Earlier this week, SymbioCellTech received confirmation that a Pre-IND Meeting has been granted with the Center for Biologics Evaluation and Research (CBER) at the FDA to discuss plans to move into human clinical trials with Neo-Islet therapy. “This represents another favorable step toward realizing a better therapy and potential cure for millions of people suffering from insulin-dependent diabetes,” states Christof Westenfelder, MD, Chief Executive Officer of SymbioCellTech, LLC.
Today, June 20th, 2019, the FDA’s Center for Biologics Evaluation and Research (CBER) confirmed receipt of SymbioCellTech’s Pre-IND Package notifying the company that a decision on scheduling a meeting this summer to discuss human Neo-Islet therapy will be communicated by July 8th.
This Pre-IND submission and interaction with the agency represents another milestone achieved toward SymbioCellTech initiating clinical trials, which are currently planned to begin in 2020.
Drs. Westenfelder and Gooch presented their SymbioCellTech scientific work on Neo-Islet therapy at the 79th Scientific Sessions of the American Diabetes Association (ADA 2019). In independent presentations, Dr. Westenfelder delivered a moderated talk entitled, INAD 012-776 Pilot Study: Allogeneic “Neo-Islets,” Composed of Mesenchymal Stem and Islet Cells, are Immune Protected and Dose-Dependently and Durably Control Autoimmune T1DM in Pet Dogs, and Dr. Gooch presented a poster entitled, Optimal Control of Glucose and Lipid Profiles is Critical to the Effective “Neo-Islet” Therapy of Insulin Dependent Pet Dogs.
Both presentations exemplify significant progress in demonstrating safety and efficacy of SymbioCellTech’s novel Neo-Islet therapy in a large animal model comparable to humans. “This is more validation that the therapeutic discoveries our scientists have made in their relentless pursuit of a cure for diabetes are both safe and feasible for moving into clinical trials,” comments Dr. Russell Reiss, Chief Operating Officer of SymbioCellTech.
Both scientific presentations generated significant interest from other national and international scientific groups, including representatives from both industry and research.
Amongst articles published between January 2017 and December 2018, SymbioCellTech’s paper discussing Neo-Islet therapy was one of the most downloaded of all in the 12 months following online publication, generating immediate impact and visibility, and contributing significantly to the advancement of the field of cell therapy and regenerative medicine (see e-letter below).
Dear CHRISTOF WESTENFELDER ,
We are pleased to let you know that your article, Durable Control of Autoimmune Diabetes in Mice Achieved by Intraperitoneal Transplantation of "Neo-Islets,- Three-Dimensional Aggregates of Allogeneic Islet and "Mesenchymal Stem Cells-<onlinelibrary.wiley.com/doi/full/10.1002/sctm.17-0005utm_source=eloqua&utm_medium=email&utm_campaign=W26CS_topauthorq1fy19&utm_content=singletemplateelq_mid=36091&elq_cid=5393580&elqCampaignId=23090&elqTrack=true>, published in STEM CELLS Translational Medicine, is one of the journal's top downloaded recent papers!
* Amongst articles published between January 2017 and December 2018, your paper received some of the most downloads in the 12 months following online publication.
* Your work generated immediate impact and visibility, contributing significantly to the advancement of your field.
In recognition of your work, we’re pleased to offer you a certificate of achievement.
Thank you for helping to grow the profile of our journal so that work like yours is more discoverable.
STEM CELLS Translational Medicine
SymbioCellTech received written notification from the U.S. Food & Drug Administration yesterday that the current state of their Neo-Islet technology was such that an INTERACT meeting was not necessary and SymbioCellTech’s regulatory questions for the agency could be discussed in the context of a Pre-IND meeting. “This represents a significant step toward SCT advancing through the arduous FDA regulatory pathway for biologics and securing additional funding for our upcoming human trials planned to begin in late 2020,” states Russ Reiss, MD, Chief Operating Officer for SymbioCellTech.
After demonstrating initial pre-clinical safety and efficacy in both rodents and pet dogs, today, SymbioCellTech, LLC, a Salt Lake City, Utah based biotechnology company submitted a complete INTERACT Package to the FDA Center for Biologics Evaluation and Research (CBER) in preparation for their Investigational New Drug (IND) application to begin human trials using their proprietary “Neo-Islet” technology to cure Type I Diabetes.
This week SymbioCellTech presented preliminary data from the first two, spontaneously diabetic pet dogs treated in its ongoing pilot study with SCT’s canine Neo-Islet product, SCT-c001, at the American Diabetes Association’s 78th Scientific Sessions in Orlando, FL. The scientific poster presentation entitled, “I.P. Administered Neo-Islets, Aggregates of Mesenchymal Stem Cells and Cultured Islet Cells, Improve Glycemic Control of Spontaneously Occurring Insulin Dependent DM in Pet Dogs: A Pilot Study, INAD 012-776” was met with great enthusiasm from the diabetes research community in attendance. “The results from the first two dogs, while preliminary, are very promising, showing that NI (Neo-Islet) therapy progressively reduces insulin requirements and improves blood sugar control. No anti-rejection drugs have been used, and these two dogs have not developed antibodies to the cells used for treatment, even though the cells are from unrelated donor dogs,” stated Anna Gooch, PhD, Chief Scientific Officer for SCT.
SALT LAKE CITY, June 30, 2017 /PRNewswire/ -- The cover of the July 2017 issue of the journal STEM CELLS Translation Medicine showcases the latest advance toward a functional cure of insulin-dependent diabetes. Scientists at SymbioCellTech (SCT), a small biotech company in Salt Lake City, developed a technology that combines Mesenchymal Stem Cells (MSCs) with culture-expanded pancreatic islet cells to form three-dimensional cellular clusters, termed "Neo-Islets". A single dose of Neo-Islets administered into the abdominal cavity provides durable blood sugar control, i.e., insulin-independence, without the need for potentially toxic anti-rejection drugs or encapsulation devices.
Type-1 diabetes is an auto-immune disease in which the patient's own immune system attacks and destroys the islet cells in the pancreas resulting in the inability of the body to produce insulin. The standard cell therapy for diabetes is islet cell transplantation into the liver; however, this approach has serious drawbacks: (1) it requires the patient to permanently take potentially-toxic immunosuppression drugs, (2) it cannot be scaled up to treat the large number of patients that would benefit from this therapy because up to 5 donor pancreata are required for a single dose, and (3) it is expensive. In order to avoid the need for immunosuppressive agents, researchers have focused on using various devices that encapsulate islets or other insulin-producing cells. These devices, made of specially-formulated materials, are designed to protect against the immune attack yet allow for glucose-sensitive insulin release. Limited success with this technology has been observed in the lab, but most encapsulation devices have failed due to foreign body reactions.
Mindful of these limitations, SCT took a different approach, termed 'natural encapsulation'. By using adult stem cells to block the immune attack on the transplanted islet cells rather than an artificial device, Neo-Islets were created that are pure cellular structures that possess all functions of a normal pancreatic islet cells, while permanently shielding their islet cell component from rejection and immune-mediated destruction.
In the journal article, SCT's scientists describe how they implanted Neo-Islets into spontaneously diabetic, immune-competent NOD mice that had naturally developed auto-immune type-1 diabetes that largely resembles human Type I diabetes. Within a few weeks, all treated mice demonstrated normal blood glucose control without the need for anti-rejection drugs or encapsulation devices. The Neo-Islets produced all physiological hormones that healthy pancreatic islets secrete.
SCT has already developed Neo-Islets for diabetic, insulin-dependent dogs and humans and, as shown in the article, successfully tested these in vitro and in vivo in diabetic NOD-SCID mice. Based on the strength of these preclinical data, SCT was granted approval by the FDA to begin testing in diabetic pet dogs. This study is currently underway. In parallel, SCT is preparing for a phase 1/2 clinical trial in patients with Type I diabetes.
SCT scientists remark that their Neo-Islet technology is a new biologic platform that has the potential to revolutionize the treatment of a number of other autoimmune diseases. Currently, SCT is focused on treating insulin-dependent diabetes due to the magnitude of this global medical problem. The American Diabetes Association estimates that over 20 percent of U.S. medical expenditures can be attributed to the provision of diabetes care, and the World Health Organization estimates over 10,000 people die every day from diabetes and its associated complications.
The cited publication can be found here.
The July issue of the cited Journal can be found here.
SymbioCellTech (SCT) is a privately-funded biotech company headquartered in Salt Lake City, UT, focused on the development of stem-cell therapies for the treatment of type-1 and type-2 diabetes, microvascular diseases, neurodegenerative diseases, and auto-immune diseases. SCT is currently engaged in an FDA-sponsored canine pilot study to test the safety, feasibility and preliminary efficacy of its cellular therapeutic to functionally control blood glucose in type-1 diabetes in pet dogs. SCT is also preparing for a phase 1/2 human clinical trial for type-1 diabetes. For more information on SymbioCellTech, please visit www.symbiocelltech.com.
Under an Investigational New Animal Drug (INAD), SymbioCellTech, LLC began it’s FDA-approved companion animal trial to treat canine diabetes. The first pet dog underwent a minor outpatient procedure to administer SCT’s proprietary, first of its kind, Neo-Islet therapy into the abdomen and is recovering quite well.
Based on the strength of its Investigational New Animal Drug (INAD) application, SymbioCellTech (SCT) received FDA approval to begin a pilot study to test the safety and efficacy of its Neo-Islet therapy in insulin-dependent diabetic pet dogs. The trials are expected to begin at Washington State University in Pullman, WA and at the Veterinary Specialty Hospital in San Diego, CA in Q1 of 2017.