for the autoimmune disease, suggesting that the vaccine could permanently reverse type 1 diabetes.
“The vaccine actually resets your genes to restore normality,” Faustman said in an interview. “What it is showing is it’s not merely the vaccine you’re being given and it causes inflammation or an immune response. It’s actually working at the most basic DNA level to normalize expression of genes related to this abnormal immune response.”
The findings were presented Saturday during the 77th Scientific Sessions of the American Diabetes Association, one of the largest diabetes gatherings in the country. The findings not only bring a broader understanding to ongoing studies of the vaccine for type 1 diabetes, but also explain why the vaccine is so effective in treating other autoimmune disorders — from multiple sclerosis (studies with the vaccine are ongoing in Italy) to food allergies (studies with the vaccine are ongoing in Australia).
“It’s because the immune system hasn’t bent been reset correctly in childhood,” Faustman said. “There are trials using this vaccine to reverse allergies in Australia. It’s putting the environment back into people.”
Used in China, Africa and South America to vaccinate against TB, the BCG vaccine has been utilized 4 billion times over the last 100 years. Last year alone, 100 million doses of the vaccine were given to newborns. Because TB isn’t common in the U.S., children here do not receive the vaccine.
The microorganism originates from the dirt. Faustman said the rise of autoimmune disorders, and the increase of food allergies and gluten intolerance, is tied to the fact that humans no longer interact with the dirt in the way they once did.
Clinical trials with the vaccine are ongoing. The lab has nearly recruited all of the 150 people for Phase II clinical trials, which have been funded largely by support from the Iacocca Family Foundation. Faustman’s lab is looking for the final $5 million of the $25 million necessary to finish the trial.
The goal of the latest clinical trial is to replicate results from the first phase of clinical trials, as well as analyze the dosing necessary to make the vaccine work quickly. Faustman’s lab has also conducted six-years of follow-up on Phase I patients within the latest study to see how patients are doing long-term. The results from those findings will be published by the end of the year.
Results from Phase 1 clinical trials, published in 2012, showed that the treatment eliminated defective immune cells that attack the pancreas, temporarily restoring the ability of the pancreas to produce small amounts of insulin. The data from that initial study only tracked patients over 20 weeks.
Success would be groundbreaking. Using an inexpensive vaccine that's already generic to reverse juvenile-onset diabetes would save the health care system billions of dollars and save patients from lifelong complication associated with the disease. According to the U.S. Centers for Disease Control and Prevention, annual medical costs for children with either type 1 or type 2 diabetes is $9,061 —
about six times the amount for youths without the disease.
While most vaccines are used preventatively, Faustman envisions making this vaccine available to anyone suffering from an autoimmune disorder.
“We’re trying to figure out the dose that’s effective and how significant of an impact it can have,” Faustman said. ----------------------------------------------------------------------------------------------------------------------------------------------------------------- aged, you know me well enough to know I would run with this. interestingly, macrophage do seem to be involved. the higher the blood glucose the higher the macrophage counts in fat. found 1/3 of the fat stores are macrophage?... I need to watch it again. I think that data was from type two. not sure it is related. however, www.youtube.com/watch?v=U_Gcq8bEUq8
if this is true, another blow to my understanding of humanity.
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Post by peppy on Jun 12, 2017 13:17:33 GMT -5
Aged, I know it is well with in your skill set to look at the study protocol and tell a physician you want the TB vaccine and use the same protocol schedule of the study.
just sayin. can you get the study protocol to display online, please, let's look?
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Post by agedhippie on Jun 12, 2017 13:47:29 GMT -5
aged, you know me well enough to know I would run with this. interestingly, macrophage do seem to be involved. the higher the blood glucose the higher the macrophage counts in fat. found 1/3 of the fat stores are macrophage?... I need to watch it again. I think that data was from type two. not sure it is related. however, www.youtube.com/watch?v=U_Gcq8bEUq8
if this is true, another blow to my understanding of humanity.
I cheated, I knew you would run with it. She has been running this project on a shoestring for about ten years now. I am fairly convinced that if she wasn't who she is, and if the Iacocca Family Foundation were not behind her this would all be over by now. It's foundations and families like these that are focused on a cure rather than a treatment and have command of huge sums of money for research that I am cheering on (well I have an interest  . |
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Post by agedhippie on Jun 12, 2017 13:48:49 GMT -5
Aged, I know it is well with in your skill set to look at the study protocol and tell a physician you want the TB vaccine and use the same protocol schedule of the study. just sayin. can you get the study protocol to display online, please, let's look? Don't know if I can get the protocol but I will give it a go. |
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Post by sayhey24 on Jun 12, 2017 20:05:53 GMT -5
Although Afrezza may qualify as the most potentially disruptive innovation for the treatment of diabetes to come along in 20 years, I suspect that there have been many other innovative drug treatments that have faced the same resistance and, perhaps, have disappeared from the market. My favorite candidate for that is the BCG vaccine as Type 1 cure. There is some evidence that the BCG vaccine resets the immune system and even a phase 1 trial but funding the phase 2 trial has been a struggle. Hopefully that will change since they just presented their interim Phase 2 results at the ADA. This is the link to the Phase 2 trial and to an article in the Boston Business Journal. Needless to say this treatment is wildly unpopular with all the pharma sector (and probably the JDRF) since it costs almost nothing and cures all the Type 1 diabetics who are a huge profit center for them. What has been the funding issue? The JDRF has been involved to some degree. Is it Denise Faustman needs help in fund raising? I don't know anything about her work but based on the JDRF article BCG itself is not going to work as the results only last a week. It rather appears tumor necrosis factor is the active agent killing the T cells. It seems she still has some lab work to do to figure out exactly what the TNF is doing. Maybe she already knows. If she does then the question is, if its really TNF if given in higher doses than what BCG is producing would this have a more lasting effect? What happens after a week? IMO, BP is not going to pay for this. Who would Sanofi and Nova sell Lantus and Tresiba too? There are plenty of grants to pay for this type of lab work but based on the JRDF article I don't think taking BCG to P2's makes much sense. Maybe there is more than whats in the article? www.jdrf.ca/news-and-media/in-the-news/human-study-re-ignites-debate-over-controversial-diabetes-cure/ |
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Post by agedhippie on Jun 12, 2017 21:18:19 GMT -5
My favorite candidate for that is the BCG vaccine as Type 1 cure. There is some evidence that the BCG vaccine resets the immune system and even a phase 1 trial but funding the phase 2 trial has been a struggle. Hopefully that will change since they just presented their interim Phase 2 results at the ADA. This is the link to the Phase 2 trial and to an article in the Boston Business Journal. Needless to say this treatment is wildly unpopular with all the pharma sector (and probably the JDRF) since it costs almost nothing and cures all the Type 1 diabetics who are a huge profit center for them. What has been the funding issue? The JDRF has been involved to some degree. Is it Denise Faustman needs help in fund raising? I don't know anything about her work but based on the JDRF article BCG itself is not going to work as the results only last a week. It rather appears tumor necrosis factor is the active agent killing the T cells. It seems she still has some lab work to do to figure out exactly what the TNF is doing. Maybe she already knows. If she does then the question is, if its really TNF if given in higher doses than what BCG is producing would this have a more lasting effect? What happens after a week? IMO, BP is not going to pay for this. Who would Sanofi and Nova sell Lantus and Tresiba too? There are plenty of grants to pay for this type of lab work but based on the JRDF article I don't think taking BCG to P2's makes much sense. Maybe there is more than whats in the article? www.jdrf.ca/news-and-media/in-the-news/human-study-re-ignites-debate-over-controversial-diabetes-cure/You probably need to read the research and not a five year old news report from Reuters (which is what that JDRF article was). They have been working on this for over a decade and have serious Foundations backing them after the Phase 1 results. The mechanism is correcting a gene expression error in the Treg cells. The Phase II trial uses 2 injections every 4 weeks for the first year and then annual injections for the next 4 years. Will it work? Who knows but it's real enough to attract $20 million of funding from Foundations who tend not to throw that sort of money about lightly. I would love to get my hands on their ADA paper. |
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Post by sayhey24 on Jun 13, 2017 5:18:01 GMT -5
What has been the funding issue? The JDRF has been involved to some degree. Is it Denise Faustman needs help in fund raising? I don't know anything about her work but based on the JDRF article BCG itself is not going to work as the results only last a week. It rather appears tumor necrosis factor is the active agent killing the T cells. It seems she still has some lab work to do to figure out exactly what the TNF is doing. Maybe she already knows. If she does then the question is, if its really TNF if given in higher doses than what BCG is producing would this have a more lasting effect? What happens after a week? IMO, BP is not going to pay for this. Who would Sanofi and Nova sell Lantus and Tresiba too? There are plenty of grants to pay for this type of lab work but based on the JRDF article I don't think taking BCG to P2's makes much sense. Maybe there is more than whats in the article? www.jdrf.ca/news-and-media/in-the-news/human-study-re-ignites-debate-over-controversial-diabetes-cure/You probably need to read the research and not a five year old news report from Reuters (which is what that JDRF article was). They have been working on this for over a decade and have serious Foundations backing them after the Phase 1 results. The mechanism is correcting a gene expression error in the Treg cells. The Phase II trial uses 2 injections every 4 weeks for the first year and then annual injections for the next 4 years. Will it work? Who knows but it's real enough to attract $20 million of funding from Foundations who tend not to throw that sort of money about lightly. I would love to get my hands on their ADA paper. OK - can you point me to the papers you recommend. I should have some time today. If what she has is more than lab hype you have my interest. $20M may not be that hard if it is not research hype. Have you talked with her? |
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