- Strengthened the clinical strategy to focus on addressing major unmet medical needs and pursuing efficient pathways towards product registration:
- CLL: In high-risk patients refractory to Bruton tyrosine kinase (BTK) inhibitors
- MM: A Phase 2 study with STAR-LLD in the post-transplant maintenance setting
PARAMUS, N.J., – Starton Therapeutics Inc. (“Starton” or the “Company”), a clinical-stage biotechnology company transforming standard-of-care therapies with proprietary dermal technologies, is pleased to announce its successful scientific Advisory Board meeting held during the American Society of Clinical Oncology (ASCO) Annual Meeting 2024. Led by Starton’s Scientific Board members and Chief Medical Officer, the meeting was attended by recognized experts and key opinion leaders in the field of oncology and yielded significant insights and outcomes that will shape the Company’s research and development efforts in Chronic Lymphocytic Leukemia (CLL) and Multiple Myeloma (MM).
Dr. Jamie Oliver, Starton’s Chief Medical Officer, stated “The feedback from the Advisory Board enhances our study design and introduces us to innovative ideas that we believe will help drive the successful clinical development of STAR-LLD in oncology. As we advance into the preliminary stages of our STAR-LLD Phase 2 clinical trials, receiving unbiased third-party information provides us invaluable support.”
“After drawing on the expertise of our advisory board members and opinion leaders in the field, we are confident in our vision for STAR-LLD’s path to market,” added Starton’s Chairman and CEO, Pedro Lichtinger. “The support from leading hematological cancer experts underscores the scientific rationale for pursuing the clinical development of STAR-LLD which positions us to initiate preparatory measures for our Phase 2 trials.”
The Advisory Board was comprised of 11 distinguished members with diverse backgrounds within the field of hematological oncology. Following ASCO and release of the early Phase 1b data in multiple myeloma, the advisors expressed strong support for the continued development of STAR-LLD and provided valuable feedback, including recommendations on optimizing future clinical trial designs, patient selection criteria, biomarker utilization, and endpoint determination. These recommendations will enhance the robustness and efficiency of the Company’s clinical development programs, while reinforcing the Company’s commitment to pioneering breakthrough treatments for MM and CLL patients worldwide.
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, grew 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 with STAR-LLD than with oral Revlimid®. The Company recently announced interim, top-line data from STAR-LLD Phase 1b clinical trial where 100% partial response or better was achieved in MM patients.
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 and adversely 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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