Starpharma (ASX:SPL) has announced it has received regulatory and ethics approvals to commence its phase 1/2 clinical trial for DEP cabazitaxel.
According to the company, the objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of DEP cabazitaxel, to define a recommended phase 2 dose (RP2D), and then determine efficacy of the product in select tumour types.
Guy’s Hospital London and University College London Hospital (UCLH) in the UK being the first sites to open for recruitment. Further sites will open and commence recruitment as dose escalation progresses and the phase 2 part of the trialgets underway. Approximately 35 patients will be enrolled across the phase 1/2 trial.
DEP cabazitaxel is Starpharma’s detergent-free version of Sanofi's PBS-listed cancer drug, Jevtana, which is currently used to treat advanced prostate cancer. It is also under clinical development for a range of other cancer types, including testicular, ovarian, breast, bladder, and head and neck.
DEP cabazitaxel is the second product to enter the clinic from Starpharma’s DEP platform, following DEP docetaxel, which delivered positive phase 1 clinical results in 2017 and recently progressed to phase 2.
The benefits observed for DEP docetaxel and DEP cabazitaxel in pre-clinical models include decreased bone marrow toxicity and enhanced efficacy, and in both cases DEP has also allowed for a detergent-free formulation resulting in significant additional benefits for patients, said the company.
In parallel, AstraZeneca’s first DEP product, AZD0466, has been developed under licence with Starpharma and has also demonstrated preclinical improvements consistent with findings for DEP docetaxel and DEP cabazitaxel.
The phase 1/2 study for DEP cabazitaxel will enrol patients with advanced solid tumours and is an open-label study.
In phase 1, DEP cabazitaxel will be administered once every three weeks at escalating doses to determine if there are any Dose Limiting Toxicities (DLTs) and to establish the Maximum Tolerated Dose (MTD).
In phase 2, the study will initially enrol up to 20 patients at the RP2D to determine the anti-tumour efficacy of DEP cabazitaxel in specific tumour types, and to further characterise the safety, tolerability and PK of theproduct.
Dr Jackie Fairley, Starpharma CEO, said: “We are delighted to advance DEP cabazitaxel – our second DEP product rom our internal portfolio to the clinic. DEP cabazitaxel has already delivered exciting preclinical results showing sustained efficacy and survival benefits, as well as eliminating neutropenia, which is a significant dose-limiting side effect of many anti-cancer drugs, including Jevtana.
“These benefits for DEP cabazitaxel are consistent with the recent positive phase 1 results for our lead internal DEP product, DEP docetaxel and findings in partnered DEP programs. The growing body of data from our DEP products illustrates the broad applicability of the DEP platform and the compelling commercial advantages of enhancing drug performance and reducing toxicity for patients, while extending patent life,” added Dr Fairley.