DEP® irinotecan is a novel, patented nanoparticle formulation of SN-38, the active metabolite of irinotecan, delivered using Starpharma’s proprietary DEP® technology. DEP® irinotecan has shown a number of benefits compared to the original form of irinotecan, including significant improvements in anti-cancer efficacy and improved survival in multiple human cancer models. DEP® irinotecan is the third DEP® product to enter the clinic from Starpharma’s internal portfolio.
The objectives of the current DEP® irinotecan phase 1/2 clinical trial are to evaluate the safety, tolerability and pharmacokinetics of DEP® irinotecan to define a recommended phase 2 dose (RP2D), and to determine anti-tumour efficacy of the product in select tumour types.
Irinotecan, a widely used cancer drug marketed by Pfizer as Camptosar® or Campto®, is used alone or in combination with other drugs for the treatment of colorectal cancer (CRC). Despite US FDA “Black Box” warnings for both neutropenia and severe diarrhoea, Camptosar® achieved peak annual sales of US$1.1 billion. The clinical use of irinotecan is limited by these toxicities.
DEP® irinotecan, alone and in combination with Lynparza®, showed significant anti-tumour efficacy and synergy compared with standard irinotecan (Camptosar®) and Lynparza® (olaparib) in an irinotecan-refractory human colon cancer model. More information is available here.