Provectus Biopharmaceuticals (PVCT) continues to make slow but steady progress on its quest to get FDA approval for its new anti-cancer drug, known as PV-10, and in other areas. I will first list the objective news of recent months, and then close with the more speculative expectations for further progress.
Breakthrough Therapy Designation (BTD)
On December 16, 2013 Provectus held a Type C meeting with the FDA's Division of Oncology Products 2. As a result, the company announced on January 24, 2014 that it would file an application with the FDA for Breakthrough Therapy Designation (BTD) for treatment of melanoma in the first quarter of 2014. On March 24, Provectus announced that it had in fact filed the application with the FDA. Many companies do not announce when they file the application. Provectus did announce this, and it has repeated the fact of its application several times since.
The FDA has an announced goal of responding to all applications for BTD within 60 days of the application and it has been very good about doing so. Therefore, a response is expected by May 23 to the application of Provectus.
Corporate Advisory Board
Dr. Craig Eagle, the head of the oncology therapeutic area global medical group for Pfizer (NYSE:PFE), has been a longstanding member of the Provectus Corporate Advisory Board. In recent months Bob Miglani, a senior Pfizer executive in sales and public relations, was also added to the Board.
In March 2014 Dr Joseph Chalil, Associate Director, Health Science Executives of Boehringer Ingelheim, also joined the board. Boehringer Ingelheim is a privately held pharmaceutical company with about $20 billion per year in sales.
Presentations at Conferences
On April 6 there was a poster presentation at the American Association of Cancer Research (AACR) meeting. It was written by a member of the Moffitt Cancer Research Institute, an independent center of cancer research and treatment. (Moffitt is one of only 41 National Cancer Institute-designated Comprehensive Cancer Centers.) In a press release describing the presentation was included the following: Dr. Pilon-Thomas of Moffitt stated, "These data are exciting and illustrate successful translation of our pre-clinical work in mice to clinical results in melanoma patients. With only 8 patients we've been able to clearly observe statistically significant increases in beneficial T cell populations in peripheral blood. Ironically, the original aim of the trial to assess tumor-infiltrating lymphocytes was thwarted when biopsies of patient tumors collected just 7-14 days after PV-10 injection no longer contained viable tumor tissue. We are following up both the human data and continuing to design more experiments in mice to better explain the systemic immune effects elicited by PV-10 ablation."
This confirms something Dr Craig Dees, CEO of Provectus, said when announcing the application for BTD: "If you inject PV-10 into melanoma tumors, the tumors go away."
On Friday April 11 there will be a presentation at HemOnc Today - Melanoma and Cutaneous Malignancies Conference. Sanjiv S. Agarwala, MD, Program Director of the Conference, has said data regarding "PV-10 will be an integral part of session 4." Dr. Robert H.I. Andtbacka, associate professor in the Division of Surgical Oncology, Department of Surgery at the University of Utah School of Medicine, will moderate Session 4: Local and Regional Therapy. The session will include Amgen's (NASDAQ:AMGN) T-Vec, Vical's (NASDAQ:VICL) failed Allovectin-7, other intralesional therapies, and a debate about the role of systemic intralesional therapy.
On May 7th, Dr. Sanjiv Agarwala, of St. Luke's University Health Network and Provectus' principal investigator, will participate in a plenary session at the 10th European Association of Dermato-Oncology ("EADO") congress entitled New Drugs and new trials. Other drugs on the agenda include Amgen's T-Vec, Bristol-Myer's (NYSE:BMY) Yervoy, Roche's (OTCQX:RHHBY) MPDL3280A, Bristol-Myer's nivolumab, Merck's (NYSE:MRK) MK-3475, and OncoSec's (NASDAQ:ONCS) ImmunoPulse.
Two separate presentations were selected for the Poster Highlights session at the American Society of Clinical Oncology (OTC:ASCO) meeting, to be held in Chicago May 30-June 3, 2014. The ASCO meeting is considered one of the most important, and to be selected for a Poster Highlights session, especially twice, is an expression of significant interest. Sanjiv S. Agarwala, MD, is lead author of abstract #9027, entitled "Efficacy of intralesional Rose Bengal in patients receiving injection of all existing melanoma in phase II study PV-10-MM-02." More details are expected to be available on April 21.
The second poster, based upon abstract #9028, is entitled "Assessment of immune and clinical efficacy after intralesional PV-10 in injected and uninjected metastatic melanoma lesions," and is authored by Amod Sarnaik, MD and colleagues at Moffitt. This is apparently related to the Moffitt poster presented at AACR since Moffitt has said that it will not release the full poster for AACR until after the ASCO presentation.
Other Uses of PV-10
On March 10, the company announced that it is enrolling patients in a new study using the therapeutic agent PV-10 for late-stage liver cancer. Sanjiv Agarwala, MD of St. Luke's Cancer Center, internationally recognized melanoma investigator and Chief of Medical Oncology and Hematology for St. Luke's University Health Network, serves as the principal investigator of this Phase I clinical trial. PV-10 has received Orphan Drug Designation from the US FDA for the treatment of liver cancer in 2011. This study is expected to be completed in 2014.
A Phase 1 clinical trial has been successfully completed for Recurrent Breast Cancer, and Provectus says that based on positive safety and tolerability results of the Phase 1 study, as well as histologic evidence of tumor ablation or shrinkage in several subjects, Provectus is well positioned for a Phase 2 study of PV-10 for recurrent breast cancer.
Up until now I have listed only facts that have happened or that are officially scheduled. What follows is possibilities that were discussed in various releases of the company, but that no dates were given. Based on the track record of the company, there is a reasonable expectation that these will all take place sooner or later. Of course PVCT longs hope these will take place sooner rather than later.
The company has announced that it is pursuing an uplisting on a major exchange. In May 2012 the company announced that it formed at independent Board of Directors to meet corporate governance requirements like that of NASDAQ, which requires a majority of independent Board Members. It has remained in compliance with these requirements and has talked about pursuing a listing on NASDAQ or NYSE/MKT. Such an uplisting would give it better exposure and credibility with major investors.
Provectus also owns and has been developing a drug known as PH-10 for Psoriasis and Atopic Dermatitis. For the first, a Phase 2c randomized clinical trial has been successfully completed and also a Phase 2 clinical trial. For Atopic Dermatitis a Phase 2 clinical trial has been successfully completed. The mechanism of action for PH-10 is currently being studied and a report about this should eventually be published, maybe soon.
In various forums, officers of Provectus have said that they have been meeting with large regional partners in Japan, India and China. No information has been released about progress, but there is hope that they will announce a regional license agreement, maybe soon after a positive response to their application for BTD is acted upon.
Disclosure: I am long PVCT. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.