Starton Therapeutics Inc, a privately-held clinical-stage biopharmaceutical company, said its target of kicking off a Phase 1 clinical study of STAR-LLD for treating chronic lymphocytic leukemia (CLL) in the fourth quarter of 2021 remains on track.
It comes after the company said it had now completed a written Type B pre-Investigational New Drug (pre-IND) meeting with the regulator, the US Food and Drug Administration (FDA).
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Based on the FDA’s feedback from the written response meeting, Starton will conduct a Phase 1 relative bioavailability (BA) study of STAR-LLD, a subcutaneously administered lenalidomide solution, compared to oral administration of REVLIMID in multiple myeloma patients currently receiving REVLIMID.
Based on the outcome of this Phase 1 study, the FDA has also confirmed a 505(b)(2) regulatory pathway is acceptable, allowing the potential to accelerate the clinical development for drug approval, noted Starton.
In today’s statement, Starton also said it expects to complete the non-clinical requirements for the IND submission in the third quarter of this year.
“We are very pleased with the outcome of the pre-IND meeting and will move forward with our plans to initiate clinical studies before the end of 2021,” said Pedro Lichtinger, Starton’s chief executive.
“We appreciate the FDA’s guidance as we work towards developing the first immunomodulatory (IMiD) drug approved for CLL.”
Starton is focused on transforming standard-of-care therapeutics, using proven continuous delivery technology. It develops transdermal and subcutaneous delivery treatments that administer continuously medicines via patches placed on the skin or ambulatory pumps under the skin, respectively.
STAR-LLD SC is a continuous subcutaneous infusion of lenalidomide parenteral solution via an infusion pump. Starton is also developing a once-weekly transdermal delivery patch system.
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 improve overall response rates and progression-free survival alone or in combination with standard therapies. STAR-LLD is expected to be the first Immunomodulatory imide (IMiD) drug available for CLL.
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