Episode 26: ViaCyte, a functional cure for Type 1 diabetes?

ViaCyte‘s President and CEO Dr. Paul K. Laikind, PhD describes the “stem cell derived islet replacement therapy” they are currently taking through clinical trials. In this episode of Everybody Talks Corinna Cornejo and Scott Johnson talk about the excitement surrounding what’s being characterized as a “functional cure” for Type 1 diabetes and asking some serious questions. What’s the tipping point for being willing to undergo stem cell implantation like the procedure ViaCyte is testing? Does this really sound like a cure or is it something else?

ViaCyte is a privately-held regenerative medicine company focused on developing a cell replacement therapy for the treatment of diabetes.  Currently, ViaCyte is conducting a Phase 1/2 clinical trial of the company’s lead VC-01 product candidate in patients with type 1 diabetes who have minimal to no insulin-producing beta cell function. Meanwhile, Vox Pop Films is documenting this process and producing the documentary film The Human Trial.

Everybody Talks Diabetes Podcast Corinna Cornejo

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Episode 8: Searching For The Cure

This week Corinna and Mike talk about some of the research that Dr. Michael Haller is doing through TrialNet. Haller’s work has focused on genetics, environment, prevention and cure. They also discuss why “prevention” is sometimes seen as a dirty word and analyze Haller’s optimistic and hopeful yet also realistic look at the race toward a cure for type 1 diabetes.

Some links discussed in this episode:

Everybody Talks Diabetes Podcast Mike Lawson Corinna Cornejo

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TuDiabetes Live interview with Dr. Ryan Fiorini, Perle Bioscience

Founded in 2013 by Dr. Claresa Levetan, Perle Bioscience is dedicated to finding original treatments for type 1 diabetes with the ultimate goal of eliminating the disease all together. Perle has discovered novel human beta regeneration peptides for which has been issued “composition of matter” patents. Perle’s total IP portfolio comprises 12 issued and pending patents all in the diabetes space. Perle’s intellectual property is established around the In Vivo use of proton pump inhibitors combined with immune tolerance agents, with the ultimate goal of eliminating any injections for the patients. To learn more, please visit us at www.PerleBioscience.com.
Dr. Fiorini received his Ph.D. in Immunology and Microbiology from the Medical University of South Carolina (MUSC) in Charleston in 2005. He later received his M.B.A. from the Citadel in 2007 and a Masters of Hospital Administration (M.H.A.) from the Medical University in 2008.
In 2010, Dr. Fiorini founded Immunologix, Inc. a company built on a specialized platform that transformed naïve human B-cells to produce 100% human monoclonal antibodies against multiple target antigens. From the company’s commencement in September 2009 through its acquisition by Intrexon Corporation (NYSE: XON) in October 2011, he served as the Founder and Chief Operating Officer. After the acquisition by Intrexon, he served as the Vice President of Antibody Development until transitioning into the role of Vice President of Therapeutics Business Development working directly under Intrexon CEO, Randal J. (R.J.) Kirk.
Dr. Fiorini left Intrexon in April 2013 to spend more time looking for “the next” start-up opportunity, building his biotech consulting company and spending time with his family. Dr. Fiorini joined Perle Bioscience as President and CEO in February 2014.

Category: Nonprofits & Activism
Uploaded by: Diabetes Hands Foundation
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TuDiabetes Live interview with Philip Toleikis, President of Sernova

Sernova is a clinical-stage company developing products for the treatment of chronic diseases using therapeutic cells transplanted into an implanted medical device to replace missing proteins or hormones.

Sernova’s device forms a natural environment promoting the long-term function of therapeutic cells. The company’s first therapeutic indication is for the treatment of insulin-dependent diabetes.
Dr. Philip Toleikis is a seasoned biotechnology executive, with over 20 years of experience in the therapeutic, medical device and combination product sectors. He has been President and CEO of Sernova Corp. a clinical stage company since 2009, successfully gaining financing for the company through grants and equity funding of over $10M, and has been leading the development of a natural and immune-protected environment for delivering therapeutic cells to patients with chronic diseases such as insulin-dependent diabetes and haemophilia.
Dr. Toleikis headed a successful consulting company for the medical device and combination product field and was previously Vice President, R&D Pharmacology and Drug Screening, at Angiotech Pharmaceuticals, Inc., where he built and oversaw product development teams working on novel combination products to improve technologies for restenosis, surgical adhesions, device related infections, and orthopedic indications as well as led the team in the development of a novel treatment for immune inflammatory disease with completed Phase II clinical studies in multiple sclerosis, psoriasis, and rheumatoid arthritis.
He also headed multiple corporate collaborations and in seeking in-licensing technologies. Dr. Toleikis is an author of multiple issued patents and over 110 patent applications. His research training and experience includes biochemical pharmacology, diabetes, oncology, inflammatory diseases (psoriasis, multiple sclerosis, surgical adhesions, Alzheimer’s disease and rheumatoid arthritis), osteoarthritis, neurological diseases and cardiovascular conditions including ischemic heart disease, cardiomyopathy, hypertension and aneurysms.
His career philosophy is in developing and empowering closely integrated product development teams and linking those to the physicians and patients who are in need of novel products to build a strong passion for success. He has been a volunteer for many years for regional science fairs, as well as Diabetes, and Heart and Stroke Foundations and on the grant writing committee for a local school council. Dr. Toleikis has earned advanced degrees from the University of Michigan and the University of British Columbia, where he completed his Ph.D.

Category: Nonprofits & Activism
Uploaded by: Diabetes Hands Foundation
Hosted: youtube


TuDiabetes Live interview: Joshua Levy "Map to a Cure for Type 1 Diabetes"

Joshua Levy is a Bay Area native who works as a software engineer. His daughter was diagnosed with type 1 diabetes at the age of 18 months, and is now 13 years old. Joshua has been blogging for many years about potential cures for T1D, at Current Research into a Cure for Type 1 Diabetes. Check it out!

Category: Nonprofits & Activism
Uploaded by: Diabetes Hands Foundation
Hosted: youtube


TuDiabetes Live Interview with Mary Rooney: clinical trial participant

Mary Rooney, Participant in T Regulatory Cells (Treg) Clinical Study

“Living with type 1 diabetes is like having a second job with no days off,” says Mary Rooney, who was diagnosed with type 1 diabetes in March 2011.

Having moved to San Francisco a year prior to finalize her doctorate in child psychology, Mary had to manage the stress of being diagnosed with a chronic disease without the benefit of nearby friends and family.

In researching type 1 diabetes, Mary learned that slowing the destruction of beta cells is critical to managing the disease, and she sought out clinical studies in this area. Through her job at University of California, San Francisco (UCSF), she learned about three ongoing studies at UCSF’s Pediatric Diabetes Program investigating different approaches to preserving beta cell function, including one evaluating the T Regulatory Cells (Treg) immunotherapy. Mary was eligible for the study, and soon became the first human patient enrolled in the Treg clinical program.

In the study, Mary’s blood was drawn, and after 14 days she was reinfused with the expanded Treg cells. During 24 hours of observation, no adverse events were reported. Follow-up blood tests to measure C-peptide levels – an indicator of pancreatic islets beta cell function – continued for two years.

Today, at 38, Mary is healthy and works as a child psychologist. Managing her diabetes can be demanding, but Mary makes an effort every day to calculate her calorie intake, exercise and monitor her blood sugar. Three years after treatment with Treg, Mary is still in the “honeymoon phase,” the period of time following the onset of diabetes when the pancreas is still able to produce significant amounts of insulin. The “honeymoon phase” period varies for each individual, but seldom lasts more than one year.

Based on what she has learned about type 1 diabetes and Treg from physicians and researchers, Mary now believes that participating in the Treg study was one of the most important decisions she made – and she encourages others diagnosed with type 1 diabetes to investigate all their treatment options as soon as possible following diagnosis.

Category: Nonprofits & Activism
Uploaded by: Diabetes Hands Foundation
Hosted: youtube


TuDiabetes Live Interview with Dr. Denise Faustman, Director of Immunobiology

Denise L. Faustman, MD, PhD, Director of Immunobiology, Massachusetts General Hospital & Associate Professor of Medicine, Harvard Medical School

Denise Faustman, MD, PhD, is Director of the Immunobiology Laboratory at the Massachusetts General Hospital (MGH) and an Associate Professor of Medicine at Harvard Medical School. She is currently leading a human clinical trial program to test the efficacy of the BCG vaccine as a treatment to reverse long-term type 1 diabetes. They are currently preparing to enroll patients in a Phase II study. Dr. Faustman’s research has been highlighted in publications including The Wall Street Journal, The New York Times, Los Angeles Times, and Scientific American. She earned her MD and PhD from Washington University School of Medicine in St. Louis, Missouri, and completed her internship, residency, and fellowships in internal medicine and endocrinology at the Massachusetts General Hospital.

Category: Nonprofits & Activism
Uploaded by: Diabetes Hands Foundation
Hosted: youtube


TuDiabetes Live Interview with the creators of the Bionic Pancreas

Drs. Damiano and Russell are part of a collaborative group from Boston University and Massachusetts General Hospital working together to make automated blood glucose control a reality. Engineers from Boston University have developed a closed-loop artificial pancreas blood glucose control system that uses frequent measurements of blood glucose concentration along with subcutaneous delivery of both rapid-acting insulin and glucagon (to raise blood glucose, if necessary) as directed by a computer algorithm. The artificial endocrine pancreas automatically makes a new decision about insulin and glucagon dosing every five minutes. The system is being tested in people with type 1 diabetes at Massachusetts General Hospital, with results recently published in Science Translational Medicine.

Category: Nonprofits & Activism
Uploaded by: Diabetes Hands Foundation
Hosted: youtube


Live Interview: Islet Cell Transplantation with Drs Gebe and Vernon

In a major collaborative effort led by matrix biologist Robert Vernon and immunologist John Gebe, scientists at the Benaroya Research Institute are developing a Bioengineered Implant (BI) for treatment of type 1 diabetes (T1D) — an autoimmune disease. The BI will combine purified islets of Langerhans (the tiny, insulin-producing units of the pancreas) with innovative structural supports made of natural biomaterials.

The BI is designed to provide a controlled microenvironment that promotes the survival and function of the transplanted islets and includes: 1) a permeable extracellular matrix (ECM) hydrogel to provide physical support for the islets and ingrowing vasculature, 2) a sustained-release component that will deliver a set of bioactive compounds that promote islet survival, vascularization, and immunoprotection, and 3) a supportive scaffold to retain the islets, ECM hydrogel, and sustained-release component within a protective, unified structure. The combination of these design elements in a single device represents a novel approach to islet transplantation. The overall goal of this research is to produce a BI that can be implanted into patients in a minimally-invasive manner (perhaps under the skin) and which would eliminate the need for exogenous insulin therapy.

Description of study in researcher’s own words
Islet transplantation can be successful where the donor of the islets and the recipient of the transplant are genetically identical (as in syngeneic strains of mice). However, islet engraftment fails in human patients with T1D as a consequence of: 1) poor shortterm survival of the islets as a result of post-implantation stress, and 2) long-term immune-mediated rejection of the islets caused by tissue mismatches between donor and recipient (alloimmune rejection) and continuance of autoimmunity. Our working hypothesis for this project is that a spectrum of bioactive compounds that promote islet survival, islet vascularization, and protection of islets from host immune attack can be combined in a single device. Importantly, the influence of these compounds would be restricted to the BI and the region immediately surrounding it (using sustainedrelease technology), thereby limiting harmful systemic effects. Advanced versions of the BI might also be used as platforms for patient-derived stem cell transplantation, incorporating bioactive compounds that would promote the survival and differentiation of stem cells into insulin-producing cells.

Roles of the BRI researchers
Dr. Robert Vernon is a matrix biologist and bioengineer who provides the expertise in designing the BI and the system for sustained release of bioactive compounds. His understanding of the importance of revascularization to islet survival is instrumental to the success of this project. Dr. John Gebe is an immunologist with expertise in animal models of T1D. He conducts the hands-on testing of the device in vivo and also determines which immunological systems can be targeted to promote long-term protection of islets from allo- and autoimmune rejection.

Category: Nonprofits & Activism
Uploaded by: Diabetes Hands Foundation
Hosted: youtube