NextCell Pharma AB (“NextCell”) gives the market updated information before its presentation at ProHearing later today by CEO, Mathias Svahn. Recruitment of patients with type-1 diabetes in the Phase II part of the ProTrans-1 clinical trial with the drug candidate ProTrans is ongoing. An application for a new trial, ProTrans-repeat, has been submitted and Cellaviva’s customer inflow has been increasing.
ProTrans-1, NXTCL’s ongoing clinical trial for the treatment of type-1 diabetes, is divided into two parts, the first being a three-step dose escalation with three patients in each step, a total of nine patients. All patients were treated in 2018 and are now being followed up for 12 months. Safety results from part one are concluded when the last patient leaves the trial, which takes place in September 2019. The second part of the trial is randomized, double-blinded and placebo-controlled, with ten patients receiving ProTrans and five patients receiving placebo, a total of fifteen patients. So far, 10 patients have been included in the trial and 5 patients have received their treatment.
ProTrans-repeat is a clinical trial, which NXTCL has applied for to start (published 2018-11-05). The new trial is an extension of ProTrans-1. After the patients’ last visit to ProTrans-1 part 1, the patients will be asked if they want to participate in a new study where they receive another treatment with ProTrans, provided the Medical Products Agency’s approval. The patients are monitored for 12 months and the treatment is evaluated for safety and efficacy, i.e. the body’s own insulin production.
NXTCL is conducting ongoing discussions with mainly academic groups about initiating clinical trials with ProTrans for a new indication. The plan is to submit an application sometime in 2019.
Cellaviva, NXTCLs stem cell bank for family saving, has seen a sharp increase in customer inflow over the past six months (published on 2019-02-05). This is partly a result of increased interest in stem cell saving in Sweden, and partly as a result of the expansion into Denmark.
Cellaviva’s long-term efforts to raise awareness of stem cells, for example through our collaboration with Nordic Tech House and Isabella Löwengrip, have begun to show results. In October 2018, Cellaviva expanded to the Danish market, which has already contributed positively to the sales figures.
NXTCL has delivered in significantly more areas than previously communicated in the prospectus for the rights issue. A few examples are:
• Cellaviva’s geographical expansion
• Preparation of the launch of stem cell saving for adults
• Two submitted patent applications
• Application for a new clinical trial, ProTrans-repeat
• Other business development opportunities that cannot yet be communicated
• Participation in several working groups, furthering the development of cell therapy in Sweden
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For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Sofia Fredrikson, CFO
Phone: 08-735 5595
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 22th of February 2019.