Starton Therapeutics Provides Update on STAR-LLD Lenalidomide Clinical Program

Starton Therapeutics Inc., a clinical stage biotechnology company provides updates on its first-in-human Phase 1 STAR-LLD clinical trial of its investigational continuous delivery lenalidomide, in healthy subjects. Four subjects in the first cohort received 24 hours of STAR-LLD continuous lenalidomide, and a single oral dose of lenalidomide after a 24 hour washout period. The Independent Data Monitoring Committee reviewed the totality of the safety data from the first cohort and recommended advancement to Part B, where subjects will receive the second-highest of three infusion strengths of STAR-LLD.

“We are encouraged by the progress of this Phase 1 clinical study so far. As expected, the STAR-LLD continuous infusion appears to be very well-tolerated with no related adverse events. I look forward to continuing to advance this program to the multiple myeloma patient popluations with a need for enhanced tolerability,” said Mohamad Hussein, Scientific Committee Chair.

The company also announced that the upcoming Phase 1b/2 clinical study in multiple myeloma is on track to begin enrollment in Q4 2022 at three already identified sites in the European Union. Starton plans to submit additional regulatory applications in the US and other countries to accelerate the Phase 1b/2 as part of its development approach for STAR-LLD.