NextCell Pharma AB (“NextCell”) hereby announces that they today have reached a significant milestone as they have now initiated the second part of the ProTrans-1 clinical trial. In addition to safety, clinical efficacy is evaluated, e.g. whether the patient’s own insulin production improves 12 months after treatment with ProTrans compared to placebo. The phase-II part is randomized, double-blind, placebo-controlled which means that neither the patient nor the doctor knows what treatment the patient is receiving. So far, two patients have undergone treatment. In total, 15 patients will be included in the study, of which ten receive ProTrans and five patients receive placebo.
The first part of the ProTrans-1 study started on November 28th, 2017. During the first weeks of 2018, the first patient underwent extensive clinical examinations and testing in order to, on January 24th, 2018 to become the first human ever to receive an infusion with ProTrans. The first part of the study consisted of a dose escalation phase where a total of nine patients were treated with low, medium and high doses of ProTrans. All patients are followed for 12 months and the first patient who was treated in January 2018 has now been in for their last study visit (first patient, last visit).
After having undergone screening visits and further clinical studies at a baseline visit, two patients have now been randomized and treated in the second part of the study. This is a phase II study where patients are randomized to treatment with either ProTrans (ten patients) or placebo (five patients). The purpose with the Phase II part is to evaluate the clinical efficacy as to whether the patient’s own insulin production improves 12 months after treatment with ProTrans compared to placebo. ProTrans is developed as a stem cell therapy for inflammatory and autoimmune diseases.
“I want to thank all the patients who participate, it is great that the interest in being involved is so great,” says Mathias Svahn, CEO of NextCell.
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For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Sofia Fredrikson, CFO
Phone: 08-735 5595