Houston startup pauses enrollment in pediatric cancer trial after patient death – Endpoints News : #Houston #startup #pauses #enrollment #pediatric #cancer #trial #patient #death #Endpoints #News CelebSurgery
A small Houston biotech is hitting the brakes on an early clinical trial after a patient’s death.
Salarius Pharmaceuticals paused new patient enrollment in a Phase I/II trial after an individual died taking an experimental therapy intended to treat certain sarcomas, the company announced Tuesday. Patients currently enrolled can continue taking the therapy for now, Salarius said, and execs have reported the details to the FDA.
The cause of death was not immediately clear in Salarius’ press release. Endpoints News has reached out for comment and will update this story accordingly.
“Unfortunately, pauses to enrollment occur in early-stage drug development, but these pauses allow time to understand new data and adjust clinical protocols and development plans as needed,” CEO David Arthur said in the release. “We plan to restart enrollment as soon as possible.”
The death qualified as a SUSAR, or suspected unexpected serious adverse reaction.
Salarius had been developing the drug, known as seclidemstat, to treat Ewing sarcoma and FET-rearranged sarcomas — rare pediatric cancers that occur in the bones or in the tissue around the bones. The Phase I/II trial consists of three dosing arms, the first of which is aiming to enroll 30 patients with Ewing sarcoma.
Researchers are trying to combine seclidemstat with two other therapies commonly used in the second- and third-line settings. The company pointed to ASCO data from 2021 that appeared to show a “synergy” with these three compounds, allowing for a possible treatment benefit over the other therapies alone.
The other two trial arms are looking at seclidemstat as a monotherapy in myxoid liposarcoma and “select sarcomas that share a similar biology to Ewing sarcoma,” or FET-rearranged sarcomas, Salarius said Tuesday.
Though Salarius wasn’t entirely specific or clear, it’s possible the hold came from results in this third arm, which the biotech noted was “due to a metastatic FET-rearranged sarcoma patient death.”
A partial or full FDA hold could be on the way given the SUSAR, but Salarius ostensibly wanted to stay ahead of the curve and pause the trial on its own first. Despite the patient death, the biotech says it still plans to report interim results from the trial later this year.
Investors did not take kindly to the news, as Salarius shares $SLRX fell 27% in early Tuesday trading.