Xintela to expand clinical development of stem cell product XSTEMLund, Sweden, September 30 2021 - Xintela announces it will expand clinical development of its stem cell product XSTEM to the next chosen indication venous leg ulcers, the most common type of difficult-to-heal (chronic) wounds in humans. A scientific advice meeting with the Swedish Medical Products Agency (MPA) has been successfully completed and preparation of clinical documentation for the clinical study application has been initiated. Xintela has previously reported excellent wound healing results with XSTEM in a preclinical animal model, which was carried out together with Prof. Folke Sjöberg and his collaborators at The Burn Center, Linköping University Hospital. A clinical study in patients with venous leg ulcers is now planned in collaboration with the Prof. Sjöberg and his team.
"Venous leg ulcers represent a large and attractive market where the medical need is substantial. In addition, time-to-market in this indication is perceived to be fast compared to many other indications", says Xintela's CEO Evy Lundgren-Åkerlund.
In parallel, Xintela is preparing to start the First-in Human study on knee osteoarthritis patients in Australia and XSTEM is currently being manufactured at the company's GMP manufacturing facility in Lund.
"The time is now right for us to extend the stem cell clinical development program. We have extensive preclinical documentation for XSTEM, strongly supporting its use in different indications, including difficult-to-heal wounds, and we have an approval from the MPA to manufacture XSTEM in our own GMP facility. In addition, we have recently expanded and strengthened our clinical development team with a new Director Clinical Development, Camilla Wennersten, a new Chief Medical Officer, Per Norlén, and a newly recruited Senior Clinical Trial Manager who will join us in December", says Xintela's CEO Evy Lundgren-Åkerlund.
Xintela AB (publ)
Evy Lundgren-Åkerlund, CEO
Tel: +46 46 275 65 00
Email: [email protected]
Medicon Village
223 81 Lund, Sweden
www.xintela.se
About Xintela
Xintela develops innovative and patent protected cell therapies and targeted cancer therapies based on the marker technology platform XINMARK. The platform is built on specific cell surface proteins (integrins) and more than 25 years of research and development. Xintela uses the marker technology to select and quality assure stem cells (XSTEM) to develop stem cell therapies for diseases that today lack efficient treatment options, including the joint disease osteoarthritis (OA). Xintela has built an in-house GMP-facility for manufacturing of stem cell products and is preparing a First in Human clinical study on patients with knee OA. In the oncology program, Xintela develops antibody-based therapies for treatment of aggressive tumors including glioblastoma and triple-negative breast cancer. Xintela 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, [email protected].
The following documents can be retrieved from beQuoted
2021-09-30-Xintela-breddar-klinisk-utveckling-av-XSTEM-final.pdf
If you want to open the text in your webbrowser
click here
______________________________________________________
This information was sent by beQuoted
If you want more information, please go to www.beQuoted.com
To change your subscription, please inform [email protected] beQuoted Press är en service till Dig som är intresserad av finansiell information. Med beQuoted Press underlättas företagens finansiella kommunikation till Dig och till nyhetsbyråer, aktieägare, placeringsrådgivare och andra intressenter på aktiemarknaden.
Vi hoppas att Du uppskattar denna service.
| 