CriPec’s building blocks have a well-known biocompatibility. The safety of CriPec®-based products was demonstrated in the following studies:

  • The crosslinked nanoparticles are biodegradable upon incubation at physiological conditions.
  • No local or system toxicity, or immunological reactions upon (repeated) intravenous administration(s) observed during pharmacokinetic and therapeutic efficacy studies in healthy and tumour-bearing mice.
  • Negative Irwin test indicating no effect on animal behaviour upon intravenous injection of 20 mg paclitaxel/kg (400 mg polymer/kg) to healthy mice, which could predict possible human side effects.
  • No acute toxicity or histopathological changes in two (independent) single dose toxicity studies upon a single intravenous injection of CD101 at the anticipated therapeutic dose or empty nanoparticles dosed at 250 mg/kg empty nanoparticles to healthy mice.
  • No toxicity signs or major histopathological changes up to 86 mg/kg CD101 or 1700 mg/kg empty nanoparticles upon a single intravenous injection to healthy mice. The MTD of CD101 is consequently at least 6-fold higher than the MTD of the commercial paclitaxel formulation Taxol®.

 These results clearly prove the good biocompatibility and favourable safety profile of CriPec® based products.

For prospective licensing partners, an extensive data package including independent research reports is available. Please use our contact page to request more information.