Update on NextCell Pharma’s clinical trial application
NextCell Pharma AB (NEXTCL) today announced that the company has responded to the Medicinal Product Agency's request for completion regarding the application for clinical trial with ProTrans ™. The study is designed to evaluate safety and efficacy in the treatment of type 1 diabetes.
NextCell’s application was registered with the Medical Products Agency on July 24th and request for supplementary information was received on September 5th. This has now been submitted within the deadline of September 14th.
The study is divided into two parts: The first part is a three-step dose escalation with three patients in each, a total of 9 patients. The second part is randomized, double-blind, placebo-controlled study where 10 patients receive ProTrans and 5 patients receive placebo, a total of 15 patients. Primary safety endpoint is safety at 3 months and primary efficacy endpoint is change in insulin production after 1 year.
The application was registered with the Medical Products Agency on July 24th and the decision is normally taken after 90 days from registration. The study sponsor is NextCell and the principal investigator is Professor Per-Ola Carlsson, who works at Uppsala University and the Academic Hospital in Uppsala. The study will be conducted together with Karolinska Trial Alliance (KTA), which holds great expertise in performing cell therapy clinical trials. Treatments are scheduled to take place at the KTA Phase I unit located at Karolinska University Hospital in Huddinge. Ulf Smith MD, PhD, Professor and Director, Lundberg Laboratory for Diabetes Research, Sahlgrenska Academy and Sahlgrenska University Hospital, Gothenburg; Anders Fasth MD, PhD, Professor of Pediatric Immunology, Sahlgrenska Academy and Chief Physician at Drottning Silvias Children's Hospital, University of Gothenburg; and Åke Lernmark PhD, Professor and Principal Investigator in Diabetes and Coeliac, MAS, Lund University; will together make up the Data Safety Monitoring Board with Ulf Smith as Chairman.
This information is the information that NextCell Pharma AB is required to disclose under the EU Market Abuse Regulation. The information was provided by the above contact person for publication on September 15, 2017.
For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Phone: 0702-615 504
About NextCell Pharma AB:
Stem cells are expected to change the way how many of today's life-threatening diseases are treated. NextCell Pharma AB develops ProTrans™, a drug candidate consisting of stem cells for the primary treatment of autoimmune and inflammatory diseases as well as for use in kidney transplants. ProTrans™ consists of selected stem cells derived from the umbilical cord tissue with NextCell Pharma AB's proprietary method. In addition, the company has a service called Cellaviva, Sweden's first and only IVO-approved stem cell bank for the family-saving of stem cells from umbilical cord blood and umbilical cord tissue.