Independent safety review approved dose escalation and initiation of third and final dosing cohort
STAR-LLD well tolerated in all subjects dosed to date
Phase 1b/2 in newly diagnosed multiple myeloma being initiated
PARAMUS, N.J., May 23, 2022 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc., a clinical stage biotechnology company announced today that the Independent Data Monitoring Committee reviewed the totality of the safety data from the first two cohorts and recommended advancement to the third- and final dose escalation, where subjects will receive the highest infusion strength of STAR-LLD. The ongoing Phase 1 STAR-LLD clinical trial is evaluating continuous delivery lenalidomide in healthy subjects. Eight subjects in the first two cohorts received 24 hours of STAR-LLD continuous lenalidomide, and a single oral dose of lenalidomide after a 24 hour washout period.
“The Phase 1 study evaluated STAR-LLD bioavailability, safety, and pharmacokinetics,” said Jamie Oliver. Chief Medical Officer. “Progressing to the final dosing interval marks a major milestone in our development program; this study has established the compatibility and utility of the continuous infusion device with our subcutaneous formulation. Lenalidomide has been an effective immunomodulatory drug in hematologic malignancies for years, however adverse events, notably neutropenia, have limited its use in certain patient settings. We believe STAR-LLD may be able to expand the use of lenalidomide where the oral form is not used today.”
The company previously announced that the upcoming Phase 1b/2 clinical study in multiple myeloma is on track to begin enrollment in Q4 2022 at three already identified sites in the European Union. Starton continues to plan to submit additional regulatory applications in the US and other countries to accelerate the Phase 1b/2 as part of its development approach for STAR-LLD.
Pedro Lichtinger, Chairman and CEO, said, “The planned Phase 1b/2 clinical study is expected to establish efficacy in multiple myeloma; based on the response rates observed in our preclinical studies we believe STAR-LLD will provide a highly efficacious treatment option in newly diagnosed multiple myeloma.”
STAR-LLD program: three delivery systems
Starton is pursuing three delivery systems for STAR-LLD, in addition to the subcutaneous ambulatory infusion under investigation in the ongoing Phase 1 clinical trial, the Company also has progressed with its transdermal adhesive patch development and development of a patch/pump on-body injector (OBI).
About The Phase 1 Clinical Trial
The clinical trial is a Phase 1 study to evaluate the 24-hour bioavailability, safety, tolerability, and pharmacokinetics of 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.
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®.
About Starton Therapeutics
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. To learn more, visit www.startontx.com
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