An additional batch of ProTrans is released prior to use in NextCell Pharma’s ongoing clinical trial.
Stem cell company NextCell Pharma AB ("NextCell") hereby announces that it has received another batch of ProTrans for clinical use. ProTrans is manufactured according to GMP (Good Manufacturing Practices) and the stem cells are selected with the company's selection algorithm to ensure quality. The selection is carried out by NextCell and the large-scale production is then produced by supplier and shareholder Polski Bank Komorek Macierzystych S.A. ("PBKM"). The delivery is intended for use in the second part of the company's ongoing Phase I/II trial with ProTrans, which includes a total of 15 patients.
The third batch of ProTrans has now been released by NXTCL’s supplier PBKM. The first batch was a so-called Technical Batch that was intended only for pre-clinical and stability analyses. After that, two additional batches have been manufactured according to GMP (Good Manufacturing Practices) and those are suitable for clinical use.
NXTCL is currently conducting a Phase I/II clinical trial with its drug candidate ProTrans. The study is divided into two parts, the first phase is a dose-escalating phase and at present three patients have been treated with a low-dose, three patients with a medium-dose and three patients are currently being treated with a high-dose of ProTrans. Assuming the safety committee's positive recommendation, the second phase of the study will start later in 2018. In this second phase we measure the effect of ProTrans and a total of 15 patients are included of which ten patients receive ProTrans and five patients receive placebo.
In the second part of the study, five patients will be treated with ProTrans from the previously obtained batch and five patients will be treated with the recently delivered batch. Furthermore, five patients will receive treatment with placebo. The purpose of using different batches is to evaluate whether the treatment effect differs between batches or not. The selection algorithm and the manufacturing method is designed to minimize the variation between batches and to ensure both quality and safety.
Mathias Svahn, CEO, comments:
"To scale up and validate GMP production of a cell therapy is cumbersome and time consuming. We have been very efficient and through smart collaborations and processes we have produced three batches during the last year. Now we have more doses of ProTrans in the freezer than we actually need for the current the study, we could use these for other interesting activities"
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For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Leo Groenewegen, CFO
Phone: 08-735 5595
E-mail: 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.