@MoffittNews' PR of its work (study) on $PVCT's PV-10 trending of Twitter

Click to enlarge figure.

Moffitt Cancer Center's PR from yesterday -- Single Injection May Revolutionize Melanoma Treatment, Moffitt Study Shows -- is trending on Twitter. A screen shot of a recent portion of it is on the left (click the picture to enlarge it). You also can observe it yourself by searching for "Moffitt" and "cancer" and looking at "All" Tweets (this link should do this for you, but it may not).

Several news and web sites have picked up Moffitt's PR thus far; however, I'm more interested in how the PR and story, brief as it currently is (since the only available information for most folks is from the PR), is circulating within and across social media.

At the moment, while the story is trending, it has not yet reached so-called biotech Twitter pros, such as those mentioned in Xconomy's Luke Timmerman's article Who Should Biotech Pros Follow on Twitter? An Update for 2013, and other more recognized names.

As a reminder, the blog is on Twitter here: @PVCTinvestor. Please follow!


Moffitt's PR, in my view, was very compelling, if not astounding. Among other things:

• The use of a single treatment (i.e., injection) of PV-10, which is not [I think] to say one injection, but rather one treatment cycle, which may or should comprise multiple injections and several vials of PV-10 (i.e., a treatment cycle) [Updated: I erred. Moffitt meant a single injection. Multiple injections are required when the initial one is applied incorrectly, or when the target tumor requires more PV-10 because of tumor volume and thus additional injections of drug],
• "Revolutionize:" 1. change (something) radically or fundamentally, "this fabulous new theory will revolutionize the whole of science," synonyms: transform, alter dramatically, shake up, turn upside down, restructure, reorganize, transmute, metamorphose, and
• The mention of boosting the immune response in the blood stream, which I believe is a focus area of Moffitt (but more on that item in a subsequent post).

It will take time for the PR to circulate on social media and elsewhere, and requires follow-up from Moffitt to further broaden and deepen the story, message and narrative. There is no mention of Provectus, as there should not be from an institution focused on translational research.

This story only has begun. There is much more Moffitt has done by way of pre-clinical and clinical studies (e.g., on PV-10, on combinations of PV-10 with other agents, on other indications, etc.). While some of these results no doubt have been provided to the FDA, Moffitt will, in its self-interest, present and promote their findings and the implications and ramifications of such, over time.

As a result, I do not think there will be any immediate impact on share price. The market primarily is focused on regulatory clarity.

But, one could well think PV-10's, and thus Provectus', legitimacy has been established. The FDA, then, follows. From there the share price naturally will react.

$PVCT: Immunology Data on PV-10 to Be Presented at the #AACR Annual Meeting

In today's PR, Craig said: "The researchers at Moffitt are providing valuable insights into how PV-10 harnesses the immune system in specific response to the injected tumor. Although the study being presented was done in murine models of melanoma and breast cancer, the currently open clinical trial at Moffitt is designed to investigate this mechanism in melanoma patients. We are pleased to enhance our understanding of intralesional PV-10 and its potential to produce a systemic benefit in cancer patients."

$PVCT: Moffitt Cancer Center's Mission & Vision

Translation into cure...

$PVCT -- @MoffittNews #AACR2013: Intralesional injection with PV-10 induces a systemic anti-tumor immune response in murine models of #breast #cancer and #melanoma

Presentation Title: Intralesional injection with PV-10 induces a systemic anti-tumor immune response in murine models of breast cancer and melanoma

Abstract Body: PV-10 is a 10% solution of Rose Bengal that is currently being examined as a novel cancer therapeutic. In melanoma patients, intralesional injection (IL) of PV-10 has led to regression of injected lesions as well as distant metastases. In this study, we examined the efficacy and potential immune mechanism of PV-10 treatment in murine models of breast cancer and melanoma. In BALB/c mice bearing MT-901 breast cancer, injection of PV-10 led to regression of injected and untreated contralateral subcutaneous lesions (p<0.05 compared to IL-PBS-treated mice). A significant increase in survival was observed in mice treated with PV-10. To examine immune response, MT901-specific IFN-gamma production and cytotoxicity were measured in splenocytes collected from mice treated with IL-PBS or IL-PV-10. MT901-bearing mice treated with IL-PV-10 demonstrated enhanced IFN-gamma production (992 ± 453 pg/ml) compared to splenocytes from PBS-treated mice (174 ± 105, p<0.05). In addition, a significant increase in lysis of MT-901 cells by T cells after PV-10 treatment was observed (p<0.01 compared to PBS-treated mice). No lysis of irrelevant CT-26 cells was detected. In a murine model of melanoma, B16-F10 cells were injected into C57BL/6 mice to establish one subcutaneous tumor and multiple lung lesions. Treatment of the subcutaneous lesion with a single injection of IL-PV-10 led to regression of the injected lesion as well as distant B16 melanoma lung metastases. In B16-bearing mice, treatment with IL-PV-10 led to the induction of T cells that produced IFN-gamma in response to B16 tumors but not irrelevant tumor (p<0.05) and demonstrated specific lysis of B16 (p<0.01 compared to T cells isolated from PBS-treated mice). In total, these studies support the induction of tumor-specific T cell-mediated immunity after single treatment with IL-PV-10 in multiple histologic subtypes. The immune mechanism of PV-10 ablation in cutaneous melanoma patients is currently under investigation at our institution.

$PVCT -- @MoffittNews #AACR2013: Intralesional injection with PV-10 induces a systemic anti-tumor immune response in murine models of #breast #cancer and #melanoma

A Moffitt poster presentation at AACR in April: Intralesional injection with PV-10 induces a systemic anti-tumor immune response in murine models of breast cancer and melanoma

Author Block: Shari A. Pilon-Thomas, Amy Weber, Krithika Kodumudi, Lisa Kuhn, Paul Toomey, Amod Sarnaik. Lee Moffitt Cancer Ctr. & Res. Inst., Tampa, FL; University of South Florida, Tampa, FL

@MoffittNews' Dr. Jeffrey S. Weber, MD, PhD -- $PVCT KOL

Moffitt's Dr. Amod Sarnaik, MD said, in Provectus' January 8, 2013 PR, "We look forward to verifying the promising pre-clinical data from our ongoing work in this translational study. These results should help elucidate the immunologic basis of the 'bystander effect' noted in previous clinical studies of PV-10 and help optimize PV-10 treatment, particularly in combination with other therapies."

On the bio page of Dr. Jeffrey Weber, MD, PhD, the director of the Donald A. Adam Comprehensive Melanoma Research Center at Moffitt Cancer Center, you will read "As a tumor immunologist & immunotherapist, I focus on translational clinical trials including development of novel trials in melanoma based on my lab work."

What does a translational study in cancer research mean? A translational study turns knowledge from the laboratory into a treatment for patients.

Such is the gravity of what Moffitt should say.

According to the October 2002 paper from the immediately prior link, "[T]he concept of translational research addresses what would be an efficient and orderly way of applying the advanced understanding and technology of the field of biology to cancer treatment. The essence of translational research lies in coming to understand the biological features of a cancer so as to translate molecular biological evidence into clinical anticancer strategies. In other words, "translational research" can simply be defined as the process of determining a treatment solely on the basis of molecular biological characteristics."

The paper goes on to say: "There has been much debate over many years as to the best approach to stimulate immunity against tumors. Previously, researchers involved in immunotherapy ground up tumors and simply gave them back to the patients they were removed from or to other patients. This is not really translational research. At present, there is an understanding that the tumor antigens can be isolated and grouped as to which are more or less likely to provoke an immune response by collaborating with HLA antigens. Knowledgeof this resulted from an understanding of the biology of how antigens are processed. We can now define which peptides in which the antigens have a likelihood of inducing a response when they are presented either as cells or with dendritic cells or in other ways. It can be said that to merely give tumor vaccines without consideration of immune response is not translational. But it is translational to have a selection of antigens based on our understanding of how the immune system operates and which antigens are likely to be or actually are expressed in a tumor, because we are incorporating the biology into the clinical trial design."

Dr. Weber was instrumental in the approval of Vemurafenib (now Zelboraf), saying in April 2012 the success of Vemurafenib represented "the single most dramatic improvement in the treatment of melanoma in 20 years."

According to more of his Moffitt biographic information, Dr. Weber is charged with "...bringing together basic scientists, clinical and translational investigators and prevention/epidemiology scientists in an integrated overall melanoma research effort that rapidly brings new drugs and ideas to the clinic."

"He works extensively with [Dr.] Vernon Sondak...[and] has an extensive history of conducting translational and investigator-initiated clinical trials."

"Dr. Weber’s research interests lie in the monitoring and characterization of T cell responses to vaccination in cancer patients, and in the establishment of in vitro models to facilitate the understanding of how immune modulating antibodies amplify T cell responses in patients. He is also interested in the mechanisms by which achieving autoimmunity induces regression of cancer."

Such is the gravitas of Moffitt's Dr. Weber.

$PVCT: Waiting for MoffittCancerCenter (@MoffittNews)

I previously wrote that: I asked Pete for his perspective on it in the context of management's work with the FDA. Regulatory approval is a complex topic, especially as it relates to local agent PV-10 versus systemic ones. PV-10 as a local agent is a reality that has driven management's MM Phase 3 trial design more than anything else. The key to the FDA, according to Peter, is proving "clinical relevance." This certainly means meeting endpoints, but it also means whether a drug should be approved or not. PV-10 needs to be clinically relevant to be approved. Provectus' Phase 3 trial design discussed with the FDA would support PV-10 as being "clinically relevant."

With two days left, the blog's poll -- What company achievement will have the greatest impact on share price in Q1? -- has 13% of participants voting for Moffitt's data. I previously wrote that I don't think Moffitt's full effect will be felt this quarter. That does not mean I think Moffitt is not important. It appears Moffitt is crucial to Provectus, PV-10 and Rose Bengals' story.

Management will not say where, when and what Moffitt will say about the cancer center's follow-up mouse work to SSO (recall here and here), and whether some of Moffitt's human trial work results will be available concurrently with the mouse work.

So, we wait...

Peter says "Everyone, and I mean everyone, wants to better understand the systemic benefit of PV-10." With that, I assume "everyone" includes the FDA. Management's silence on Moffitt's results as well as the timing and venues of their presentation and publication suggest to me the FDA, Big Pharma and serious life sciences investors also have not seen Moffitt's full data-set.

In Provectus' CEO Letter last April, management discussed how Moffitt's work was "...fundamental for full characterization of PV-10's systemic benefit and may provide pivotal support for accelerated approval in the U.S." Accelerated approval is a real possibility, given the basis for seeking such is the import of Moffitt's work.

Moffitt weighing in on PV-10's clinical relevance and the timing of these comments should give us great insight into whether and when the management might state it is appropriate to seek accelerated approval based on discussions with the FDA.