Our focus is on delivering meaningful patient outcomes by leveraging the untapped potential of continuous delivery and transdermal technology.
STAR-LLD in CLL
STAR-LLD is being developed to establish the only product in its class approved for chronic lymphocytic leukemia (CLL).
CLL is the most common form of leukemia. Lenalidomide has been shown to be efficacious and well tolerated in CLL previous randomized controlled trials did not obtain an indication for the product but Even in the absence of a formal approval, NCCN guidelines recommend lenalidomide for the maintenance treatment of CLL. Continuous delivery of LLD has the potential to build on the proven lenalidomide efficacy in CLL while improving tolerability
STAR-LLD is in development for the treatment of three new indications in CLL.
STAR-LLD is in development in two continuous delivery systems: subcutaneous and transdermal. The SC program is preparing to enter Phase 1/2 clinical studies in 2021.
STAR-LLD in MM
STAR-LLD is in development for new indications for lenalidomide and achievement of superiority versus oral lenalidomide in maintenance treatment of multiple myeloma. The STAR-LLD delivery system is expected to provide significant reductions in discontinuations and treatment abandonment by reducing area under the curve (AUC) by more than 50%+
Lenalidomide is standard of care in multiple myeloma, but can have poor tolerability from dose-dependent side effects:
Flattening the plasma concentration curve by reducing the Cmax and increasing the Cmin during a dose interval, continuous delivery is expected to improve tolerability.
STAR-LLD is targeting two new indications for lenalidomide and expects to obtain superior outcomes versus oral lenalidomide in multiple myeloma maintenance indication.
STAR-LLD is in development in two continuous delivery systems: subcutaneous and transdermal. Animal proof of concept studies have been completed.
The SC program is preparing to enter Phase 1/2 clinical studies.
STAR-OLZ in CINV
STAR-OLZ is a 7-day transdermal patch in development for the treatment of chemotherapy induced nausea and vomiting (CINV).
The standard of care antiemetic regimen for patients treated with highly emetogenic chemotherapy (HEC) results in breakthrough nausea in up to 72% of patients and breakthrough vomiting in up to 50% of patients.
STAR-OLZ technology allows for sustained release efficacy protection for at least five days. The product is in development to substitute NK1 receptor antagonists in the guideline-recommended CINV prophylaxis regimen and provide Superior Total Control.
STAR-OLZ successfully completed its Phase 1 human bioavailability study in December 2019 and is now preparing to advance to a Phase 2/3 clinical trial.
STAR-OLZ in PIINV
STAR-OLZ is a 7-day transdermal patch in development 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 preparing to advance to a Phase 2/3 clinical trial.
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