PARAMUS, N.J., JUNE 9, 2021 – Starton Therapeutics Inc.,a clinical stage biotechnology company transforming standard of care therapies with proprietary transdermal technology, today announced that it has developed several formulations to successfully deliver lenalidomide across the skin. With this milestone, Starton has advanced multiple formulation candidates in its transdermal lenalidomide (STAR-LLD) program into nonclinical studies. STAR-LLD is a proprietary, medicated, adhesive patch placed on the skin to deliver lenalidomide continuously at the optimal dose using up to 90% less drug when compared to approved oral formulations.
“Oral lenalidomide has provided patients with multiple myeloma a life-changing therapy; however, many patients struggle with long-term tolerance which comes with a multitude of side effects,” said Mohamad Hussein, MD, Starton Board Member/Scientific Advisor, currently professor of medicine and oncology at University of South Florida and former Global Lead of Multiple Myeloma at Celgene (2008-2019). “I think STAR-LLD will be the second coming of lenalidomide by avoiding the cycle of high and low drug levels caused by short half life of oral administration, while increasing efficacy with fewer side effects.”
Each formulation candidate uses proprietary technology to enhance its solubility, stability, and permeability – provisional patent applications have been filed. The invention includes a unique Method of Use with a pretreatment to modulate the outermost layer of the skin reversibly and facilitate drug uptake.
“By overcoming the limits of how lenalidomide is dosed, we will potentially be able to help more people with multiple myeloma to benefit from this globally successful treatment in addition to those with chronic lymphocytic leukemia (CLL),” said Asher Chanan-Khan, MD, Starton Board Member/Scientific Advisor and Co-Chairman Hematologic Malignancies Program, Mayo Clinic Cancer Center. “Dose-related side effects previously limited the success of oral lenalidomide formulations despite showing efficacy in CLL. STAR-LLD is likely to become the first immunomodulatory drug (IMiD) to treat this blood cancer and a potential breakthrough for patients by becoming the first maintenance therapy to help people stay in remission.”
Using a 505(b)(2) approval path, Starton is not anticipating to have to repeat nonclinical safety studies. Once target blood levels and skin tolerability are demonstrated, Starton will select a lead candidate to advance into human clinical trials.
About STAR-LLD
STAR-LLD is in development to expand the standard of care for the most common and rarely curable blood cancers, CLL and MM. 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.
High-risk smoldering multiple myeloma (SMM) is also a target indication for STAR-LLD after a randomized trial showed that 40% with SMM treated with oral lenalidomide discontinued due to drug-related side effects, despite 91% achieving three-year progression-free survival versus the 66% who were monitored without receiving active treatment (the current standard of care) (Lonial 2020).
In addition to a transdermal formulation, STAR-LLD is also in development as a continuous subcutaneous (SC) infusion of lenalidomide parenteral solution via an infusion pump. STAR-LLD SC is expected to enter clinical studies in Q4-2021. Starton has completed a pre-IND meeting for STAR-LLD SC and its final IND-enabling study is currently underway.
Starton expects to reference prior findings of nonclinical safety for key sections of the New Drug Application (NDA) for REVLIMID(r).
About Starton Therapeutics
A clinical-stage biotechnology company focused on transforming standard of care therapies with proprietary transdermal 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.
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