The failure of previous clinical trials of Aprea Therapeutics’ lead drug continues to haunt the company’s testing of the small molecule in other forms of cancer.On Thursday, the company announced that the FDA had placed a Clinical reservation In the study of lymphoma drugs, the drug was discontinued for the second time within a week.
The FDA’s clinical control of the drug eprenetapopt did not mention the issue of lymphoma research. Instead, according to Boston-based Aprea, regulators have expressed concerns about the safety and efficacy data of the drug in clinical trials conducted in myelodysplastic syndrome (MDS), a cancer that affects blood cell production. This phase 3 clinical trial tested the combination of the Aprea drug with azacitidine, a chemotherapy used to treat MDS.Last December, the drug Failure The main goal of showing complete remission is reached.
Data from the failed study has been provided to the FDA. In a conference call on August 6, Eyal Attar, Area Chief Medical Officer, said that the regulator pointed out that compared with the control group, the treatment group had a higher incidence of serious adverse events. In both groups of serious adverse events, deaths were all caused by infection.
“It should be pointed out that serious adverse events are mainly the result of low blood cell counts, which of course is a sign of patients with myelodysplastic syndromes, especially for myelodysplastic syndromes that receive azacitidine-based chemotherapy in the treatment regimen. Patient,” Attar said. “Therefore, the adverse events in the two groups were largely related to the consequences of infection or bleeding and low blood counts.”
Attar added that some of the complications reported in the study occurred several weeks after the patient stopped receiving the Aprrea drug. In some cases, these problems arise after the patient starts other therapies to treat the underlying disease.
Aprea aims to treat cancer with drugs that activate p53, a protein that inhibits tumors. Although p53’s anti-cancer ability is well documented, many companies have failed to hit the protein with drugs. Eprenetapopt is a small molecule designed to reactivate mutated but non-functional p53, restoring the protein’s ability to trigger the death of cancer cells instead of normal cells.
Clinical trials for lymphoma are testing the combination of the Apra drug with acalabrutinib or venetoclax and rituximab, which are currently used to treat these cancers. Clinical shelving means that no new patients can participate in the study. Patients who currently show clinical benefit in the trial can continue to receive experimental treatment.Complete clinical trials follow Partial clinical reservation It was announced last week to test the Aprea drug in myeloid malignancies, which are cancers of the bone marrow and blood cells.
Aprea did not elaborate on the FDA’s specific issues. The company said when announcing the full clinical hold that it intends to work closely with the agency to resolve its issues and resolve the matter.
Picture by National Cancer Institute
