Positive feedback on the paediatric plan of the EMA

January 18, 2023

NextCell Pharma AB ("NextCell") has received positive comments and recommendations for the pediatric investigational plan (PIP) submitted to the Europeans Medicines Agency’s (EMA) pediatric committee (PDCO).

As previously announced, NextCell submitted a proposal in Q4 outlining how ProTrans should be developed for the treatment of children with type-1 diabetes. The agency has returned with comments and recommendations that aiming to ensure that children younger than 7 years old can also receive treatment in the future.

"The PDCO has been very helpful with the development plan and the proposed changes strengthen our proposal.  We will of course implement these before the PIP is finally submitted for approval", says Mathias Svahn, CEO.

A PIP is a development plan aimed at ensuring that all necessary safety and efficacy data are obtained through clinical studies in children, prior to application for authorisation of a medicine for pediatric usage. All applications for marketing authorisation for new medicines have to include the results of studies as described in an agreed PIP.

Only small changes have been requested by EMA, aimed at allowing even younger age groups to be treated after a possible market approval than what is treated in the ongoing pediatric study, ie children younger than 7 years. The changes do not affect the study design of the planned phase 3 study.

In addition to clinical trials, the plan also includes preclinical studies of biodistribution and toxicology. NextCell is currently reviewing the recommendations by the PDCO and amending the proposal prior to submitting for approval.

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
Webpage: 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

NextCellis a cell therapy company in clinical phase II. The company has developed a proprietary and patented platform technology to produce mesenchymal stromal 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 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 FamicordTX, 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)
2021-06-17
Advisory meeting with the European Medicines Agency
NextCell Pharma AB (“NextCell” or “the Company”) announces that a scientific advisory meeting with the European Medicines Agency (EMA) has been held regarding ProTrans and the path forward to a possible market approval. The focus was the design of the phase III study ProTrans-3, which NextCell intends to submit an application for later this year.
NextCell Pharma AB (“NextCell” or “the Company”) announces that a scientific advisory meeting with the European Medicines Agency (EMA) has been held regarding ProTrans and the path forward to a possible market approval.
Read moreRead more
2021-06-10
COVID-19 patient treated with ProTrans
NextCell Pharma AB (“NextCell” or “the Company”) announces that the first patient with severe pneumonia, as a result of COVID-19 infection, has now been treated with ProTrans. The patient was hospitalized at Örebro University Hospital, where the phase 1b study ProTrans19+SE is in progress led by Principal Investigator Associate Professor Josefin Sundh. NextCell's drug candidate, ProTrans, is an immune- balancing cell therapy for the treatment of autoimmune diseases and inflammatory conditions. Patients with severe pneumonia as a result of by SARS-CoV-2 infection are at risk of rapid
NextCell Pharma AB (“NextCell” or “the Company”) announces that the first patient with severe pneumonia, as a result of COVID-19 infection, has now been treated with ProTrans. The patient was hospitalized at Örebro University Hospital, where the phase 1b study ProTrans19+SE is in progress led by ...
Read moreRead more
2021-06-08
Article about Gene and Cell Therapy
Professor Edvard Smith, CMO NextCell Pharma AB ("NextCell" or the "Company") has written a review article in the Swedish Medical Journal (Läkartidningen) entitled "Gene therapy now comes in many medical specialties", together with Associate Professor Pontus Blomberg, Director of Operations; both at the Department of Laboratory Medicine, Karolinska Institutet; Karolinska Centre for Cell Therapy, Karolinska University Hospital, Stockholm. The main message of the article is that the development of gene therapy has been rapid, and more and more preparations are reaching patients and in many
Professor Edvard Smith, CMO NextCell Pharma AB ("NextCell" or the "Company") has written a review article in the Swedish Medical Journal (Läkartidningen) entitled "Gene therapy now comes in many medical specialties", together with Associate Professor Pontus Blomberg, Director of Operations; both ...
Read moreRead more
2021-05-28
NextCell presents their latest phase II clinical data at ISCT 2021
NextCell Pharma AB (“NextCell”) announces today that they will present their findings from their Phase I/II study entitled “Wharton´s Jelly Derived Mesenchymal Stromal Cell Treatment of Adult Patients Diagnosed With Type I Diabetes” (NCT 03406585) at the International Society of Cell and Gene Therapy virtual conference 2021 (May 26[th]-28[th]). NextCell’s CSO, Dr. Lindsay Davies will attend the meeting and present a poster entitled “Protrans Wharton’s Jelly Mesenchymal Stromal Cells Preserve Beta Cell Function in Newly Diagnosed Type I Diabetes Patients – A Randomised, Double-Blinded,
NextCell Pharma AB (“NextCell”) announces today that they will present their findings from their Phase I/II study entitled “Wharton´s Jelly Derived Mesenchymal Stromal Cell Treatment of Adult Patients Diagnosed With Type I Diabetes” (NCT 03406585) at the International Society of Cell and Gene The...
Read moreRead more
2021-05-26
Study start for ProTrans in COVID-19
NextCell Pharma AB (“NextCell”) announces today that both the Canadian and Swedish COVID-19 studies have been initiated and are now ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of needing ventilatory support. ProTrans is given as a peripheral infusion. With the aim of reducing hyper-inflammation within the lungs. The goal of the treatment is to shorten hospital stay and time for rehabilitation, and to save lives. · ProTrans19 + CA, a randomized placebo-controlled phase-II study
NextCell Pharma AB (“NextCell”) announces today that both the Canadian and Swedish COVID-19 studies have been initiated and are now ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of ne...
Read moreRead more
2021-05-21
Recruitment start for the ProTrans study for treatment of COVID-19
NextCell Pharma AB (“NextCell”) announces today that the Swedish COVID-19 stuy has been initiated and is now ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of needing ventilatory support. ProTrans is given as a peripheralinfusion. With the aim of reducing hyper-inflammation within the lungs. The goal of the treatment is to shorten hospital stay and time for rehabilitation and save lifes. The study will be performed at the University Hospital in Örebro in collaboration with the
NextCell Pharma AB (“NextCell”) announces today that the Swedish COVID-19 stuy has been initiated and is now ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of needing ventilatory suppo...
Read moreRead more
2021-04-29
NextCell Pharma publishes Interim Report 2 2020/2021
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period September 1, 2020 - February 28, 2021 The report is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report NextCells share is traded on Nasdaq First North Growth Market under the ticker "NXTCL". The amount in brackets refers to the corresponding period in the previous year. Second quarter (2020-12-01 until 2021-02-28) · Operating income amounted to SEK 1 007 846 (1 364 645). · Operating result amounted to SEK -8 148 299 (-4 228 449). · Earnings
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period September 1, 2020 - February 28, 2021 The report is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report NextCells share is traded on Nasdaq First North Growth ...
Read moreRead more
2021-04-27
Presentation of the pediatric diabetes study tomorrow Wednesday
NextCell Pharma AB (“NextCell”) has invited Professor Per-Ola Carlsson to present study design and rational for the pediatric study, ProTrans-Young. The trial, recently approved, is a phase I / II study with a total of 66 patients with newly diagnosed type-1 diabetes. The presentation will be broadcasted tomorrow, Wednesday April 28, at 14:00. Afterwards, there is an opportunity to ask questions to Professor Carlsson and NextCell's CEO and CSO. https://youtu.be/kE4POLMlXWA.
NextCell Pharma AB (“NextCell”) has invited Professor Per-Ola Carlsson to present study design and rational for the pediatric study, ProTrans-Young. The trial, recently approved, is a phase I / II study with a total of 66 patients with newly diagnosed type-1 diabetes. The presentation will be br...
Read moreRead more