The first children have been treated in the younger age group of the ProTrans-Young study

October 1, 2024

NextCell Pharma AB ("NextCell" or the "Company", Nasdaq First North Growth Market: NXTCL), announces that the first four children in the 7–11 year age group have been treated in the latest phase of the ProTrans-Young study. An additional four children have been screened and are expected to begin their treatment shortly. These advancements mark an important milestone in the progress of the study, which is proceeding faster than anticipated.

“There is a high level of interest in the study, and many are signing up from all over the country,” comments Karin Kjellström, research nurse at Uppsala University Hospital. The study aims to evaluate the efficacy and safety of ProTrans, a treatment developed to protect insulin-producing cells, which in this study is being administered for the first time to children and adolescents with newly diagnosed type 1 diabetes.

The ProTrans-Young study is a double-blind, randomized, and placebo-controlled trial divided into two phases. In the first phase (Phase Ib), all patients, including those aged 7–18 years, were treated to ensure the safety of the treatment. The second phase (Phase IIb) includes a total of 60 children and adolescents, with 30 treated with ProTrans and 30 with placebo. The treatment of the first 30 patients aged 12–21 years has already been completed, and the safety data has been thoroughly reviewed and approved by the study’s safety committee.

The purpose of the ProTrans treatment is to halt the autoimmune destruction of insulin-producing cells in children and adolescents, slowing the disease progression and reduce the risk of serious complications associated with type 1 diabetes. The study aims to demonstrate that the treatment can preserve a greater portion of the body’s own insulin production, which would result in improved blood sugar regulation, reduced associated illnesses and thereby a better quality of life for the young patients.

For more information about the study and participation, please visit: NextCell Pharma - Study Information.

Professor Per-Ola Carlsson is the principal investigator for ProTrans-Young and the study is sponsored by Uppsala University. NextCell continues to contribute ProTrans, placebo, as well as support for logistics, documentation, and expert competence. The cells used for the production of ProTrans are of the same type as the cells that the subsidiary Cellaviva collects for family stem cell banking.

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, 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. NextCell is also a 100% owner of the daughter company, QVance which will offer quality control analytics for advanced therapy developers.

Download attachmentRead full press release on Cision (external link)
2017-09-21
NextCell Pharma receives wholesale distribution authorisation
NextCell Pharma AB ("NextCell") today announces that the company has been granted license for wholesale of cell based investigational medicinal products. The company was inspected earlier this summer by the Swedish Medical Products Agency. The permission is required for NextCell to acquire, stock and distribute investigational drugs in the planned clinical trial of ProTrans™ for treatment of diabetes. CEO Mathias Svahn says “This license is a good next step towards the start of our first clinical trial with ProTrans™ for the treatment of patients with Type 1 diabetes”. About the clinical
NextCell Pharma AB ("NextCell") today announces that the company has been granted license for wholesale of cell based investigational medicinal products. The company was inspected earlier this summer by the Swedish Medical Products Agency. The permission is required for NextCell to acquire, stock...
Read moreRead more
2017-09-15
Update on NextCell Pharma’s clinical trial application
NextCell Pharma AB (NEXTCL) today announced that the company has responded to the Medicinal Product Agency's request for completion regarding the application for clinical trial with ProTrans ™. The study is designed to evaluate safety and efficacy in the treatment of type 1 diabetes. NextCell’s application was registered with the Medical Products Agency on July 24th and request for supplementary information was received on September 5th. This has now been submitted within the deadline of September 14th. The study is divided into two parts: The first part is a three-step dose escalation
NextCell Pharma AB (NEXTCL) today announced that the company has responded to the Medicinal Product Agency's request for completion regarding the application for clinical trial with ProTrans ™. The study is designed to evaluate safety and efficacy in the treatment of type 1 diabetes. NextCell’s a...
Read moreRead more
2017-09-05
NextCell Pharma AB receives approval from Ethics Committee for Clinical Trial
NextCell Pharma AB (NEXTCL) announced today that the clinical trial application for ProTrans™ has been granted by the Ehtics Committee. ProTrans™ is a stem cell product developed with NextCell's Proprietary Selection Algorithm. The clinical trial is designed to evaluate the safety and efficacy of ProTrans™ for treatment of patients with type 1 diabetes. The study sponsor is NextCell and the principal investigator is Professor Per-Ola Carlsson, who works at Uppsala University and the Academic Hospital in Uppsala. The study will be conducted together with Karolinska Trial Alliance (KTA), which
NextCell Pharma AB (NEXTCL) announced today that the clinical trial application for ProTrans™ has been granted by the Ehtics Committee. ProTrans™ is a stem cell product developed with NextCell's Proprietary Selection Algorithm. The clinical trial is designed to evaluate the safety and efficacy of...
Read moreRead more
2017-09-04
NextCell Pharma AB to present at several events in next 2 weeks
NextCell Pharma AB (”NextCell”) informs that during the next two weeks there is ample opportunities for (potential) investors to attend presentations given by and conduct discussions with NextCell Pharma personnel. Sessions where NextCell Pharma representatives will be present: · Aktiespararna Södertälje – September 4th 18:30-21:00 · Advanced Medicinal Therapy Products  – A game changer in medicine? – Malmoe, September 12th 13:00-17:00 · Nordic Life Science days, Malmoe  – September 12th – 14th · Aktiespararna Burlöv – September 13th 19:00-21:00 During these meetings
NextCell Pharma AB (”NextCell”) informs that during the next two weeks there is ample opportunities for (potential) investors to attend presentations given by and conduct discussions with NextCell Pharma personnel. Sessions where NextCell Pharma representatives will be present: · Aktiespararna...
Read moreRead more
2017-08-10
NextCell Pharmas first delivery of ProTrans™
NextCell Pharma AB (”NextCell”) today, received the first delivery of the drug candidate ProTrans™ from their manufacturer PBKM.
NextCell Pharma AB (”NextCell”) today, received the first delivery of the drug candidate ProTrans™ from their manufacturer PBKM....
Read moreRead more
2017-08-08
Stem cell company NextCell Pharma receives approval from Ethics Committee
NextCell Pharma AB (NEXTCL) announced today that approval has been obtained from the Ethics Testing Board EPN, to develop assays from umbilical cord tissue. The collection is performed by regular staff at the clinic at Karolinska University Hospital in Huddinge. The project is conducted by Edvard Smith, Professor of Molecular Genetics at the Department of Laboratory Medicine at Karolinska Institutet, and one of the founders of the Company. The results may be included in the Company's proprietary intellectual property regarding ProTrans. ProTrans is developed for stem cell therapies for
NextCell Pharma AB (NEXTCL) announced today that approval has been obtained from the Ethics Testing Board EPN, to develop assays from umbilical cord tissue. The collection is performed by regular staff at the clinic at Karolinska University Hospital in Huddinge. The project is conducted by Edvard...
Read moreRead more
2017-07-31
NextCell Pharma updates on its current situation in its first quarterly report
NextCell Pharma AB (”NEXTCL”, “NextCell”) today, released its first quarterly report (April-June) since its introduction on Aktietorget. Following the issue in July, and after payment of study drug the Company has approximately SEK 20 million in cash, while the "burn rate" for the reporting period (April-June) was 3.5 MSEK (listing on Aktietorget occurred after the closing of this quarterly report). During the reporting period NextCell Pharma has recruited Leo Groenewegen, who took up the position of CFO. Besides his duties as CFO, Leo Groenewegen, together with Chairman Anders Essen-Moller,
NextCell Pharma AB (”NEXTCL”, “NextCell”) today, released its first quarterly report (April-June) since its introduction on Aktietorget. Following the issue in July, and after payment of study drug the Company has approximately SEK 20 million in cash, while the "burn rate" for the reporting perio...
Read moreRead more
2017-07-24
NextCell Pharma AB submits clinical trial application for its drug candidate ProTrans™
NextCell Pharma AB ("NextCell") announced today that a clinical trial application for ProTrans™, a stem cell product developed with NextCell's Proprietary Selection Algorithm, has been submitted to the Medical Products Agency (Läkemedelsverket). The study is planned to evaluate the safety and efficacy of ProTrans™ in adult patients with type 1 diabetes diagnosed within two years. The study sponsor is NextCell and the principal investigator is Professor Per-Ola Carlsson, who works at Uppsala University and the Academic Hospital in Uppsala. The study will be conducted together with Karolinska
NextCell Pharma AB ("NextCell") announced today that a clinical trial application for ProTrans™, a stem cell product developed with NextCell's Proprietary Selection Algorithm, has been submitted to the Medical Products Agency (Läkemedelsverket). The study is planned to evaluate the safety and eff...
Read moreRead more