1. ALLA AKTIER
  2. NYHETER
  3. XINTELA

Xintela

Nyheter Xintela Nyheter alla bolag

Xintela has started last dose level of XSTEM 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 assessed the treatment of the eight patients on the second dose level with XSTEM at the one-month follow-up, concluded the dose is safe, and approved the continuation to dosing of patients at the third and last dose level. 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 one injection of XSTEM into the knee joint. Three different dose levels are being evaluated in 24 patients with the option to add additional patients up to 54 patients. Each patient will be followed for 18 months with an efficacy reading every six 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. Safety data from all dose levels and early efficacy results are expected in 2023.

"We are very pleased to see that our study with XSTEM in the treatment of knee osteoarthritis is progressing well and that the last dose level has started. We look forward to establishing the safety for all dose levels and to start evaluating the effect of the treatment”, 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, +46 8-463 80 00, certifiedadviser@penser.se.

Attachments

Xintela has started last dose level of XSTEM in knee osteoarthritis clinical study

Datum 2023-04-13, kl 11:35
Källa MFN
Bifogade filer
Xintela has started last dose level of XSTEM in knee osteoarthritis clinical study
Affiliate
SAVR är investeringsplattformen som utmanar branschen och gör det både enklare och roligare att investera. Betala aldrig för mycket! Alla aktier och ETF:er från 1 kr, och få upp till 50 % rabatt på alla fonder. Automatiskt courtage och samma enkla prismodell på alla marknader.
Investeringar i värdepapper och fonder innebär alltid en risk och det är inte säkert att du får tillbaka det investerade kapitalet