ProTrans cell therapy provides long-term effect in type-1 diabetes with a single treatment

October 20, 2022

NextCell Pharma AB ("NextCell" or the "Company") today announces that patients who 3 years ago were treated with ProTrans in the phase II study ProTrans-2 have maintained significantly higher endogenous insulin production than patients who received placebo, (63% compared to 23%).The results from the interim follow-up study ProTrans-Obs suggest that the treatment changes the course of the disease and that the effect persists overtime.

In 2018, the randomized double-blind phase II clinical trial, ProTrans-2 started at Karolinska University Hospital. A total of 15 patients were randomized 2:1 to treatment with ProTrans or placebo. The primary endpoint is percentage of endogenous insulin production one year after therapy and patients treated with ProTrans maintained an average of 90% compared to the placebo group who maintained 53%.

The 14 patients who completed ProTrans-2 were after completion offered to participate in a follow-up study, where they are followed for another 5 years, ProTrans-Obs. Some patients abstained from participation due to long journeys, 6 patients treated with ProTrans and 5patients who received placebo are included in the study. In ProTrans-Obs, the patients' endogenous insulin production is measured semi-annually and the latest analysis was carried out after 3 years of follow-up. In this interim analysis, ProTrans shows a statically significant treatment effect at all analyzed timepoints (p<0.05).

NextCell announced on October 18, 2022 that patients with type-1 diabetes undergoing two high-dose treatments of ProTrans cell therapy retain significantly higher endogenous insulin production than patients treated with low and medium dose in the clinical drug trial, ProTrans-Repeat. The results from ProTrans-Obs (one treatment with ProTrans)and ProTrans-Repeat (two treatments with ProTrans) cannot be directly compared, but both studies clearly show that ProTrans has a long-term effect for the treatment of type-1 diabetes.

 

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 contactperson for publication on 20th October 2022, 13.30 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
Hemsida: 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 with the drug candidate ProTrans for the 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 production of ProTrans. The GMP facility is expected to be ready for production of smaller quantities of ProTrans in2023. NextCell furthermore owns 8,5% in FamicordTX, a CAR-T start-up in oncology and 100 % of Cellaviva, Scandinavia's largest stem cell bank for family saving stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).

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2018-11-05
Application for clinical trial submitted to the Medical Products Agency, ProTrans-2.
NextCell Pharma AB ("NXTCL") today announced that a new application to conduct a clinical trial with ProTrans has been submitted to the Swedish Medical Products Agency. The purpose of the study is to evaluate repeated treatment with ProTrans, including patients with type 1 diabetes who participated in the dose escalating part of the original NXTCL trial. The ongoing clinical trial called ProTrans-1, was initiated with a dose escalation phase for 9 patients all followed for 12 months. After their last visit in the study, patients will be asked if they want to participate in a new study where
NextCell Pharma AB ("NXTCL") today announced that a new application to conduct a clinical trial with ProTrans has been submitted to the Swedish Medical Products Agency. The purpose of the study is to evaluate repeated treatment with ProTrans, including patients with type 1 diabetes who participat...
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2018-11-02
Update regarding targeted new issue to Nordic Tech House
NextCell Pharma (NXTCL), announces today that the Board, with the authorization of the Annual General Meeting of December 5, 2017, has decided to implement a directed new issue of Nordic Tech House AB ("NTH") of a maximum of approximately SEK 1.5 million. The reasons for the deviation from shareholders' pre-emption rights are to fulfil the company's commitment in accordance with an agreement with Nordic Tech House AB, which was concluded to provide the company with new owners of strategic importance. Current decision replaces previous resolutions on directed new issue from March 13, 2018,
NextCell Pharma (NXTCL), announces today that the Board, with the authorization of the Annual General Meeting of December 5, 2017, has decided to implement a directed new issue of Nordic Tech House AB ("NTH") of a maximum of approximately SEK 1.5 million. The reasons for the deviation from shareh...
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2018-10-31
Publication of year-end report
NextCell Pharma AB (”NXTCL”, “NextCell”) today, released its year-end report for book year 2017/2018 (September 2017 – August 2018). Twelve Months (2017-09-01 until 2018-08-31)  · Net sales amounted to SEK 655 413 (517 203). · Operating result amounted to SEK –14 032 294 (-13 245 206).                   · Result per share amounted to SEK -0,61 (-0,64). · Cash and bank amounted to SEK 3 115 876 (16 600 937). · Solidity amounted to 59 (88) %. · Net sales amounted to SEK 127 868 (198 765). · Operating result amounted to SEK -3 422 282 (-4 757 996).
NextCell Pharma AB (”NXTCL”, “NextCell”) today, released its year-end report for book year 2017/2018 (September 2017 – August 2018). Twelve Months (2017-09-01 until 2018-08-31)  · Net sales amounted to SEK 655 413 (517 203). · Operating result amounted to SEK –14 032 294 (-13 245 206).      ...
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2018-10-25
The Safety Committee recommends proceeding with part 2 of the stem cell trial in type 1 diabetes
The stem cell company NextCell Pharma AB ("NXTCL") today announced that the Data and Safety Monitoring Board recommends Professor Per-Ola Carlsson Academic Hospital, Uppsala University and NXTCL to proceed with the second part of the clinical trial with ProTrans. Patients with type 1 diabetes aged 18-40 years old who had the disease for a maximum of 2 years and who have some own insulin production are candidates to be included in the study. The second part of the ProTrans trial is a Phase-II study with the aim to further evaluate the efficacy and safety of ProTrans. The efficacy of the
The stem cell company NextCell Pharma AB ("NXTCL") today announced that the Data and Safety Monitoring Board recommends Professor Per-Ola Carlsson Academic Hospital, Uppsala University and NXTCL to proceed with the second part of the clinical trial with ProTrans. Patients with type 1 diabetes age...
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2018-10-01
NXTCL’s Cellaviva brand is expanding into Denmark
NextCell Pharma AB ("NXTCL") announced today, that the Cellaviva brand will expand its operations into Denmark. As of 1st October 2018, Cellaviva will offer family stem cell banking there. The idea of family saving of stem cells is already an established business in Denmark and NXTCL estimates that its entrance into Denmark will allow for a doubling of annual sales for Cellaviva. The establishment fits within the existing budget and does not affect NXTCL's capital requirements. Cellaviva has now decided to expand its operations to Denmark as of 1st October 2018. The company holds all the
NextCell Pharma AB ("NXTCL") announced today, that the Cellaviva brand will expand its operations into Denmark. As of 1st October 2018, Cellaviva will offer family stem cell banking there. The idea of family saving of stem cells is already an established business in Denmark and NXTCL estimates th...
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2018-09-20
Redeemed warrants are now registered with the Swedish Companies Registration Office
NextCell Pharma AB ("NXTCL") announced today, 20th September 2018, that the exercised series TO 1 warrants, whose subscription period ended on 13th September 2018, have now been registered with the Swedish Companies Registration Office. A total of 2 720 931 new shares have been registered, which means that the number of shares in NXTCL after registration amounts to 11 226 356. The share capital amounts to SEK 2 301 402.98. Conversion of interim shares to shares is expected to take place on 28th September 2018. Different agents may take a different amount of time to convert, which means that
NextCell Pharma AB ("NXTCL") announced today, 20th September 2018, that the exercised series TO 1 warrants, whose subscription period ended on 13th September 2018, have now been registered with the Swedish Companies Registration Office. A total of 2 720 931 new shares have been registered, which ...
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2018-09-17
NXTCL is allocated approximately SEK 12.9 million through redemption of warrants
During the period 23rd August – 13th September 2018, holders of series TO 1 warrants in NextCell Pharma AB ("NXTCL") have been able to subscribe for shares on the basis of their warrants. In total 2 720 931 warrants of series TO 1 were exercised, which means a subscription rate of 95.11 percent. NXTCL is therefore allocated approx. SEK 13.6 million before issue costs, which are estimated to amount to approx. SEK 0.7 million. CEO Mathias Svahn comments "I would like to thank all of those who have shown - and continue to show - their interest and trust in the stem cell company NXTCL. We
During the period 23rd August – 13th September 2018, holders of series TO 1 warrants in NextCell Pharma AB ("NXTCL") have been able to subscribe for shares on the basis of their warrants. In total 2 720 931 warrants of series TO 1 were exercised, which means a subscription rate of 95.11 percent. ...
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2018-09-11
NextCell to present status of ongoing clinical trial at the Nordic Life Science Days
Stem cell company NextCell Pharma AB ("NXTCL") today presents a status update of its ongoing Phase I/II trial with ProTrans for the treatment of type 1 diabetes. Two out of three patients in the high dose cohort have now undergone treatment and the third patient is scheduled for treatment later this week. NXTCL's clinical trial is divided into two parts, the first part is a three-step dose escalation phase with three patients in each cohort, a total of nine patients. The second part of the trial is randomized, double-blind and placebo-controlled, with ten patients receiving ProTrans and five
Stem cell company NextCell Pharma AB ("NXTCL") today presents a status update of its ongoing Phase I/II trial with ProTrans for the treatment of type 1 diabetes. Two out of three patients in the high dose cohort have now undergone treatment and the third patient is scheduled for treatment later t...
Read moreRead more