NextCell presentation of Interim analysis data today at 15:00

October 27, 2022

NextCell Pharma AB ("NextCell" or the "Company") has developed a proprietary and patented platform technology where stem cells can be selected for allogeneic treatment of various specific diseases. CEO Mathias Svahn will present the results on Thursday, October 27 at 15:00 CET, which will be broadcast live via Nyhetsbytrån Direkt, link https://youtu.be/Y9BSbt31tqc.

·       Thursday, October 27, CET 3:00 pm

·       https://youtu.be/Y9BSbt31tqc


Below follows an update on the Company's completed and ongoing clinical trials with the drug candidate ProTrans, which has been developed for type-1 diabetes, autoimmune and inflammatory diseases.


ProTrans-1
.
A 2019 completed open-label dose-escalation Phase-1 study in nine type-1 diabetes patients demonstrated a) good safety and b) dose-dependent efficacy regarding preservation of endogenous insulin production one year aftertreatment.

ProTrans-2.
A since 2020 completed placebo-controlled Phase-2study in 15 type-1 diabetes patients showed significant treatment efficacy (p<0.05), in which ProTrans-treated patients maintained 90% of their endogenous insulin production one year after treatment, versus 53% in the placebo group.

ProTrans-Repeat
is an open-label follow-up study in the patients who participated in ProTrans-1 above. The nine patients were treated, after first treatment, with an additional equal dose they had received about one-two years earlier in ProTrans-1. On October 18 this year, an interim analysis after the second treatment was presented, which concludes that treatment with the highest dose gives significant the best long-term effect regarding the preservation of one's own insulin production. On average, the three cohorts retained low-, medium-, and high-dose, 41%, 45%, and 81% of their insulin-producing ability at the first time of treatment after about 3.5-4years. The long-term effect is followed up for another two years.

ProTrans-Obs (11 patients, ongoing).
Long-term follow-up of patients who previously participated in ProTrans-2. The study lasts for 5 years and 3-year interim results are presented here: " out of 14patients who completed ProTrans-2, 6 ProTrans-treated and 5 placebo treated patients accepted to participate in follow-up study ProTrans-Note after completion of the study, where the yare followed for another 5 years. In the study, the patients' endogenous insulin production is measured semi-annually and a 3-year follow-up has been done. The results of this interim analysis show statistically significant treatment effect at all analyzed timepoints (p<0.05).

ProTrans-Young (66 patients, ongoing)
is a Phase 1/2 study where the first part is an open-label safety study with 6 children newly diagnosed with type-1 diabetes. All patients have been treated and a safety committee is expected to recommend continuation with Part 2 in early November.
The second part of the study is a randomized, placebo-controlled double-blinded study with 30 patients aged 12-21 years and30 patients aged 7-11 years.

Pediatric Investigation Plan, PIP.
A pediatric development plan has been submitted to the European Medicines Agency's Expert Committee on Drug Development for the Treatment of Children. The plan describes the clinical trial program until commercialization and is a requirement forphase-3 studies. The application includes ProTrans-3, a pivotal phase III study for including both adults and children that, in the event of a positive outcome, can give ProTrans marketing approval.

 Protrans19+SE (9 patients,ongoing).
Swedish open-label dose escalation study (phase 1) with ProTrans for the treatment of adult patients (not type-1 diabetes), who suffered from severe pneumonia as a result of Sars-CoV-2 infection.

Protrans19+CA (48 patients,ongoing).
Canadian randomized, placebo-controlled, double-blinded (Phase 2)study for the treatment of adult patients (not diabetes), who suffered from severe pneumonia as a result of Sars-CoV-2 infection.


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
Hemsida: www.nextcellpharma.com
 
LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma
 

About NextCell Pharma AB

NextCell is a cell therapy company in clinical phase II. The company has developed a proprietary and patented platform technology to produce mesenchymal stem cells adapted for allogeneic treatment of various autoimmune and immunological diseases. The drug candidate ProTrans is now being tested for the treatment of type-1 diabetes as well as respiratory complications caused by Sars-CoV-2 infection. The focus is to take ProTrans to a market approval for type-1 diabetes via a phase III study.  ProTrans is evaluated in two clinical Covid-19studies, in Sweden and Canada. NextCell is working on completing its own GMP facility for the manufacture of ProTrans. The GMP facility is expected to be ready for manufacturing smaller quantities of ProTrans in 2023. NextCell also owns 8.5% of FamicordTX, a start-up company in CAR-T  ‘and oncology, and 100% of Cellaviva, Scandinavia's largest stem cell bank for family savings 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)
2019-09-24
Last patient, last visit completed in the dose escalation part
NextCell Pharma AB (NextCell) is today announcing that the last patient in the dose escalation part of the clinical trial ProTrans-1 for diabetes is completed. The last patient was today at the last visit and has now left the trial. ProTrans-1 is a two-part phase I / II clinical trial where the phase I part evaluates safety for three doses. All nine patients have now been followed up for 12 months and have left the study. As previously communicated, all 15 patients in the phase II part of ProTrans-1 have been treated and will be followed for 12 months. The second part is randomized,
NextCell Pharma AB (NextCell) is today announcing that the last patient in the dose escalation part of the clinical trial ProTrans-1 for diabetes is completed. The last patient was today at the last visit and has now left the trial. ProTrans-1 is a two-part phase I / II clinical trial where the p...
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2019-09-12
Update on the ongoing clinical trials
NextCell Pharma AB (NextCell) is today providing a status update regarding its two ongoing clinical trials, presented at the Nordic Life Science days in Malmö. All patients in ProTrans-1 were treated by June 2019 and 8 out of 9 patients in the dose escalation part have already left the trial after 12 months follow-up. The ProTrans-Repeat has included 5 out of 18 patients. NextCell is conducting two parallel clinical trials with the drug candidate ProTrans, with the aim to treat type-1 diabetes. A single dose of ProTrans is given and the patients own ability to produce insulin is compared
NextCell Pharma AB (NextCell) is today providing a status update regarding its two ongoing clinical trials, presented at the Nordic Life Science days in Malmö. All patients in ProTrans-1 were treated by June 2019 and 8 out of 9 patients in the dose escalation part have already left the trial afte...
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2019-08-16
NextCell Pharma files another patent application
NextCell Pharma AB ("NextCell") today announces that they have filed a new patent application to the Swedish Patent and Registration Office. The patent relates to the Company's proprietary selection algorithm, now with extended and tailored analyses for diseases and conditions affecting the central nervous system. The application was submitted to the Swedish Patent and Registration Agency on August 15 and is formulated to cover the general production of all types of mesenchymal stem cell products derived from multiple donors and cells selected by the selection algorithm. Furthermore, the
NextCell Pharma AB ("NextCell") today announces that they have filed a new patent application to the Swedish Patent and Registration Office. The patent relates to the Company's proprietary selection algorithm, now with extended and tailored analyses for diseases and conditions affecting the centr...
Read moreRead more
2019-07-31
Interim report 2018-09-01 - 2019-05-31
Third quarter report By "NextCell", “NXTCL” or "Company" is meant NextCell Pharma AB with organization number 556965-8361. “Spotlight" refers to the Spotlight Stock Market (previous AktieTorget). Amount in brackets refer to the corresponding period in the previous year. Note that the Company's fiscal year is September 1 - August 31. This English version is a translation of the Swedish version. The Swedish version is at all time to be seen as the leading document. Nine months (2018-09-01 until 2019-05-31) · Operating income amounted to SEK 1 410 055 (527 545). · Operating result
Third quarter report By "NextCell", “NXTCL” or "Company" is meant NextCell Pharma AB with organization number 556965-8361. “Spotlight" refers to the Spotlight Stock Market (previous AktieTorget). Amount in brackets refer to the corresponding period in the previous year. Note that the Company's f...
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2019-06-20
Final patient treated in the phase II part of the ProTrans-1 trial
NextCell Pharma AB (NextCell) today treated the last diabetic patient in the phase II part of the ProTrans-1 trial. This means that all patients included in the clinical study have been treated and are now subject to a 12-month follow-up period before efficacy and safety data will be available. The final patient has been treated in the randomized, placebo controlled ProTrans-1 phase II part trial. Efficacy and safety data will be collected through regular clinical assessments visits during a 12 month period. Last patient, last will be assessed in July 2020 and thereafter the code will be
NextCell Pharma AB (NextCell) today treated the last diabetic patient in the phase II part of the ProTrans-1 trial. This means that all patients included in the clinical study have been treated and are now subject to a 12-month follow-up period before efficacy and safety data will be available. T...
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2019-06-20
New collaboration and increased digital presence - Cellaviva is gearing for growth
NextCell Pharma AB ("NextCell") today announces that they, via its biobank Cellaviva, have entered into a partnership with Bonzun Health Information AB ("Bonzun"), who are providing the first global health app for pregnant women. Bonzun has launched the first virtual midwife for pregnant women which can be downloaded in Appstores under the name Bonzun Pregnant. The app is currently available in 79 countries worldwide under the name Bonzun and in Sweden under the name Min Graviditet. The collaboration has been entered into with the common goal of strengthening the work of sharing knowledge
NextCell Pharma AB ("NextCell") today announces that they, via its biobank Cellaviva, have entered into a partnership with Bonzun Health Information AB ("Bonzun"), who are providing the first global health app for pregnant women. Bonzun has launched the first virtual midwife for pregnant women wh...
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2019-06-19
NextCell has treated the first patient in the ProTrans-Repeat trial
NextCell Pharma AB (NextCell) announces that earlier today the first patient was treated as part of the ProTrans-Repeat trial, which is NextCell’s second clinical trial. ProTrans-Repeat is a Phase IIa clinical trial which includes patients receiving active treatment with ProTrans and who have previously been treated in the ProTrans-1 study's dose escalation phase. This means that the participants receive their second treatment with ProTrans, just over a year after the first. The goal of the ProTrans-Repeat trial is to test whether repeated treatment can increase or maintain the effect of
NextCell Pharma AB (NextCell) announces that earlier today the first patient was treated as part of the ProTrans-Repeat trial, which is NextCell’s second clinical trial. ProTrans-Repeat is a Phase IIa clinical trial which includes patients receiving active treatment with ProTrans and who have pre...
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2019-06-11
Anders Essen-Möller subscribes to his entire stakes in NextCell Pharmas right issue
The two largest owners of NextCell Pharma AB (“NextCell” or “The Company”) Anders Essen-Möller and Diamyd Medical AB, fully subscribe for their respective shares in NextCells ongoing rights issue. This means that both parties consolidate their ownership interests and that Essen-Möllers ownership in NextCell after the investments increases from approximately SEK 3.6 million to 6.0 million. Regarding the ongoing rights issue in NextCell, the principal owner Anders Essen-Möller, also the chairman of the company, has chosen to fully utilize its allotted subscription rights, which means that he
The two largest owners of NextCell Pharma AB (“NextCell” or “The Company”) Anders Essen-Möller and Diamyd Medical AB, fully subscribe for their respective shares in NextCells ongoing rights issue. This means that both parties consolidate their ownership interests and that Essen-Möllers ownership ...
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