- Successful feasibility study underscores compatibility of STAR-LLD using On-body Injector (OBI) technology and Starton’s proprietary low-dose formulation of lenalidomide (LLD)
- Based on the positive feasibility study outcomes, delivery of STAR-LLD via the BD Evolve™ On-body Injector may offer a more convenient and acceptable alternative for patients when compared to subcutaneous ambulatory pump infusion systems
PARAMUS, N.J., Sept. 18, 2024 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical-stage biotechnology company transforming standard-of-care therapies with proprietary dermal technologies, announced today their successful feasibility demonstration to deliver their low-dose lenalidomide formulation, STAR-LLD, utilizing the BD Evolve™ On-body Injector. The in-depth study evaluated several critical parameters to demonstrate the capability of the device to successfully deliver STAR-LLD at a continuous low-dose using the on-body injector.
“We are excited to see such promising compatibility results of STAR-LLD with this state-of-the-art delivery system,” said Pedro Lichtinger, Starton’s Chairman and CEO. “The positive results from this study enables us to expand the use of STAR-LLD, which is expected to lead to improved quality of life for patients undergoing lenalidomide treatment. We believe the on-body technology provides the convenience, comfortability, and patient/oncologist acceptability for significantly increasing the number of patients that can benefit from STAR-LLD.”
In June, Starton announced positive interim, top-line data from their Phase 1b clinical trial in multiple myeloma. Phase 2 clinical trials in chronic lymphocytic leukemia and multiple myeloma are planned for 2025.
About STAR-LLD
STAR-LLD is a continuous delivery lenalidomide (LLD) in development to expand and replace the standard-of-care for the most common blood cancers, multiple myeloma (MM), 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 daily lenalidomide, and shrank by 80% with STAR-LLD over a single 28-day cycle. The study also showed a 100% overall response rate (ORR) using continuous delivery LLD and 20% of animals in this cohort were tumor-free after 100 days, compared to a 0% ORR in animals treated with a 70% higher dose of lenalidomide given in single daily doses. In addition, a Phase 1 bioavailability study in healthy men comparing STAR-LLD to Revlimid® demonstrated the drug is well tolerated and is >91% bioavailable by the subcutaneous route. It was also observed that the Cmax is <90% lower than oral Revlimid®.
About Starton Therapeutics
Starton Therapeutics is a clinical-stage biotechnology platform company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, so people with cancer can receive continuous treatment to live better, longer. Starton’s proprietary transdermal technology is intended to increase the efficacy of approved drugs, make them more tolerable, and expand their potential use. To learn more, visit www.startontx.com.
Forward Looking Statements
All statements other than statements of historical facts included in this press release, including, without limitation, statements regarding our plans and objectives for future operations and expectations about current and future clinical trials, constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions and known and unknown risks and uncertainties that could cause our actual results or events to differ materially from those included within the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, and except as required by law, the Company undertakes no obligation to disclose any revision to these forward-looking statements whether as a result of new information, future events, or otherwise.
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