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Lund, Sweden, 28th of June 2018 - Xintela announces today that the company has received MUMS-status (Minor Use Minor Species) in Europe for the treatment of degenerative joint disease, including osteoarthritis, in horses. MUMS-status is the veterinary equivalent of Orphan Drug in human medicine.
The MUMS classification gives a significant reduction of documentation requirements prior to the registration of the drug. Examples of such reductions are lower requirements in clinical trials, which may shorten the time to product approval and lead to lower development costs. In addition, Xintela will receive administrative assistance for registration of the product within the EU.
Xintela develops stem cell-based products for the treatment of osteoarthritis in humans and animals. The development work is based on the company's marker technology used to select and quality assure stem cells for medical use.
In a successful study on horses, Xintela has shown that the selected stem cells, are safe and have a protective effect on cartilage and bones after a cartilage injury. These results are now part of the preclinical documentation that Xintela is preparing for an application to do clinical trials for the treatment of osteoarthritis. MUMS-status both facilitates and speeds up development work and gives Xintela a competitive edge in developing a stem cell treatment for degenerative joint disease in horses.
"The EMA granting us MUMS-status of our horse product is a big milestone. It gives us several advantages in the development work and will shorten the time to market for a horse product. In addition, the MUMS approval makes us an extraordinarily attractive partner for veterinary companies, says Caroline Ehrencrona, Director of Clinical Development and Regulatory Affairs.
Xintela AB (publ)
Evy Lundgren-Åkerlund, CEO
Tel: 070-329 18 71
Email: evy@xintela.se
Medicon Village
223 81 Lund
www.xintela.se
For investor relations and media questions, please contact:
Mårten Svanberg, Laika Consulting
Tel: 070-362 70 05
Email: marten.svanberg@laika.se
www.laika.se
About Xintela
Xintela develops medical products within regenerative medicine and oncology based on its proprietary marker technology, XINMARK®. Xintela uses the technology to isolate and quality assure stem cells for the treatment of the joint disease osteoarthritis. Studies on horses have shown that the stem cells are safe and that they have a therapeutic effect on the articular cartilage and the underlying bone after an injury. Xintela has recently established its own GMP-facility to produce stem cells for clinical studies. In the oncology program, XINMARK® is used for the development of an antibody-based treatment (Antibody Drug Conjugate, ADC) against specific tumors with first focus on the aggressive brain tumor glioblastoma. Positive preclinical results from cell studies and animal model have shown that the ADC treatment has a targeting and killing effect on specific tumor cells supporting further development of the company’s oncology business. Xintela is listed on Nasdaq First North Stockholm since 22 March 2016. Xintela's Certified Adviser at Nasdaq First North is Erik Penser Bank AB, +46 8-463 80 00.
This information is such information that Xintela AB (publ) is obligated to publish in compliance with the EU market abuse regulation. The information was provided, through the above contact, for publication on the 28th of June 2018, at 13.30 CET.
Below you will find the collected information on Xintela’s press releases, newsletters, diary events, films, media coverage and analyses.
Chairman Gregory Batcheller visited BioStock’s studio to tell us more about the company’s journey and business development.
CEO Evy Lundgren-Åkerlund presents the company at BioStock Investor Meeting on March 16, 2023.
CEO Evy Lundgren-Åkerlund presents the company at BioStock Life Science Fall Summit 2022 on November 30.
CEO Evy Lundgren-Åkerlund presents the company at Aktiespararnas Småbolagsdagarna 2022 (in Swedish).
Targinta's CEO Per Norlén presents the company at Aktiespararnas Småbolagsdagarna 2022 (in Swedish).
CEO Evy Lundgren-Åkerlund presents the company at BioStock Life Science Spring Summit 2022.
Watch the video interview with CEO Evy Lundgren-Åkerlund (in Swedish).
BioStock interview with Xintela's CMO and board member Sven Kili.
BioStock was given the opportunity to interview Sven Kili in connection with his visit to Sweden for board and strategy work in Xintela.
Dr. Marcus Keep comments on Xintelas glioblastoma project.
Xintelas Chairman of the board and strategic advisor Greg Batcheller, tells us more about Xintelas potential and prospects.
Dr. Lisa Fortier at Cornell University, New York is interviewed by BioStock about Xintelas positive results in horse study.
In the following video interview, Karin explains her role at Xintela and what she considers to be Xintela’s primary strengths.
See the interview with Claes Post, member of the board in Xintela. The interview is in swedish with english subtitles.
See the interview with Sven Kili, member of the board in Xintela. The interview is in English (introduction is in Swedish).
See an interview with Xintela's CEO Evy Lundgren-Åkerlund, after the listing ceremony at Nasdaq First North.