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Beskrivning
Land | Sverige |
---|---|
Lista | First North Stockholm |
Sektor | Hälsovård |
Industri | Medicinteknik |
All patients on the third and final dose level have now been dosed in Xintela’s first-in-human study (Phase I/IIa) for the treatment of knee osteoarthritis in Australia where three different dose levels of the stem cell product XSTEM® are being tested. The primary goal of the study is to show that XSTEM is safe but also to investigate preliminary efficacy signals.
XSTEM, which consists of allogeneic (donated) integrin α10β1-selected mesenchymal stem cells, is developed and produced by Xintela. Patients with moderate knee osteoarthritis (grade II-III) receive one injection of XSTEM into the knee joint. Three different dose levels are being evaluated in a total of 24 patients with the possibility to increase the number up to 54 patients. The first two dose levels have been considered safe at the one month follow-up and all patients have now been dosed at the third and final dose level.
Each patient will be followed for 18 months with efficacy readings every six months. The primary goal is to show that XSTEM is safe, but also investigate preliminary efficacy signals, such as reduced pain, reduced degradation of articular cartilage, regeneration of damaged cartilage and improved joint function. Xintela has previously reported that patients treated with the lowest dose of XSTEM, experience reduced pain and improved function of the knee after six months.
"All 24 osteoarthritis patients have now been treated with one dose of XSTEM. It is encouraging that the study is progressing so well and that patients experience a positive effect of the treatment at the lowest dose level. We look forward to the continued evaluation of all dose levels and to take the next step in the clinical development," says Camilla Wennersten, Director Clinical Development.
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.