On September 27, 2021 Cothera Bioscience reported that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a global multi-center phase 2 clinical trial to test PC-002, an inhibitor that targets MYC mutations, in combination with carboplatin and etoposide (PE) in patients with castration resistant and neuroendocrine prostate cancer (NEPC) (Press release, Cothera Bioscience, SEP 27, 2021, View Source [SID1234618851]).
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NEPC most frequently develops in patients with castration-resistant prostate adenocarcinoma following standard treatment with androgen receptor antagonists, other hormonal therapy or taxane-based chemotherapy. Clinically, NEPC is highly aggressive and metastasizes to visceral organs, such as the liver, much more avidly than prostate adenocarcinoma. MYC is overexpressed in the majority of NEPC and appears to be critical to the development of NEPC. Recent data indicate that NEPC occurs in approximately one out of six patients who develop progressive hormone-resistant prostate cancer. The incidence of treatment-related NEPC is expected to rise due to the prevalent use of hormonal therapies in prostate cancer.
PC-002 is a first-in-class small molecule drug targeting MYC- mutated tumors. With more than 50% of human cancers showing increased expression, MYC is regarded as one of the most important yet "undruggable" cancer targets. With a unique mechanism of action, PC-002 selectively induces MYC protein degradation and cell apoptosis in MYC-dependent tumors. PC-002 may potentially target multiple indications in cancers involving MYC dysregulation.
Dr. Vernon Jiang, Co-founder and EVP of Cothera Bioscience, said: "The FDA’s approval of PC-002 to initiate human phase 2 clinical trials in NEPC is another important milestone for Cothera. The team worked efficiently to file the IND and obtained approval expeditiously. We will continue our effort to launch and execute late-stage clinical trials for other cancer indications, bringing breakthroughs and better treatment options to more cancer patients."