Fda Approves The Second Phase Of Dr. Denise Faustmans Clinical Testing Of A Type 1 Diabetes Vaccine
News FDA Approves The Second Phase Of Dr. Denise Faustmans Clinical Testing Of A Type 1 Diabetes Vaccine FDA Approves The Second Phase Of Dr. Denise Faustmans Clinical Testing Of A Type 1 Diabetes Vaccine Published 2 weeks ago by Albert McKeon in Diabetes, Donor Recognition, and Medical Research. Click here to read original article . After nearly 20 years of research, Massachusetts General Hospital researcher Denise Faustman, MD, PhD, has made a promising advance in her quest to cure type 1 diabetes. Her team recently passed a major threshold by receiving FDA clearance to test a large group of long-term diabetics with an old tuberculosis vaccine that could also combat type 1 diabetes. The phase 2 trial of the bacillus Calmette-Gurin (BCG) vaccine was announced last month at an American Diabetes Association conference in Boston, an exciting next step in Dr. Faustmans pursuit of a therapy to reverse the disease. While thrilled about receiving the FDAs blessing, Dr. Faustman and her staff didnt celebrate for long. Theyre already accepting applications for patients who want to participate in the five-year trial that starts this summer. Were in full action mode. The phones are ringing off the hook, Dr. Faustman says. As many as 100,000 diabetics are expected to volunteer for the clinical trial, but the MGH Immunobiology Laboratory will winnow the number of participants to 150 adults, with some receiving BCG and others taking a placebo. The FDA approved the phase 2 trial essentially by certifying MGHs use of BCG that will be produced by the Japanese government. Academics usually dont have to look around the world to find a drug supply chain, Dr. Faustman says, but her lab in collaboration with the Bill & Melinda Gates Foundation and the World Health Organization searched as Continue reading >>
Vaccine Against Diabetes Has Been Announced, World Celebrating
Vaccine against Diabetes has been announced, world celebrating The Vaccine Against Diabetes Has Been Officially Announced And The Entire World Is Celebrating In the United States alone, 1.25 million individuals suffer from type 1 diabetes. A vaccine used over 100 years ago for tuberculosis (bacillus Calmette-Guerin) has actually shown pledge in reversing this illness. This vaccine is now typically utilized for treating bladder cancer and is considered to be safe. The Vaccine Versus Diabetes Has Been Formally Revealed And The Entire World Is Celebrating The News!An announcement made yesterday at the 75th Scientific Sessions of the American Diabetes Association said that the FDA will evaluate the vaccine on 150 people who are in an innovative stage of type one diabetes. The body of an individual with type 1 diabetes does not produce insulin due to the immune system damaging the cells that develop insulin. T cells are produced, and these cells produce issues in the pancreatic islets, where insulin is produced. The vaccine works by removing these T cells. Clients with diabetes injected with the vaccine saw a boost in the levels of a compound called tumor necrosis factor. The increased level of TNF in the system ruins the T cells that are impeding the production of insulin. In a previous trial, patients were injected with the tuberculosis vaccine twice within a four-week amount of time. The results revealed that the harmful T cells were gone, and some people even started to produce insulin by themselves. Dr. Denise Faustman, director of the Massachusetts General Healthcare facility Immunobiology Laboratory in Boston, is extremely excited about the outcomes the BCG vaccine has been revealing. In the phase I (preliminary) trial we demonstrated a statistically considerable act Continue reading >>
- The Vaccine Against Diabetes Has Been Officially Announced And The Entire World Is Celebrating The News!
- The Vaccine Against Diabetes Has Been Officially Announced And The Entire World Is Celebrating The News!
- Vaccine to Reverse Diabetes Has Been Officially Announced and the Whole World is Celebrating the News!
Bcg Vaccine - Can It Reverse Type 1 Diabetes Mellitus?
Type 1 diabetes is an autoimmune disease characterized by the destruction of pancreatic islet cells , which are critical to glucose metabolism by producing insulin,by autoreactive T cells. These lymphocytes mistakenly attack pancreatic islet cells as if they were a foreign body, like a viral or bacterial infection. In addition, regulatory T-cells (which are often called Tregs) modulate the immune system and would generally reduce the effect of an autoimmune attack. Tregs act like brakes that normally prevent the mistaken attacks, like on the pancreatic islet cells, without affecting the whole immune system. A branch of diabetes research has suggested that Tregs could be the key to treating type 1 diabetes. Once the pancreatic islet cells are damaged, they no longer produce hormones, especially insulin , that help regulate the levels of blood glucose. Without insulin, the blood glucose levels increase rapidly leading to long-term damage to eyesight, kidneys, limbs, heart and other organs. In fact, type 1 diabetes can be deadly if the uncontrolled blood sugar leads to a life-threatening condition called diabetic ketoacidosis . Without regular insulin injections, a patient has little chance of living beyond a short period of time, and even then it could be a horrifically painful demise. It is not known what causes this autoimmune disease, although there is strong evidence that genetics is the most important factor. However, other things may be implicated, like vaccine-preventable diseases , which could be important co-factors in the development of the disease. Just to be clear, vaccines are not linked to type 1 diabetes . Currently, there are no known cures for type 1 diabetes. The only treatment for the disease are regular injections of human insulin, manufactured from g Continue reading >>
Dr. Faustman’s Type 1 Reversal Trial Seeks More Participants
Denise Faustman, MD, PhD, is the Director of the Immunobiology Lab at Massachusetts General Hospital and an Associate Professor of Medicine at Harvard Medical School. She was interviewed by Diabetes Daily about 9 years ago when she was about to begin human clinical trials based on the results from her successful mice-curing BCG vaccine. Mice are certainly cured from type 1 diabetes a lot these days, but in clinical trials, they are often given type 1 diabetes through an interventional chemical administration. It is notable that Dr. Faustman cured mice who had naturally occurring type 1 diabetes which is rooted in the autoimmune attack on the insulin-making beta cells. The BCG vaccine, or Bacillus Calmette-Guerin vaccine, is about 100 years old and used around the world, though no longer in the United States, for the prevention of tuberculosis. It is being studied in various labs around the world due to its ability to spark the production of tumor necrosis factor, a hormone that kills disease-causing autoimmune cells. Without these bad autoimmune cells the pancreas’s beta-cell function may be theoretically restored. Dr. Faustman spoke frankly with me over the phone. She explained how in global studies, the effects of this treatment is being shown to occur in 2-3 years after treatment versus a few weeks. For example, promising results have been shown involving the BCG vaccine and another autoimmune disease–multiple sclerosis. Phase II of Trial in Process Dr. Faustman’s lab reported positive results from their Phase I study in 2012 and are now in Phase II of that study trying to repeat the tests with a larger number of participants. Phase II should be completed in 2023. Dr. Faustman said that the endpoint of this trial is unique because it is going to focus on the lo Continue reading >>
Repeat Bcg Vaccinations For The Treatment Of Established Type 1 Diabetes
The purpose of this study is to see if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on Type 1 diabetes. Published Phase I data on repeat BCG vaccinations in long term diabetics showed specific death of some of the disease causing bad white blood cells and also showed a short and small pancreas effect of restored insulin secretion. In this Phase II study, the investigators will attempt to vaccinate more frequently to see if these desirable effects can be more sustained. Eligible volunteers will either be vaccinated with BCG in a repeat fashion over a period of four years or receive a placebo treatment. The investigators hypothesize that each BCG vaccination will eliminate more and more of the disease causing white blood cells that could offer relief to the pancreas for increased survival and restoration of insulin secretion from the pancreas. Study Type : Interventional (Clinical Trial) Estimated Enrollment : 150 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment Official Title: Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes Study Start Date : June 2015 Estimated Primary Completion Date : July 2020 Estimated Study Completion Date : July 2023 Resource links provided by the National Library of Medicine U.S. FDA Resources Arm Intervention/treatment Experimental: Bacillus Calmette-Guérin 2 BCG vaccinations spaced 4 weeks apart during the first year and then 1 vaccination every year for the next 4 years Biological: Bacillus Calmette-Guérin 2 BCG vaccinations spaced 4 weeks apart during the first year and then 1 vaccination every year for the next 4 years Placebo Comparator: Saline Continue reading >>
How Bcg Vaccine Works To Stimulate The Reversal Of Type-1 Diabetes
Researchers from the Faustman Laboratory at Massachusetts General Hospital, who successfully carried out Phase I of bacillus Calmette-Guérin (BCG) human clinical trials, presented the interim results of their phase II research at the 77th Scientific Sessions of the American Diabetes Association on June 10. The researchers have previously found that proper BCG treatment could result in permanent reversal from the autoimmune disease. During the presentation, principal investigator Dr. Denise Faustman offered an explanation with regard to how the BCG potentially works to prevent and treat type-1 diabetes. How BCG Vaccine Works Against Type-1 Diabetes According to Dr. Faustman, the effectiveness of the BCG vaccine lies in how it encourages a permanent increase in regulatory genes that prevent an autoimmune response. Their findings show that the BCG vaccine targets rogue T-cells that mistakenly attack insulin secreting islets. When the attacks let up, the immune system gets a much need reboot to enable cells to properly function and Tregs, the immune system "brakes" which should have been able to stop rogue cells, would be able to function properly again and stop further attacks. "The vaccine actually resets your genes to restore normality," Dr. Faustman said. BCG Vaccine Human Clinical Trials Dr. Faustman's research team was the first to confirm positive results with using the BCG vaccine to target abnormal cells that cause autoimmune diseases. Specifically, mice with advanced type-1 diabetes fully recovered from the disease using the treatment. Findings from the Phase I trials, which concluded in 2012, show that the vaccine BCG may be capable of fully restoring balance in human genes to stimulate remission from Type-1 diabetes, but administration of the vaccine only happe Continue reading >>
Type 1 Diabetes Reversal May Be Possible With Tb Vaccine
Type 1 Diabetes Reversal May Be Possible with TB Vaccine BCG therapy may change current methods to restoring and enhancing immune response This article is part of MPR's coverage of the American Diabetes Association's 77th Scientific Sessions (ADA 2017) , taking place in San Diego, CA. Our staff will report on medical research and technological advances in diabetes and diabetes education, conducted by experts in the field. Check back regularly for more news from ADA 2017 . According to data from a recent Phase 1 trial directed by the Massachusetts General Hospital Immunobiology Laboratory, the vaccine bacillus Calmette-Gurin (BCG) may have the potential to reverse type 1 diabetes. This interim report was presented at the 2017 American Diabetes Association 77th Scientific Session, San Diego, CA, by Denise Faustman, MD, PhD and her teamthe first to document the reversal in mice. Type 1 diabetes is an autoimmune disease presenting as an overall loss of pancreatic islets which are responsible for the endocrine activity of the pancreas. Autoreactive T cells are not adequately controlled by regulatory T (Treg) cells, and destroy glucose-sensitive beta cells which produce insulin. The approach to reversing autoimmune irregularity has been theorized and in development in previous studies. "We and other global efforts have known for some time that restoring beneficial Treg cells might halt the abnormal self-reactivity in type 1 diabetes and other autoimmune diseases, but therapies to restore this immune balance have not achieved long-lasting results, stated Dr. Faustman. Similar A1C Reductions, Less Hypoglycemia with Xultophy Compared to Basal-Bolus Tx BCG therapy may change current methods to restoring and enhancing immune response. In international studies, repeat vaccinations Continue reading >>
Human Study Re-ignites Debate Over Controversial Diabetes "cure"
* TB vaccine seen attacking disease-caused autoimmunity * Long-term type 1 diabetes patients produce insulin again * Effect lasts for a week, further trials to boost dosing NEW YORK, Aug 8 (Reuters) - A controversial experimental cure for type 1 diabetes, using a tuberculosis vaccine invented a century ago, appears to temporarily vanquish the disease, according to a study in a handful of patients led by a scientist long criticized by her peers. There is no guarantee the results from this early-stage trial, published on Wednesday in the journal PLoS One, will stand up in larger studies, which are now under way. Other diabetes researchers criticized it for going beyond the evidence in its claims about what caused the observed effects. If the findings do hold up, however, they would mean that the generic bacillus Calmette-Guerin (BCG) vaccine, in use since 1921, can regenerate insulin-secreting cells in the pancreas, whose loss causes the disease. "We think we're seeing early evidence of effectiveness," said immunology researcher Denise Faustman of Massachusetts General Hospital, who led the trial. "This simple, inexpensive vaccine attacks the autoimmunity underlying type 1 diabetes." That autoimmunity, in which the immune system turns on the body's own cells rather than invaders, destroys insulin-producing "islet" cells in the pancreas. As a result, patients have to regularly inject themselves with insulin to control their blood sugar, or glucose. Also known as juvenile diabetes, the disease affects as many as 3 million Americans, estimates JDRF (formerly the Juvenile Diabetes Research Foundation). Another 30,000 people in the United States, half of them adults, are diagnosed every year with the disease, which has long been considered incurable. "We found that even low do Continue reading >>
Endocrine Society Reading Room | Type 1 Diabetes Vaccines Move Through Research Pipelines | Medpage Today
Type 1 Diabetes Vaccines Move Through Research Pipelines Human trials for separate vaccines in U.S. and Europe, but still not ready for prime time This Reading Room is a collaboration between MedPage Today and: Justin B. Echouffo Tcheugui MD, PhD Brigham and Women's Hospital Boston, MA Type 1 diabetes is considered an autoimmune disease. The worldwide increase in its incidence has sparked research efforts geared toward developing interventions to prevent or halt the condition. Indeed, two separate vaccines for type 1 diabetes are being explored in human clinical trials. The two vaccinal options, including bacillus Calmette-Guerin (BCG) and an unnamed vaccine, are being tested in the US and Finland, respectively. At this stage, their therapeutic potential remains only putative. Although the BCG may possess curative and preventive potentials, its assessment has so far focused on its ability to reverse type 1 diabetes, including among those with long-standing disease. BCG acts by increasing the levels of the tumor necrosis factor (TNF) protein, thus reducing the number of autoreactive T cells and increasing the so called good T cells or Tregs. The latter cells would then reset the immune system and thereby stopping beta cells destruction with a restoration of insulin production. The ongoing human trial of BCG is testing against placebo, the effect of two injections four weeks apart during the first year followed by one injection each year for the next four years. The unnamed vaccine aims at preventing type 1 diabetes. After being found to be effective and safe in mice, it is currently being tested in humans. Like the BCG, it also affects autoimmunity, but targets the coxsackievirus B1 (CVB1), an enterovirus linked to an increased risk of autoimmunity and known to destroys Continue reading >>
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J Ayub Med Coll Abbottabad 2017;29(1)
1 EDITORIAL BCG VACCINE - AN INNOVATION FOR DIABETES TREATMENT IN PAKISTAN? Zohair Lilani, Afrinah Ahmed, Rabbia Tazeem, Erum Naeem Karachi Medical and Dental College, Karachi-Pakistan Pakistan is a third world country with very small health budget and a diabetes prevalence of about 6.9% among adults, accounting for over 86,000 deaths. If phase 2 trials testing the ability of BCG to reverse type 1 Diabetes become successful in remission of insulin from pancreas this would be very useful to treat diabetes in Pakistan as BCG is readily available, less expensive, has less storage problems, less side effects and doesn't require skilful person to administer. Keywords: Diabetes; BCG; Pakistan J Ayub Med Coll Abbottabad 2017;29(1): According to International Diabetes Federation's published statistics about diabetes in Pakistan in 2015, Pakistan has a diabetes prevalence of about 6.9% among adults, accounting for over 86,000 deaths.1 IDDM (also known as diabetes type 1) is an autoimmune disorder in which body's own T cells react with beta cells of pancreas resulting in depletion of insulin which is responsible for glucose uptake in the cells.2 Diabetes also forms a major risk factor of MI and increases mortality due to masking of alarming symptoms. It also leads to serious irreversible complications like neuropathy, retinopathy etc. According to Phase 1 randomized control trials, which was published in the August 8 20123, the BCG (Bacillus Calmette- GuÃ©rin) vaccine induces the production of TNF which eliminates auto reactive "bad" T cells resulting in remission of insulin production from the pancreas. Another study in July 1 20014, also demonstrated reversal of type 1 diabetes by restoration of endogenous beta cell function by inducing TNF alpha through BCG vaccine. On the o Continue reading >>
Practical Cure Project Update: Bcg
Summary: The BCG Human Clinical Trial Program is one of twelve T1D Practical Cure projects currently in human trials. A phase I trial was completed in 2012 and confirmed the safety of using BCG in patients with established T1D. An eight-year follow-up report on phase I participants is expected by the end of 2017. A phase II 150 person trial hoping to demonstrate the effectiveness of BCG in reversing T1D in established adults is currently recruiting. There are 25 more patient slots available for type 1 diabetics interested in participating in the trial. This is the second in a series of reports detailing individual research projects currently in human trials with the potential to deliver a Practical Cure. The twelve Practical Cure projects that will be profiled were identified and summarized in the 2016 State of the Cure for Type 1 Diabetes, which was published during the first week of January 2017 (Click here to view). This report focuses on the BCG Human Clinical Trial Program at Massachusetts General Hospital and features an interview with the lead researcher Dr. Denise Faustman. The program is testing BCG (bacillus calmette-guérin), a drug currently used as a vaccine for tuberculosis, as a possible cure or permanent reversal for established type 1 diabetes. BCG is unique in that it is an inexpensive generic drug which, if approved, would be a cost-effective treatment for type 1. The trial is funded entirely by private philanthropic donations and is not supported by any for-profit research efforts or JDRF. BCG Background Faustman’s hypothesis is that the administration of BCG can stop the autoimmune attack in T1D and enable the restoration of near normal HbA1c values in part from beta cell regeneration. The rationale for why this works, according to Faustman, is ba Continue reading >>
Get Information On Our Clinical Trials
BCG Human Clinical Trials Program The Faustman Lab is conducting clinical trials in long-term type 1 diabetes through the BCG Human Clinical Trial Program. This program is testing Bacillus Calmette-Guérin (BCG), an inexpensive generic drug that temporarily elevates levels of TNF (a signaling protein involved in the body’s immune responses), to see if it will benefit patients living with type 1 diabetes by eliminating the disease-causing T cells that attack and destroy the insulin-secreting cells of the pancreas. Under the direction of Dr. Faustman and David Nathan, MD, director of the MGH Diabetes Center, a double-blind, placebo-controlled Phase I human clinical trial was conducted and demonstrated that BCG vaccination is not only safe in individuals with advanced type 1 diabetes, but may also be effective in reversing long-term disease. In the study, BCG was administered to adults who had been living with type 1 diabetes for an average of 15 years. Treatment helped eliminate the defective T cells that mistakenly attack and destroy the insulin-producing cells of the pancreas, also temporarily restoring the ability of the pancreas to produce small amounts of insulin. The results of the Phase I study were published in 2012. Major Findings from the Phase I Trial The major findings from the Phase I study were: • The BCG vaccine with multi-dosing was safe in advanced type 1 diabetes. • Although the drug was given in relatively small doses, we saw targeted death of the “bad” T cells that attack the insulin-secreting islets, an early sign that BCG has the potential to stop the autoimmune attack and successfully reverse disease. • In people living with diabetes for an average of 15 years, there was a transient increase in/restoration of pancreatic insulin secretion Continue reading >>
Bcg Vaccine Could Restore Proper Immune Response In Type 1 Diabetes
The results of a new clinical trial testing a type 1 diabetes vaccine have been presented at the 75th Scientific Sessions of the American Diabetes Association. The genetic vaccine bacillus Calmette-Guerin (BCG) has been shown to reverse advanced type 1 diabetes in mice, and could help to restore proper immune response to insulin-producing beta cells. The findings of this FDA-approved clinical trial were presented by principal investigator Dr Denise Faustman, PhD, director of the Massachusetts General Hospital Immunobiology Laboratory. The BCG vaccine is based on a harmless strain of bacteria related to one that causes tuberculosis. It is also approved by the FDA for treatment of bladder cancer. Faustman explained the BCG could induce a permanent gene expression that restores regulatory T cells (Tregs), helping to prevent the immune system attack which characterises type 1 diabetes. "BCG is interesting because it brings into play so many areas of immunology that we as a community have been looking at for decades, including Tregs and the hygiene hypothesis," said Faustman. "Repeat BCG vaccination appears to permanently turn on signature Treg genes, and the vaccine's beneficial effect on host immune response recapitulates decades of human co-evolution with myocbacteria, a relationship that has been lost with modern eating and living habits." Researchers worldwide have been examining the benefits of Tregs, but Faustman said that existing therapies have struggled to achieve long-term results. However, with BCG able to restore Tregs, this provides a clearer picture as to how vaccination works to reset the immune system within type 1 diabetes. Faustman's team was the first to document type 1 diabetes reversal in mice and in a subsequent phase I trial demonstrated successful hu Continue reading >>
Towards A Game-changing Type 1 Diabetes Vaccine
Home / Conditions / Type 1 Diabetes / Towards a Game-Changing Type 1 Diabetes Vaccine Towards a Game-Changing Type 1 Diabetes Vaccine Dr. Denise Faustman, M.D, Ph.D. Exclusive Interview from theDiabetes Symposium Seminar 2016 in Boston, featuring Steve Freed, Publisher, Diabetes in Control. In part 3 of this exclusive interview, Dr. Faustman discusses how a cure based on the inexpensive BCG vaccine could permanently change type 1 treatment, and whether results could also apply to type 2. Steve Freed: So, I know in the past youve been researching trying to find the T-cells that cause the autoimmune disease specifically for diabetes. Then if you could just keep the bucket half full. Steve Freed: Where does that stand in all this? Dr. Faustman: So, one of the surprising things about the phase 1 clinical trial data was after we gave each dose of BCG, the blood was filled with dead autoreactive T-cells. These are people that are 15-20 years out from disease. So what that taught us was one, BCG was killing autoreactive cells, but it also taught us that people with long-standing type 1 diabetes have huge reservoirs of autoreactive T-cells. Thats probably because the pancreas is continually regenerating and getting bumped off by these bad T-cells. We have quite a large repertoire, numbers wise, of autoreactive T-cells even with long standing disease that need to be eliminated. So the dosing of BCG will become very important to get that balance and get rid of the majority of those cells. Steve Freed: So, what about the time frame? When do you expect to have phase 2 completed? Obviously you cant talk about phase 3. Dr. Faustman: So, there will be two sets of clinical trial data coming. The next set of data that youll hear about, probably in the next year or so is that we went ba Continue reading >>
Can Tb Vaccine Stop Type 1 Diabetes?
Maybe. A small clinical study found "proof of principle" that the BCG tuberculosis vaccine might help adults with long-standing type 1 diabetes. Over a decade ago, Denise Faustman, MD, PhD, and colleagues at Massachusetts General Hospital and Harvard Medical School showed that the BCG vaccine worked in diabetic mice. By stimulating positive immune responses, the vaccine stopped the haywire immune responses that cause diabetes. Once this happened, the animals' insulin-making cells regenerated. Other researchers duplicated the mouse studies. This led to "a lot of happy mice," Faustman says. But translating the findings to humans hasn't been easy. For starters, it required learning a lot more about the immune system and a lot more about type 1 diabetes. It didn't look promising. A 1999 study found no effect of BCG vaccination in kids newly diagnosed with type 1 diabetes. "When we started, there wasn't too much enthusiasm about trying to reverse diabetes in people 15 to 20 years out with this disease," Faustman tells WebMD. She persisted. "Surprisingly, our data was so good we got a signoff on doing a safety trial from the FDA," she says. "Even more surprising was that in this safety study, at a very low dose and after only two BCG vaccinations, we started seeing indications that this vaccine is doing the same thing in people as it does in the mouse." Hopeful Signs but No Lasting Effect In the study, six insulin-dependent adults with type 1 diabetes received either two doses of BCG or two fake vaccinations. The two groups were compared to one another, to 57 diabetes patients, and to 16 people without diabetes. In the three patients who received the vaccine: "Bad" anti-insulin T cells began dying off. New "good" regulatory T cells increased. There were signs of new, albeit t Continue reading >>