KNOXVILLE, Tenn.--(BUSINESS WIRE)--Headline and subhead of release should reference "Markers" instead of "Makers."
The corrected release reads:
PROVECTUS BIOPHARMACEUTICALS PROTOCOL FOR PHASE 2 STUDY OF MECHANISM OF ACTION OF PH-10 ON IMMUNOLOGIC MARKERS OF PSORIASIS NOW AVAILABLE ONLINE
Study Will Assess Effects Of PH-10 On Immunologic Markers of Psoriasis
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT, http://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.
Originally posted here:
Provectus Biopharmaceuticals Protocol for Phase 2 Study of Mechanism of Action of PH-10 on Immunologic Makers of ...
- What is Psoriasis? (Part 1 of 3) | HealthiNation - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Psoriasis Treatment - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Psoriasis (Understanding Disease: Dermatology) - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- I'm Just Like You - Kids and Psoriasis - 2011 Trailer - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Psoriasis And Me - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Psoriasis?..... - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Natural Treatment For Psoriasis - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- psoriasis / eczema diet help skin care advice [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- plaque psoriasis picture m3b - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Restless Legs, Arthritis, and Psoriasis Gone Going Gluten Free - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Vitamin D can Cure Psoriasis - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Reversing Psoriasis With Green Smoothies - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Effectively Treat Psoriasis [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Scalp Treatment for Psoriasis - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Scalp Psoriasis - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- How To Treat Psoriasis - Video [Last Updated On: September 7th, 2012] [Originally Added On: September 7th, 2012]
- Research and Markets: Global Psoriasis Drug Pipeline Capsule - 2012 Update [Last Updated On: September 18th, 2012] [Originally Added On: September 18th, 2012]
- Press Release [Last Updated On: September 19th, 2012] [Originally Added On: September 19th, 2012]
- $1.8 million grant supports investigation of psoriasis link to cardiovascular disease [Last Updated On: September 20th, 2012] [Originally Added On: September 20th, 2012]
- $1.8M Grant Supports Investigation of Psoriasis Link to CVD [Last Updated On: September 20th, 2012] [Originally Added On: September 20th, 2012]
- Kiwi Company Provides Scalp Relief For Coeliac Community [Last Updated On: September 20th, 2012] [Originally Added On: September 20th, 2012]
- Community News: Sept. 28 paper [Last Updated On: September 27th, 2012] [Originally Added On: September 27th, 2012]
- Novartis Psoriasis Drug Shows Promising Results [Last Updated On: September 28th, 2012] [Originally Added On: September 28th, 2012]
- Novartis data show AIN457 significantly reduced signs and symptoms in patients with hard-to-treat moderate-to-severe ... [Last Updated On: September 28th, 2012] [Originally Added On: September 28th, 2012]
- International Study Highlights Need to Support Patients With Psoriasis Suffering Feelings of Isolation, Stigmatisation ... [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Research and Markets: Psoriasis (Event Driven) [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Stiefel receives US FDA approval of Sorilux™ Foam, 0.005% for topical treatment of plaque psoriasis of the scalp [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Many options for psoriasis treatments [Last Updated On: October 1st, 2012] [Originally Added On: October 1st, 2012]
- Study: Psoriasis patients more prone to diabetes [Last Updated On: October 2nd, 2012] [Originally Added On: October 2nd, 2012]
- Novartis Progresses with AIN457 [Last Updated On: October 2nd, 2012] [Originally Added On: October 2nd, 2012]
- Gum disease linked to psoriasis: study [Last Updated On: October 5th, 2012] [Originally Added On: October 5th, 2012]
- Gum disease linked to psoriasis: Taiwanese study [Last Updated On: October 5th, 2012] [Originally Added On: October 5th, 2012]
- Study: People with gum disease 54% more likely to develop psoriasis [Last Updated On: October 5th, 2012] [Originally Added On: October 5th, 2012]
- Large menu of treatments for psoriasis [Last Updated On: October 6th, 2012] [Originally Added On: October 6th, 2012]
- Psoriasis Free For Life Guide for Natural Psoriasis Treatment Now Available [Last Updated On: October 7th, 2012] [Originally Added On: October 7th, 2012]
- Interim Analysis Supports Continuation of Can-Fite's Phase 2/3 Psoriasis Clinical Study with CF101 [Last Updated On: October 10th, 2012] [Originally Added On: October 10th, 2012]
- Research and Markets: Key Findings from Treatment Algorithms: Psoriasis [Last Updated On: October 10th, 2012] [Originally Added On: October 10th, 2012]
- Research and Markets: Psoriasis - Thought Leader Panel 2012 - A Summary of Persepectives from 6 Key Opinion Leaders [Last Updated On: October 11th, 2012] [Originally Added On: October 11th, 2012]
- People with severe psoriasis nearly twice at risk for diabetes [Last Updated On: October 15th, 2012] [Originally Added On: October 15th, 2012]
- Idera Pharmaceuticals Announces Completion of Patient Enrollment in Phase 2 Trial of IMO-3100 in Patients with Psoriasis [Last Updated On: October 15th, 2012] [Originally Added On: October 15th, 2012]
- Psoriasis nearly doubles diabetes risk [Last Updated On: October 16th, 2012] [Originally Added On: October 16th, 2012]
- Rise in number of Pakistanis suffering from psoriasis [Last Updated On: October 16th, 2012] [Originally Added On: October 16th, 2012]
- Psoriasis Remedies Book Teaches How to Get Rid of Psoriasis [Last Updated On: October 17th, 2012] [Originally Added On: October 17th, 2012]
- Psoriasis Patients Twice As Likely To Develop Diabetes [Last Updated On: October 17th, 2012] [Originally Added On: October 17th, 2012]
- Idera Pharma: Itching For Touch Up... [Last Updated On: October 17th, 2012] [Originally Added On: October 17th, 2012]
- Psoriasis Mandate Results Released to Mark World Psoriasis Day [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Psoriasis Care Failing Patients [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- UK Survey Calls for Further Education to Help Eliminate Common Misconceptions About Psoriasis [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- International Federation of Psoriasis Associations: Put Psoriasis on the Agenda Now! [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Analysis links psoriasis, diabetes [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Psoriasis isn't skin deep [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Lake Consumer Products Announces Innovative New MG217® Psoriasis Treatment Cream that's Unlike Anything Else on the ... [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Psoriasis and Heart Disease: It's More Than Skin Deep - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- I'm back - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Purifying Lotion - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Dr stephen ferguson ND PhD psoriasis cured - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- NATURES ANTIBIOTIC - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- DIY Face Scrub Natural [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Psoriasis Free For Life E-book... - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Buy: Psoriasis Free For Life Ebook - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Ahava Liquid Salt review by Paola Bassanese Energya Ltd - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Psoriasis Free For Life Ebook - Download - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Psoriasis Free For Life Ebook - Web Link - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Vampire Transformation! - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Evans Dermatology Evans GA - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Psoriasis Treatment Discovery Could Cure Psoriasis New Book Claims [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- My life with Psoriasis - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Johns Creek Dermatology and Family Medicine Practice Profile - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Radio Psoriasis 2 - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Joel Schlessinger MD Visits the Avene Hydrotherapy Center - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Radio Psoriasis - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Skin Salvation and Psoriasis - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Can Psoriasis Treatment Cause Hair Lost? - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Healed from Multiple Sclerosis and psoriasis! RELOAD from thedurianKing - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Psoriasis Natural Treatment - Psoriasis Cure - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- psoriasis getting cure in acupuncture-indian accu touch - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Psoriasis Interview 18010154 - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Psoriasis does not spread by touch - Skin experts - Tv9 - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Psoriasis presentation - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]
- Home Remedies for Scalp Psoriasis - Cure Psoriasis without Medication - Video [Last Updated On: November 2nd, 2012] [Originally Added On: November 2nd, 2012]