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StarpharmaDEP® irinotecan (Phase 2)

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DEP® irinotecan is an improved version of irinotecan (Camptosar®), predominantly used for colorectal cancer. DEP® irinotecan is a novel, patented nanoparticle formulation of SN-38, the active metabolite of irinotecan, delivered using Starpharma’s proprietary DEP® technology. Irinotecan (Camptosar®) is a major cancer drug used to treat colorectal cancer with peak global sales of >US$1.1 billion despite having multiple US FDA “Black Box” warnings. Irinotecan is a pro-drug that requires conversion to its active metabolite, SN38. The need for this conversion may lead to variable clinical effect/efficacy and toxicity among patients. DEP® solubilises SN38 and allows direct dosing, avoiding the need for liver conversion. DEP® irinotecan has been shown to demonstrate improved efficacy in multiple animal models and has patent filings to 2039 (plus up to an additional ~5 years).

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DEP® irinotecan phase 2 program is currently underway. The program is an open-label trial, with the objective of establishing anti-tumour activity (efficacy) and safety at the Recommended Phase 2 Dose (RP2D).

Encouraging efficacy signals have been observed in trial patients for multiple tumour types, including colorectal, ovarian, breast, pancreatic, lung and oesophageal cancer. The DEP® irinotecan phase 2 program has received enthusiastic support from clinicians due to limited treatment options for colorectal cancer. Starpharma is exploring commercially relevant value-adding combinations for DEP® irinotecan, including with immuno-oncology (IO) agents.