$PVCT White Paper: Evidence for Systemic Effects Moves PV-10 Toward Further Clinical Trials

The company, via Provectus News, circulated a white paper written by freelance medical writer Walter Alexander.

You can read the paper here, and I encourage you to do so if you already have not read it.

The paper and quotes reflect, in part, discussion about Moffitt and Provectus' work at AACR during a dinner attended by Alexander, Moffitt's Dr. Shari Pilon-Thomas, PhD, Melanoma Research Alliance's Wendy Selig, LiveSTRONG's Doug Ulman and Peter.

The white paper speaks to the overriding focus of oncology (e.g., FDA, Big Pharma, KOLs, clinicians, researchers, etc.), which is harnessing the immune system to treat and cure cancer, and the uniqueness of how PV-10 works in that regard.

I think the paper makes several tremendous points, and I will blog my thoughts in due course.

@dealbook: With Wall Street Support, @MelanomaReAlli Grows Up

A reader of the blog forwarded this article to me from Dealbook. Thank you.

"It was a “real wake-up call,” recalled the billionaire financier Leon D. Black, when his wife, Debra, received a diagnosis of melanoma in 2007. After the skin cancer was successfully treated, the experience led the Blacks to form the Melanoma Research Alliance, a group that has attracted the support of several prominent Wall Street figures. Later this month, the organization is holding its second-annual benefit geared toward the leveraged finance industry."

Read the full article here.



Individuals, like Debra Black and her husband Leon Black (and Doug Ulman), and organizations, like the Melanoma Research Alliance and its President and CEO Wendy Selig (and Livestrong), advocate for cancer patients and ultimately can play roles in the advancement of a drug candidate.

@MelanomaReAlli: Mobilizing the Immune System vs Cancer at Milken Institute Global Conference 2013

$PVCT: Merck Anti-PD-1 Agent MK-3475 (lambrolizumab) and Breakthrough Therapy Designation

Last week, Merck announced the FDA had designated lambrolizumab (MK-3475) as a Breakthrough Therapy for the treatment of patients with advanced melanoma.

On MK-3475 & BTD: "Wendy Selig, president and chief executive of the Melanoma Research Alliance, an advocacy organization based in Washington, DC, welcomes the new designation for lambrolizumab. “We view it as a really important step in the process of creating this ‘all hands on deck’ mentality, where you have a serious unmet medical need and where there are big gaps in terms of what’s available,” she says."

In November 2012, Merck presented early-stage interim data for MK-3475 of a single-arm, open-label Phase IB study. "Patients were administered MK-3475 in one of three regimens: low dose every 3 weeks, high dose every 3 weeks and high dose every 2 weeks. Following an initial disease evaluation, patients received one of the three regimens of MK-3475. After 12 weeks, disease status was evaluated by the investigator and compared to baseline using immune-related response criteria (irRC). Those patients demonstrating stable disease or response at the 12-week evaluation time point continued to receive MK-3475 and follow-up monitoring."

"Data has so far been obtained for 85 of the 132 patients enrolled in the study. Of those patients, a total of 43 patients (51 percent) showed an objective anti-tumor response, and of those, 8 patients (9 percent) showed a complete response at or after the 12-week assessment. Notably, of the 27 patients who had previously been treated with ipilimumab monotherapy, the current standard of care for late-stage melanoma, 11 patients (41 percent) showed an objective anti-tumor response to MK-3475 monotherapy; none of those patients showed a complete response."

PV-10's final MM Phase 2 data from ESMO 2012:

• An Objective Response Rate (OR) of 51% in subjects' target lesions (25% Complete Response and 26% Partial Response),
• 69% disease control in these lesions (combined Complete, Partial and Stable Response subjects);
• 33% of subjects having an untreated bystander melanoma lesion achieved an OR in their bystander lesions while 50% achieved disease control in these lesions,
• Response of bystander lesions was highly correlated with outcome in treated target lesions, with a bystander lesion OR of 61% in subjects achieving complete or partial response in their target lesions versus 18% bystander lesion OR in subjects that did not achieve this level or response in their target lesions, and 
• Stage III subjects experienced a substantially higher target lesion response rate (60% OR and 79% disease control) versus Stage IV subjects (22% and 33%, respectively).

Wendy Selig attended $PVCT's Pete's #BIOCEO13 presentation

Wendy Selig, President and CEO of the Melanoma Research Alliance attended Peter's presentation at BIOCEO13 last week.