January 27, 2015

"Provectus Biopharmaceuticals' Novel Synthesis Patent Application Allowed by Chinese Patent Office"

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Provectus issued press release Provectus Biopharmaceuticals' Novel Synthesis Patent Application Allowed by Chinese Patent Office on Monday, noting the company "...received notification of allowance from the Chinese Patent Office for its patent application protecting the synthetic process used to produce the small molecule Rose Bengal, the active pharmaceutical ingredient (API) in PV-10, the Company's lead oncology drug candidate."

The synthesis patent, according to Provectus, "...covers the process under which pharmaceutical grade Rose Bengal and related xanthenes are produced, reducing the formation of certain previously unknown transhalogenated impurities that currently exist in commercial grade Rose Bengal in uncontrolled amounts. The requirement to identify and control related substances is in accordance with International Conference on Harmonisation (ICH) guidelines for manufacture of API suitable for clinical trial material and commercial pharmaceutical use."

A screenshot of the allowance is below:
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The joint Provectus-Pfizer combination patent application filed in China also is below and, according to Provectus, "...covers a method of treatment of cancer that comprises administering a therapeutically effective amount of an intralesional chemoablative pharmaceutical composition in combination with a therapeutically effective amount of a systemic immunomodulatory anticancer agent. The systemic immunomodulatory anticancer agent comprises anti-CTLA-4 antibodies including ipilimumab and tremelimumab." Claims not yet made public purportedly include anti-PD-1 and anti-PD-L1 antibodies.
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Both patent applications were submitted at the same time to their respective geographic regulatory agencies. That is, the synthesis patent was filed on September 17, 2010 with both the U.S. and Chinese patent offices, and the combination patent was filed with both agencies on March 9, 2012. According to Eric (paraphrasing), Provectus files Patent Cooperation Treaty ("PCT") versions of the company's PTO patent applications simultaneously in designated jurisdictions within their respective PCT deadlines. Such filings may be made months after the U.S. case is filed. This allows management to obtain initial input from U.S. examination before the process commences in earnest in other jurisdictions, and to fine tune claims before international prosecution starts. Additionally, Provectus also typically elects to file first in certain key jurisdictions the company has learned are both important and rigorous, which allows management to further refine their international claims before proceeding with other jurisdictions. See IP & China (December 26, 2014) on the blog's Archived News II page.

Protecting intellectual property around the world is good process, and a valuation driver for Provectus. An important component of the company's upcoming pivotal Phase 3 trial for locally advanced cutaneous melanoma would be clinical sites in international locations, such as Australia (a given based on prior participation in Provectus' metastatic melanoma Phase 1 and 2 trials), Western Europe, and so-called emerging market/developing countries.

A China site, and its associated investigator, should be on the roster when the trial starts, or shortly thereafter. The site, at least one of them in the country, should be the Peking University Cancer Hospital (also known as, or having the other titles of, the Beijing Cancer Hospital, the Beijing Institute for Cancer Research, and Peking University School of Oncology). Clinical studies registered on ClinicalTrials.gov for the Beijing Cancer Hospital may be found here (there are 3 that are recruiting).

The investigator should be  Professor and Dr. Jun Guo, M.D., Ph.D (Vice President of Clinical Oncology, Peking University; Deputy Director, Beijing Institute for Cancer Research; Director of Department of Melanoma & Renal Cancer, Peking University School of Oncology). Clinical studies registered on ClinicalTrials.gov for Dr. Gou may be found here (there are 102 of them of various statuses). See also The Asia Melanoma Group (November 26, 2014) on the blog's Archived News II page.

St. Luke's University Health Network's and Provectus' lead melanoma Phase 2 trial investigator Dr. Sanjiv Agarwala spoke at Dr. Guo's October 17th-19th Beijing melanoma conference (2014 Beijing International Melanoma Congress), which was co-chaired by Dana-Farber/Harvard Cancer Center's Professor and Dr. Keith Flaherty, M.D. See 2014 Beijing International Melanoma Congress (October 7, 2014) on the blog's Archived News II page.

Dr. Guo is the head of the Asia Melanoma Group, the establishment of which was announced at above mentioned Beijing conference. See China Daily article New group offers hope to melanoma sufferers:
"The new group consists of 17 leading melanoma experts from countries including China, Singapore, Korea and Hong Kong. "Given Asian patients' differences in genetic background and disease types to Europeans, it is high time Asian experts stand together to form a group that will break down barriers in research on melanoma," said Guo Jun, deputy director of the Beijing Cancer Hospital and head of the newly-established group. The incidence of melanoma is higher among white people than Asians but Asian people have a much higher probability of mucous melanoma than Caucasians, which usually has a poorer prognosis than melanoma on the skin, Guo explained."
Dr. Guo also is a member of Melanoma International Foundation's Scientific Advisory Board, which is co-chaired by Dr. Flaherty.

Amgen's pivotal metastatic melanoma Phase 3 trial for T-Vec did not include any clinical trial sites in China. International locations included sites in Canada, South Africa, and the United Kingdom

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