Starton Therapeutics Announces Opening of Second Clinical Site for STAR-LLD Phase 1b Trial in Multiple Myeloma and Provides Study Update

Starton Therapeutics Announces Opening of Second Clinical Site for STAR-LLD Phase 1b Trial in Multiple Myeloma and Provides Study Update




Starton Therapeutics Announces Opening of Second Clinical Site for STAR-LLD Phase 1b Trial in Multiple Myeloma and Provides Study Update

  • Regional Medical Oncology Center is activated and open to screen patients
  • Study enrollment is ahead of schedule with half of the patients enrolled and complete enrollment which was previously anticipated Q3/24 is now expected by Q1/24
  • Early data may suggest superiority in safety compared to oral Revlimid®
  • Clinical data reflect the unexpected superior responses seen in animals – a partial response or better was observed in all 3 patients after their second cycle of treatment

PARAMUS, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) — Starton Therapeutics Inc. (“Starton” or “the Company”), a clinical-stage biotechnology company focused on transforming standard-of-care therapies with proprietary continuous delivery technology, announced Regional Medical Oncology Center (RMOC) in Wilson, NC as the second site activated in the STAR-LLD Phase 1b clinical trial. The ongoing study evaluates the safety, pharmacokinetics, and efficacy of continuous subcutaneous administration of low-dose lenalidomide (STAR-LLD) in conjunction with dexamethasone and bortezomib (Velcade®). Remarkably, the trial is progressing ahead of schedule and with the addition of RMOC is now projected to conclude enrollment by Q1/2024.

Medical oncologist and hematologist Dr. Keith Lerro, who has been practicing in Wilson since 2003, stated, “RMOC is committed to providing excellence to patients and their loved ones, and doing so with compassion. I’m excited about the potential opportunity STAR-LLD can bring to multiple myeloma patients.”

Earlier last month, Starton disclosed preliminary trial findings regarding the safety and efficacy of STAR-LLD for multiple myeloma. Notably, no hematologic toxicities greater than Grade 1 have been observed following up to 3 cycles of treatment thus far. Additionally, no drug-related non-hematologic toxicities beyond Grade 1 have been observed with only a singular drug-related adverse event associated with STAR-LLD over 6 cumulative cycles was reported—subcutaneous induration at the injection site, which resolved within two weeks. In contrast, a previous regimen in the same patients involving Revlimid® exhibited adverse events such as nausea, vomiting, deep vein thrombosis (DVT), upper respiratory tract infections (URTI), anemia, and fatigue. None of the common side effects associated with lenalidomide (Revlimid®) have been identified with STAR-LLD.

Pedro Lichtinger, CEO of Starton, conveyed a positive outlook, expressing confidence by stating, “We are very pleased with the acceleration of our Phase 1b clinical study and with efficacy and tolerability patient outcomes to date. Results like these keep our team laser focused on achieving our important mission to have patients live longer while improving their quality of life, all while driving value for our stakeholders.” Mr. Lichtinger underscored the absence of significant hematologic toxicity and drug-related adverse events, aligning with the findings from preclinical studies conducted during the Investigational New Drug (IND) enabling phase.

Dr. Mohamad Hussein, a global leader in multiple myeloma treatment and a member of Starton’s Board of Directors, commended the innovative lenalidomide administration method, suggesting it enhances safety and tolerability, providing patients with a potentially more effective and secure approach to utilizing the drug.

Common side effects of lenalidomide (Revlimid®), including diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, and tremor, have not been observed with STAR-LLD. 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 compared to oral Revlimid, potentially expanding the patient population benefiting from the full Revlimid® advantage and enhancing overall quality of life.

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 efficacy of approved drugs, to make them more tolerable and expand their potential use. To learn more, visit www.startontx.com.

Forward looking statements

This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

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