$PVCT's PV-10 Data to Be Presented at European Cancer Congress 2013 (update)

A blog reader informed me, after reading my post entitled "$PVCT's PV-10 Data on Locoregional Disease Control in Metastatic Melanoma to Be Presented at European Cancer Congress 2013," that Provectus PI Dr. Sanjiv Agarwala is presenting at the conference with a presentation entitled "Current perspectives on intralesional therapies." It's quite possible he also mentions PV-10 in a session sponsored by OncoSec, where he is on its melanoma advisory board.

Thank you.

$PVCT's PV-10 Data on Locoregional Disease Control in Metastatic Melanoma to Be Presented at European Cancer Congress 2013

Monday, the company issued a PR about its poster presentation at ECCO 2013 calendared for the end of September. These data are key and this presentation is important for several reasons.

The poster should draw the distinction and note the subsequent dramatic difference in outcome between (i) patients in Provectus' MM Phase 2 trial whose total tumor burden was treated and (ii) patients whose burden was partially or not completely treated.

The ability to treat as much of a patient's tumor burden is key to PV-10's success.

Recall the company's poster presentation at AACR. "Advanced melanoma patients, particularly those with stage IV disease, have substantial tumor burden in areas that are often non-accessible... immuno-chemoablation with PV-10 is highly effective when all tumors are accessible for injection, providing rapid reduction of tumor burden and tumor-specific immunity."

This is particularly relevant for Stage III melanoma patients, where there is no evidence of distant metastasis and tumor burden should be highly accessible.

Query what data are shown to make Provectus' case that efficacy outcome is much better when all tumors are treated: objective response rate (elucidation of both complete and partial responses), target lesion response rate, progression free survival ("PFS"), etc.

The poster also should draw attention to the presence and work of a local-regional immunological response, in contrast and addition to the presence and benefit of a systemic one.

This presentation should reinforce the case to the FDA for the beneficial impact of PV-10 on Stage III patients (the target population of the BTD application), for which there is no agreed upon or approved standard of care but rather several available options (see NCCN Clinical Practice Guidelines). I would expect this data already has been transmitted to the FDA as part of Provectus' pursuit of and application for BTD.

I will be interested to see if conference data are provided about durability of response and PFS updates.

Provectus is a sponsor of and will have an exhibitor booth at the 8th World Congress of Melanoma in Hamburg, Germany from July 17-20.

The company's ad is on page 46 of the program.

Provectus PI Dr. John Thompson is speaking about limb perfusion & PV-10 during the Loco regional melanoma treatment session co-chaired by Moffitt's Dr. Vernon Sondak on Friday, July 19.

@MelanomaReAlli CEO Wendy Selig Attended $PVCT's Presentation at BIO CEO 2013

Melanoma Research Alliance ("MRA") CEO Wendy K.D. Selig attended Peter's February presentation at BIO CEO 2013. Provectus was one of several sponsors of MRA's Fifth Annual Scientific Retreat in Washington, DC in February. I imagine the company participated in some fashion at the retreat.

$PVCT: Current Status of Injectable Therapy

Dr. Robert H.I. Andtbacka, Assistant Professor of Surgical Oncology, Huntsman Cancer Institute at the University of Utah in Salt Lake City: "Current Status of Injectable Therapy" at the HemOnc Today - Melanoma and Cutaneous Malignancies Conference on March 22, 2013.

$PVCT @ 14th Annual B. RILEY Investor Conference

It looks like Provectus is participating in this event.

$PVCT: MRA Convenes Top Melanoma Researchers at Fifth Annual Scientific Retreat

Agenda
Sponsorship

$PVCT: HemOnc Today #Melanoma and Cutaneous Malignancies Conference

Several PIs are participating, but it is unclear to me at the current time if the company will participate in some way. I imagine Dr. Andtbacka's Current Status of Injectable Therapy presentation may mention or reference PV-10.

The agenda is here.

$PVCT: Proposed MOA & Tumor Immunity (#BIOCEO13 Presentation?)

The company's website presentation was updated to include the two slides below. I wonder if Peter will be using this version today?

PVCT: Change -- Pete is presenting at #BIOCEO13 on February 11 @ 1100 ET

Conference details may be found here. Craig is under the weather, and cannot travel to BioCEO in New York.

$PVCT: A reminder Craig is presenting at #BIOCEO13 on Monday @ 1100 ET

Conference details may be found here.

$PVCT: Noble Financial Capital Markets Ninth Annual Equity Conference (update)

A webcast of Craig's presentation is here.

$PVCT: Noble Financial Capital Markets Ninth Annual Equity Conference (update)

Provectus released Craig's conference slides today. See here.

This slide (below) highlights what to potentially or possibly look out for this month and quarter. It also appears to confirm the rumor another Big Pharma company approached the company with interest in a global license for PV-10.

This slide (below) highlights several very under-appreciated aspects of the new rose bengal synthesis patent application and process.

$PVCT: Noble Financial Capital Markets Ninth Annual Equity Conference

Management will be presenting at the above conference on January 22.

$PVCT: The 15th Annual BIO CEO & Investor Conference

Conference details may be found here.

$PVCT: If Not China, Then What?

In a prior post, I illustrated the then current snapshot of the horserace.

There may be a second geographic region in play (Australia?, India?*). My take on a comparison of license or deal headline numbers is below:

If the company wanted to hold onto oncology longer, a cost breakdown of the contemplated pivotal, key and other trials appears to be:

A China deal (or whatever possible combination of outlying geographic deals) that net a $25-50MM upfront payment goes a long way to providing the necessary funding for Provectus to make even more clinical trial progress.

Could dermatology nose out oncology at the finish line? Sure.

Recall the path Provectus traveled with PV-10 and oncology: clinical trials and regulatory discussions, followed by immunologic mechanism of action characterization work by a world-class institution. The early spadework to demonstrate efficacy, safety and multi-indication viability was followed and enhanced by Moffitt's past and future murine model results (not including, yet, human immunologic work). And while shareholders wished for Big/International Pharma to snap to attention (i.e., license PV-10) because of outstanding early-phase trial results, it now appears the immunology work already presented by Moffitt at SSO and Craig at SITC, followed by forthcoming work to be presented by Moffitt, is accelerating license interest and discussions of both regional and global natures.

Could PH-10 be following a similar path?

The "hang-up" with PV-10 appeared to have been with Big Pharma folks being unable to wrap their heads around how well PV-10 worked. They needed help to understand something they had never seen before. They appear to understand now, or at least are getting closer. As such, license interest and discussions are heating up.

It is not unreasonable to analogize PV-10's path to PH-10's, and thus potentially explain the delay in getting to a dermatology license or sale transaction. Perhaps immunologic mechanism of action characterization work is being done on PH-10 by a world-class institution to complete the understanding of prospective dermatology licensees before they fully commit to jumping into the pool. I think this immunology mechanism of action work is being at The Rockefeller University (the Laboratory for Investigative Dermatology?).

Once this PH-10 immunologic mechanism of action characterization work is completed and provided to prospective partners (I do not know when the work was started and when it and the subsequent analysis was or will be completed), and assuming this knowledge concludes their thinking, dermatology might well beat oncology to the finish line.

In this horse race, however, the more horses that cross the finish line -- Provectus licenses deals -- the better.

* I suspect PV-10's extremely low cost structure, and thus tremendous pricing flexibility, helps facilitate country discussions without fear or risk of patent loss (or too much of it).

$PVCT.OB: PV-10 -- A Vaccine, or Vaccine-like

Click on the figure to enlarge it.

The abstract and poster from Craig et al.'s participation at the Society for Immunotherapy of Cancer (SITC) 27th Annual Meeting has begun the elaboration of the anti-tumor immune response to PV-10 immuno-chemoablation. This publicly builds upon Moffitt's description of PV-10's immunologic mechanism of action, presented at the 2012 Society of Surgical Oncology Annual Meeting, that confirmed PV-10 chemoablation of melanoma lesions leads to a systemic response and the induction of systemic anti-tumor immunity.

In the SITC abstract (above) Craig et al. hypothesized production of a vaccine- like immune response using a small molecule drug was possible and required:

• An intralesional route of injection that generates rapid, durable tumor destruction via autolysis;
• Rapid clearance of drug from normal tissue; and
• Anti-tumor effects targeted only to tumor tissue.

According to Provectus, PV-10 appeared to meet each of these requirements.

"Treating cancer has historically relied on a trifecta of treatments—surgery, chemotherapy, and radiation—known colloquially as “slash, poison, and burn.” Vaccines have a potential advantage over these three options in that the body’s response is longer lasting (on a scale of years as opposed to weeks or months), which could possibly eradicate the micro-metastases that often linger after standard treatments end. Moreover, cancer vaccines have similar minor side effects to traditional vaccines: inflammation at the injection site and flu-like symptoms." Read more here.

"Cancer vaccines are designed to boost the body’s natural ability to protect itself, through the immune system, from dangers posed by damaged or abnormal cells such as cancer cells. The FDA has approved two types of vaccines to prevent cancer (Gardasil® and Cervarix®): vaccines against the hepatitis B virus, which can cause liver cancer, and vaccines against human papillomavirus types 16 and 18, which are responsible for about 70 percent of cervical cancer cases. The FDA has approved one cancer treatment vaccine for certain men with metastatic prostate cancer (Provenge®)." Read more here.

Click on the figure to enlarge it.

The great anticipation of Moffitt's next presentation(s), purportedly at the AACR Annual Meeting 2013 that will be held April 6-10 in Washington, DC (according to sources external to Provectus), derives from the release of more results and conclusory statements regarding the production of a vaccine-like immune response from PV-10 immuno-chemoablation, and both the preventative and therapeutic vaccine or vaccine-like benefit of the drug.

$PVCT.OB: NYSSA Life Sciences Conference

Craig is speaking at the New York Society of Security Analysts' Life Sciences Conference on Thursday, November 29 at 11:45 am EST.

$PVCT.OB: Provectus Presents Nonclinical Data on Antitumor Immune Response to PV-10 Immuno-Chemoablation

Provectus issued a PR today about Craig et al.'s poster presentation at SITC 27th Annual Meeting. I have a lot of blogging to do on this topic this week. The time to progression graphs caught my eye at the outset.

Combining Chemotherapy Drugs and Immunotherapy Cancer Vaccines Results in an Enhanced Anti-Tumor Effect: Study

"Researchers at Moffitt Cancer Center and colleagues at the University of South Florida and Tianjin Medical University Cancer Institute and Hospital in China have discovered that combining chemotherapy drugs and immunotherapy cancer vaccines results in an enhanced anti-tumor effect." Article here. Abstract here.

This is a corollary to Moffitt's work with PV-10. In connecting several dots outside the company, I will speculate Moffitt could very likely seek an oral presentation of its ground-breaking PV-10-related immunology work at the annual meeting of the American Association of Cancer Research in April 2013.

$PVCT.OB: MD Becker Webcast Today

Due to weather-related travel problems, it does not appear Craig will present at the MD Becker conference in NYC later this morning.