It is both pleasing and stimulating to look back on the intensive past six months. Our projects have shown great progress and Xintela has made significant advances. One key focus was the completion of our own GMP facility to produce stem cells for clinical trials. We opened the facility, which is located at Medicon Village in direct conjunction to our laboratories and offices, at the end of May. The facility is expected to be ready for production by the end of 2018 and we are now working to complete documentation before applying for manufacturing authorisation from the Swedish Medical Products Agency. In this newsletter, you can read more about the GMP facility in an article from BioStock, which attended the opening ceremony.
We are also focusing on finalising the processes and quality systems required for stem cell production for clinical trials. At the same time, we are preparing a new preclinical equine study where we will look closer at the mechanisms of action for our stem cells. This is an important study, as it offers us a greater understanding of how our stem cells help to protect cartilage and bone after articular cartilage damage. The study will form an important part of our application to the Swedish Medical Products Agency to conduct a clinical trial on humans at the same time as we establish a sound basis for clinical trials on animals. It is particularly pleasing that we recently received minor-use-minor-species (MUMS) status for treating degenerative joint disease, including osteoarthritis, in horses. This can both shorten times and reduce costs in developing equine products. We talk more about MUMS later in this newsletter.
This newsletter also provides an update to the status of oncology projects and a possible spin-off of the oncology operations into a separate company. Taking into account the important milestones we have achieved in the glioblastoma project, combined with new and exciting results in other oncology indications, the time is right to offer the oncology operations an opportunity to grow and develop as its own company. This will enable us to accelerate the pace of development of our oncology activities and increase the value of the oncology business.
In addition, we had the pleasure of announcing that by using our marker technology we have developed new methods for identifying and purifying neural stem cells from the brain. This opens up a completely new field for the company’s cell therapy activities for the treatment of traumatic damage and central nervous system (CNS) diseases that lead to the death of brain cells. You can find out more in this newsletter.
Finally, I like to wish all shareholders and stakeholders a pleasant summer, as we look forward to an exciting continuation of the year.
With warm summer greetings,
Evy Lundgren-Åkerlund,
CEO, Xintela AB
