Starton Successfully Completes Proof of Concept Study for Transdermal Lenalidomide

12/27/19

NEW YORK, Dec. 27, 2019 (GLOBE NEWSWIRE) — Starton Therapeutics Inc. (“Starton” or the “Company”), a biotechnology company focused on transforming standard of care therapeutics, today announced the completion of a proof of concept study of multiple myeloma with lenalidomide using a model which emulates transdermal delivery. The results of the study demonstrate that a continuous subcutaneous (SC) delivery of lenalidomide is superior in terms of efficacy and equivalent in tolerability when compared to a standard once daily pulsatile dosing of Revlimid® (Celgene Corporation) in mice. The positive outcome provides a clear path for development of transdermal lenalidomide in hematologic malignancies including multiple myeloma and chronic lymphocytic leukemia. Given the unexpected nature of the positive results, patent applications have been filed for low dose continuous transdermal delivery of the thalidomide class of compounds.

The highest dose administered in the transdermal model produced complete (40%) or partial responses (60%) in all animals at a daily exposure, which is 72% lower than the standard once daily lenalidomide dose. The standard once daily lenalidomide treatment produced no CRs or PRs.  The median tumor volume at the end of the study was 14 mm3 at the highest infusion dose and was 33-fold larger (473 mm3) in the lenalidomide once daily dosed control group. In the 4 animals with a CR which received a continuous delivery, there has been no recurrence of their tumors for 10 days after stopping treatment whereas all other animals have experienced additional tumor progression.  Additionally, the tolerability in terms of physical findings, body weight, and key hematology parameters were comparable among the treatment groups.

“These results are unprecedented to our knowledge in this multiple myeloma model. Transdermal delivery is unique in that it “flattens” plasma pharmacokinetics – it lowers the overall exposure of lenalidomide by delivering a targeted continuous blood level equal to the 12 hour blood level observed with a traditional daily pulsatile dose; this lowers the peak levels significantly and elevates the trough level for an extended period,” said Dr. Jamie Oliver, Chief Medical Officer. “This delivery creates a completely new therapeutic form of lenalidomide, which may perform better than pulsatile treatment.”

The model selected was the NCI-H929 cell line human tumor xenograft in a SCID mouse, one of the most common cell lines used to study multiple myeloma. The 29-day study was performed in six groups of 10 animals each. To evaluate efficacy and overall tolerability, pharmacokinetics, tumor volume, body weight, physical findings, and CBC were assessed during the treatment period. The standard dosing regimen for REVLIMID (lenalidomide) was used as a comparator to four different continuous delivery dose levels. 

“Having spent my career in hematological malignancies, these data suggest an exciting breakthrough for patients,” said Dr. Mohamad Hussein. “Starton’s 7-day lenalidomide may be particularly valuable for the CLL patient population where lenalidomide is recommended by NCCN guidelines but is lacking FDA approval.”

About Starton Therapeutics

Starton Therapeutics is a clinical-stage biotechnology company focused on transforming standard of care therapeutics with a focus on hematology and oncology. Starton uses proven transdermal technology with proprietary drivers to obtain new indications or develop on-label superiority.

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