NextCell to present status of ongoing clinical trial at the Nordic Life Science Days
Stem cell company NextCell Pharma AB ("NXTCL") today presents a status update of its ongoing Phase I/II trial with ProTrans for the treatment of type 1 diabetes. Two out of three patients in the high dose cohort have now undergone treatment and the third patient is scheduled for treatment later this week.
NXTCL's clinical trial is divided into two parts, the first part is a three-step dose escalation phase with three patients in each cohort, a total of nine patients. The second part of the trial is randomized, double-blind and placebo-controlled, with ten patients receiving ProTrans and five patients receiving a placebo, in total fifteen patients.
By the end of this week, we have planned for all patients in the first part of the trial to have undergone treatment. The Data Safety Monitoring Board will then evaluate the safety of the high dose patients after one month of follow-up and, hopefully, gives a positive recommendation to proceed with the second part of the trial.
The patients treated in the low-dose cohort have now all been subject to six-months of follow-up and the three patients in the medium-dose have all been subject to three-months of follow-up. No serious adverse events have been recorded for any of these patients, nor for the two patients currently treated in the high-dose cohort. In fact, so far there have been no adverse reactions suspected to be related to the treatment.
The clinical trial is performed by Karolinska Trial Alliance, led by Professor Per-Ola Carlsson and Dr. Daniel Espes, from Uppsala University, who are principle investigators of the study. The Data Safety Monitoring Board of consists of chairman Professors Ulf Smith and Anders Fasth from the University of Gothenburg, and Åke Lernmark from Lund University.
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 below contact person for publication on 11th of September 2018.
För mer information om NextCell Pharma AB, vänligen kontakta:
Mathias Svahn, VD
Leo Groenewegen, CFO
Telefon: 08-735 5595
E-post: info@nextcellpharma.com
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.