I believe we are not too far away with a combination trial and a...

I believe we are not too far away with a combination trial and a stand alone drug entering clinical trials






DEP® irinotecan in combination with 5-FU+ Leucovorin (‘FOLFIRI’

Below is the recent timeline



November 30^th 2021
DEP® irinotecan in combination with 5-FU+ Leucovorin (‘FOLFIRI’ – a commonly used combination treatment, particularly first-line, in colorectal cancer – to commence shortly in the UK and Australia

28^th January 2022
In parallel with ongoing phase 2 monotherapy investigations for DEP® irinotecan, Starpharma is progressing a phase 1/2 combination arm that will investigate DEP® irinotecan in combination with 5-FU + Leucovorin (‘FOLFIRI’. FOLFIRI is a commonly used combination treatment regimen in colorectal cancer. Enrolment of patients in the DEP® irinotecan combination arm is expected to commence shortly

February 21^st 2022
Preparations continue for the addition of a phase 1/2 combination arm of DEP® irinotecan + 5-FU + Leucovorin (‘FOLFIRI’. FOLFIRI is a commonly used combination treatment regimen for colorectal cancer. This combination arm will run in parallel with the ongoing monotherapy arm for DEP® irinotecan, with recruitment of patients expected to commence shortly.

April 29^th 2022
Starpharma is in advanced stages of preparation for commencement of the phase 1/2 combination arm of DEP® irinotecan used in combination with 5-FU + Leucovorin (‘FOLFIRI’. FOLFIRI is a commonly used combination treatment regimen in colorectal cancer. This combination arm will run in parallel with ongoing phase 2 monotherapy investigations and enrolment of patients in the DEP® irinotecan combination arm is expected to commence shortly.

June 3^rd 2022
Starpharma is progressing a DEP® irinotecan combination arm, which will run in parallel to the phase 2 monotherapy investigations for DEP® irinotecan. DEP® irinotecan will be used in combination with 5-FU + Leucovorin (FOLFIRI), which is a commonly used treatment regimen in colorectal cancer. Enrolment of patients in this combination arm is expected to commence shortly, pending finalisation of the recommended combination dose




DEP® gemcitabine FIHT

*If my memory serves me correctly, DEP® gemcitabine was initially going to enter a phase 1 trial and not a seamless phase 1/2 trial.


February 21st 2022
Preparations for DEP® gemcitabine’s commencement of a phase 1/2 clinical trial, including manufacture of clinical product, are well advanced.


April 29^th 2022
Starpharma continues to progress DEP® gemcitabine, which is undergoing scale-up, clinical product manufacture and other trial preparations ahead of commencement of DEP® gemcitabine’s phase 1/2 clinical trial.




June 3^rd 2022
Starpharma is progressing a phase 1/2 clinical trial of DEP® gemcitabine, following encouraging preclinical results and significant clinician interest. The company is completing final preclinical activities, including product manufacture, prior to commencing the first in-human study for this DEP® product.

DEP® gemcitabine is a DEP® version of Lilly’s Gemzar® (gemcitabine), which is a widely used anti-cancer drug that achieved peak sales of US$1.7 billion. Gemzar® is one of the leading chemotherapeutic drugs used to treat pancreatic cancer and can be administered as a monotherapy or in combination with other therapies such as Abraxane®. In Starpharma’s preclinical studies, DEP® gemcitabine demonstrated significantly improved anti-tumour activity compared to Gemzar® in human pancreatic cancer xenograft models. When used in combination with Abraxane®, DEP® gemcijtabine also significantly outperformed a combination of Gemzar® and Abraxane®. DEP® gemcitabine will be the company’s fourth internal DEP® product to enter the clinic.