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.

Download attachmentRead full press release on Cision (external link)
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
2017-07-19
Disclosure notice: NextCell Pharma AB’s Chairman of the Board acquires additional shares
NextCell Pharma AB (”NextCell”) announces today, on July 19th 2017, that Chairman of the Board, Anders Essen-Möller, has acquired 263.020 shares in the company. Before the acquisition, Essen-Möller held 737.033 shares, equivalent to approximately 8.74 percent of the votes and capital. After the acquisition, Essen-Möller holds 1.000.053 shares, equivalent to approximately 11.76 percent of the votes and capital in NextCell.
NextCell Pharma AB (”NextCell”) announces today, on July 19th 2017, that Chairman of the Board, Anders Essen-Möller, has acquired 263.020 shares in the company. Before the acquisition, Essen-Möller held 737.033 shares, equivalent to approximately 8.74 percent of the votes and capital. After the a...
Read moreRead more