Category Archives: Psoriasis

By RTT News, December 26, 2014, 02:39:00 AM EDT

(RTTNews.com) - Novartis ( NVS ) said Friday that the Japanese Ministry of Health, Labour and Welfare or MHLW approved Cosentyx (secukinumab, formerly known as AIN457), for the treatment of both psoriasis vulgaris and psoriatic arthritis or PsA in adults who are not adequately responding to systemic therapies (except for biologics).

The company noted that the approval marks the first country approval for Cosentyx in the world and makes it the first interleukin-17A or IL-17A inhibitor to receive regulatory approval in either of these indications in Japan.

The approval was based on the safety and efficacy results from more than 10 Phase II and Phase III studies which included nearly 4,000 patients with moderate-to-severe plaque psoriasis and supported by two pivotal Phase III studies, FUTURE 1 and FUTURE 2, involving more than 1,000 patients with PsA.

In all studies, Cosentyx demonstrated a favorable safety profile, with similar incidence and severity of adverse events or AEs between Cosentyx treatment arms (300 mg and 150 mg).

Cosentyx works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by psoriasis and central to the development of inflammatory diseases, including psoriasis and PsA. As approximately 30% of psoriasis patients are also affected by PsA globally.

Psoriatic arthritis is a debilitating, long-lasting inflammatory disease linked with significant disability, poor quality of life and reduced life expectancy.

The company said that the US Food and Drug Administration approval in the same indication is anticipated in early 2015 following the unanimous recommendation of approval in October 2014 from the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US FDA.

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Novartis'' Cosentyx Approved In Japan For Both Psoriasis And Psoriatic Arthritis

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.

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Provectus Biopharmaceuticals Protocol for Phase 2 Study of Mechanism of Action of PH-10 on Immunologic Makers of ...

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