Starton Therapeutics Inc announced it has received its first Clinical Trial Authorization in the Netherlands to start a Phase 1 study on its STAR-LLD continuous delivery lenalidomide.
STAR-LLD is a continuous delivery lenalidomide in development to expand the standard of care for the most common blood cancers, multiple myeloma and chronic lymphocytic leukemia (CLL).
The study will evaluate the 24-hour bioavailability, safety, tolerability and pharmacokinetics in human subjects compared to oral lenalidomide.
READ: Starton Therapeutics advances transdermal lenalidomide STAR-LLD program following successful skin permeation studies
Phase 1 is an open-label, crossover design used to confirm the plasma concentrations of STAR-LLD versus oral lenalidomide that will be further evaluated in a randomized Phase 1b study in patients with multiple myeloma, Starton told investors.
The firm’s CEO Pedro Lichtinger called the authorization an “important milestone” for the Paramus, New Jersey-based company, highlighting it as Starton’s first clinical regulatory authorization for the STAR-LLD program.
The study provides comparative rapid confirmation of blood levels so that Starton can move in to the clinic in multiple myeloma, chief medical officer Jamie Oliver told shareholders.
“We have designed the most efficient study to meet regulatory requirements, assess safety, and bring STAR-LLD to a patient population as soon as possible,” Oliver added.
Starton said it plans to submit additional regulatory applications in other countries as part of its development approach for STAR-LLD.
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