Baylor Research Institute, Tiko Med Collaborate In Phase II Clinical Trial For Treatment Of Chronic Pancreatitis

Baylor Research Institute (BRI), the research arm of Baylor Health Care System, and TikoMed AB announced today that an agreement has been established to investigate TikoMed´s product IBsolvMIR® in a phase II clinical trial. The goal is to improve the engraftment of auto islet cell transplantation (AICT) in patients with severe, chronic pancreatitis. BRI has developed a therapy for treatment of chronic pancreatitis and TikoMed believes its 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 study, with the objective of documenting efficacy, safety and tolerability of IBsolvMIR in auto islet transplants for patients with chronic pancreatitis. The study will be conducted at BRI under the direction of Marlon F. Levy, MD, principal investigator

“The Baylor islet transplantation team is looking forward to working with TikoMed to try to better the lives of patients who undergo auto islet cell transplantation,” Dr. Levy said.
 
“Since TikoMed is dedicated to improve treatment of severe and life threatening diseases it is very inspiring to work with 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, TikoMed chairman.

Added Anders Waas, TikoMed CEO, "Entering into a phase II study in the US 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 US.”

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 of the pancreas, islet cells are extracted from the organ and purified in Baylor’s 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 BUMC.

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 Göran B. Klintmalm, MD, PhD, FACS, chairman and chief of Baylor’s 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 of market exclusivity in the US and 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.

Contact:
Kristine Hughes
kristine.hughes@baylorhealth.edu
214.820.7556

Press contacts/TikoMed:

Anders Waas (CEO)
anders.waas@tikomed.com
+46-734-045141

Adam Bruce (Chairman of the board)
adam.bruce@tikomed.com
+46-708-238444

About Baylor Scott & White Health
As the largest not-for-profit health system in the state of Texas, Baylor Scott & White promotes the health and well-being of every individual, family and community it serves. It is committed to making quality care more accessible, convenient and affordable through its integrated delivery network, which includes the Baylor Scott & White Health Plan, Baylor Scott & White Research Institute, the Baylor Scott & White Quality Alliance and its leading digital health platform – MyBSWHealth. Through 51 hospitals and more than 1,200 access points, including flagship academic medical centers in Dallas, Fort Worth and Temple, the system offers the full continuum of care, from primary to award-winning specialty care. Founded as a Christian ministry of healing more than a century ago, Baylor Scott & White today serves more than three million Texans. For more information, visit: BSWHealth.com