Product Pipeline

Indication

Pre-Clinical

Phase 1

Phase 2

Phase 3

Status

PV-10

  • Protocol for Phase 3 study for treatment of locally advanced cutaneous melanoma submitted to FDA.
  • Phase 1b/2 combination study of PV-10 + immune checkpoint blockade is being designed.
  • Request for Breakthrough Therapy Designation submitted to FDA Mar 2014
  • Type C FDA meeting Dec 2013
  • Full Phase 2 study report submitted to FDA Aug 2013
  • Finalized Phase 2 data Oct 2012 and Sep 2013
  • Third End-of-Phase 2 FDA meeting Oct 2011
  • Second End-of-Phase 2 FDA meeting Mar 2011
  • Phase 2 study completed May 2010
  • End-of-Phase 2 FDA meeting Apr 2010
  • Phase 2 treatments completed Sep 2009
  • Phase 2 recruitment completed May 2009
  • Phase 2 study initiated Sep 2007
  • Orphan drug status Jan 2007

PV-10

  • Phase 1 study at H. Lee Moffitt Cancer Center and Research Institute to detect immune cell infiltration into melanomas treated with PV-10 initiated Jan 2013 into 2014

PV-10

  • Phase 1b/2 study being planned
  • Phase 1 protocol expansion Sep 2012 into 2014
  • Orphan drug status Apr 2011
  • Phase 1 patient accrual and treatment completed Jan 2011
  • Phase 1 study initiated Oct 2009

PV-10

  • Phase 1 study completed Jul 2008
  • Phase 1 initial cohort treatment completed April 2006
  • Phase 1 study initiated October 2005

PH-10

  • Full Phase 2c study report submitted to FDA Feb 2014
  • Toxicity study R&D for advanced studies 2012 to 2014
  • Phase 2c final data collection Feb 2012
  • Phase 2c randomized study initiated Dec 2010
  • Phase 2b study completed Apr 2010
  • Phase 2b recruitment completed Oct 2009
  • Replacement Phase 2b initiated Jul 2009 due to dose regimen change
  • Phase 2 study initiated Nov 2007

PH-10

  • Toxicity study R&D for advanced studies 2012 to 2014
  • Full Phase 2 study report submitted to FDA May 2010
  • Phase 2 recruitment completed Jun 2009
  • Phase 2 study initiated Jun 2008

* In addition to clinical trials, patients enrolled in the Compassionate Use Program for PV-10 are also receiving PV-10 treatments.