Jul 09, 2020

New Australian site opening for DEP® trials

New Australian site opening for DEP® trials

Melbourne, Australia; 9 July 2020: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced the opening of a new trial site for the phase 2 DEP® irinotecan trial, at the Kinghorn Cancer Centre in Sydney. The DEP® irinotecan trial is also being conducted at multiple leading UK cancer centres including The Christie, The Royal Marsden, Newcastle Freeman Hospital, and The Beatson West of Scotland Cancer Centre. The Kinghorn Cancer Centre will also be opened shortly as an additional site for the phase 2 DEP® cabazitaxel trial.

The phase 2 study for DEP® irinotecan is an open-label trial, with the objective of establishing anti-tumour activity (efficacy) and safety of the product. The trial has already enrolled several colorectal cancer (CRC) patients, and will enrol a total of approximately 20‑30 patients with CRC and other cancers. As part of this clinical program, Starpharma is currently also evaluating a number of potential value-adding clinical combinations, including with immuno-oncology (IO) agents following impressive data from a recent combination study with DEP® irinotecan plus an IO agent (anti PD-1 antibody) in multiple preclinical CRC models.

Dr Jackie Fairley, Starpharma CEO, commented: “The Kinghorn Cancer Centre is a world-class facility and we’re very pleased that Australian patients will be able to access Starpharma’s innovative DEP® products in these trials.”

About DEP® irinotecan & colorectal cancer

DEP® irinotecan is a novel, patented dendrimer nanoparticle of SN-38, the active metabolite of irinotecan.

DEP® irinotecan recently progressed to phase 2 following positive human clinical results in phase 1 announced on 7 May 2020. In the phase 1 trial conducted in major cancer centres in the UK, DEP® irinotecan was well-tolerated and patients generally experienced fewer severe side effects than are reported with conventional irinotecan, including no cases of the problematic severe diarrhoea, for which conventional irinotecan has an FDA black box warning. Encouraging efficacy signals with DEP® irinotecan were also observed in 50% of evaluable patients - not only in patients with CRC but also in patients with breast and pancreatic cancer.

These encouraging clinical results follow an extensive body of preclinical data in which DEP® irinotecan has shown multiple benefits compared to the original form of irinotecan, including significant improvements in anti-cancer efficacy and improved survival in multiple human cancer models (colorectal, pancreatic and breast). It has also shown benefit in combination in a range of current therapies including 5-FU, Erbitux® and Lynparza® in a variety of human cancer models.

CRC is one of the most common cancers in the world, affecting more than 1 million individuals annually, and is the fourth-leading cause of cancer-related death. The efficacy of Camptosar® in the treatment of cancer is dependent on the conversion of irinotecan in the liver to the active metabolite, SN-38, and this process can be highly variable within and between patients. The variability can lead to difficulties in patient management and dosing.

Download ASX Announcement: New Australian site opening for DEP® trials (PDF, 55kb)

 This contains certain forward-looking statements.