Starton Therapeutics Announces Enrollment Completion for STAR-LLD Phase 1b Clinical Trial in Multiple Myeloma

• Phase 1b data in the first 50% of patients reflect the responses seen in animals and may suggest superiority in both safety and efficacy when compared to oral Revlimid^®
• Anticipate FDA alignment and guidance on Phase 2 clinical trials in multiple myeloma (MM) and chronic lymphocytic leukemia (CLL) in 4Q24

/EIN News/ -- PARAMUS, N.J., April 25, 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 the successful completion of enrollment for its STAR-LLD Phase 1b clinical trial in multiple myeloma.

“This milestone marks a significant step forward in our commitment to bringing more advanced therapies to patients. We extend our gratitude to the participants, investigators, and clinical teams whose dedication and collaboration have made this achievement possible significantly ahead of our original timelines,” stated Pedro Lichtinger, Chairman and CEO of Starton Therapeutics. “With enrollment now complete, we are poised to advance to the next stages of clinical development, furthering our mission to expand and replace lenalidomide in key segments of MM and bring to CLL patients a new mode of action with proven efficacy.”

The study, which is assessing the safety, pharmacokinetics, and efficacy of continuous subcutaneous administration of low-dose lenalidomide (STAR-LLD) in combination with dexamethasone and bortezomib (Velcade^®), was originally anticipated to take ten months to enroll. The Company announced the opening of its second clinical site in February 2024.

Dr. Jamie Oliver, Starton’s Chief Medical Officer, added, “In the journey toward groundbreaking healthcare solutions, it takes unwavering dedication and collaborative spirit to make a difference. We are profoundly grateful to our esteemed partners at Gabrail Cancer & Research Center and Regional Medical Oncology Center for their remarkable commitment to our clinical trial, tirelessly caring for every patient’s needs along the way. We also want to thank the patients for their participation in the study. Together, we are not just advancing science; we are transforming lives.”

Starton previously disclosed preliminary trial findings regarding the safety and efficacy of STAR-LLD for multiple myeloma. Only two drug-related events have been observed to date. One patient experienced a drug-related intermittent injection site rash but continued with treatment, and a second patient was discontinued due to a Revlimid^® skin rash. None of the more serious typical lenalidomide side effects, including neutropenia, gastrointestinal issues, and severe fatigue, have been observed. Given that up to 30% of patients discontinue the use of Revlimid^® and approximately 70% undergo dose reduction due to adverse effects, these findings suggest that STAR-LLD may offer superior tolerability, potentially expanding the eligible patient population.

As part of the development plans agreed to with the FDA, the Company will prepare an initial summary of data on safety and activity while patients continue treatment for efficacy endpoints. This interim review for the End of Phase 1 meeting, anticipated for 4Q24, is aimed at helping develop the plans for the approval path forward with Phase 2 studies for MM and other malignancies where lenalidomide has shown activity but is not approved.

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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