provectus biopharmaceutica-a (PVCT) Key Developments
Provectus Biopharmaceuticals Held Type C Meeting with Food and Drug Administration on Operational Aspects of PV-10 Phase 3 Melanoma Study
Feb 9 15
Provectus Biopharmaceuticals, Inc. announced that it has held a Type C meeting with the U.S. Food and Drug Administration to review certain operational aspects of the protocol for its planned phase 3 clinical trial of intralesional PV-10, its novel investigational drug for cancer, as a treatment for melanoma. The meeting was held by teleconference on January 29, 2015. Topics formally reviewed included subject eligibility requirements, primary and secondary study end points, and study lesion definitions and conventions for defining disease progression.
Provectus Biopharmaceuticals, Inc.’ Protocol for Phase 2 Study of Mechanism of Action of PH-10 on Immunologic Makers of Psoriasis Now Available Online
Dec 23 14
Provectus Biopharmaceuticals, Inc. announced 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. 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.
Provectus Biopharmaceuticals, Inc. Presents at 17th Annual BIO CEO & Investor Conference, Feb-10-2015 03:00 PM
Dec 15 14
Provectus Biopharmaceuticals, Inc. Presents at 17th Annual BIO CEO & Investor Conference, Feb-10-2015 03:00 PM. Venue: The Waldorf Astoria, New York, New York, United States.
Provectus Biopharmaceuticals, Inc. Extends Memorandum of Understanding with Sinopharm-China State Institute of Pharmaceutical Industry and Sinopharm A-Think Pharmaceutical Co., Ltd
Nov 14 14
Provectus Biopharmaceuticals, Inc. announced that it has agreed to extend the term of its existing Memorandum of Understanding with Sinopharm-China State Institute of Pharmaceutical Industry and Sinopharm A-THINK Pharmaceutical Co. Ltd., the only injectable anti-tumor drug research and development, manufacture and distribution integrated platform within Sinopharm Group to May 16, 2015. The MOU remains in effect and unchanged other than this extension of the term. During the last 90 days, since the signing of the MOU, management of Provectus and senior personnel at Sinopharm-CSIPI and Sinopharm A-THINK have held numerous conference calls, have met face-to-face in both China and the US, and Chinese scientists on staff at Sinopharm have discussed in person PV-10 and its clinical results with the lead investigators at St. Luke's Cancer Center and Moffitt Cancer Center. The company stated that it is hopeful that a contract will be finalized in the coming weeks, and this extension illustrates that there is sufficient interest on both sides to continue to work out the details. With the new data from the Moffitt Cancer Center on combination therapy with IL PV-10 and co-inhibitory blockade, and considering Provectus' filing of the phase 3 protocol with the FDA in Washington, both parties agreed to take the additional time needed to ensure that the final contract is the best agreement possible for everyone. The MOU will now terminate upon the signature of a licensing agreement or other contract, on May 16, 2015, or with one-month written notice by either party.
Provectus Biopharmaceuticals Submits PV-10 Phase 3 Melanoma Protocol to FDA
Nov 6 14
Provectus Biopharmaceuticals, Inc. announced that it has submitted its phase 3 protocol for evaluation of PV-10 for treatment of locally advanced cutaneous melanoma to the FDA. The FDA is expected to review the submission and comment on the proposed study population, clinical endpoints, and statistical analyses within 30 to 45 days. The submission of the protocol follows completion of the due diligence audit of Provectus' regulatory documents for PV-10 and PH-10. The purpose of the audit was to ensure that all the regulatory documents were in order. Provectus anticipates few, if any, significant issues to arise from review of the protocol based on the substantive contact it has had with the FDA since the company had its Type C meeting with the Agency on December 16, 2013. In particular in its letter of May 16, 2014 to the company, the FDA gave guidance on assessment methods and endpoints that Provectus has incorporated into its phase 3 submission.