NextCell cell therapy shows long-term effect in two independent diabetes studies "ProTrans-Repeat" and "ProTrans-Obs" – live presentation
October 24, 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
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 after treatment.
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 3.5-4 years. 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 14 patients who completed ProTrans-2, 6 ProTrans-treated and 5 placebo treated patients accepted to participate in follow-up study on ProTrans-Note after completion of the study, where they are 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 time points (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 30patients aged 12-21 years and 30 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 ofSars-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:
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 Famicord TX, 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).
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 1 for the period September 1, 2023 – November 30, 2023. 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.
Updates regarding NextCell’s Clinical Trials with ProTrans
NextCell Pharma has several ongoing clinical trials with ProTrans. The largest ongoing study ProTrans Young, which includes 66 patients, is progressing well. All 30 patients in the older age group have been recruited and will be treated with ProTrans. In the long-term follow-up studies ProTrans-Obs and ProTrans-Repeat the first diabetes patients have now completed the studies after five years of follow-up.
Repeated treatment with ProTrans is immunologically safe
NextCell Pharma AB ("NextCell" or the "Company") today announces that multiple treatments with ProTrans cell therapy does not induce donor specific antibodies in type-1 diabetes patients. A detailed analysis of how the immune system reacts to infusion of ProTrans cells show that treatment can be given to any adult type 1 diabetic, irrespective of pre-existing HLA antibodies.
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Year-End Report for the period September 1, 2022 – August 31, 2023. 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.
NextCell signs an agreement for a new tissue product
NextCell Pharma AB (“NextCell” or “the company”) announces that the company has signed an agreement with the Finnish biotechnology company Linio to warehouse and distribute Tience® in Sweden. The value of the agreement for the first year amounts to approximately 400 000 SEK in fixed remuneration and a variable remuneration per product delivered. Tience is a tissue product that is injected to combat scarring and can also be used for aesthetic purposes such as skin rejuvenation and to combat wrinkles. The product is marketed and sold by Linio to clinics and hospitals.
NextCell Pharma presents at the Advanced Therapies Europe conference
NextCell Pharma participates in Advanced Therapies Europe, a European conference in Portugal on advanced cell therapies. NextCell's CSO Dr. Lindsay Davies will talk about NextCell's platform technology and the internationally recognized research generated during the development of drug product ProTrans for type 1 diabetes.