The Company noted that an amended phase 3 protocol for the testing of PV-10, its novel investigational drug for cancer, for the treatment of melanoma has been submitted to the U.S. Food and Drug Administration. There were a number of minor changes made to the protocol that the Company discussed in its press release of February 9, 2015, which addressed the FDA review. The Company does not require additional FDA review to start the phase 3 study, and has begun the process of gaining IRB approval for the amended protocol In addition, the Company's study of PV-10 for liver tumors is continuing to accrue patients, in particular those with tumors metastatic to the liver. The Company expects to report initial data at one or more international cancer conferences this summer. The Company also announced that enrollment has begun in its mechanism of action [MOA] study for PH-10, its topical investigational drug for dermatology. The Company expects to recruit up to 30 patients at three study centers in the U.S. At the same time, Provectus announced the completion of enrollment in the PV-10 MOA study, meeting the target of enrolling 15 patients in the study. Enrollment and data collection for the PH-10 study are expected to be completed in December 2015. The Company expects further data from the PV-10 MOA study to be reported later this year or early in 2016.The Company also noted that enrollment is continuing under its expanded access protocol for PV-10, with well over 100 melanoma patients having received PV-10 in the U.S. and Australia. The Company noted that the January 2015 allowance of its novel synthesis patent application by the Chinese Patent Office, following on the issuance of the parent case in the U.S. in September 2013, represents a continued expansion of its global patent strategy, in particular protecting the key component of both PV-10 and PH-10 in major markets. Such process patents serve to strengthen its product-specific patents, such as U.S. Patent No. 8,974,363 issued earlier this week covering PH-10.
