Jul 30, 2020

DEP® docetaxel and gemcitabine combination trial commences

DEP® docetaxel and gemcitabine combination trial commences
  • Starpharma has commenced its DEP® docetaxel + gemcitabine combination study, to run in parallel with its phase 2 DEP® docetaxel trial
  • Advancement of the combination study follows impressive data for DEP® docetaxel + gemcitabine in combination in preclinical human pancreatic cancer models
  • Clinical data for DEP® docetaxel + gemcitabine will feed into commercial discussions and further enhance the commercial potential of DEP® docetaxel

Melbourne, Australia; 30 July 2020: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that it has commenced its DEP® docetaxel + gemcitabine combination study for patients with advanced cancers, including pancreatic cancer. Recruitment into the study has commenced at the Christie in the UK, with two further sites expected to open in the coming weeks.

This study will recruit an initial cohort of approximately 10-12 patients and will run in parallel with the phase 2 DEP® docetaxel trial. The study will explore the potential benefits of DEP® docetaxel in combination with gemcitabine (Gemzar®) and builds on the impressive performance of DEP® docetaxel combined with gemcitabine in a preclinical human pancreatic cancer model, as reported previously. In that study DEP® docetaxel in combination with gemcitabine resulted in complete tumour regression and 100% survival, significantly outperforming each standard treatment, gemcitabine and Abraxane® alone and in combination.

Dr Jackie Fairley, Starpharma CEO, commented: “We have had enthusiastic feedback from clinicians for this combination given the bone marrow toxicities experienced with current pancreatic cancer therapies. Therefore, there is a significant unmet need in advanced pancreatic cancer and data from this study are expected to further enhance the commercial potential for DEP® docetaxel.”

This combination study will run in parallel with the phase 2 DEP® docetaxel trial program, which is currently recruiting at sites in the UK and continues to show encouraging efficacy signals including stable disease and substantial target tumour shrinkage in patients with cancers including lung, prostate, pancreatic, gastric and oesophageal.

About DEP® docetaxel and gemcitabine (Gemzar®)

DEP® docetaxel is a detergent-free nanoparticle formulation of the widely used anti-cancer drug, docetaxel (Taxotere®), and is currently in phase 2. Docetaxel is one of the most widely used cancer drugs for treatment of a wide range of solid tumours including breast, lung and prostate. It is marketed by Sanofi Aventis as Taxotere® and generated peak global sales in excess of US$3 billion. These products have US Food and Drug Administration (FDA)-mandated ‘black box’ warnings due to serious adverse events including neutropenia and anaphylaxis.

Gemcitabine is a major anti-cancer drug and Lilly’s Gemzar® had peak sales prior to patent expiry of US$1.7 billion. Gemcitabine is one of the leading chemotherapeutic drugs used to treat cancer of the pancreas, bladder, ovary and breast, and non-small cell lung cancer. Gemcitabine is used as a first-line treatment alone for pancreatic cancer, and in combination with other anti-cancer medicines, such as taxanes.

Download full announcement: DEP® docetaxel and gemcitabine combination trial commences (PDF 67kb)

 This contains certain forward-looking statements.