PARAMUS, N.J., Sept. 30, 2021 (GLOBE NEWSWIRE) -- Starton Therapeutics Inc., a clinical stage biotechnology company transforming standard of care therapies with proprietary dermal technologies, announces 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.
About STAR-LLD
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).
About Starton Therapeutics
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. To learn more, visit www.startontx.com
This press release contains forward-looking statements that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, liquidity, results of operations, plans and objectives. In some cases, you may identify forward-looking statements by words such as "may," "should," "plan," "intend," "potential," "continue," "believe," "expect," "predict," "anticipate" and "estimate," the negative of these words or other comparable words. These statements are only predictions. One should not place undue reliance on these forward-looking statements. The forward-looking statements are qualified by their terms and/or important factors, many of which are outside the Company's control and involve a number of risks, uncertainties and other factors that could cause actual results and events to differ materially from the statements made. The forward-looking statements are based on the Company's beliefs, assumptions and expectations of future performance, taking into account information currently available to the Company. Neither the Company nor any other person assumes responsibility for the accuracy or completeness of these statements. Information in this press release will be updated only to the extent required under applicable laws. If a change occurs, the Company’s business, financial condition, liquidity, results of operations, plans and objectives may vary materially from those expressed in the aforementioned forward-looking statements.
Starton Investor Relations:
investors@startontx.com
+1 551 287 6456
