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Product Pipeline

  Pre-Clinical Clinical*  
 

Lead Optimization

IND Enabling

IND Filing

Phase 1

Phase 2

Phase 3

Market
PV-10
Melanoma
  • Prep for Breakthrough Therapy Designation request 2013 into 2014
  • Finalized Phase 2 data Oct 2012 and Sep 2013
  • End-of-Phase 2 FDA meeting Oct 2011
  • 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
PH-10
Psoriasis
  • Toxicity study R&D for advanced studies 2012, 2013 and into 2014
  • Phase 2C randomized study final data collection Feb 2012
  • Phase 2C randomized study completed Aug 2011
  • Phase 2C randomized study initiated Dec 2010
  • Phase 2 study completed Apr 2010
  • Phase 2 recruitment completed Oct 2009
  • Replacement Phase 2 initiated Jul 2009 due to dose regimen change
  • Phase 2 study initiated Nov 2007
PH-10
Atopic Dermatitis
  • Toxicity study R&D for advanced studies 2012, 2013 and into 2014
  • Phase 2 study completed Sep 2009
  • Phase 2 recruitment completed Jun 2009
  • Phase 2 study initiated Jun 2008
PV-10
Breast Cancer
  • Assessing further development 2013 and 2014 in conjunction with Moffitt Cancer Center research
  • Phase 1 study completed Jul 2008
  • Phase 1 initial cohort treatment completed April 2006
  • Phase 1 study initiated October 2005
PV-10
Liver Metastasis
  • Phase 1 protocol expansion Sep 2012-2013 into 2014
  • Orphan drug status Apr 2011
  • Phase 1 patient accrual and treatment completed Jan 2011
  • Phase 1 study initiated Oct 2009
PV-10
Mechanism of Action
  • Moffitt Cancer Center initiates Phase 1 feasibility study to detect immune cell infiltration into melanomas treated by PV-10 Jan 2013 into 2014

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

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