Starton Therapeutics Inc said it has obtained promising results in a non-GLP (good laboratory practice) rabbit pharmacokinetic (PK) and skin irritation study of its STAR-LLD continuous-delivery transdermal patch containing lenalidomide.
The privately-held clinical-stage biopharmaceutical company said the outcome of this study confirms transdermal administration of lenalidomide is feasible.
“We are thrilled with the results of this non-GLP study,” the company’s chairman and CEO Pedro Lichtinger said in a statement.
“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,” he added.
READ: Starton Therapeutics receives first clinical regulatory authorization for its STAR-LLD program
Starton noted that the 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.
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).
“Starton’s lenalidomide transdermal technology uses unique, novel formulation techniques and methods for continuous delivery of this important immunomodulatory drug,” chief medical officer Jamie Oliver continued.
“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.”
The company said 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.
It said provisional and non-provisional applications have been filed focusing on the aforementioned transdermal patch formulations.
Starton uses proven continuous delivery technology with proprietary drivers to obtain new indications, or develop on-label superiority for patients with hematological malignancies, which are cancers that affect the blood, bone marrow, and lymph nodes.
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