- Starpharma (SPL) has successfully completed the phase 1 component of its phase 1/2 trial for DEP cabazitaxel
- Phase 1 enrolled 14 patients of which efficacy signals were observed in 67 per cent of the patients
- Efficacy signals were seen in a range of tumour types including prostate, ovarian and pancreatic
- The trial will now transition seamlessly into phase 2 with two new sites initiated and recruitment activities already underway
- Starpharma’s share price is up 4.49 per cent this morning with shares trading for $1.28 apiece
Starpharma (SPL) has successfully completed the phase 1 component of its phase 1/2 trial for DEP cabazitaxel.
The trial met its objective of evaluating safety, tolerability and preliminary efficacy data, and identifying a recommended phase 2 dose of 20 mg/m2.
Phase 1 enrolled 14 patients with a range of cancers including prostate, ovarian, cholangiocarcinoma (bile duct cancer) and pancreatic tumours.
Efficacy signals were observed in 67 per cent of evaluable patients and included prolonged stable disease and significant reductions in specific tumour biomarkers such as prostate-specific antigen (PSA).
On top of this, efficacy signals in prostate cancer were observed at doses up to 40 per cent lower than usually used for standard cabazitaxel (Jevtana).
Jevtana is approved for the treatment of prostate cancer however, ovarian, pancreatic and cholangiocarcinoma are not currently approved.
These efficacy signals are particularly encouraging given all patients in the study were heavily pre-treated and had either progressed or had stopped responding to anti-cancer therapies to qualify for entry into the DEP cabazitaxel study.
Most patients in the trial and been previously treated with multiple cancer therapies including taxane chemotherapies such as Taxotere, Jevtana and Abraxane.
Some patients received up to 33 cycles of treatment and up to 10 different treatments before entering the DEP cabazitaxel trial.
One prostate cancer patient who had been unable to tolerate conventional treatment, Taxotere, due to dose-limiting severe neutropenia (low levels of white blood cells) received 15 cycles of DEP cabazitaxel without neutropenia and experienced more than 47 weeks of stable disease.
DEP cabazitaxel trial participants experienced significantly fewer side effects, such as bone marrow toxicity, anorexia and vomiting, than those typically seen with Jevtana.
Patients did not require anti-nausea, antihistamine or cortisone pre-treatments that is standard with Jevtana and there were no cases of hypersensitivity or anaphylaxis.
“We’re pleased to advance our second DEP product 2, and are very excited to see the promising efficacy signals observed in such a resistant patient cohort, and the remarkably low incidence of adverse events with DEP cabazitaxel,” Starpharma CEO Dr Jackie Fairley said.
The trial will now transition seamlessly into phase 2, with two new sites initiated and recruitment activities already underway.
The phase 2 trial will be conducted at multiple sites including Guy’s Hospital in London, University College in London, the Velindre Cancer Centre in Cardiff and Imperial College London.
Recruitment activities, including patient screening for phase 2 have already begun and Starpharma is also exploring opportunities to initiate further sites to speed up recruitment.
The phase 2 study is an open-label trial with the objective of establishing anti-tumour activity and safety of DEP cabazitaxel at 20 mg/m2.
The first stage will enrol approximately 20 patients with a variety of cancers and may be adjusted based on results in certain patient groups.
Starpharma’s share price is up 4.49 per cent this morning with shares trading for $1.28 at 11:36 am AEDT.