The objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of DEP® cabazitaxel.
This is central to defining a recommended phase II dose (RP2D), and then to determining anti-tumour efficacy of the product in select tumour types.
Transitions DEP® product from portfolio to clinic
The approval advances DEP® cabazitaxel, Starpharma’s second DEP® product, from its internal portfolio to the clinic.
DEP® cabazitaxel has already delivered impressive pre-clinical results showing sustained efficacy and survival benefits.
it has also eliminated neutropenia, which is a significant dose-limiting side effect of many anti-cancer drugs, including Jevtana®.
Jevtana® sales expected to reach circa US$500 million
DEP® cabazitaxel is Starpharma’s detergent-free version of cancer drug, Jevtana®, which is marketed by global pharmaceutical group Sanofi Aventis.
It is used in the treatment of advanced prostate cancer.
The drug is also under clinical development for a range of other cancer types, including testicular, ovarian, breast, bladder, and head and neck.
Jevtana® sales are estimated to reach approximately US$500 million this year.
Follows success of DEP® docetaxel
DEP® cabazitaxel is the second product from Starpharma’s DEP® platform to enter the clinic.
It follows DEP® docetaxel, which delivered positive phase I clinical results in 2017 and recently progressed to phase II.
The reproducible benefits observed for DEP® docetaxel and DEP® cabazitaxel in pre-clinical models included decreased bone marrow toxicity and enhanced efficacy.
In both cases DEP® has also allowed for a detergent-free formulation resulting in significant additional benefits for patients.