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
223 81 Lund
For investor relations and media questions, please contact:
Mårten Svanberg, Laika Consulting
Tel: 070-362 70 05
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.
Dr. Marcus Keep comments on Xintelas glioblastoma project.
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Interview with Xintelas CEO