DEP® docetaxel (Phase 2)

DEP® docetaxel is a dendrimer version of docetaxel, which is widely used for breast, lung & prostate cancer.

Docetaxel (Taxotere®) is a commonly used chemotherapy agent despite having multiple US FDA “Black Box” warnings.

DEP® docetaxel is a detergent free, aqueous formulation of docetaxel.

The advantages* of DEP® docetaxel include:

  • Reduction in neutropenia
  • No steroid pre-treatment
  • Tumour-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.

Download DEP® Drug Delivery Summary (pdf file, 1007kb).

 

 

DEP® docetaxel 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-tumour activity (efficacy) & safety. 

Interim observations:

  • Efficacy signals observed, including prolonged stable disease and tumour shrinkage in patients with pancreatic, oesophageal, and gastric cancer. These tumour responses include stable disease for up to 40 weeks and significant tumour 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®).

Related Announcements

 

DEP® docetaxel phase 1 results

  • No steroid pre-treatment required due to DEP® docetaxel’s detergent-free formulation - unlike Taxotere®
  • No neutropenia (compares to >>90% with Taxotere®)
  • No protocol-defined Dose Limiting Toxicities
  • Only one patient (1/27) with mild alopecia/hair loss – compared to ~75% with Taxotere®
  • No reports of other problematic adverse events observed with docetaxel treatment, including anaphylaxis, fluid retention, diarrhoea and nail disorders
  • Encouraging efficacy signals in 13/27 DEP® docetaxel patients including:
    • Stable disease (SD) in multiple patients with lung, pancreatic (SD>20 weeks), gastro-oesophageal (SD >18 weeks) cancers, and in other patients with glioblastoma (brain) and renal cancers
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Full Results Announcement

 

DEP® docetaxel Preclinical Studies

DEP® posters showcased at AACR 2020 Annual Meeting

DEP® docetaxel was one of Starpharma's three clinical DEP® products featured in poster presentations at the 2020 Annual American Association for Cancer Research Annual Meeting. These posters showcase preclinical data from Starpharma’s products DEP® docetaxel, DEP® cabazitaxel and DEP® irinotecan, which are all in phase 2 clinical trials. The preclinical data presented at AACR comprises a series of xenograft studies showing enhanced efficacy of DEP® candidates/products used as a monotherapy or in combination with standard of care therapies. 

Related Announcements

 

Download DEP® Drug Delivery Summary (pdf file, 1007kb) or Contact Us for further information.