Quick Hits for March 26

Impressive poster results. Although I'd like to use "incredible," I'll stick with "impressive" as the lead-in to this quick hit. With the poster out, takeaways include:

• Severe. I don't think we fully appreciate the severity or harshness of Moffitt's lung metastases model, which makes the result of 0, 1 and 3 tumors in 3 of 5 mice treated with PV-10 versus >250 tumors in each of the control mice indeed incredible.

• Repeated. Independently reproduced results of what already has been demonstrated by the company is important as well: systemic response, t-cell involvement, remote effect, tumor-specific immune response, interferon response, etc.

PV-10 has a specific immune response. "...[A]n immune-mediated anti-tumor response to PV-10 treatment was observed, including induction of tumor-specific interferon-gamma production by splenocytes derived after PV-10 treatment compared to control." (company comments, March 26 PR)

...[I]ntratumoral PV-10 causes both a direct anti-tumoral response of the injected tumor and a systemic tumor-specific activation of the immune system. (Toomey, March 26 PR) This is third party validation and, more importantly, I think essentially reproduces management's work in the area. Repetition is good.

May 16, 2012 now becomes an important date. I think more information on Moffitt's continuing immunology-related work on PV-10 and those results should be revealed and displayed at ASCO 2012, as speculated by Maxim's equity research analyst. The SSO abstract was submitted in the October-November time frame. The ASCO abstract submission deadline was in February.

SSO takeaways are, in some ways, comparable to the takeaways from the ASCO 2010 presentation on visceral metastases. The PIs at ASCO highlighted the correlation between visceral response with response of injected lesions similar to that observed with cutaneous bystander lesions. Using preliminary efficacy data from the first MM Phase 2 cohort of 40 patients, bystander lesion OR for subjects with a positive OR of target lesions was 62%, while the bystander lesion OR for subjects with a negative OR of target lesions was 12% (a statistically significant result).

More answers now create more questions. They include:

• Success with other types of cancers. What else has Moffitt achieved and accomplished? The SSO-presented work or study focused on melanoma and lung metastases. Has Moffitt conducted work on other types of cancers?

• Ongoing accelerated approval dialogue with DOP2. Based on statistically and clinically superior PFS results in the MM Phase 1 and 2 trials and, now, buttressed by Moffitt's statistically- and clinically-demonstrated immunology outcome (that builds upon, validates and reproduces the company's prior immunology-related work), is accelerated approval at some reasonable point in the near-future more likely?

• Human studies to come. When will the human MOA study commence?

• How now Pfizer? I think I am not the only one impressed by Moffitt's publicly announced results to date and inferences of their likely future outcomes.

It's clear there are more layers of the onion to peel. As they say, more to come from Moffitt.