Our focus is to deliver meaningful patient outcomes by leveraging the untapped potential of transdermal technology.
STAR-LLD in CLL
STAR-LLD is being developed to establish the only lenalidomide product approved for chronic lymphocytic leukemia (CLL).
CLL is the most common form of leukemia. Lenalidomide has been shown to be efficacious in CLL, however has not been successful in achieving a labeled indication due to toxicities at higher doses.
STAR-LLD is in development to reduce toxicity and reduce discontinuations at higher doses in 3rd line CLL and in CLL maintenance treatment.
STAR-LLD in MM
STAR-LLD is in development for achievement of superior outcomes in multiple myeloma maintenance treatment versus oral lenalidomide.
Up to 30% of MM patients discontinue treatment due to GI effects; avoidance of the GI system via transdermal delivery may reduce dose interruptions or discontinuations due to GI side effects.
35% of MM patients experience neutropenia (package insert); 24% of patients reduce lenalidomide exposure due to neutropenia (Leleu et al 2018); avoidance of dose interruptions and discontinuations by reducing lenalidomide toxicity may lead to improved outcomes.
STAR-LLD is in development to reduce toxicity and reduce discontinuations at higher doses in multiple myeloma maintenance.
STAR-OLZ is being developed as the first product indicated for PARP inhibitor (PARPi) induced nausea and vomiting (PIINV). PARP inhibitors are a rapidly growing class of cancer therapies currently used in ovarian and breast cancer maintenance therapy, and expected to expand into prostate, pancreatic, lung, and other solid tumors. Nausea and vomiting occur in 77 and 36% of patients respectively, existing antiemetics are contraindicated for use with PARP inhibitors or are not suited for long-term use.
Olanzapine is a proven antiemetic, but currently available forms have not been widely adopted due to fear of side effects.
STAR-OLZ is designed to improve quality of life and outcomes by controlling PIINV without significant side effects. This program successfully completed its Phase 1 human bioavailability study in December 2019 and is now clinically ready to advance to Phase 3.
Transdermal delivery systems use an adhesive patch to deliver medicine through the skin. The delivery is a controlled, sustained release over multiple days. Starton uses proven transdermal technology to transform approved medicines – establishing superiority or new indications.
Starton is focused on flattening the plasma concentration curve to reduce dose-limiting toxicity and deliver improved efficacy.
- The patch is expected to deliver between 50% to 90% lower AUC with equal or better tumor control vs oral
- Avoidance of toxicity with the patch due to the lower AUC will inherently lead to longer PFS due to the ability to continue treatment with the avoidance of withdrawals and dose-limiting toxicity
- Eliminate periods of subtherapeutic dosing due to short half-life