Not only the first patient across the ocean, but absolutely everyone must now wish that Victoria-01, as the phase 1 clinical trial that Sotio has just launched is called, turns into Victory, a definitive victory.
It is still a long way off, but the potential of the developed preparation is clearly signaled by the very fact that it is beginning to be tested on humans.
In any case, for Sotio, the current step is one of the milestones on the way to fulfilling what is probably the most daring business plan in the Czech Republic. This is the development and subsequent global commercialization of an original cancer drug.
We have started research on the product in patients who have failed other treatments.
The "child" of the late businessman thus continues to carry the hope of saving many more lives, and a study started in the United States, which evaluates the safety and efficacy of SOT201, strengthens this hope.
"The start of the clinical trial is an important part of our efforts to develop innovative immunotherapies that can solve the challenges of treating solid tumors. We have now begun investigating the activity of SOT201 in patients who have failed other available treatments," said Dr. Richard Sachse, Sotio's Director of Clinical Development.
The point is that although current medicinal products based on the inhibition of the PD-1 receptor, which is a receptor on the surface of cells that ranks among the so-called checkpoints of the immune system, represent great progress in anti-tumor medicine, only a minority still respond positively to them patients.
"Furthermore, even successfully treated patients often develop resistance to these therapies, leading to further development of tumor growth. New treatments are therefore needed to overcome these therapeutic limitations," added Sachse.
The preparation SOT201 has a promising antitumor potential especially in patients with primary or acquired resistance to inhibitors of the aforementioned immune system checkpoints. The clinical phase that has started will result in an evaluation of the safety, tolerability and preliminary effectiveness of the product in monotherapy in patients older than eighteen years in advanced stages of cancer.
The study is now enrolling patients at MD Anderson Cancer Center in Houston. Other clinical sites will start recruiting patients in the following months, for example in the Czech Republic, Belgium or Spain.