Xintela recently announced that they have initiated the third and last dose level in the phase I/IIa study with the stem cell product XSTEM in patients with knee osteoarthritis. The company’s goal is to present safety data from all dose levels and early efficacy results in 2023. BioStock contacted Camilla Wennersten, Director Clinical Development at Xintela, to find out more about the study.

Biopharma company Xintela develops medical products in stem cell therapy and targeted cancer therapy. In stem cell therapy, the company’s cell surface marker integrin α10β1 is used to select and quality assure stem cells in the production of the stem cell product XSTEM.

The company is currently conducting two clinical phase I/IIa studies with XSTEM – one for the treatment of knee osteoarthritis and one for difficult-to-heal venous leg ulcers. The primary objective of both studies is to evaluate the safety as well as preliminary efficacy of XSTEM.

Osteoarthritis study in Australia

In the osteoarthritis study, Xintela investigates preliminary efficacy signals such as reduced breakdown of joint cartilage, regeneration of damaged cartilage and improved joint function.

The study includes 24 patients with moderate knee osteoarthritis (grade II-III), with the possibility to increase the number of patients to 54 patients. The patients receive one injection of XSTEM into the knee joint and each patient will be followed for 18 months, with an efficacy reading every six months.

Third dose level

The study is a dose escalation study where three dose levels are evaluated in eight patients at each level. The Safety Review Committee has assessed the treatment on the first and second dose level as safe at the one-month follow-up. The committee has approved the continuation to dosing of patients at the third and last dose level. 

Camilla Wennersten, Director Clinical Development at Xintela, commented on the progress in a press release:

»We are very pleased to see that our study with XSTEM in the treatment of knee osteoarthritis is progressing well and that the last dose level has started. We look forward to establishing the safety for all dose levels and to start evaluating the effect of the treatment«

Interview with Director Clinical Development

BioStock contacted Camilla Wennersten to learn more about Xintela’s phase I/IIa study with XSTEM in patients with knee osteoarthritis.

Could you first tell us a bit about your role at Xintela?

– I have worked at Xintela for 1,5 years and I am responsible for activities related to Xintela’s clinical studies.

Could you then tell us about the patients in Xintela’s osteoarthritis study and why they need new treatment options?

– For patients with osteoarthritis, there is no regenerative treatment available that can slow down or cure osteoarthritis. What is available today is self-care with physical exercise and weight loss as well as alleviating the patients’ problems in various ways. The available treatments are primarily symptom-relieving such as painkillers and anti-inflammatory drugs. In more severe cases, it might be necessary to replace the damaged joint with a prosthesis.

– If treatment with our stem cells proves to contribute to regeneration of cartilage in the knee joint and reduced pain in osteoarthritis patients, it would make a big difference for many patients.

»If treatment with our stem cells proves to contribute to regeneration of cartilage in the knee joint and reduced pain in osteoarthritis patients, it would make a big difference for many patients«

Why is the study conducted at different dose levels?

– The reason why we evaluate different dose levels in the study is mainly to ensure that treatment with XSTEM is safe. To do this, we begin to treat patients at the lowest dose level. If this is deemed safe by the safety committee, patients are dosed at the next (higher) dose level. We have completed dosing of all patients at the two lowest dose levels of XSTEM, both of which were deemed safe, and have now dosed the first three patients at the third and highest dose level in the study.

– This gives us the opportunity to evaluate the preliminary efficacy of XSTEM and also get an indication of whether there is a difference in efficacy at the different dose levels. The results will guide us in selection of dose and efficacy parameters for the continued clinical development.

In your press release, you mention that there is an option to increase the number of patients from 24 to 54 patients. How do you decide if this is needed?

– Depending on the early efficacy signals we receive in the study at the different dose levels, we will assess whether additional patients are needed in the different groups to select dose and efficacy parameters in future clinical studies.

Finally, what do you hope to get out of the study?

– In addition to showing that our stem cell product XSTEM is safe, we hope to see indications that the treatment is effective, for example that patients experience less pain and better mobility. We also hope to show that treatment with XSTEM leads to structural improvements in articular cartilage and that we can see a difference after treatment with XSTEM compared to when the patients entered the study. It is worth pointing out that cartilage regeneration is a slow process. It may therefore take time before an improvement can be detected with MRI even if patients experience a clear positive effect of the treatment.

»In addition to showing that our stem cell product XSTEM is safe, we hope to see indications that the treatment is effective, for example that patients experience less pain and better mobility. We also hope to show that treatment with XSTEM leads to structural improvements in articular cartilage«

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