Single treatment with ProTrans demonstrates long-term therapeutic effect over 5 years

May 28, 2024

NextCell Pharma AB ("NextCell" or the "Company") today announces that patients who were treated with a single dose of ProTrans five years ago in the randomized, placebo-controlled phase II study ProTrans-2 have retained significantly higher endogenous insulin production than patients who received placebo. ProTrans treated patients maintained 57% of their endogenous insulin production compared to 15% in the placebo group. The results are in line with NextCell’s previously reported three year data and demonstrates that ProTrans offers a disease-modifying treatment with long-lasting clinically relevant effect.

ProTrans Placebo
1 year 89% (± 10%) 53% (± 34%)
2 years 71% (± 21%) 33% (± 26%)
3 years 63% (± 33%) 23% (± 19%)
4 years 66% (± 41%) 14% (± 12%)
5 years 57% (± 29%) 14% (± 13%)










Table 1: Maintenance of endogenous insulin production per year after a single infusion of ProTrans, mean value for each treatment arm + standard deviation.

NextCell's Chief Scientific Officer, Dr. Lindsay Davies, will present the data and explain how a single dose of ProTrans can provide such a long-lasting effect. The presentation will be available at https://www.redeye.se/events/1012070/nextcell-pharma from Wednesday 29 May at 09:00 CET.

In 2018, the randomized double-blinded phase II study ProTrans-2 started at Karolinska University Hospital. A total of 15 patients were randomized 2:1 for treatment with one infusion of ProTrans or placebo control. The primary endpoint was the percentage of retained endogenous insulin production capacity one year after treatment, with patients treated with ProTrans maintaining an average of 89% compared to placebo controls which maintained 53%.

The 14 patients who completed ProTrans-2 were invited, after completion of the study, to participate in a non-interventional follow-up study where they would be followed for an additional 5 years, ProTrans-Obs. In total 6 patients treated with ProTrans and 5 patients who received placebo completed the study. In ProTrans-Obs, the patients' endogenous insulin production capability was measured. ProTrans treatment demonstrated a statistically significant effect (p<0.05) compared to placebo.

No serious adverse reactions related to treatment have been reported. The company continues to analyses the data and will present more detailed results in the coming weeks.


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 28-05-2024 14:15 CET.

For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 5595
E-mail: info@nextcellpharma.com

Websites:
NextCell Pharma AB: www.nextcellpharma.com
Cellaviva Sverige: www.cellaviva.se
Cellaviva Danmark: www.cellaviva.dk

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

Certified Adviser
FNCA Sweden AB is assigned as Certified Adviser.

About NextCell Pharma AB

NextCell is a cell therapy company that is in phase 2 studies with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to obtain market approval of ProTrans via a phase 3 study. ProTrans is manufactured utilizing the patented platform technology for selection of optimal cells with potency to treat inflammatory disorders including autoimmune diseases. NextCell owns Cellaviva, the largest stem cell bank in the Nordics and QVance, a quality analysis CRO company in start up.

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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