TikoMed and Baylor Research Institute reports having established an agreement for a phase II clinical study. In the study IBsolvMIR will be used for chronic pancreatitis patients receiving islet transplantation.

TikoMed AB and Baylor Research Institute (BRI), the research arm of Baylor Health Care System today announced that an agreement has been established to investigate TikoMed´s product IBsolvMIR® in a Phase II clinical trial for the improvement of engraftment of auto islet cell transplantation (AICT), in patients with severe chronic pancreatitis. BRI have developed a therapy for treatment of chronic pancreatitis and TikoMed’s product can enhance the outcome of the treatment by improving the survival of transplanted cells by inhibiting a destructive immunological reaction (IBMIR) and through stimulation of growth factors.

This BRI study “Attenuating Instant Blood-Mediated Inflammatory Reaction in Autologous Islet Transplantation” is a Phase II single center, with the objective to document efficacy, safety and tolerability of IBsolvMIR in auto islet transplants for patients with chronic pancreatitis. The study will be conducted at Baylor Research Institute, under the direction of Principal Investigator Marlon F. Levy, M.D..

“The Baylor islet transplantation team is delighted to be working with such a strong partner as TikoMed to try to better the lives of patients who undergo auto islet cell transplantation,” said Dr. Marlon Levy.

Since TikoMed is dedicated to improve treatment of severe and life threatening diseases it is very inspiring to work with the BRI. Building a long term relationships between Sweden and world leading institutions, such as Baylor is of great importance making it possible to establish better treatments for severe diseases,” said Adam Bruce, Chairman of TikoMed.

"Entering into a phase II study in the U.S. is a significant step in the clinical development of IBsolvMIR. It strengthens TikoMed’s competitive position in partnership discussions and for commercialization for IBsolvMIR in the U.S.,” said Anders Waas, CEO of TikoMed.

Auto Islet Cell Transplantation for Chronic Pancreatitis
The islet cell transplant program at Baylor University Medical Center (BUMC) was the first in Texas to receive FDA approval to independently process pancreatic islet cells for transplantation.  Since March of 2006, islet cell transplant has been an option for two specially selected groups of patients, those with chronic pancreatitis and those with type 1 diabetes.

Chronic pancreatitis is often a long-term, debilitating disease process that frustrates patients and the physicians who treat them.  Approximately 15,000 Americans are diagnosed each year with chronic pancreatitis.  Recurrent bouts of pancreatitis result in inflammation, scarring and blockage of the pancreatic ducts and constant pain that is difficult to control with medications.   Although the pancreas can be surgically removed to alleviate the pain, the patients become severely diabetic because they no longer have the insulin-producing pancreatic islet cells.  However, with Auto Islet Cell Transplantation (AICT), the patient’s functioning islets are retained after total pancreatectomy.  Immediately after surgical removal pancreas, islet cells are extracted from the organ and purified in our FDA approved laboratory. Within hours the islet cells are infused back into the portal vein of the patient’s liver.  Shortly after transplant, these islets can start producing insulin.  Auto Islet Cell Transplantation may be a good option for some chronic pancreatitis patients who successfully complete a full transplant evaluation at Baylor University Medical Center.

About Baylor Research Institute
Established in 1984 in Dallas, Texas, Baylor Research Institute (BRI) promotes and supports research to bring innovative treatments from the laboratory workbench to the patient bedside. To achieve this bench-to-bedside concept, BRI focuses on basic science, clinical trials, healthcare effectiveness and quality-of-care research. Today, BRI is conducting more than 800 active research protocols with 250 research investigators, spanning more than 20 medical specialties. BRI has research and development projects in areas ranging from human immunology and orphan metabolic diseases to transplantation, diabetes, cardiovascular disease and many other unmet medical needs.

Transplant Services is made up of an elite group of surgeons, headed by Goran B. Klintmalm, M.D., Ph.D., F.A.C.S., Chairman and Chief of Annette C. and Harold C. Simmons Transplant Institute. Established in 1984, Transplant Services works in collaboration with Annette C. and Harold C. Simmons Transplant Institute and is considered one of the leading transplant centers in the nation and one of the largest adult transplant centers in the United States. http://www.baylortransplant.com/

About TikoMed
Swedish-based TikoMed is an innovation driven Biotechnology Company developing and commercializing life-saving products for severe diseases, and has Orphan Drug Designation for IBsolvMIR and TM-400, providing 7 years market exclusivity in the US respectively 10 years in the EU. It has several projects aiming to improve the outcome of transplantation therapies:

IBsolvMIR is already in clinical phase II development to improve islet cell transplantation for patients with severe type 1 diabetes. An ongoing Phase II clinical study has gained a $15 million grant from the National Institutes of Health (NIH) through Uppsala University, Sweden. IBsolvMIR has the ability to improve the transplantation outcome through avoiding destruction of the insulin producing islet cells by the immune system. Successful islet transplantation has the potential to make severe type 1 diabetics insulin independent and avoid hypoglycemic crises. In a previous Phase I study, IBsolvMIR was well tolerated by healthy volunteers, with no clear treatment effects documented.

TM–400, is a product to improve the outcome of hematopoietic stem cell transplantations (HSCT) by increasing eradication of cancer and increasing the survival. There is a high unmet need to improve HSCT, with globally more than 60 000 performed yearly, primarily for non-Hodgkin’s lymphoma and Multiple Myeloma.

For more information, please visit www.tikomed.com.

Press contacts/TikoMed:
Anders Waas (CEO)              

Adam Bruce (Chairman of the board)


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