Houston startup pauses enrollment in pediatric cancer trial after patient death – Endpoints News

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.

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