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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2018-10-31
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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
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Last day of trading in series TO 1 warrants
Today, 11th September 2018, is the last day of trading in warrants of series TO 1 issued as part of NextCell Pharma AB's ("NXTCL") listing in the spring of 2017. Last day to subscribe for shares on the basis of warrants of series TO 1 is 13th September 2018. The teaser and subscription form are available on the following websites: NXTCL (www.nextcellpharma.com (http://file///C:/Users/ErikBerggren/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/TLO3KWR6/www.nextcellpharma.com)); Sedermera Fondkommission (www.sedermera.se (http://file///C:/Users/ErikBerggren/AppData/Local/Microsoft/
Today, 11th September 2018, is the last day of trading in warrants of series TO 1 issued as part of NextCell Pharma AB's ("NXTCL") listing in the spring of 2017. Last day to subscribe for shares on the basis of warrants of series TO 1 is 13th September 2018. The teaser and subscription form are a...
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2018-09-05
Reminder to exercise your series TO 1 warrants
The subscription period for the series TO 1 warrants issued as part of NextCell Pharma AB’s ("NXTCL") issue of units during the spring of 2017 will continue until 13th September 2018. The last day for trading with the series TO 1 warrants is 11th September 2018. Holders of the series TO 1 warrants are entitled to subscribe for a new share for each warrant at a price of SEK 5.00 per share. If all of the series TO 1 warrants are exercised, 2 860 940 new shares will be issued and NXTCL is receives approximately MSEK 14.3 before issue costs. The subscription of series TO 1 warrants to be
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