Starton Therapeutics Announces Phase 2a Clinical Trial for Continuous Low-Dose Lenalidomide (STAR-LLD) in Multiple Myeloma Open for Enrollment

• Gabrail Cancer & Research Center activated and open to screen patients, with Nash Gabrail, MD as lead investigator
• Second site, Regional Medical Oncology Center, also activated
• Recent Phase 1b clinical study results concluded continuous low dose lenalidomide provides meaningful efficacy and improved tolerability with no grade >3 drug-related hematologic toxicity
  

PARAMUS, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc. (“Starton”), a clinical-stage biotechnology company transforming standard-of-care therapies with proprietary continuous delivery technologies, announced today Gabrail Cancer Center (GCC) in Canton, Ohio is now activated and open for enrolling patients in its Phase 2a clinical trial evaluating their continuous low-dose lenalidomide, STAR-LLD, for the treatment of multiple myeloma (MM). Dr. Nash Gabrail, medical oncologist and founder of the Center, is the study’s lead investigator. Regional Medical Oncology Center, located in Wilson, NC, has also opened as the trial’s second active clinical site.

“We are excited to announce this major milestone in our mission to bring breakthrough therapies to patients. This marks the next phase of development for our lead candidate, STAR-LLD, and represents a significant step forward for the entire team," stated Pedro Lichtinger, Chairman and Chief Executive Officer of Starton Therapeutics.

“We expect this study to expand on what we observed in our prior Phase 1b study, that continuous low-dose lenalidomide provides meaningful efficacy and improved tolerability,” added Dr. Jamie Oliver, Starton’s Chief Medical Officer. “The expanded cohort and dose escalation will help us determine the most effective dose, with the goal of maintaining acceptable safety and tolerability.”

Starton, which recently presented the results of the Phase 1b portion of the study at the 2025 American Association for Cancer Research, will assess the safety and tolerability of low-dose lenalidomide in heavily treated MM patients. Continuous SC infusion (STAR-LLD) in combination with dexamethasone and a protease inhibitor (PI) will be compared to oral lenalidomide (Revlimid^®) in combination with dexamethasone and a PI. The study will include at least 24 patients randomized to STAR-LLD and oral lenalidomide (Revlimid^®). Up to 45 additional patients may be enrolled to identify the optimal dose for a future registrational study (based on ORR vs dose vs Grade 3-4 toxicity). Starton anticipates opening approximately 10 clinical sites.

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 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 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 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 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.

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Managing Director
LifeSci Advisors
astarr@lifesciadvisors.com

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