Starton Therapeutics Successfully Demonstrates Continuous Drug Delivery of Lenalidomide From a Transdermal Patch in an In Vivo Nonclinical Study With STAR-LLD
Starton Therapeutics Inc. recently announced it successfully obtained promising results in a non-GLP rabbit pharmacokinetic (PK) and skin irritation study of STAR-LLD continuous delivery transdermal patch containing lenalidomide. The outcome of this study confirms transdermal administration of lenalidomide is feasible.
Pedro Lichtinger, Chairman and Chief Executive Officer, said “We are thrilled with the results of this non-GLP study. STAR-LLD is potentially a transformational opportunity to expand the use of the current standard of care in multiple myeloma and eventually replace it so that patients can live longer and better.”
Jamie Oliver, PharmD, Chief Medical Officer, added “Starton’s lenalidomide transdermal technology uses unique, novel formulation techniques and methods to for continuous delivery of this important immunomodulatory drug. Based on the results of the current animal study, we intend to accelerate the availability of a transdermal patch in our STAR-LLD clinical studies.”
This primary objective of the study was to measure lenalidomide plasma concentrations following the application of transdermal patches over the clinical dosing interval in rabbits. The current data shows that it is feasible to prepare an adhesive transdermal patch of a commercially viable size capable of delivering therapeutic quantities of lenalidomide through the skin.
A continuous subcutaneous formulation of STAR-LLD is currently preparing to enroll a Phase 1 clinical study. The STAR-LLD transdermal delivery system (TDS) is expected to further support continuous delivery of lenalidomide (US Patent #US11197852B2) in a transdermal patch formulation that is expected to allow caregivers to provide another important treatment option for convenient administration of lenalidomide in cancer patients. Provisional and non-provisional applications have been filed focusing on the aforementioned transdermal patch formulations.
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 expects to reference prior FDA 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.
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