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Imagine Pharma Completes More Than 32 Clinical Human Islet Cell Isolation Procedures For Leading Hospital Systems In 2023

Partners with Cook MyoSite to establish a state-of-the-art facility to conduct human islet isolations for hospital systems without in-house capabilities

PITTSBURGH, Dec. 19, 2023 /PRNewswire/ -- Imagine Pharma, a biotech company focused on advancing the commercialization of its novel IMG-1 polypeptide in Oral Delivery, Therapeutics, and Regenerative Medicine, announced today that it has successfully completed more than 32 clinical islet cell isolation procedures for several leading hospital systems across the United States, including the Cincinnati Children's Hospital Medical Center.

As part of expanding its clinical islet cell isolation capabilities, Imagine Pharma has also formed a partnership with Cook MyoSite, enabling the Company to support those hospital systems without their own in-house isolation facilities. Human islet cell isolation and preparation involve specialized expertise and costly processes, typically available in only a handful of hospital facilities and outside laboratories.

Under the leadership of Dr. Rita Bottino, Director of Imagine Pharma's Islet Programs and a globally-renowned expert in islet isolations, Imagine has quickly established itself as a leader in both research and clinical islet isolation procedures, pioneering advancements in the treatment of pancreatitis and auto-islet transplants. "The availability of high-quality human islet cells is critical to medical centers that perform autologous transplantations for patients undergoing pancreatectomies," said Bottino. "Our prominence in clinical isolations and the increasing demand for our expertise are testaments to the trust the medical community has placed in us to perform this very specialized procedure."

"We are proud to collaborate with Imagine Pharma in their pursuit of innovative medical solutions and to support their clinical work at our cutting-edge facilities," said Carl Cook, President of Cook MyoSite, Inc. "Our commitment to excellence aligns with Imagine Pharma's mission, and we look forward to expanding our partnership in the year ahead."

Imagine Islet CenterImagine Islet Center, a key component of Imagine Pharma's Islet Programs, provides clinical islets for autologous islet transplantation for various hospital Institutions, research-grade human isolated islets, tissue processing, and related services to the diabetes research community. The Center currently supplies human islet cells as part of the National Institute of Diabetes and Digestive and Kidney Diseases' Islet Integrated Distribution Program (IIDP) and to support leading academic diabetes centers in the United States, including Vanderbilt University, Stanford University, University of Florida, Mt. Sinai Icahn School of Medicine in New York, the University of Pittsburgh, and the Network for Pancreatic Donors with Diabetes (nPOD), among others.

About Imagine PharmaImagine Pharma is a biotechnology company focused on the development of its IMG-1 polypeptide across its Oral Delivery, Therapeutics, and Regenerative Medicine platforms, each with first-in-class programs that address multiple disease states in large, underserved markets. Imagine Pharma is also an approved Islet Isolation Center for the National Institute of Diabetes and Digestive and Kidney Diseases Integrated Islet Distribution Program. For more information visit: www.Imaginepharma.Com.

About Cook MyoSiteCook MyoSite is dedicated to the development and subsequent commercialization of technology related to the collection, selection, and expansion of human skeletal muscle cells for the treatment of various disorders. In addition to operating several regulated clinical studies, Cook MyoSite provides a range of custom services, including modified cell samples to contract manufacturing arrangements, procurement and processing of muscle cells from specific donor populations, custom media formulations, CMO/CDMO arrangements, and QC analytical testing and assay development. Learn more about Cook MyoSite at www.Cookmyosite.Com.

Contact: Andie Levine, andie@0to5.Com

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SOURCE Imagine Pharma

Transplanted Pig Cells In Human Produce Insulin

Australia-based Living Cell Technologies (LCT) Limited has published evidence outlining the survival and identification of live porcine islet cells and insulin production in a human patient 10 years after receiving a pig islet cell transplant.

The scientific paper published in the March 2007 issue of the international journal Xenotransplantation outlines how LCT has demonstrated the long-term safety, viability and function of its encapsulated porcine islets in a human patient over an extended period of time, without the use of immunosuppression.

In 1996, a 41-year-old diabetic was injected with LCT's prototype diabetes product containing pig islet cells to help regulate his blood glucose levels and control of diabetes. The transplanted cells helped reduce the patient's insulin requirement by 34 percent for over a year, which provided better control and overall well-being. By 2005, the patient's glycated hemoglobin levels remained lower than the pre-transplant levels pointing to improved long-term control of blood glucose levels.

Ten years later, the patient suggested that he was still obtaining benefit from the transplant. LCT scientists assumed that the cells would not be alive or functioning after that period, but the patient convinced LCT scientists to organize for a laparoscopy to check. This resulted in finding both living and functioning pig islet cells in his abdomen.

"This has never been achieved before. It is a profound step forward for safe, effective and long term diabetes control and shows the ability for pig cells to survive inside a human for an extended period of time and without immune suppression," said Prof Bob Elliott, LCT Medical Director.

Dr Christina Buchanan, a Biochemist from the University of Auckland and an expert in insulin, conducted the analysis to ensure that the insulin detected in the patient's blood samples were unequivocally pig and not human insulin – the final proof of efficacy.

Dr John Court, a Diabetologist and Scientific Advisor to LCT, said, "This is only one patient's experience but it does show that pig cells can survive at least 10 years in a micro-capsule coating and continue to release insulin into the patient's bloodstream."

LCT has significantly advanced the encapsulation process since the 1996 clinical trial and there is an even greater understanding and control over the longevity and robustness of the encapsulation process, as well as the porcine islet cells. The product is produced under a GMP manufacturing license.

LCT will be conduct trials of the DiabeCell pig islet cell transplant in patients in a phase I/IIa clinical trial in the second quarter of 2007. In addition, LCT is awaiting approval to conduct an additional trial in New Zealand this year with a different treatment protocol. Subsequent trials in the US or Europe are intended following initial results from these studies.

The trial will involve the simple injection of encapsulated neo-natal pig islet cells into them peritoneal (abdominal) cavity of the diabetic patients. The procedure is quite simple and carried out under local anesthetic. Patients will then be monitored by LCT's well-established protocols, which are in accordance with international xenotransplantation guidelines.

"This is strong evidence that LCT's DiabeCell product holds significant potential to address the key issues of finding renewable donor cells and not using immunosuppression, as outlined in the National Institutes of Health (USA) and Juvenile Diabetes Research Foundation (JDRF) strategic plans," said Dr Paul Tan, LCT's CEO.

"LCT's clinical trial program intends to test three different treatment regimens, in order to find the most appropriate, long-lasting and effective transplant possible," Dr Tan said.

DiabeCell is a porcine pancreatic cell product for the treatment of insulin-dependent diabetes. The neo-natal pig cells produce insulin and help regulate blood glucose levels appropriate to the amount of glucose detected in the blood stream of the diabetic recipient. Extensive pre-clinical testing of DiabeCell in animal models has shown no adverse effects with any dose or repeated transplants, extended survival of the islets, a significant reduction in insulin requirements, and prolonged insulin independence in some individual animals.

Source- BioSpectrumSRM/L

Successful Islet Cell Transplant In Mice With Type 1 Diabetes

Researchers have determined a way to pre-screen cancer patients to see if they are suitable candidates for proteasome inhibitors, a promising class of anti-cancer drugs . They propose to test for p53, a well-known tumor-suppressor protein that is broken down by cellular machinery called proteasomes.

In cancer patients whose tumors do not produce p53, proteasome inhibitors might be ineffective. This patient group could be spared unnecessary treatment with possible harmful side effects. On the other hand, proteasome inhibitors are highly effective against lymphomas that do have the ability to produce p53.

"Proteasomes resemble paper shredders – they break down proteins such as p53 into smaller pieces," says senior author Andrei Thomas-Tikhonenko, PhD, Associate Professor of Pathology. "A proteosome inhibitor effectively jams the shredder so that p53 is not immediately broken down."

In this study, the research team used a mutant strain of mice in which p53 activity can be switched on and off. "In principle, tumors in these mice could be obliterated by turning p53 back on," says Thomas-Tikhonenko. "The problem was that a protein called MDM2 sent p53 into the teeth of the proteasome shredder." The proteasome inhibitor bortezomib (Velcade®) causes this jamming process and restores p53 function. However, if p53 was inactivated in the mice, bortezomib treatment failed to kill tumors. Similar effects were seen with cell lines derived from human Burkitt's lymphomas. When implanted into mice, these lymphoma cells were highly sensitive to the proteasome inhibitor, but as soon as p53 was removed, the inhibitor had no effect.

"These findings have important implications for clinical practice," Thomas-Tikhonenko adds. "Bortezomib is approved by the Food and Drug Administration for the treatment of multiple myeloma, another cancer of lymphoid cells. Yet, only a fraction of multiple myeloma patients respond to the drug."

The researchers speculate that responsive myelomas are the ones retaining the p53 protein, which gets stabilized during treatment and triggers self-destruction of cancerous cells. "If confirmed experimentally, our hypothesis will serve to pre-select patients with the best chances of success – those with p53 – and spare the rest – those without p53 – the severe side effects of bortezomib therapy," explains Thomas-Tikhonenko.

There are two ways, suggest the researchers, to test for p53 production in cancer patients. First, if MDM2 is expressed at abnormally high levels, it is a good indicator that p53 is constantly being made. Second, genetic tests can also be conducted to see if the malignant cells still have the gene for p53 or if the portion of the chromosome on which p53 is found has been deleted.

Source-NewswiseSRM

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