JDRF Funds Zucara Therapeutics Approach To Preventing Hypoglycemia In People With Type 1 Diabetes

JDRF Funds Zucara Therapeutics Approach To Preventing Hypoglycemia In People With Type 1 Diabetes

http://www.zucara.ca/technology/

'Our technology is aimed at creating the first treatment to prevent dangerous low blood sugar by restoring the body’s ability to counter-regulate hypoglycemia. This approach will reduce the likelihood of insulin therapy to cause hypoglycemia without affecting its efficacy. The immediate patient benefits would include the reduced occurrence of hypoglycemia and its associated acute symptoms and effects. This in turn would allow diabetic patients to more aggressively treat themselves with insulin, resulting in better overall health outcomes in the long term.'

Novartis-Parvus-Collaboration-Press-Release-2017-04-19.pdf

Novartis-Parvus-Collaboration-Press-Release-2017-04-19.pdf

Parvus is pioneering a breakthrough class of disease-specific biological therapeutics called Navacims^TM that are designed to halt and potentially cure autoimmune disease by restoring immune tolerance. The Company’s robust therapeutic platform is capable of generating a rich pipeline of therapeutic candidates for a wide range of autoimmune diseases. Parvus has validated two lead drug candidates to take into clinical development for Type 1 diabetes (T1D) and Multiple Sclerosis (MS), and is scaling up drug product manufacture for GLP toxicology studies.

Practical Cure Update: BCG

Practical Cure Update: BCG

Practical Cure Project Update: BCG March 21, 2017

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 based on an understanding of "TNF", a cell signaling protein whose presence tells the body’s immune system to stop attacking insulin-producing beta cells. Faustman claims that people with T1D have insufficient levels of TNF, resulting in an imbalance in the immune system (too many effector T cells, which attack the pancreas, and not enough regulatory T cells, which regulate the effector T cells and identify what cells to attack and what not to attack). In theory, administration of BCG should result in higher levels of TNF and, therefore, rebalance the immune system, stopping the auto-immune attack. “BCG is the drug that led to the discovery of TNF in 1985,” Faustman says, “it was well known that when you get vaccinated with BCG, your TNF levels went up. That was the fundamental link that drove us, alongside the ability to get into the clinic and introduce something inexpensive.” Current Testing: A phase II human trial is currently recruiting. It will attempt to demonstrate the effectiveness of BCG and will follow patients for five years.  Faustman underscores that these trials will focus on people with established T1D: “We are treating people who have the disease,” Faustman says, “They are five, ten, twenty years out and we are trying to reverse it. It’s a huge distinguishing point of what we do.”

Human Trials Research Design Summary (Active): Clinical Trials Link: https://clinicaltrials.gov/ct2/show/NCT02081326 Website Link: http://www.faustmanlab.org/research/BCGTrials.html To learn more or make a donation: www.faustmanlab.org, email diabetestrial@partners.org, or call 617-726-4048.