2cureX Newsletter March 2nd 2021
March 2, 2021
2cureX CLINICAL NEWS
IndiTreat® clinical trial in colorectal cancer meets its primary endpoint.
Yesterday, March 1st, 2cureX released a press release for a highly important result of our interventional clinical trial in colorectal cancer (link). The trial (NCT03251612) has successfully met its primary endpoint (improvement in progression free survival 8 weeks after start of treatment).
The clinical trial is an Investigator Initiated Trial (IIT), meaning that the Principal Investigator (Dr Lars H Jensen, from Vejle Hospital, Denmark) is in control of the full process from designing the trial to conducting it, analyzing the results, and publishing them. At 2cureX we believe in the importance of IITs because they are conducted independently and are focused on real clinical needs.
According to the trial protocol, patients enrolled have metastatic colorectal cancer, and they need to show tumor growth (progression) after treatment with all standard treatments. In the protocol, the primary endpoint (overall goal) of the trial is that at least 40% of the patients experience no growth (Progression-free-Survival, PFS) of their liver metastases after eight weeks of IndiTreat-guided treatment. The standard of care for these difficult to treat cancer patients is 20%.
The Principal Investigator has submitted the data for publication at the Annual Meeting of ASCO (American Society of Clinical Oncology). The ASCO conference is the largest and most prestigious worldwide congress on Clinical Oncology, gathering over 30,000 physicians and health professionals from all over the world. Results of the most important studies addressing cancer are presented during this event, many of them with positive impact on the clinical oncology practice. We think that ASCO is therefore the perfect place for presenting these important results from the world’s first interventional clinical trial where 3D micro-tumors are guiding treatment.
ASCO has very stringent guidelines demanding that data to be presented at the ASCO conference cannot be published before the meeting in June (https://meetings.asco.org/am/abstract-policies). However, a publicly traded company who is legally required to disclose certain data, is exceptionally allowed to send out a short press release with certain restrictions:
- Study data can only be cited in the abstract in a qualitative fashion rather than providing specific quantitative information.
- The press release cannot include interpretations about the implications of the data for clinical practice.
- The press release must include a statement that full data has been submitted to the ’21 ASCO–Meeting.
At 2cureX we consider the result of the clinical trial are so important that the market should be informed about it, even with the restrictions mentioned above. We are truly excited about the results of the trial, which are exactly what we had hoped for. We are looking forward to the full disclosure of the detailed results at the ASCO meeting on the 1st week of June 2021 and are thankful to the all the professionals and stakeholders that have participated in it.