Starton Therapeutics Doses First Subjects in Phase 1 Clinical Trial of STAR-LLD Continuous Delivery Lenalidomide

Starton Therapeutics Inc. recently announced it has dosed the first subjects in a first-in-human Phase 1 STAR-LLD clinical trial of its investigational continuous delivery lenalidomide, in healthy 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 multiple myeloma patient population as soon as possible. In preclinical studies continuous delivery of LLD showed an over 90% reduction in CMax, a 60% reduction in the area under the curve and the Cmin was increased to the optimum efficacious level,” said Jamie Oliver, Chief Medical Officer.

The STAR-LLD Phase 1 trial is being conducted in Groningen, the Netherlands and will enroll 16 healthy human subjects. The objective is the study is to assess and compare the pharmacokinetics of a 24-hour continuous subcutaneous infusion of lenalidomide versus lenalidomide oral capsules at three escalating infusion rates and reference oral doses. The study seeks to validate the safety required for selecting the dose for the upcoming Phase 1b/2 clinical study in multiple myeloma.

Pedro Lichtinger, Chairman and Chief Executive Officer, added “We are excited to bring our STAR-LLD program into the clinic. Our vision is to help multiple myeloma patients live longer better lives and this study represents our first-in-human experience.”

The Phase 1 study will evaluate the 24-hour bioavailability, safety, tolerability, and pharmacokinetics STAR-LLD in healthy human subjects. 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/2 study in patients with multiple myeloma. STAR-LLD uses an ambulatory continuous subcutaneous infusion pump to deliver Starton’s proprietary solubilized lenalidomide in a continuous low dose delivery rather than once-a-day (QD) oral dose. The implication of this precise control is the maintenance of adequate and efficacious drug levels over the entire dosage interval. 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. Starton has completed a pre-IND meeting for STAR-LLD SC and all IND-enabling preclinical and CMC studies. Starton expects to reference prior findings of nonclinical safety for key sections of the New Drug Application (NDA) for REVLIMID.

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. For more information, visit www.startontx.com.