Starton Therapeutics Inc, a clinical stage biotechnology company, has updated on its first-in-human Phase 1 STAR-LLD clinical trial, where continuous delivery lenalidomide infusion in healthy subjects appears to be well tolerated.
The company noted that 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.
“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,” said Mohamad Hussein, Starton's Scientific Committee Chair.
The Independent Data Monitoring Committee has reviewed the totality of the safety data from the first cohort and recommended advancement to Part B, where the subjects will receive the second-highest of three infusion strengths of STAR-LLD, the company said.
READ: Starton Therapeutics says poised for Phase 2 dose-optimization study following FDA clearance of IND application for STAR-OLZ
STAR-LLD is a continuous delivery lenalidomide in development to expand the standard of care for the most common blood cancers, multiple myeloma (MM) and chronic lymphocytic leukemia (CLL).
The company said a preclinical proof-of-concept study for STAR-LLD demonstrated that MM tumors caused by human myeloma cells grew 25-fold if untreated, five-fold when treated with oral lenalidomide and shrank by 80% with STAR-LLD. The study also showed 100% efficacy at 144 mcg continuous LLD and 20% tumor elimination with daily pulsatile once daily dosing.
Starton is pursuing three delivery systems for STAR-LLD: in addition to subcutaneous ambulatory infusion under investigation in the ongoing Phase 1 clinical trial, the company has also progressed with its transdermal adhesive patch development and development of a patch/pump on-body injector (OBI).
Starton 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. The company 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.
“I look forward to continuing to advance this program to the multiple myeloma patient populations with a need for enhanced tolerability,” Mohamad Hussein added.
Contact the author at jon.hopkins@proactiveinvestors.com