Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT, www.pvct.com), a
development-stage oncology and dermatology biopharmaceutical company
("Provectus"), announced today that the protocol for its phase 2 study of the
mechanism of action of PH-10 in psoriasis is now available on
ClinicalTrials.gov, Identifier NCT02322086:
https://www.clinicaltrials.gov/ct2/show/NCT02322086.
The protocol states that the multicenter study is designed to assess treated
psoriatic plaque for “changes in immunologic, structural and
hyperproliferative state and for any evidence of cellular atypia” when treated
with PH-10 and to “correlate observed changes in the skin with clinical
response to treatment.” These assessments are expected to advance the
understanding of the mechanism of action of PH-10 in psoriasis and other
inflammatory dermatoses, such as atopic dermatitis, and further substantiate
the safety profile of the agent.
The study will enroll up to 30 subjects with mild to moderate plaque
psoriasis. Subjects will apply vehicle daily for 28 consecutive days followed
by active PH-10 daily for 28 consecutive days to their psoriatic plaques.
Biopsies of one plaque will be collected at baseline and immediately after
completion of vehicle application and PH-10 application. This will allow data
from each subject to serve as an internal control for assessment of clinical
and cellular response to PH-10. Biopsy specimens will be assessed for changes
in epidermal hyperplasia (i.e., disordered condition of the skin creating
thickening and scaling); infiltration with immune cells; and molecular markers
of inflammation. Correlation of clinical response to these cellular and
molecular changes will be performed at the plaque level using Psoriasis
Severity Index (PSI) assessment data.
Safety will be assessed by monitoring the frequency, duration, severity and
attribution of clinical adverse events; evaluating changes in laboratory
values and vital signs; and by correlation of clinical adverse events with
observed histopathologic and immunohistopathologic changes in the skin.
Eric Wachter, PhD, Chief Technology Officer of Provectus, noted, “By capturing
data at the clinical and cellular level, this study should allow us to
establish how PH-10 affects psoriatic plaque and other similar inflammatory
diseases of the skin, and to relate the safety profile from earlier studies to
such effects. We believe that understanding these effects with this level of
detail will allow us to properly position PH-10 within the competitive
landscape and should provide crucial safety data to support extended dosing.”
Dr. Wachter added, “We expect this effort to provide a comparable level of
understanding of the effects of PH-10 in diseased skin to the keen insight we
have gained through our clinical and nonclinical mechanism studies of PV-10,
Provectus' novel investigational cancer drug, in melanoma and other cancers.
Because there are no good model systems for psoriasis, we believe this study
affords a critical opportunity to link the clinical effects we have observed
to changes in well established immunologic drivers of the disease.”
The study will be performed at three centers in the United States, with
enrollment expected to commence by mid-January 2015.
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