November 25, 2011

Trailing 12 Months, Forward 12 Months

A lot of good things have happened in the last twelve months or so, since November 2010's Australian melanoma conference: clinical data, regulatory interaction, corporate partnering. Starting from this month's Tampa melanoma conference, the next twelve months should be even more fruitful: clinical data, regulatory interaction, corporate partnering, monetization.

I know that comparing data from clinical trials, to some, is like comparing apples and dolphins. To others, it is an exercise in navel gazing. Nevertheless, such comparisons are germane in so far as they are directionally correct.

Despite the approval/progress of ipilimumab and vemurafenib, the landscape for melanoma treatments remains more wide open than ever. It is clear that PV-10 has:

  • Demonstrated unprecedented response in the MM P2;
  • Demonstrated response correlations that exceed the state of the art, with an unparalleled complete response rate;
  • Demonstrated an unparalleled durable response rate that also exceeds the state of the art;
  • Exceeded the response rate, by stage comparison (from Stage III through M1a-c), of both OncoVEX and ipilimumab;
  • Is suitable for development in first or second line therapy;
  • Has impressive survival compared to previous studies. When compared to Korn et al's 2008 meta-analysis of 42 MM P2 studies (70 arms, and >2,100 patients), PV-10 one year survival rate is statistically greater than the mean (i.e. fall outside the 95% confidence interval), which no study in Korn's analysis did, save for OncoVEX;
  • Demonstrated impressive clinical data in multiple tumor types;
  • Destroys injected and non-injected tumors (treats local and metastatic disease);
  • Has the potential to develop a new standard of care in the treatment of solid tumors;
  • Possesses an excellent tolerability profile, and,
  • Can be simply administered in an out-patient setting.
BioVex's OPTiM Trial in Stage IIIb/c and IV Advanced Melanoma presentation is a must read, particularly when you carefully compare the material within to Provectus' metastatic melanoma Phase 2 trial data. Recall that Amgen acquired BioVex for up to a $1 billion earlier this year. Ask OncoVex PIs about their view on PV-10.

When the full MM Phase 2 trial dataset is revealed -- remember that the company continued to collect certain data to expand the previously released dataset -- you'll understand why the valuation floor for this indication is well above that paid by Amgen for BioVex.

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