May 2, 2012

HemOnc Today - Melanoma and Cutaneous Malignancies Conference (update)

Dr. Robert Andtbacka's presentation at HemOnc Today, entitled Intralesional Therapy for Systemic Disease: Where Will It Fit In?, provided an opportunity to distinguish PV-10 from its intralesional therapy competitors. Dr. Andtbacka, who has no affiliation or association with Provectus, appeared to provide an independent assessment of intralesional therapies and their role in treatment Stage IV melanoma patients.

The key comparison table is this one, which I previously had summarized here:

Dr. Andtbacka, later in his presentation, communicated there was no preferred choice of intralesional therapy at this time:

Many at the conference as well as others in the medical community, to whom I have spoken, recognize the recent resurgence in intralesional therapy has created real potential (potential now, tools later) for doctors to help treat their melanoma patients more successfully and sustainably.

Dr. Sanjiv Agarwala authored a recently published article, entitled PV-10, aka Rose Bengal: Intralesional Therapy For Metastatic Melanoma, in The Melanoma Letter (Spring 2012 Vol. 30, No. 1). His article discussions intralesional therapies like BCG, OncoVEX, Allovectin and PV-10.

A consensus appears to be developing about the opportunity to use intralesional therapy for systemic disease. Of course, more information is desired and required about these treatment options.

Provectus hopes to commence its pivotal MM Phase 3 trial in the second-half of 2012. Designed for a 30-month duration to complete collection of OS information, it's expected the comparator arm will collapse in a couple of months and those patients transferred to the PV-10 arm for more successful treatment.

Amgen changed their guidance, during their Q1 2012 earnings call, regarding disseminating OncoVEX's interim pivotal MM Phase 3 trial results and analysis from late-2012 to some time in 2013 after the trial was completed. Amgen terminated OncoVEX's other Phase 3 trial for patients with head and neck cancers. In addition to the speculation of poor trial results, industry people also have questioned the comparator in the OncoVEX trial. The primary end point for trial is durable complete response, but Amgen increased enrollment in hopes of observing an overall survival signal.

Vical faces similarly bleak speculation about the outcome of Allovectin's pivotal MM Phase 3 trial because of its choice of durable response rate (tumor response at 24 weeks) for the trial's primary endpoint. You can read an example of a negative viewpoint on Vical and Allovectin here.

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