Starpharma Clinical Trial Demonstrates Antitumour Efficacy Of DEP Irinotecan

Starpharma Holdings Ltd (ASX: SPL) has reported clinically significant results from its Phase 2 clinical trial of DEP irinotecan.

DEP irinotecan is a novel, patented nanoparticle formulation of SN381, the active metabolite of the widely used anti-cancer drug, irinotecan.

Developed using Starpharma’s proprietary DEP dendrimer technology, DEP irinotecan was designed to solubilise and directly deliver SN38 to cancer tissue.

Antitumour efficacy

The DEP irinotecan Phase 2 trial met its objectives, with endpoints demonstrating positive antitumour efficacy in multiple cancers.

The trial also confirmed the product’s favourable safety and tolerability profile.

Key efficacy results in heavily pre-treated patients with advanced colorectal cancer, 98% of whom experienced cancer progression following prior irinotecan treatment, include:

DEP irinotecan in combination with 5-fluorouracil (5-FU) and leucovorin (LV) achieved median progression-free survival (mPFS) of 4.2 months, which is ~68% longer than published data on mPFS for conventional irinotecan plus 5-FU/LV as secondline therapy.

In these patients, the disease control rate (DCR) was 86%, and the objective response rate (ORR) was 14%, which also compares favourably to the published ORR of 4% for conventional irinotecan plus 5-FU/LV.

“Significant and sustained tumour shrinkage”

Dr Jia (Jenny) Liu MD PhD FRACP, Medical Oncologist and Principal Investigator at the Kinghorn Cancer Centre, St Vincent’s Hospital in Sydney, said: “The full DEP irinotecan / DEP SN38 trial results are very exciting.

“DEP irinotecan in heavily pretreated, advanced cancer patients demonstrated highly encouraging efficacy results in a range of tumour types.

“These responses include significant and sustained tumour shrinkage and disease control in patients with irinotecan-pre-treated colorectal cancer and platinum-resistant ovarian cancer.”

Liu noted that DEP irinotecan exhibits excellent tolerability, with a distinct lack of severe gastrointestinal toxicity that is a common and problematic feature of standard irinotecan treatment.



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