Provectus Biopharmaceuticals Provides Drug Development Update

Provectus recently 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.”

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.

 Provectus Biopharmaceuticals, Inc. 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 more information, visit www.provectusbio.com.