Starpharma (ASX: SPL) 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.
CEO, Dr Jackie Fairley, said 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.
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.
Pancreatic cancer is a leading cause of cancer deaths, with a one-year relative survival rate of 20%, and a five-year survival rate of only 7%. Gemcitabine is commonly used both alone and in combination with Abraxane in pancreatic cancer as a first line treatment.
Current therapeutic approaches for pancreatic cancer have significant bone marrow toxicities. An important feature of DEPdocetaxel is a significant reduction in bone marrow toxicity observed in both preclinical and clinical studies.
Gemzar (gemcitabine) is one of the leading chemotherapeutics used to treat pancreatic cancer. It can be administered as a monotherapy or in combination with other therapies such as taxanes (e.g. Abraxane). Annual sales of Abraxane are approximately US$1.2 billion. Gemcitabine, which is now generic, had peak sales prior to patent expiry of US$1.7 billion.
We have had enthusiastic feedback from clinicians for this combination given the bone marrow toxicities experienced with current pancreatic cancer therapies,” Dr Fairley said.
“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.”
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.
