ProTrans cell therapy maintains insulin production effect 3.5 years after treatment

October 18, 2022

NextCell Pharma AB ("NextCell" or the "Company") today announces that type-1 diabetes patients receiving two treatments with a high dose of ProTrans cell therapy maintain a significantly higher endogenous insulin production than patients treated with low or medium doses.

Type I diabetes patients enrolled in the ProTrans Repeat Study, treated with the highest dose of ProTrans, maintained a significantly higher preserved endogenous insulin production than patients treated with low and medium doses (p<0.05). On average, the 3 patients treated in each of the low, medium and high-dose cohorts have maintained 41%, 45% and 81% of their insulin production capacity at the time of treatment i.e. 3.5–4 years ago.

 In 2018, 9 patients were treated in the Phase I ProTrans-1 dose escalation study. Treatment with ProTrans demonstrated a dose-dependent therapeutic effect, with medium and high-doses maintaining a statistically significant higher insulin production than patients receiving low-dose therapy. Patients treated with low dose ProTrans reduced an average of 28% of their endogenous insulin production, compared to 6% in medium and high-dose treated patients.

 All the 9 patients, who participated in ProTrans-1 above, agreed to be included in a continuation study, ProTrans-Repeat. All patients received an additional treatment of ProTrans, with the same dose that they previously received (one year after the initial treatment), with evaluation subsequently performed twelve months later, i.e. 2 to 2.5 years after the initial treatment. The study was designed to evaluate the safety of repeated treatments.  All doses were shown to be safe and did not result in any antibody responses to the allogeneic treatment.  Maintained insulin production after 2 years was 94% for high, 56% for medium and 51% for low dose.

 An interim analysis is now presented that concludes that high-dose treatment provides the highest and longest-lasting therapeutic effect in type I diabetic patients. Maintenance of insulin production has been assessed on 3 occasions for each patient- after 1year, 2 years and 3.5 years where the average for high dose was 96%, 94% and81% compared to medium dose 91%, 56% and 45% and low dose 72%, 51% and 41%. The ProTrans-Repeat study is set to last for 5 years i.e. a total of 6-6.5 years from inclusion in ProTrans-1.

 This disclosure contains information that NextCell Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 18th October 2022 at 13.20 CET.

For more information about NextCell Pharma AB, please contact:

Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8-735 5595
E-mail: info@nextcellpharma.com
Home page: www.nextcellpharma.com
 
LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma
 

Certified Adviser

FNCA Sweden AB is assigned as Certified Adviser, 08-528 00 399, info@fnca.se.

About NextCell Pharma AB

NextCell is a phase II cell therapy company. It’s lead candidate drug ProTrans is being developed for the prevention and treatment of type 1 diabetes. The focus is to take ProTrans to market approval via a Phase III study. ProTrans is in addition to diabetes, used in two clinical trials for Covid-19, in Örebro and Montreal (Canada). The Company is in the processes of establishing its own GMP facility for ProTrans manufacturing. The GMP facility is expected to be ready for production of smaller quantities of ProTrans in 2023. NextCell furthermore owns 8,5% in FamicordTX, a CAR-T start-up in oncology and 100 % of Cellaviva, Scandinavia's largest stem cellbank for family saving of stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).

Download attachmentRead full press release on Cision (external link)
2020-12-16
NextCell Pharma publishes prospectus supplement
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, HONG KONG, JAPAN, CANADA, NEW ZEALAND, SOUTH AFRICA, SWITZERLAND, SINGAPORE OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES. The Board of Directors of NextCell Pharma AB ("NextCell" or the “Company”) has prepared a supplement to the prospectus regarding the invitation to subscribe for shares in the Company’s resolved rights issue, which was approved by the Swedish
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, HONG KONG, JAPAN, CANADA, NEW ZEALAND, SOUTH AFRICA, SWITZERLAND, SINGAPORE OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFU...
Read moreRead more
2020-12-15
ProTrans Observation Study for long term efficacy in diabetes
NextCell Pharma AB (“NextCell” or “the Company”) today announces that an observational study, ProTrans-OBS, has been approved by the Swedish Ethical Review Board for long-term follow-up of patients previously participating in the ProTrans-2 clinical trial. The study is conducted by professor Per-Ola Carlsson, at Uppsala University. The observational study, ProTrans-OBS, is a non-interventional study, i.e.  patients will not be treated with additional doses of ProTrans. Participants that completed the ProTrans-2 trial will be asked for informed consent for biannual clinical assessment of
NextCell Pharma AB (“NextCell” or “the Company”) today announces that an observational study, ProTrans-OBS, has been approved by the Swedish Ethical Review Board for long-term follow-up of patients previously participating in the ProTrans-2 clinical trial. The study is conducted by professor Per-...
Read moreRead more
2020-12-10
ProTrans demonstrates effect at 2 years after repeated treatments
NextCell Pharma AB ("NextCell") today announces that the ProTrans-Repeat trial met its primary safety endpoint. There were no severe adverse events recorded during the 12-month follow-up period after a second dose of ProTrans™ (ProTrans). Furthermore, a strong tendency of sustained efficacy was observed in the three patients receiving high dose ProTrans. · Primary safety endpoint met · Tendency of sustained efficacy observed for high dose patients · 2-year preservation of insulin production significantly higher for patients treated with high dose as compared to low dose ProTrans-
NextCell Pharma AB ("NextCell") today announces that the ProTrans-Repeat trial met its primary safety endpoint. There were no severe adverse events recorded during the 12-month follow-up period after a second dose of ProTrans™ (ProTrans). Furthermore, a strong tendency of sustained efficacy was o...
Read moreRead more
2020-12-03
NextCell Pharma publishes prospectus relating to the rights issue
The Board of Directors of NextCell Pharma AB ("NextCell" or the “Company”) has prepared a prospectus (the “Prospectus”) relating to the new issue of shares with preferential rights for existing shareholders of approximately SEK 150 million (the Rights Issue”), which was resolved by the Board of Directors on 26 November 2020 pursuant to the authorisation from the annual general meeting. The Prospectus has today been approved and registered by the Swedish Financial Supervisory Authority. NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE
The Board of Directors of NextCell Pharma AB ("NextCell" or the “Company”) has prepared a prospectus (the “Prospectus”) relating to the new issue of shares with preferential rights for existing shareholders of approximately SEK 150 million (the Rights Issue”), which was resolved by the Board of D...
Read moreRead more
2020-11-20
The Board of Directors of NextCell Pharma intends on resolving on a fully guaranteed preferential rights issue of approximately SEK 150 million
The Board of Directors of NextCell Pharma AB (“NextCell” or the “Company”) today announces its intention to resolve on a fully guaranteed rights issue of up to approximately SEK 150 million with preferential rights for the Company’s existing shareholders (the “Rights Issue”). The Board of Directors’ intent to resolve on the Rights Issue requires that the shareholders at the Annual General Meeting on 24 November 2020 authorizes the Board of Directors to resolve on share issues. In the notice convening the Annual General Meeting, which was published by press release on 23 October 2020, the
The Board of Directors of NextCell Pharma AB (“NextCell” or the “Company”) today announces its intention to resolve on a fully guaranteed rights issue of up to approximately SEK 150 million with preferential rights for the Company’s existing shareholders (the “Rights Issue”). The Board of Directo...
Read moreRead more
2020-11-16
NextCell supports ProTrans study for children and adolescents
NextCell Pharma AB (“NextCell”) has entered into an agreement with Professor Per-Ola Carlsson, at Uppsala University Hospital and Uppsala University, with the aim of contributing the stem cell product ProTrans™ (ProTrans) for the treatment of children and adolescents with type 1 diabetes, within the framework of clinical drug trials. The study, which is in the planning stage, is part of NextCell's strategy to support academic groups with drugs to be able to evaluate ProTrans for a wider use. NextCell's drug candidate, ProTrans, for the treatment of type 1 diabetes is a mesenchymal stem cell
NextCell Pharma AB (“NextCell”) has entered into an agreement with Professor Per-Ola Carlsson, at Uppsala University Hospital and Uppsala University, with the aim of contributing the stem cell product ProTrans™ (ProTrans) for the treatment of children and adolescents with type 1 diabetes, within ...
Read moreRead more
2020-11-09
NextCell has formally kicked-off its Eurostars funded project ‘ Bioscale ’
NextCell Pharma AB (“NextCell” or the “Company”) announces today that it, in cooperation with the consortium members: MyCellHub, SEFA and Scinus Cell Expansion, now officially has kicked-off the earlier announced Eurostars project. The Eurostars project Bioscale will focus on using a novel cell expansion system developed by Scinus Cell Expansion, to further test, develop and validate the involved bioprocesses used in the production of NextCell’s drug candidate ProTrans™ (ProTrans). · NextCell has been granted €470,000 of a Eurostar grant totalling €1.6M. The total budget of the project is €2.
NextCell Pharma AB (“NextCell” or the “Company”) announces today that it, in cooperation with the consortium members: MyCellHub, SEFA and Scinus Cell Expansion, now officially has kicked-off the earlier announced Eurostars project. The Eurostars project Bioscale will focus on using a novel cell e...
Read moreRead more
2020-10-30
NextCell publishes its Year-End Report
NextCell Pharma AB (publ) (NXTCL) publishes its Year-End Report for the period September 1, 2019 - August 31, 2020 The report is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report NextCells share is traded on Nasdaq First North Growth Market under the ticker "NXTCL". The amount in brackets refers to the corresponding period in the previous year. Twelve months (2019-09-01 until 2020-08-31) ● Operating income amounted to SEK 4 166 123 (1 964 132). ● Operating result amounted to SEK -17 680 697 (-17 997 787). ● Earnings per share* amounted
NextCell Pharma AB (publ) (NXTCL) publishes its Year-End Report for the period September 1, 2019 - August 31, 2020 The report is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report NextCells share is traded on Nasdaq First North Growth Market under th...
Read moreRead more