Starton Therapeutics selects formulation for continuous subcutaneous lenalidomide delivery system for CLL treatment
Starton Therapeutics Inc announced Monday that it has selected a subcutaneous (under the skin) lenalidomide formulation as the lead formulation candidate for its continuous subcutaneous delivery system (STAR-LLD SC) for chronic lymphocytic leukemia (CLL), which is a type of cancer of the blood and bone marrow, and other hematological malignancies.
“Lenalidomide is an exceptionally challenging molecule to formulate,” said Starton Therapeutics Chief Manufacturing Officer Andy Rensink.
“By using unique and novel technology, we are thrilled to have successfully developed a stable solution for use in the STAR-LLD SC delivery system and are excited to move this product closer to benefitting patients.”
READ: ChemioCare USA Inc rebrands itself as Starton Therapeutics as it hones it on bigger opportunities
The privately-held, Paramus, New Jersey-based clinical-stage biotechnology company powering continuous delivery of approved drugs, said it has filed a provisional patent application based on “the novelty of the formulation,” which is being co-developed and co-manufactured in collaboration with a large international FDA-compliant contract manufacturing partner. Any IP generated from co-development and co-manufacturing will be solely owned by Starton Therapeutics, added the company.
STAR-LLD SC clinical trial materials are expected to be shipped in the second quarter of 2021 for initiation of Phase 1/2 clinical studies for CLL in the second half of 2021. The studies are expected to use an open-label design with arms in multiple indications in CLL, with each target indication using different sub-population characteristics.
“Starton believes that this strategy provides multiple shots on goal with at least one indication with the potential for FDA breakthrough therapy designation,” the company said in a statement.
STAR-LLD SC is the first delivery system in the STAR-LLD continuous delivery platform. Starton is also developing a once-weekly transdermal delivery patch system, which is also rapidly progressing in formulation development.
The company explained that STAR-LLD SC will “use an ambulatory pump to infuse low-dose lenalidomide continuously,” based on Starton research showing that “low-dose continuous delivery may have superiority in survival and complete response rates.” STAR-LLD is expected to offer a new mode of action for CLL patients and be the first immunomodulatory drug (IMiD) available for patients battling this condition.
Starton uses proven continuous delivery technology with proprietary drivers to obtain new indications, or develop on-label superiority for patients with hematological malignancies, which are cancers that affect the blood, bone marrow, and lymph nodes.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive
Story by ProactiveInvestors
Source: https://www.proactiveinvestors.com/companies/news/938080/starton-therapeutics-selects-formulation-for-continuous-subcutaneous-lenalidomide-delivery-system-for-cll-treatment-938080.html
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