DEP® docetaxel
DEP® docetaxel is water-soluble and does not require surfactant such as polysorbate 80 for dissolution. Drug substance is readily manufactured at scale using standard chemistry under cGMP.
Properties
- Pharma and Nutraceuticals Functions
- Anti-Cancer Agent
Product families
Applications
- Other Medical Applications
Product Families
- Active Pharmaceutical Ingredients (APIs)
Other characteristics
- Brand
- DEP
- Certifications & Compliance
- cGMP
- Usage
Docetaxel is a leading chemotherapy drug used to treat a wide range of solid tumors including breast, lung and prostate. It is marketed by Sanofi Aventis as Taxotere® and generated sales in excess of US$3 billion in 2010.. In pre-clinical studies DEP® docetaxel was shown to have substantially better efficacy and lower toxicity than Taxotere® alone. Of particular significance was the absence of neutropenia, the major dose-limiting toxicity for Taxotere®.
- Markets
- Healthcare & Pharma
- Advantages
The advantages* of DEP® docetaxel include:; Reduction in neutropenia; No steroid pre-treatment; Tumor-targeting (~70x more), improved efficacy; Improved pharmacokinetics; Clinical studies have demonstrated reduction in important side effects with DEP® including bone marrow toxicity, anaphylaxis, oedema, and hair-loss. DEP® docetaxel has patent filings to 2032 (plus up to an additional ~5 years).; *Multiple preclinical studies have established improved efficacy, survival, and safety with DEP® with many different drugs.
- Technology
- Pharmaceuticals & Nutraceuticals
- Wider Applications
Starpharma applies its DEP® dendrimer drug delivery platform to its own pipeline, and in collaboration with a number of well known pharmaceutical companies.; DEP™ is applicable to small molecules, peptides, proteins and antibodies, yielding benefits such as efficacy, targeting, improved pharmacokinetics and reduced toxicity, as well as greatly increased aqueous solubility.; Applying DEP® in this way has the potential to create innovative products with increased patient compliance and effectiveness and also provide companies with a unique market position leading to enhanced commercial returns.; DEP™ docetaxel is in Phase 2 clinical trials.
- Certifications and Compliance
- cGMP
- Clinical Status
DEP® docetaxel phase 2 program is ongoing and includes both a monotherapy arm and the use of the product in combination with other anti-cancer treatment(s). The monotherapy trial is an open-label trial, with the objective of establishing anti-tumor activity (efficacy) & safety.; Efficacy signals observed, including prolonged stable disease and tumor shrinkage in patients with pancreatic, oesophageal, and gastric cancer. These tumor responses include stable disease for up to 40 weeks and significant tumor shrinkage in a heavily pre-treated oesophageal cancer patient, maintained for more than 28 weeks.; Notable lack of bone marrow toxicity (e.g. neutropenia) and other common side effects including hair-loss, mouth ulcers, anaphylaxis and oedema; Efficacy signals observed in heavily pre-treated patients (treated with up to 40 cycles and 9 different anti-cancer regimens previously); Combination program includes DEP® docetaxel + nintedanib (Vargatef®) and DEP® docetaxel + gemcitabine (Gemzar®).
