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 30th 2021DEP® 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
28th January 2022In 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 21st 2022Preparations 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 29th 2022Starpharma 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 3rd 2022Starpharma 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 doseDEP® 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 2022Preparations for DEP® gemcitabine’s commencement of a phase 1/2 clinical trial, including manufacture of clinical product, are
well advanced.
April 29th 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 3rd 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.
(20min delay)