Starton Therapeutics Announces Dosing of First Patient in Phase 2a Study Evaluating STAR-LLD for the Treatment of Multiple Myeloma

Study expected to enroll 24 patients with the option to enroll an additional 45 patients at the recommended Phase 2 dose
Protocol calls for three doses of STAR-LLD administered by continuous subcutaneous (SC) infusion and compared with daily 25 mg oral Revlimid^®
Enrollment completion estimated in 1H 2027

PARAMUS, N.J., Feb. 19, 2026 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc. (“Starton”), a clinical-stage biotechnology company transforming standard-of-care therapies with proprietary continuous delivery technologies, announced today the dosing of the first patient in its Phase 2a study evaluating STAR-LLD for the treatment of relapsed/refractory multiple myeloma (RRMM).

“STAR-LLD is designed to improve tolerability while maintaining meaningful minimum effective dose delivery of lenalidomide, which we believe will mitigate the toxic effects of the therapy compared to oral lenalidomide” said Jamie Oliver, PharmD., Chief Medical Officer at Starton Therapeutics. “Building on encouraging early clinical experience through our Phase 1b trial, we look forward to advancing STAR-LLD in the next stage of development and to further establish its potential in enabling more patients to remain on therapy longer to experience the full potential benefit of treatment”.

Pedro Lichtinger, Chairman and Chief Executive Officer of Starton, added, “Dosing the first patient in our Phase 2 study of STAR-LLD marks an important milestone in our mission to redefine the standard of care in multiple myeloma with our proprietary lenalidomide formulation technology. We expect to deliver clinical results that demonstrate improved tolerability and efficacy over current oral dosing, with the ultimate goal of improving patient outcomes. This protocol expansion marks an important milestone for the study and underscores the Company’s growing momentum in forging collaborations with some of the leading clinical research centers nationwide.”

Through the Sargon Site Network, the Company’s Phase 2 study is expanding from two to six investigational sites across the United States, broadening its geographic reach and patient access. The newly activated sites are led by distinguished principal investigators in the field of multiple myeloma research:

Dr. Steven Bettag in Sheboygan, Wisconsin
Dr. Sumit Sawhney in Coral Springs, Florida
Dr. Ghassan Al-Jazayrly in Los Angeles, California
Dr. Hamdy Mohtaseb in Bullhead City, Arizona

The study’s original sites are led by Dr. Nash Gabrail in Canton, Ohio, and Dr. Keith Lerro in Wilson, North Carolina. Dr Nash Gabrail, the lead Investigator noted, “We are excited to expand the use of STAR-LLD in relapsed and refractory multiple myeloma. Our experience with the Phase 1b study demonstrated positive responses and no meaningful hematologic toxicity, which had a notable impact on the patients’ experience.”

The study is a randomized dose-escalation trial that will assess the tolerability and efficacy of low-dose lenalidomide in heavily treated MM patients and will compare three doses of continuous subcutaneous infusion with STAR-LLD, combined with dexamethasone and a proteasome inhibitor (PI), to oral lenalidomide (Revlimid^®) with the same combination. It will enroll 24 transplant ineligible patients in 2^nd or greater line of therapy and has the option to expand enrollment to a total of 69 patients based on tolerability of selected dose (TSD) and response rate.

More information can be found on https://clinicaltrials.gov/study/NCT06087653.

About STAR-LLD

STAR-LLD is a continuous delivery lenalidomide (LLD) in development seeking 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 subcutaneous 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 with 20% of animals in this cohort tumor-free after 100 days; by contrast, there was a 0% ORR in animals treated with a 70% higher dose of lenalidomide given in single daily doses. In addition, a Phase 1b clinical study of six relapsed/refractory MM patients resulted in all patients that received STAR-LLD achieving an objective response (1 CR and 5 PRs); no patients experienced drug-related anemia, neutropenia, leukopenia, or thrombocytopenia greater than grade 2 in up to 12 cycles of therapy. The Phase 1b clinical study concluded that continuous delivery of low dose lenalidomide (STAR-LLD) provides meaningful efficacy and improved tolerability with no grade > 2 drug-related hematologic toxicity.

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 live better, for longer. Starton’s proprietary 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, Starton undertakes no obligation to disclose any revision to these forward-looking statements whether as a result of new information, future events, or otherwise.

Investor Relations Contact

Eric Ribner
Managing Director
LifeSci Advisors
eric@lifesciadvisors.com

Media Contact

Jason Braco, PhD
LifeSci Communications
jbraco@lifescicomms.com

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.