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Related Experiment Videos

OvaRex (AltaRex).

I Brukner1

  • 1SignalGene Inc, 8475 avenue Christophe-Colomb, Bureau 1000, Montreal H2M 2N9, Quebec, Canada. ivanb@signalgene.com

Idrugs : the Investigational Drugs Journal
|July 15, 2005
PubMed
Summary
This summary is machine-generated.

OvaRex, a monoclonal antibody vaccine, is being developed for ovarian cancer treatment. Clinical trials are underway, with regulatory submissions planned for 2001-2002, potentially leading to commercialization.

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Area of Science:

  • Oncology
  • Immunotherapy
  • Vaccinology

Background:

  • Ovarian cancer remains a significant health challenge.
  • CA125 antigen expression is observed in ovarian, breast, and lung cancers.
  • Monoclonal antibody-based immunotherapies show promise for cancer treatment.

Purpose of the Study:

  • To evaluate OvaRex (B43.13), a monoclonal antibody vaccine, for ovarian cancer treatment.
  • To explore the potential of OvaRex in other CA125-expressing cancers.
  • To advance OvaRex through clinical trials and regulatory processes.

Main Methods:

  • A multicenter, placebo-controlled, double-blind, randomized phase IIb trial for advanced ovarian cancer was initiated in 1997.
  • Investigational New Drug (IND) application submitted to the FDA in 1998.

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  • Phase II trial expanded with US Oncology, involving over 33 satellite sites.

    • Main Results:

    • Data analysis from the phase IIb trial is anticipated in the first half of 2001.
    • OvaRex has received Fast Track designation for advanced ovarian cancer.
    • OvaRex has been granted Orphan Drug status in the US.

    Conclusions:

    • OvaRex demonstrates potential as an immunotherapy for ovarian cancer.
    • Regulatory submissions (BLA, NDA) are planned for late 2001, with potential commercialization in 2002.
    • The development of OvaRex signifies progress in targeted cancer therapies.