Broader health benefits of ProTrans in treatment of type 1 diabetes

September 5, 2024

NextCell Pharma AB ("NextCell" or the "Company", Nasdaq First North Growth Market: NXTCL), has presented new long-term clinical data at the International Society for Cell and Gene Therapy (ISCT) 2024 Regional Meeting, held in Gothenburg, Sweden. The results show the long-term safety of the treatment, the effect of preserving the patient's own insulin production and more health benefits in patients with type 1 diabetes (T1D), such as lower BMI and blood pressure.

A Single Dose of ProTrans Slows Disease Progression for More Than 5 Years. Patients from the Phase II trial have been monitored for over 5 years following a single dose of ProTrans. The long-term data that was presented in a press release 2024-05-28 shows that ProTrans treatment significantly slows the progression of T1D. This was described in detail at ISCT, using a non-linear regression analysis of the percentage loss of endogenous insulin production over time. The slopes of placebo-treated individuals were significantly steeper than those of ProTrans-treated individuals, indicating statistically significant differences in slowing disease progression year to year in the latter group (p<0.05-0.01).

ProTrans Treatment Supports Long-Term Health Benefits in T1D Patients. In addition to preserving insulin production, new data was presented where ProTrans also supported broader health benefits in patients over a multi-year follow-up period. Key findings include:

  • Body mass index (BMI) increased significantly in placebo-treated individuals, while BMI was maintained in ProTrans-treated patients after 2 years (p<0.05-0.01).
  • ProTrans-treated patients also exhibited a consistent trend of lower diastolic and systolic blood pressure, with significant differences emerging after 4-4.5 years compared to placebo-treated individuals (p<0.05).

The findings reinforce ProTrans as a promising cell therapy for T1D, capable of slowing disease progression and supporting broader metabolic health benefits in treated individuals.

NextCell Pharma also presented data on its strategy for delivering an off-the-shelf therapeutic that is accessible for patients irrespective of their geographical location. Cold chain management, standardised handling of the product and a long-term storage and stability of the product are a few of the unique features of ProTrans and how it has been developed with a commercial mindset.

For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 55 95
E-mail: info@nextcellpharma.com
Website:www.nextcellpharma.com

Linkedin: https://www.linkedin.com/NextCell-Pharma
Twitter: https://twitter.com/NextCellPharma


For more information about Cellaviva, please contact
Sofie Falk Jansson, CEO Cellaviva AB
Tel: +46 8 735 20 10
E-mail: info@cellaviva.se
Website:www.cellaviva.se


Facebook: https://www.facebook.com/cellavivasverige
Instagram: https://www,instagram.com/cellaviva

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About NextCell Pharma AB

NextCell is a cell therapy company in Phase II trials with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to obtain market approval of ProTrans via a phase III trial. In addition to type 1 diabetes, ProTrans is used in two clinical trials for COVID-19, in Örebro and in Montreal, Canada. Furthermore, NextCell owns 8.5% in FamicordTX, a CAR-T start-up in oncology, and 100% of Cellaviva AB, Scandinavia’s largest private stem cell bank licensed by the Swedish Health Authority (IVO) to preserve and store stem cells from umbilical cord blood and umbilical cord tissue for family use.

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2020-12-23
NextCell Pharma’s rights issue was oversubscribed
NextCell Pharma AB ("NextCell" or the ”Company”) announces today the outcome in the Company’s new issue of shares with preferential rights for existing shareholders of approximately SEK 150 million (the “Rights Issue”). The Rights Issue was oversubscribed. Thus, no guarantees have been utilized. 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
NextCell Pharma AB ("NextCell" or the ”Company”) announces today the outcome in the Company’s new issue of shares with preferential rights for existing shareholders of approximately SEK 150 million (the “Rights Issue”). The Rights Issue was oversubscribed. Thus, no guarantees have been utilized. ...
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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...
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2020-12-15
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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-...
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ProTrans demonstrates effect at 2 years after repeated treatments
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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...
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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...
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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...
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2020-11-16
NextCell supports ProTrans study for children and adolescents
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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 ...
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2020-11-09
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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...
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