Xintela’s stem cell product, XSTEM, has been assessed as safe at all dose levels 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 three different dose levels of the stem cell product XSTEM®. The Safety Review Committee for the clinical study has now assessed all three dose levels safe at the planned three-month follow-up. XSTEM, which consists of allogeneic (donated) integrin α10β1-selected mesenchymal stem cells, is being developed and manufactured by Xintela.

Patients with moderate knee osteoarthritis (grade II-III) have received one injection of XSTEM into the knee joint. Three different dose levels have so far been dosed in 24 patients (8 patients/dose level). The study enables an expansion of up to a total of 54 patients. Each patient is followed for 18 months with an efficacy reading every six months. The primary goal of the study is to show that XSTEM is safe. In addition, preliminary efficacy signals, such as reduced pain and improved joint function as well as reduced breakdown of joint cartilage and regeneration of damaged cartilage are being investigated.

“It is very gratifying and an important milestone that the safety of all three dose levels of XSTEM has now been established in the clinical study in osteoarthritis patients. We now look forward to continuing to evaluate the clinical efficacy of the treatment. When we have additional data from the three doses, we will decide on the possible expansion of the study”, says Camilla Wennersten, Director Clinical Development of Xintela.

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.

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