GTL 001

Drug Profile

GTL 001

Alternative Names: CyAa-HPV-16E7 CyaA-HPV-18E7 vaccine; GTL001; HPV 16E7 HPV 18E7 protein vaccine; HPV 16E7-HPV 18E7; ProCervix

Latest Information Update: 05 Apr 2017

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At a glance

  • Originator GENTICEL
  • Developer GenKyoTex; GENTICEL
  • Class Papillomavirus vaccines; Protein-vaccines; Recombinant proteins; Synthetic vaccines
  • Mechanism of Action CD4-positive T lymphocyte stimulants; CD8 positive T lymphocyte stimulants; Immunostimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Preclinical Oropharyngeal cancer
  • Discontinued Anal cancer; Cancer; Cervical cancer; Human papillomavirus infections

Most Recent Events

  • 13 Dec 2016 Final efficacy and adverse events data from the phase II RHEIA-VAC trial in Cervical cancer released by Genticel
  • 01 Dec 2016 Genticel terminates a phase I trial in Human papillomavirus infections in USA due to lack of efficacy in European Phase II study (Parenteral) (NCT02689726)
  • 01 Oct 2016 Genticel completes the RHEIA-VAC trial in Cervical cancer (Prevention)/Human papillomavirus infections in United Kingdom, Belgium, Finland, France, Germany, Netherlands and Spain (NCT01957878)
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