Xintela signs agreement with CRO for phase I/II study
Biopharma company Xintela continues to take important steps towards its first clinical trial with the drug candidate XSTEM-OA. This spring, the company was granted permission to produce cell therapy products in its own GMP facility and has now signed an agreement with the Australian CRO GreenLight Clinical to conduct the first clinical trial in humans with the candidate.
Lundbased Xintela uses its patented marker technology XINMARK to develop treatments within cell therapy and targeted cancer therapy. In cell therapy, the company develops stem cell treatments based on the company’s stem cell platform XSTEM, with an initial focus on the joint disease osteoarthritis (OA) where the company’s product candidate XSTEM-OA is about to enter clinical studies. New study results indicate that XSTEM-OA has the potential to become a so-called disease-modifying OA drug (DMOAD), i.e. a treatment that can inhibit the development of osteoarthritis and repair damaged articular cartilage, which would mean that there is a significant potential for the company as there are currently no approved drugs on the market with these properties.
In recent months, the company has worked intensively on preparations for the phase I/II clinical trial that it aims to start during 2021.
Key milestones for clinical studies
Xintela reached an important milestone at the end of May when the company received permission from the Swedish Medical Products Agency to produce XSTEM-OA at its own GMP facility in Lund. The fact that the company carries out production on its own instead of in collaboration with partners gives them full control and flexibility over production while increasing its appeal in conversations with potential partners. Read more here.
Another important milestone was recently achieved when Xintela announced that it had reached an agreement with the Australian Contract Research Organisation (CRO) GreenLight Clinical to carry out the planned study. The agreement concerns a combined phase I/II clinical trial in patients with knee osteoarthritis that will be carried out in Australia with a planned start in the fourth quarter of 2021.
CEO comments
BioStock contacted Xintela’s CEO Evy Lundgren-Åkerlund to find out more.
What does it mean for the project that you have now signed an agreement regarding the implementation of the phase I/II study?
– The agreement with GreenLight Clinical (GLC) is an important part of the preparation for our clinical study inAustralia on patients with knee osteoarthritis.
What can you tell us about your new partner and why you chose to collaborate with them?
– GreenLight is an experienced clinical CRO with extensive network and expertise in clinical studies in Australia. We have already worked with GLC for some time regarding regulatory issues and our experience from this work is very positive so conducting the clinical study together with GLC was a natural step to take.
What will Xintela’s focus be during the autumn until the start of the study?
– The main focus is of course to produce the stem cell product XSTEM-OA in our own GMP facility and carry out a variety of quality and safety analyses for the transport of the cells to Australia.
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