Starton Therapeutics Receives Clinical Trial Authorization in Europe to Initiate Phase 1 Clinical Trial of STAR-LLD Continuous Delivery Lenalidomide
Starton Therapeutics Inc. recently announced it has received a Clinical Trial Authorization (CTA) in the Netherlands to initiate a Phase 1 study evaluating STAR-LLD bioavailability in human subjects.
“This study provides comparative rapid confirmation of blood levels so we can move in to the clinic in multiple myeloma. 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,” said Jamie Oliver, Chief Medical Officer.
Pedro Lichtinger, Chairman and Chief Executive Officer, emphasizes “This CTA authorization is an important milestone for Starton, as our first clinical regulatory authorization for the STAR-LLD program.”
The Phase 1 study will evaluate the 24-hour bioavailability, safety, tolerability, and pharmacokinetics STAR-LLD in healthy human subjects compared to oral lenalidomide. The Phase 1 portion of the study 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. STAR-LLD uses an ambulatory continuous subcutaneous infusion pump to deliver Starton’s proprietary solubilized lenalidomide. Starton’s previous in vivo studies found a 77% reduction in plasma lenalidomide exposure using a continuous subcutaneous infusion versus pulsatile dosing at the daily oral equivalent.
Starton plans to submit additional regulatory applications in other countries as part of its development approach for STAR-LLD.
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). 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 (overall response rate ORR) at 144 mcg continuous LLD and 20% tumor elimination vs. 0% ORR with active control with daily pulsatile once daily dosing. STAR-LLD SC is expected to enter clinical studies in Q1 2022. Starton has completed a pre-IND meeting for STAR-LLD SC and all IND-enabling studies. Starton expects to reference prior findings of nonclinical safety for key sections of the New Drug Application (NDA) for REVLIMID(r).
A clinical-stage biotechnology company focused on transforming standard of care therapies with proprietary dermal technology, so people with cancer can receive continuous treatment to live better, longer. Starton’s proprietary transdermal technology is intended to increase efficacy of approved drugs, to make them more tolerable and expand their potential use.To learn more, visit www.startontx.com.
Total Page Views: 650
