Starton Therapeutics Announces Successful Results in STAR-LLD Toxicology Study: No Myelosuppression & Excellent Tolerability
Starton Therapeutics Inc. recently announced the results of a preclinical toxicology study for STAR-LLD. STAR-LLD is a continuous delivery system of lenalidomide in development for chronic lymphocytic leukemia and multiple myeloma.
“This final IND-enabling study for STAR-LLD provides additional rationale for the potential tolerability benefit of Starton’s continuous delivery program,” said Jamie Oliver, Chief Medical Officer.
Pedro Lichtinger, Chairman and Chief Executive Officer, emphasizes “The preclinical program signals potential for introducing a new mode of action for CLL patients and for LLD-intolerant patients with multiple myeloma. We are positioned to help CLL and myeloma patients live longer better lives.”
The study was a GLP continuous subcutaneous infusion tolerability study of lenalidomide in mice. Key tolerability and hematology parameters were assessed over a 28-day period. At day 28, the total white blood cell, neutrophil, and lymphocyte counts showed no significant difference between the continuous administration of lenalidomide (STAR-LLD, Group 2 and 3) and vehicle treated mice (group 1). Platelets and all other differentials were not different than those observed in sham-treated animals (Group 1). These results contribute to the STAR-LLD patent filings.
Chronic lymphocytic leukemia (CLL) and multiple myeloma (MM) are the most common blood cancers in the US with 21,250 and 34,920 new diagnoses expected in 2021, respectively. Both CLL and MM are rarely curable; although current treatments extend survival, deteriorating quality of life remains a challenge due to drug-related side effects. Up to 30% of MM patients do not tolerate lenalidomide, with 80% of patients dose reducing during their treatment and CLL patients have been deprived of access to immunomodulatory drugs (IMiDs) due to tolerability.
STAR-LLD is a continuous delivery lenalidomide in development to expand the standard of care for the most common blood cancers, multiple myeloma 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 oral lenalidomide, and shrank by 80% with STAR-LLD. The study also showed 100% efficacy (overall response rate ORR) at 144-mcg continuous LLD vs. 0% ORR with active control and 20% tumor elimination at 144-mcg continuous LLD vs. 0% tumor elimination with daily pulsatile dosing.
STAR-LLD SC is expected to enter clinical studies in Q1 2022. Starton has completed a pre-IND meeting for STAR-LLD SC and all IND-enabling studies. Starton expects to reference prior findings of nonclinical safety for key sections of the New Drug Application (NDA) for REVLIMID(r).
A clinical-stage biotechnology company focused on transforming standard of care therapies with proprietary dermal 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. For more information, visit www.startontx.com.
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