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).

Download attachmentRead full press release on Cision (external link)
2019-05-17
Six out of nine patients in the phase-II part of the ProTrans-1 study have completed treatment
NextCell Pharma AB (NextCell) announces that six out of the nine patients included in ProTrans-1, the trial with the drug candidate ProTrans, now have completed treatment and left the study. Earlier this week, the last of the three patients in the so-called medium-dose-cohort visited for their 12-month follow-up, the final part of the trial, which means that all three now have completed their part of the trial. In early March, the three patients in the low-dose cohort had already completed the trial. This means that six out of nine patients in the phase II part have now successfully
NextCell Pharma AB (NextCell) announces that six out of the nine patients included in ProTrans-1, the trial with the drug candidate ProTrans, now have completed treatment and left the study. Earlier this week, the last of the three patients in the so-called medium-dose-cohort visited for their 12...
Read moreRead more
2019-05-15
NextCell Pharma invited speaker at the World Advanced Therapies & Regenerative Medicine Congress
NextCell Pharma AB ("NextCell") and Cellaviva have been invited to attend and speak at the 14th annual World Advanced Therapies & Regenerative Medicine Congress, which is held at the Business Design Centre, London 15 - 17 May. On 16 May, CEO Dr. Mathias Svahn will be chairing the Roundtable Discussion Session regarding hospital exemption procedures. For the duration of the conference NextCell/Cellaviva delegates will be participating in workshops, attending lectures and engaging in a variety of networking activities.  The World Advanced Therapies & Regenerative Medicine Congress is an
NextCell Pharma AB ("NextCell") and Cellaviva have been invited to attend and speak at the 14th annual World Advanced Therapies & Regenerative Medicine Congress, which is held at the Business Design Centre, London 15 - 17 May. On 16 May, CEO Dr. Mathias Svahn will be chairing the Roundtable Discu...
Read moreRead more
2019-05-09
ProTrans-Repeat, an approved clinical trial for repeated treatment of patients with diabetes
The Medical Products Agency has granted NextCell Pharma AB ("NextCell") permission to conduct the new study, ProTrans-Repeat. The study is a continuation of ProTrans-1 where patients with type-1 diabetes who participated in the dose escalation part will be asked to participate in ProTrans-Repeat. The purpose is to investigate whether repeated treatment is safe and gives increased effect on the patient's ability to produce insulin. ProTrans-Repeat is a Phase IIa clinical trial that aims to evaluate whether repeated treatment can increase or maintain the effect of ProTrans over a longer period
The Medical Products Agency has granted NextCell Pharma AB ("NextCell") permission to conduct the new study, ProTrans-Repeat. The study is a continuation of ProTrans-1 where patients with type-1 diabetes who participated in the dose escalation part will be asked to participate in ProTrans-Repeat....
Read moreRead more
2019-05-08
The Medical Products Agency grants NextCell permission to initiate the ProTrans-Repeat trial
NextCell Pharma AB ("NextCell") today received a permit from the Medical Products Agency granting permission to initiate a new clinical trial, called ProTrans-Repeat. The trials is a continuation of the ongoing ProTrans-1 trial and of great importance to the further development of ProTrans. The goal for this study is to include those patients with type 1 diabetes who participated in the dose escalation part of the ongoing ProTrans-1 study and the study purpose is to demonstrate that ProTrans also has a positive effect when using a repeated treatment approach. ProTrans-Repeat is a Phase IIa
NextCell Pharma AB ("NextCell") today received a permit from the Medical Products Agency granting permission to initiate a new clinical trial, called ProTrans-Repeat. The trials is a continuation of the ongoing ProTrans-1 trial and of great importance to the further development of ProTrans. The g...
Read moreRead more
2019-05-08
The NextCell Pharma AB board of directors proposes an Rights Issue of MSEK 24.9 and calls for an extraordinary general meeting
The Board of NextCell Pharma AB (publ) ("NextCell" or "the Company") has decided to propose an extraordinary general meeting on May 24, 2019 to decide on a rights issue of shares ("Rights Issue") totaling SEK 24.9 million. The rights issue is secured through subscription commitments and letter of intent of approximately 21 per cent and guarantee commitments of approximately 59 per cent, which corresponds to approximately 80 per cent of the total issue volume. The reason for the rights issue is to obtain working capital to expand the clinical trial program with the company's first drug
The Board of NextCell Pharma AB (publ) ("NextCell" or "the Company") has decided to propose an extraordinary general meeting on May 24, 2019 to decide on a rights issue of shares ("Rights Issue") totaling SEK 24.9 million. The rights issue is secured through subscription commitments and letter of...
Read moreRead more
2019-05-08
Discussions on a merger between NextCell AB and Idogen AB are suspended
The discussions that took place between the boards of NextCell Pharma AB ("NextCell") and Idogen AB ("Idogen") (together "The Companies"), regarding a possible merger, are suspended. Although the discussions have been characterized by pragmatism, but the boards of the companies have concluded that both companies will benefit from continuing to pursue their own activities. Even though the discussions regarding a possible merger have now been suspended, the companies choose to continue discussions on how the companies could further cooperate in the future. "We saw it as commercially logica
The discussions that took place between the boards of NextCell Pharma AB ("NextCell") and Idogen AB ("Idogen") (together "The Companies"), regarding a possible merger, are suspended. Although the discussions have been characterized by pragmatism, but the boards of the companies have concluded tha...
Read moreRead more
2019-05-06
Update regarding possible merger between NextCell Pharma AB and Idogen AB
Discussions between the boards of NextCell Pharma AB (publ) ("NextCell") and Idogen AB (publ) ("Idogen") (together "The companies") regarding a possible merger, are still ongoing. Further information will be published no later than the opening of trading on Wednesday, 08 May 2019. The companies have initiated a limited customary, legal, financial and technical/scientific due diligence. At the same time, discussions are taking place between the boards of the Companies. Additionally, the merger if implemented, will take place through an exchange offer from NextCell with consideration in
Discussions between the boards of NextCell Pharma AB (publ) ("NextCell") and Idogen AB (publ) ("Idogen") (together "The companies") regarding a possible merger, are still ongoing. Further information will be published no later than the opening of trading on Wednesday, 08 May 2019. The companies h...
Read moreRead more
2019-04-30
Half-year report
First Half (2018-09-01 till 2018-02-28) · Operating income amounted to SEK 508,7795 (391,204). · Operating result amounted to SEK -8,929,084 (-7,524,256).                         · Earnings per share* amounted to SEK -0.83 (-0.88). · Cash and bank amounted to SEK 6,886,879 (9,444,381). · Solidity** amounted to 87 (59) %. **Result per share: operating results divided by the average number of shares. Average number of shares for the first half of 2018/2019: 11,486,456 shares (8,505,425). Number of shares in NextCell as per February 28th, 11,486,456 shares (8,505,425). *
First Half (2018-09-01 till 2018-02-28) · Operating income amounted to SEK 508,7795 (391,204). · Operating result amounted to SEK -8,929,084 (-7,524,256).                         · Earnings per share* amounted to SEK -0.83 (-0.88). · Cash and bank amounted to SEK 6,886,879 (9,444,381). ...
Read moreRead more