KNOXVILLE, TN, Nov. 14, 2018 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today provided an update on the Company’s
small molecule clinical development program for its investigational immuno-dermatology drug PH-10 for the treatments of psoriasis
and atopic dermatitis. Pathways significantly improved by PH-10 use include published psoriasis transcriptomes and cellular
responses mediated by IL-17, IL-22, and interferons.
Provectus has begun work in support of extended 12-week administration (proof-of-concept or POC) for topically
applied, non-steroidal PH-10:
- The Company has finished two toxicology-focused, non-clinical, single administration studies using carbon-14-
(14C-) labeled rose bengal disodium (RB) to demonstrate lack of systemic uptake. RB is PH-10’s active pharmaceutical
ingredient. Radio-labeled RB, however, is easier to detect in plasma and tissues at very low levels than RB itself. These data
suggest there is minimal potential of visceral target organ effects from topical application of PH-10.
- The goal of a planned, non-clinical, toxicology-focused, 12-week administration study would be to demonstrate local effects
in the skin from the extended use of PH-10 and identify any potential systemic toxicities.
- When completed, the 12-week POC program may allow for direct comparison of PH-10 to approved topical treatments for psoriasis
and atopic dermatitis.
PH-10’s mechanism of action (MOA), as well as its implications for immunology, are beginning to be understood.
James Krueger, MD, PhD and members of the Laboratory for Investigative Dermatology at The Rockefeller University have elucidated
PH-10’s MOA for psoriasis in a previous clinical study (NCT02322086).
A clinical study of PH-10’s MOA for atopic dermatitis is planned for 2019, and would be undertaken by a
different dermatology and immunology investigator.
Dominic Rodrigues, Vice Chair of the Company's Board of Directors, said, “PH-10 is a clinical-stage,
multi-indication viable, and immuno-dermatology-capable pharmaceutical asset. It has a novel mechanism of action; exhibits
attractive preliminary safety and efficacy properties; has compelling product, manufacturing, and pricing characteristics; and is
based on a family of small molecules entirely and wholly owned by Provectus. We are committed to properly monetizing this important
asset for shareholders by developing PH-10 into a Phase 3-ready candidate, for both psoriasis and atopic dermatitis, in an
efficient, effective, and industry-recognized manner.”
About PH-10
Provectus’ investigational dermatology drug, PH-10, a topically applied, non-steroidal, small molecule-based
gel, is undergoing clinical study for inflammatory dermatoses like psoriasis and atopic dermatitis. PH-10 is self-applied to
affected skin with photoactivation via ambient exposure to visible light.
About Provectus
Provectus Biopharmaceuticals, Inc. (Provectus or the Company) is a clinical-stage biotechnology company leading
the development of a new class of drugs for oncology and dermatology based on a family of molecules called halogenated xanthenes.
The Company’s lead investigational cancer drug product, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor
cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers. Information about the Company’s clinical trials can be
found at the NIH registry, www.clinicaltrials.gov. For additional information about Provectus, please visit the Company's
website at www.provectusbio.com.
FORWARD-LOOKING STATEMENTS: This release contains “forward-looking statements” as defined under U.S. federal
securities laws. These statements reflect management's current knowledge, assumptions, beliefs, estimates, and expectations and
express management's current views of future performance, results, and trends and may be identified by their use of terms such as
“anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” and other similar
terms. Forward-looking statements are subject to a number of risks and uncertainties that could cause our actual results to
materially differ from those described in the forward-looking statements. Readers should not place undue reliance on
forward-looking statements. Such statements are made as of the date hereof, and we undertake no obligation to update such
statements after this date.
Risks and uncertainties that could cause our actual results to materially differ from those described in
forward-looking statements include those discussed in our filings with the Securities and Exchange Commission (including those
described in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2017).
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Contact:
Provectus Biopharmaceuticals, Inc.
Tim Scott, Ph.D.
President
Phone: (866) 594-5999
