Provectus Phase III Melanoma Trial Results Earlier Than Planned?

PROVECTUS COMPANY OVERVIEW

Provectus (PVCT) is a clinical stage bio-pharmaceutical drug development company. There are 3 key scientific managers running the business along with the CFO, who is also the Chief Operating Officer. They preside over a stable of expert and specialized consultants. The company has two lead drug candidates: PH-10 for significant, often severe, and common skin disorders and PV-10, a dual action, local ablation and immunological anti-cancer drug. PH-10 is currently the subject of post-Phase II trial research into mode of action. PV-10 has successfully completed Phase II trials for malignant melanoma, is currently the subject of independent research on mode of action and efficacy in conjunction with radiation, and it will have a Phase III pivotal trial starting shortly.

Both drugs are based upon a dye that has been in human medical use for over 100 years and has an extraordinarily benign safety profile, especially surprising since most cancer-killing agents tend to be quite toxic and debilitating, to the host: the patient. Provectus has patents on the composition of their drugs, as well as for their use in cancer, and a variety of other human ailments. The patents do not expire until 2031. They also have partnered with Pfizer on a joint patent on the use of PV-10 in combination with other cancer drugs.

The FDA has granted PV-10 Orphan Drug Status for the treatment of highly lethal metastatic melanoma and metastatic liver cancer. It has a successful and expanding Compassionate Use Program in operation and successfully completed trials on metastatic cancer of the breast, liver and melanoma, with positive results in all three. Positive effects in this context is that, if you inject PV-10 into a solid tumor, it kills cancer cells, usually within a week and doesn't harm normal tissue. Many injected tumors actually disappear while others shrink and stop growing. The dual action of the drug is that the destruction of the cancer by direct injection of PV-10 serves to sensitize the patient's immune system to seek out and kill similar cancer throughout the body. There is convincing evidence that untreated cancer distant from the treated cancer is attacked by the patient's immune system after treatment.

MELANOMA RESEARCH:

Provectus has long focused on getting their first FDA approval for PV-10 to treat recurrent melanoma. They successfully completed a Phase II trial on the use of PV-10 in metastatic melanoma. Results showed there were only minimal side effects. The trial showed excellent efficacy results that were better than other treatments even though the average patient in the Provectus Phase II trial had failed a median of 6 other treatments. Both Complete Response (CR: a tumor disappearing) and Overall Response (OR: tumors eliminated+shrinking+not growing) effects were observed in both the treated and untreated tumors (a demonstration of the immunological bystander effect). The 2014 ASCO data presentation indicated that, for the patients who had all tumors treated, CR was 50% and OR was 71%.

The excellent tumor responses prompted Provectus to apply for Breakthrough Therapy Designation in hopes of speeding progress to an NDA submission and ultimate approval. The FDA denied the application, apparently because they wanted more than just tumor-response. Provectus management revealed their alternative path to NDA submission on June 3rd. Provectus announced that they would conduct a

...phase 3 randomized controlled trial of PV-10 in patients with unresectable locally advanced cutaneous melanoma will assess response to PV-10 vs that of systemic chemotherapy in patients who have disease limited to cutaneous and subcutaneous sites and who have failed or are ineligible for systemic immunotherapy. Progression-free survival and complete response rate will be assessed using standard criteria (RECIST 1.1). Overall survival and exploratory assessment of patient reported outcomes related to lesion pain and other melanoma symptoms will also be assessed. The study is expected to commence this year, and will allow for interim assessment when 50% of the required events have occurred (i.e., disease progressions).”

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Disclosure: I am long Provectus stock (PVCT). 

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Comments

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Cynthia Decker 3 years ago Member's comment

Excellent article Alan Robert Ross! What are your current feelings on $PVCT?

Alan Robert Ross 3 years ago Author's comment

Even more of a bargain at this point, but it is a waiting game for news. Q1'16 should see some, fundamental advance, although only time will tell market reaction.

Cynthia Decker 3 years ago Member's comment

Thanks, what other stocks do you like/are you looking at?

Terrence Howard 4 years ago Member's comment

Thanks for this Alan, any updates on this stock?

Alan Robert Ross 4 years ago Author's comment

Lots of things happening for Provectus and in a direction opposite the share price. Their Phase 3 trial has started and will be gaining momentum. See my latest, here: www.trustintelligence.com/.../viewtopic.php

New and probably stunningly good liver cancer data is due out in less than 6 weeks. Hints indicate that this will show efficacy that is way better than anything other drug available or in development. There are over a million people with liver cancer in the US. And with China having 55% of world primary liver cancer, the recently extended MOU with govt.-owned Sinopharm may soon be converted into an official license deal.

They just started talking with Brazil for a South American license and have a number of other deals they are working on. Should be a surprising summer for a stock that does not deserve to be so cheap!

Alan Robert Ross 5 years ago Author's comment
You are welcome Kent. Hope you found the possibilities interesting. More to come.
Kent Livezey 5 years ago Member's comment
Thank you for your thorough and objective reporting. It's very welcome after being subjected to the incomplete and negatively biased articles about PVCT written by others in Seeking Alpha.