Rose Bengal (PV-10) + Oncology + Pediatrics

Updated below: 12/8/16 and 12/15/16.

Provectus issued a press release and filed an associated 8-K today regarding a collaboration (currently, an "agreement to establish a framework for collaborative pre-clinical research projects") to explore the use of Rose Bengal/PV-10 in pediatric cancer, Announces Agreement with POETIC (Pediatric Oncology Experimental Therapeutics Investigators Consortium) to Study Potential of PV-10 for Pediatric Cancer.

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POETIC's website is here. POETIC co-founder Dr. Tanya Trippett, MD (Memorial Sloan Kettering Cancer Center) attended April healthcare conference at the Vatican, where Australia's Peter MacCallum Cancer Centre's Dr. Grant McArthur discussed PV-10.

See Infantile (July 26, 2016) on the blog's Archived News VI page:

"There also is a robust library of biomedical literature experimenting on/with, describing and discussing Rose Bengal's diagnostic applications in adults, and notably in children. See, for example October 15, 2015 blog post Still Standing, or Rose Bengal in children (hepatoblastoma, radiopharmaceutical) (May 6, 2016) on the blog's Archived News V page. In medicine, children are not small adults when it comes to safety, efficacy, dosing, etc. Most of the pediatric literature related to Rose Bengal refers to the API as liver function diagnostic 131I-Rose Bengal. From a safety and PK perspective, it is interesting, available for review, and dates back to at least the 1960s."

See also October 15, 2015 blog post Still Standing:

"Rose Bengal’s medical properties have been established in the clinic, adults and children[5], and the literature, as well as with the FDA. The compound was noted as a stain for visualizing corneal ulcers in 1919[6] and a marker for impaired liver function in 1923[7]. Currently there are more than 3,800 Rose Bengal references in the U.S. National Institutes of Health's National Library of Medicine’s PubMed Central database.[8] The compound has [non-therapeutic] FDA safety profiles as an intravenous hepatic diagnostic called Robengatope® and a topical ophthalmic diagnostic called Rosettes® or Minims®."

Updated (12/8/16).1: Additional Information & Takeaways

• I'm led to believe MSKCC (Memorial Sloan Kettering Cancer Center) [on the pediatric oncology side] began using reagent grade Rose Bengal (i.e., drug substance, or the active pharmaceutical ingredient [API] in PV-10; e.g., available from Sigma-Aldrich) -- presumably in in vitro models -- in the spring (following the above mentioned Vatican healthcare conference). Apparently, PV-10 (i.e., pharmaceutical grade drug product) was shipped to MSKCC and other POETIC partners (specifically, I would imagine to Alberta Children's Hospital, which will lead the pre-clinical development of another POETIC collaboration; see CorMedix below).

• I imagine one of Dr. Trippett and others' pediatric oncology focus areas may be sarcomas, which are tumors that occur in the bones and soft tissues.

• I also imagine POETIC and others' treatment approach to pediatric cancer patients may mirror the approach being taken with adult cancer patients in the current"age," "era" or time of immuno-oncology; that is, combination of PV-10 with checkpoint inhibition.

• See also CorMedix's collaboration with POETIC -- the parties' press release from September 2016, and Grammatical error (September 21, 2016) on the blog's Archived News VI page.

Updated (12/15/16).2: "Copyright infringement?" Yuck, yuck...

Click to enlarge. Tweet image source

Provectus' attendance link is here:

$PVCT CEO Letter: PV-10 selective, does not harm healthy tissue, safe, effective, multi-indication, monotherapy, sequenced/combination therapy

This probably is the most communicative portion of the annual CEO letter, describing PV-10's clinical value proposition (a critical component of my investment thesis, and really for any investment thesis involving Provectus):

• Selectively targets and destroys cancer cells without harming surrounding healthy tissue (efficacy),
• Continues to demonstrate its local and systemic benefits (efficacy),
• Excellent safety profile (safety), and
• Potential applicability in multiple cancer indications (platform drug).

Building awareness in the medical and medical researcher community, particularly among key opinion leaders (KOLs), as a means of advancing PV-10 as a new paradigm for cancer treatment, has been a key component of Provectus' business strategy, starting as far back as Australia's Professor John Thompson, MD and the first PV-10 clinical trial for metastatic melanoma. PV-10’s unique characteristics and safety profile are attracting the attention of clinicians at nationally recognized medical research institutions. For example, I heard a recent rumor [as yet unvalidated] a high profile Memorial Sloan-Kettering Cancer Center researcher (and, thus, presumably a KOL) commented that PV-10 will be the future of cancer treatment.

...safe and effective as a monotherapy,...as an adjunct...and in combination... In addition to being, again, safe and effective (efficacious) as a monotherapy, the letter highlights PV-10's orthogonal nature and, thus, significant potential in appropriately pairing it with traditional chemotherapeutic, immunomodulatory (in the same general class as immunomodulatory agents like ipilimumab, tremelimumab, PD-1, PDL-1, etc.) and metabolic (the same general class as inhibitors) agents. "Combination" does not just mean giving PV-10 and another drug at the same, such as PV-10 and ipilimumab/Yervoy, together, but also "sequencing" (i.e., give PV-10 first, then give drug no. 2). I heard from some in Europe (Paris) [but cannot confirm] that Moffitt Cancer Center's Jeffrey Weber spoke about PV-10, both monotherapeutically and combinatorially, in meetings.