Starton Therapeutics Inc. has announced the successful results of a preclinical toxicology study for STAR-LLD, a continuous delivery system of lenalidomide in development for chronic lymphocytic leukemia (CLL) and multiple myeloma (MM).
“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, Starton’s chief medical officer, in a statement.
CLL and MM are the most common blood cancers in the US with 21,250 and 34,920 new diagnoses expected in 2021, respectively.
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CEO Pedro Lichtinger added: “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.”
Starton said 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.
The company noted that 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.
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.
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