Broader health benefits of ProTrans in treatment of type 1 diabetes

September 5, 2024

NextCell Pharma AB ("NextCell" or the "Company", Nasdaq First North Growth Market: NXTCL), has presented new long-term clinical data at the International Society for Cell and Gene Therapy (ISCT) 2024 Regional Meeting, held in Gothenburg, Sweden. The results show the long-term safety of the treatment, the effect of preserving the patient's own insulin production and more health benefits in patients with type 1 diabetes (T1D), such as lower BMI and blood pressure.

A Single Dose of ProTrans Slows Disease Progression for More Than 5 Years. Patients from the Phase II trial have been monitored for over 5 years following a single dose of ProTrans. The long-term data that was presented in a press release 2024-05-28 shows that ProTrans treatment significantly slows the progression of T1D. This was described in detail at ISCT, using a non-linear regression analysis of the percentage loss of endogenous insulin production over time. The slopes of placebo-treated individuals were significantly steeper than those of ProTrans-treated individuals, indicating statistically significant differences in slowing disease progression year to year in the latter group (p<0.05-0.01).

ProTrans Treatment Supports Long-Term Health Benefits in T1D Patients. In addition to preserving insulin production, new data was presented where ProTrans also supported broader health benefits in patients over a multi-year follow-up period. Key findings include:

  • Body mass index (BMI) increased significantly in placebo-treated individuals, while BMI was maintained in ProTrans-treated patients after 2 years (p<0.05-0.01).
  • ProTrans-treated patients also exhibited a consistent trend of lower diastolic and systolic blood pressure, with significant differences emerging after 4-4.5 years compared to placebo-treated individuals (p<0.05).

The findings reinforce ProTrans as a promising cell therapy for T1D, capable of slowing disease progression and supporting broader metabolic health benefits in treated individuals.

NextCell Pharma also presented data on its strategy for delivering an off-the-shelf therapeutic that is accessible for patients irrespective of their geographical location. Cold chain management, standardised handling of the product and a long-term storage and stability of the product are a few of the unique features of ProTrans and how it has been developed with a commercial mindset.

For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 55 95
E-mail: info@nextcellpharma.com
Website:www.nextcellpharma.com

Linkedin: https://www.linkedin.com/NextCell-Pharma
Twitter: https://twitter.com/NextCellPharma


For more information about Cellaviva, please contact
Sofie Falk Jansson, CEO Cellaviva AB
Tel: +46 8 735 20 10
E-mail: info@cellaviva.se
Website:www.cellaviva.se


Facebook: https://www.facebook.com/cellavivasverige
Instagram: https://www,instagram.com/cellaviva

Certified Adviser
FNCA Sweden AB is assigned as Certified Adviser.

About NextCell Pharma AB

NextCell is a cell therapy company in Phase II trials with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to obtain market approval of ProTrans via a phase III trial. In addition to type 1 diabetes, ProTrans is used in two clinical trials for COVID-19, in Örebro and in Montreal, Canada. Furthermore, NextCell owns 8.5% in FamicordTX, a CAR-T start-up in oncology, and 100% of Cellaviva AB, Scandinavia’s largest private stem cell bank licensed by the Swedish Health Authority (IVO) to preserve and store stem cells from umbilical cord blood and umbilical cord tissue for family use.

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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...
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2019-05-15
NextCell Pharma invited speaker at the World Advanced Therapies & Regenerative Medicine Congress
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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....
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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...
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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...
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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...
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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
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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). ...
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