Clinical investigative sponsors claim a breathing artificial pancreas, created using lung tissue from a pig, will commence in clinical trials within 12 months. It is reported that the new approach has evidenced success in preclinical research-based animal trials. Betalin Therapeutics, a startup out of Jerusalem seeks the financing to move forward.
Born in Hebrew University
Betalin Therapeutics, based in Jerusalem, Israel has raised $3.5 million and is in search of an additional $5 million to prepare to conduct a clinical trial to put the artificial pancreas to the ultimate test. The investigational product, known as an “Engineered Micro Pancreas (EMP)” was designed to improve the quality of life for millions of people with diabetes. The EMP technology was developed at the Hebrew University of Jerusalem, Israel. The university partnered with Betalin Therapeutics which secured an exclusive worldwide license upon its founding in 2015.
Preclinical Results To Date
Betalin Therapeutics reports that it recently submitted a “pre-pre-IND (Investigational New Drug) application to the U.S. Food and Drug Administration (FDA) and upon a positive response are preparing for the pre-IND meetings as they attempt to execute their plan toward ultimate IND submission.
Competitive forces are at work to utilize living islet cells however many challenges exist including the complicated nature of keeping living cells alive within the body of type 1 diabetics. Living islet cells need oxygen and must be ensured protection from type 1 diabetes autoimmune responses—these reactions attempt to kill insulin-producing cells.
The Opportunity: Challenges with Transplants
The EMP enables the secretion of significant levels of glucose-regulated insulin over long durations. In Type 1 diabetes, the patient’s beta cells (ones that store and release insulin) of the pancreas, reports Diabetes News Journal, are the focus of attack by the body’s immune system. In some cases of Type 1 diabetes physicians will perform a transplant of pancreatic islets containing beta cells. Made from a deceased donor, the transplant procedure includes collected, purified and laboratory-processed islets before transplant to patient.
Transplants involving pancreatic islets are challenging with limited outcomes primarily due to the following:
- Require two separate infusions
- Considerable numbers of cells required
- A majority of cells die within a short timeframe (typically 2 days)
- 50% of transplants still end up with an outcome where the patient is insulin-dependent one year after the procedure
- Only about 10% of the patient that receives transplant are insulin-independent post five years after transplantation
The EMP Technology Study
This technology, designed under the assumption that beta cells properly function only if they benefit from a sufficient connective tissue scaffold to ensure long-term survival, supports the development of organ-derived micro-scaffolds with a “natural architecture” involving the “same basic connective tissue composition” and offers a “guarantee” that every cell is adjacent to sources of essential gases and nutrients report Diabetes News Journal.
A recently published study in the journal Tissue Engineering, Part A, reveals that the EMP’s human islet-derived beta cells function similarly to dissected pancreatic islets in vitro. The study “Beta Cells Secrete Significant and Regulated Levels of Insulin for Long Periods when Seeded onto Acellular Micro-Scaffolds” proposed that to obtain proper ex vivo beta-cell function requires three-dimensional structures mimicking natural islet tissue microenvironment. The study evidences their preparation of the endocrine micro-pancreata (EMPs) consisting of acellular organ-derived micro-scaffolds seed with human intact or enzymatically disassociated outlets.
The study reveals that artificial pancreas expresses high levels of key beta-cell specific genes and secrete quantities of insulin per cell similar to freshly isolated human islets in a glucose-regulated manner for more than 3 months in vitro.
The leadership includes founder Joshua (Shuki) Herchovici, and Sidney Altman (Board) a 1989 Nobel Prize winner for chemistry. Dr. Altman acknowledged to the Jerusalem Post that he and his mom struggle with type 2 diabetes.
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