Redx Pharma has temporarily interrupted recruitment in a Phase I/IIa cancer trial following “significant adverse events” of its drug on the first patient treated.
The first time Redx Pharma’s cancer drug RXC004 has been tested in a patient has resulted in adverse side effects. According to Redx, the dose tested resulted in a higher exposure of the body to the drug than it was predicted in preclinical studies with animal models. The company has resolved to halt recruitment to change the trial protocol and start with a lower dose, a process that can take several months.
The cancer drug RXC004 is an oral inhibitor of a cellular signaling pathway called Wnt that is involved in maintaining cancer stem cells. Wnt is a popular cancer target in early research, but blocking it in humans can induce toxicity given the pathway is necessary for many functions of healthy stem cells.
It remains to see whether RXC004 proves effective and non-toxic at lower doses. Considering that Redx is planning to test the drug in combination with checkpoint inhibitors, which despite being effective are also known for their side effects, the company might have to stop to rethink its plan.
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