NextCell cell therapy shows long-term effect in two independent diabetes studies "ProTrans-Repeat" and "ProTrans-Obs" – live presentation

October 24, 2022

NextCell Pharma AB ("NextCell" or the "Company") has developed a proprietary and patented platform technology where stem cells can be selected for allogeneic treatment of various specific diseases. CEO Mathias Svahn will present the results on Thursday, October 27 at 15:00 CET, which will be broadcast live via Nyhetsbytrån Direkt, link https://youtu.be/Y9BSbt31tqc.

·       Thursday, October 27, CET 3:00 pm

·       https://youtu.be/Y9BSbt31tqc

Below follows an update on the Company's completed and ongoing clinical trials with the drug candidate ProTrans, which has been developed for type-1 diabetes, autoimmune and inflammatory diseases.


ProTrans-1
.
A 2019 completed open-label dose-escalation Phase-1 study in nine type-1 diabetes patients demonstrated a) good safety and b) dose-dependent efficacy regarding preservation of endogenous insulin production one year after treatment.


ProTrans-2
.
A since 2020 completed placebo-controlled Phase-2study in 15 type-1 diabetes patients showed significant treatment efficacy (p<0.05),in which ProTrans-treated patients maintained 90% of their endogenous insulin production one year after treatment, versus 53% in the placebo group.


ProTrans-Repeat

is an open-label follow-up study in the patients who participated in ProTrans-1 above. The nine patients were treated, after first treatment, with an additional equal dose they had received about one-two years earlier in ProTrans-1. On October 18 this year, an interim analysis after the second treatment was presented, which concludes that treatment with the highest dose gives significant the best long-term effect regarding the preservation of one's own insulin production. On average, the three cohorts retained low-,medium-, and high-dose, 41%, 45%, and 81% of their insulin-producing ability at the first time of treatment after about 3.5-4 years. The long-term effect is followed up for another two years.


ProTrans-Obs
(11 patients, ongoing).
Long-term follow-up of patients who previously participated in ProTrans-2. The study lasts for 5 years and 3-year interim results are presented here: " out of 14 patients who completed ProTrans-2, 6 ProTrans-treated and 5 placebo treated patients accepted to participate in follow-up study on ProTrans-Note after completion of the study, where they are followed for another 5 years. In the study, the patients' endogenous insulin production is measured semi-annually and a 3-year follow-up has been done. The results of this interim analysis show statistically significant treatment effect at all analyzed time points (p<0.05).


ProTrans-Young
(66 patients, ongoing)
is a Phase 1/2 study where the first part is an open-label safety study with 6 children newly diagnosed with type-1 diabetes. All patients have been treated and a safety committee is expected to recommend continuation with Part 2 in early November.

The second part of the study is a randomized, placebo-controlled double-blinded study with 30patients aged 12-21 years and 30 patients aged 7-11 years.


Pediatric Investigation Plan, PIP.
A pediatric development plan has been submitted to the European Medicines Agency's Expert Committee on Drug Development for the Treatment of Children. The plan describes the clinical trial program until commercialization and is a requirement forphase-3 studies. The application includes ProTrans-3, a pivotal phase III study for including both adults and children that, in the event of a positive outcome, can give ProTrans marketing approval.


Protrans19+SE (9 patients, ongoing).
Swedish open-label dose escalation study (phase 1) with ProTrans for the treatment of adult patients(not type-1 diabetes), who suffered from severe pneumonia as a result ofSars-CoV-2 infection.


Protrans19+CA
(48 patients, ongoing).
Canadian randomized, placebo-controlled, double-blinded (Phase 2) study for the treatment of adult patients (not diabetes), who suffered from severe pneumonia as a result of Sars-CoV-2 infection.

 

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
 

About NextCell Pharma AB

NextCell is a cell therapy company in clinical phase II. The company has developed a proprietary and patented platform technology to produce mesenchymal stem cells adapted for allogeneic treatment of various autoimmune and immunological diseases. The drug candidate ProTrans is now being tested for the treatment of type-1 diabetes as well as respiratory complications caused by Sars-CoV-2 infection. The focus is to take ProTrans to a market approval for type-1 diabetes via a phase III study.  ProTrans is evaluated in two clinical Covid-19studies, in Sweden and Canada. NextCell is working on completing its own GMP facility for the manufacture of ProTrans. The GMP facility is expected to be ready for manufacturing smaller quantities of ProTrans in 2023. NextCell also owns 8.5% of Famicord TX, a start-up company in CAR-T  ‘and oncology, and 100% of Cellaviva, Scandinavia's largest stem cell bank for family savings of 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