Showing posts with label Laboratory for Investigative Dermatology. Show all posts
Showing posts with label Laboratory for Investigative Dermatology. Show all posts

May 13, 2013

$PVCT CEO Letter: Comprehensive PH-10 MOA and toxicity profile data to follow


While PH-10 has (and obviously should have) the same clinical value proposition as PV-10, near-fully or fully characterizing the compound from a dermatological perspective is incomplete to date. Historical overtures from potential partners to license the compound have been turned away by Provectus because valuations offered have not matched the value PH-10's safety, efficacy and low toxicity, which strongly influences use and frequency of use, engenders (and management's expectations). The MOA and toxicity profile data to which the letter points should, as the company writes, facilitate a New Drug Approval filing and and greatly further licensee discussions.

I heard [but cannot confirm] that Rockefeller University is the research facility (specifically Dr. James G. Krueger, MD, Ph.D. and his Laboratory for Investigative Dermatology) conducting the MOA and toxicity profiling work.

PH-10 licensing activity appeared to have taken a back seat to PV-10 activity for a while. As such, I was struck by management's comments regarding "... the best potential licensees, based on product fit, sales and distribution infrastructure, and other important criteria. Moving forward, we can now focus our efforts on this select group of companies." I plan to follow-up on this.

April 24, 2013

Just Put Some [of $PVCT's] PH-10 On It

From My Big Fat Greek Wedding. Toula Portokalos: [narrating] My dad believed in two things: That Greeks should educate non Greeks about being Greek and every ailment from psoriasis to poison ivy can be cured with Windex.

I am, of course, relentlessly bullish on rose bengal, and thus PV-10 and PH-10; in the case of PH-10 for inflammatory skin disorders, a topical agent with what appears to be a very high or, literally, no dosing limit.

Peter said "We are pursuing translational research with PH-10 comparable to that underway with PV-10 to clarify the regulatory and commercialization pathways of PH-10."

Translational research? As we saw with Moffitt's work (among others, including Provectus'), answers were provided to questions about PV-10, such as how does PV-10 do what it does, or what is PV-10's clinical relevance -- how and when do you use the drug. Very effective. Very safe. Regular, frequent use. Locoregional monotherapy. Systemtic benefit. Anti-tumor immunity. Tumor-specific immunity. Combination therapy for inaccessible tumors.

By doing this translational research work, Moffitt provides Provectus with a key piece of data, information and knowledge to convince the FDA of PV-10's benefit and explain the drug's clinical relevance to Big Pharma. Both drive value.

Derived from the same active ingredient, why would one think any differently of PH-10? Such translational work is being done at a world-renowned university in a laboratory whose head has a world-class reputation with the FDA. I connected the dots. This work may well be completed by now, or it may soon be completed.