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2022-09-30

Xintela completes dosing of XSTEM first dose level in knee osteoarthritis clinical study

Xintela’s first-in-human study (Phase I/IIa) for the treatment of knee osteoarthritis, being conducted in Australia, is testing 3 different dose levels of the stem cell product XSTEM®. All patients at the lowest dose level have now been dosed. XSTEM, which consists of allogeneic (donated) integrin α10β1-selected mesenchymal stem cells, is developed and manufactured by Xintela.

Patients with moderate knee osteoarthritis (grade II-III) receive an injection of XSTEM into the knee joint. Three different dose levels are being evaluated in up to 54 patients and each patient will be followed for 18 months with an efficacy reading every 6 months. The primary goal is to show that XSTEM is safe, and also to investigate preliminary efficacy signals, such as reduced breakdown of joint cartilage, regeneration of damaged cartilage, and improved joint function. Initial safety data are expected before the end of this year and early efficacy results in 2023.

“The first 8 patients with knee osteoarthritis have now been injected with XSTEM. Each patient will be evaluated for 1 month for safety before we start dosing patients at the next dose level. We are pleased that our Phase I/IIa study is progressing well and are looking forward to the first safety readouts”, says Xintela's CEO Evy Lundgren-Åkerlund.

Contacts


Xintela AB (publ)
Evy Lundgren-Åkerlund, CEO
Tel: +46 46 275 65 00
Email: evy@xintela.se
Medicon Village
223 81 Lund, Sweden
www.xintela.se

About Xintela


Xintela develops medical products in stem cell therapy and targeted cancer therapy based on the Company's cell surface marker integrin α10β1 which is found on mesenchymal stem cells and on certain aggressive cancer cells. The stem cell marker is used to select and quality-assure the patent-protected stem cell product XSTEM®, which is in clinical development for treatment of knee osteoarthritis and difficult-to-heal leg ulcers. The company produces XSTEM for the clinical studies in its GMP-approved manufacturing facility. In cancer therapy, which is run by the wholly owned subsidiary Targinta AB, therapeutic antibodies, targeting integrin α10β1 (First-in-Class) are being developed for the treatment of triple-negative breast cancer and the brain tumor glioblastoma. Xintela conducts its business at Medicon Village in Lund, Sweden, and is listed on Nasdaq First North Growth Market Stockholm since 22 March 2016. Xintela's Certified Adviser at Nasdaq First North Growth Market is Erik Penser Bank AB, +46 8-463 80 00, certifiedadviser@penser.se.

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Xintela completes dosing of XSTEM first dose level in knee osteoarthritis clinical study

Författare MFN