Trial Launched to Analyze Safety of Novel Drug to Treat Severe Side Effect that Occurs in Approximately Half of Patients With Advanced Cancer

The first patient enrolled onto a phase 1 trial has received TCMB07, an investigational drug, for the treatment of cachexia, a severe disorder that may occur in more than half of patients with advanced-stage cancer.

The first of up to 97 healthy volunteers has received the investigational drug TCMB07 in an early-phase clinical trial, according to a news release from the agent’s manufacturer, Endevica Bio.

The aim of the phase 1 trial is to analyze the safety of TCMB07 in a group of healthy volunteers so the investigators can determine treatment indications for a phase 2 trial.

Data from the phase 1 trial, according to the release, are expected to be reported within the first three months of 2023.

“This important milestone represents our commitment to rapidly develop TCMCB07, which could be one of the first pharmaceutical treatment interventions to meaningfully improve the effects of cachexia,” Russ Potterfield, CEO and executive chairman of Endevica, said in the release. “If our previous animal results translate to positive human data, TCMCB07 would potentially have a strong impact on patients’ lives across multiple underlying conditions.”

A common and potentially deadly disorder, cachexia is often referred to as a “wasting” syndrome. Patients who develop cachexia often have a lack of appetite and subsequently experience dramatic muscle mass loss alongside substantial weight loss.

Cachexia, according to information published in the Journal of Clinical Oncology, occurs in approximately half of patients with advanced cancer. Some estimates, according to the National Cancer Institute (NCI), attribute approximately one-third of cancer deaths to cachexia.

The NCI notes that cachexia can develop in patients with a variety of cancer types. However, the agency explains that the “wasting” syndrome is most commonly seen in patients with gastric and pancreatic cancer, as well as head and neck, colorectal and lung cancer.

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