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news and we hit .075 ish - .08 easy.
same here.
But i dont see the SP dipping below .06.
ratchet warrants at .0533 so unless they are desperate to sell there wont be downward pressure to dip below .06. Although with the low volatility the MM's can walk it down to .04 ish
based no TA, hearsay, a dream?
unless we get a interim readout of some sort I think we can cross liver off our list.
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of PV-10 Chemoablation of Cancer Metastatic to the Liver or Hepatocellular Carcinoma Not Amenable to Resection or Transplant
Study Start Date : October 2009
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020
liver data?
abstract posted on IV.
Key takeaways combo P2 set to start in "early" 2018.
Immunotherapy Bridge 2017 and Melanoma Bridge 2017: meeting abstracts
P5 Oncolytic immunotherapy with PV-10
Sanjiv Agarwala, B. Mark Smithers, Axel Haushild, Paolo A. Ascierto, Eric Watcher
1St Luke’s University Hospital and Health Network, Easton, Pennsylvania, USA; 2Princess Alexandra Hospital, Brisbane, Queensland, Australia; 3Department of Dermatology, University Hospital Schleswig–Holstein, Kiel, Germany; 4Istituto Nazionale Tumori IRCCS Fondazione “G Pascale”, Naples, Italy; 5Provectus Biopharmaceuticals, Inc., Knoxville, Tennessee, United States
Journal of Translational Medicine 2018, 16 (Suppl 1):P5
Background: PV-10 is an investigational small molecule oncolytic immunotherapy (10% w/v rose bengal disodium for injection). Intralesional (IL) injection can elicit a primary, local effect in injected tumor tissue (immunogenic cell death and release of tumor antigens) capable of stimulating a secondary, functional systemic immune response (including tumor-specific reactivity in circulating T cells in treatment-refractory patients). PV-10 has been investigated in Phase 1 and 2 clinical trials in 130 patients with melanoma; an expanded access protocol accrued an additional 180 melanoma patients.
Materials and methods: PV-10 is currently under clinical investigation in two melanoma studies. Phase 3 study PV-10-MM-31 (NCT02288897), an international multicenter, randomized controlled trial (RCT), is assessing effectiveness of PV-10 compared to the investigator’s choice of systemic chemotherapy or intralesional oncolytic viral therapy in up to 225 patients with locally advanced cutaneous melanoma (AJCC Stage IIIB to IV M1a). The primary endpoint is progression-free survival (PFS) assessed via RECIST 1.1. Phase 1b/2 combination study PV-10-MM-1201 (NCT02557321), an international multicenter, open-label, sequential phase study, is assessing safety and efficacy of PV-10 in combination with systemic immune checkpoint inhibition. Stage IV metastatic melanoma patients with at least one injectable cutaneous or subcutaneous lesion who are candidates for pembrolizumab are eligible for study participation. In the Phase 1b portion of the study, up to 24 subjects will receive the combination (i.e., PV-10 + SoC) with PFS and objective response (OR) as key secondary endpoints. In the Phase 2 portion of the study up to 120 study participants will be randomized 1:1 to receive either the combination or pembrolizumab alone (i.e., PV-10 + SoC vs SoC) with PFS as the primary endpoint.
Results: Both studies are currently enrolling patients. The Phase 3 study is open at centers in the USA, AUS, Italy and Germany; additional regulatory approval has been received in Mexico, with approval pending in France, Poland and Argentina. The Phase 1b study is open at centers in the USA and AUS. To date, no unexpected safety signals have been observed in either study, and Phase 2 of the combination study is expected to begin in early 2018. Preliminary efficacy data from Phase 1b of the combination trial-in-progress will be presented.
Conclusion: Pivotal testing of single agent PV-10 is ongoing. Conclusion of Phase 1b testing of PV-10 in combination with checkpoint inhibition is anticipated to lead to Phase 2 randomized testing in 2018.
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-017-1352-z
closed at .071 not .072
What does your chart say or it does not really make a difference?
Ill take a stab and say we will drift around .065 - 7ish till news. I can't see the SP going back to 4 or 5 cents.
Quick question. Is Eric's 2.5mm loan in 1Q of 2017 part of the 20mm PHR fund raise?
plenty of Maxim warrants to go around, and will be so for some time.
Perhaps the ongoing snow storm has affected wall street? Not much action today. Then again maybe its the end of the rally. Figures since I bought a couple days ago. Next time i buy, I will post this way everyone can sell there shares since it is guaranteed the SP will dip.
better off. We don't need anymore day traders. We DO need is institutional buying since 95+% is held by retail.
perhaps shorting against the box to lock in profits?
If so, it would benefit them to do so above the .0533 exercise price and not bury the SP. This BS may go on for a while till we get some solid news.
Bought several blocks today. Hopefully we will continue to rise. I hate buying then the next day the SP crashes with me holding the bag. Any chart TA folks out there?
"Remember, February ought to be a pretty significant month for us."
You referring to the upcoming liver data?
Thanks for the reply. Let me ask you, the SP when rises, the ask has over 100K at the ask. How do you explain this? Naked shorts? Maxim ratchet warrants?
any guess on what happens next week? the MM's suggestion (on IV) of profit taking at .06 never happened. He now claims the 1st of the week.
FIRST STUDY OF QUALITY OF LIFE OF PATIENTS WITH LOCALLY ADVANCED CUTANEOUS MELANOMA PUBLISHED IN MELANOMA RESEARCH
13 minutes ago - DJNF
FIRST STUDY OF QUALITY OF LIFE OF PATIENTS WITH LOCALLY ADVANCED CUTANEOUS MELANOMA PUBLISHED IN MELANOMA RESEARCH
-- Emotional health/self-perception issues were most common; limitations of
lifestyle and activities as well as coping strategies were also
important
-- Provectus Biopharmaceuticals expands pivotal Phase 3 trial of
intralesional PV-10 for this patient population to EU and LATAM; U.S.
sites continue to enroll
KNOXVILLE, TN, Dec. 27, 2017 (GLOBE NEWSWIRE) -- Provectus Biopharmaceuticals, Inc. (OTCQB: PVCT, www.provectusbio.com) ("Provectus" or the "Company"), a clinical-stage biotechnology company developing the first small molecule oncolytic immunotherapy for solid tumor cancers, today announced that Melanoma Research (the "Journal") published results from a Provectus-sponsored study to understand the daily experiences of patients with locally advanced cutaneous melanoma. Physical and emotional experiences, symptom management, and subsequent impacts on quality of life historically have not been well understood or sufficiently described for this patient population.
The article may be accessed via the Journal's website under Published Ahead-of-Print at http://journals.lww.com/melanomaresearch/Abstract/publishahead/Quality_of_life_patient_reported_outcomes_for.99332.aspx.
Interviews of adults with Stage IIIB, IIIC or IV M1a cutaneous melanoma at three cancer centers in the U.S. (Moffitt Cancer Center, Tampa, Florida and Huntsman Cancer Institute, Salt Lake City, Utah) and Australia (Melanoma Institute Australia, Sydney) were conducted to assess how locoregionally advanced cutaneous melanoma impacted everyday life. According to the Journal article, "[e]motional health/self-perception issues were the most commonly identified (41% of patient impact expressions), including worry, concern, embarrassment, self-consciousness, fear, and thoughts of death. Limitations of lifestyle and activities were also identified (28% of expressions) including leisure and social activities, physical functioning, general functioning, and personal care. Coping strategies such as modified clothing choices, increased use of pain and/or anti-inflammatory medications, and avoidance/protection from the sun represented 20% of all impact expressions."
Study investigators "collected information on disease-specific patient-reported assessment of symptoms and quality of life (patient-reported outcomes, or PROs) that may provide a basis for supporting the clinical significance of objective response parameters such as progression-free survival (PFS) and complete response."
The Journal article also noted that "oth the US Food and Drug Administration and the European Medicines Agency have highlighted the value of establishing content validity in the development of tools to assess patient-reported outcomes. Such PRO-geared tools can extract critical concepts and impacts pertinent to the patient experience. Focus groups and interview sessions can be among those tools to elicit the patient experience."
Provectus previously supported Stage III melanoma patient advocacy efforts by the Melanoma Research Foundation ("MRF"):
-- A focus group, which addressed initial diagnosis, treatment, disease
progression and the need for self-education and support; a summary of
this group's outcome is available on Provectus' website at
http://provectusbio.com/media/docs/MRF_Stage_III_Focus_Group_Summary_BRIEF_FINAL.pdf,
and
-- MRF's Stage III Melanoma Patient Guide, which may be found on MRF's
website at
https://www.melanoma.org/understand-melanoma/cutaneous-melanoma/stage-iii-melanoma.
In its Summary Basis of Regulatory Action for IMLYGIC(R)(1) , the first intralesional therapy approved for melanoma, the U.S. Food and Drug Administration ("FDA") noted that "patients and their caregivers spoke of the value, both cosmetic and psychological, of watching their skin lesions disappear" during the April 2015 Joint Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee. The FDA also noted "[t]here may be associated psychological benefit, which may be substantial in patients who can see their visible lesions recede."
For patients with locally advanced cutaneous melanoma, Provectus is evaluating intralesional PV-10 versus chemotherapy (dacarbazine or temozolomide) or oncolytic viral therapy (IMLYGIC) in an international, multi-center, pivotal Phase 3 trial (NCT02288897). In-transit, satellite and locally recurrent melanoma patients (Stage IIIB, IIIC or IV M1a) with at least one injectable lesion who are not candidates for treatment with either a checkpoint inhibitor or targeted therapy (with BRAF or combined BRAF/MEK inhibitors) are eligible. The trial's primary endpoint is PFS (assessed via RECIST 1.1 every 12 weeks up to 18 months); complete response rate and overall survival are key secondary endpoints. PV-10 currently is or soon will be available at 19 clinical sites in five countries. The study is enrolling in Germany, Italy and the U.S., and clinical trial authorizations have been received for France and Mexico.
More information about this Phase 3 trial is available via ClinicalTrials.gov, the registry of clinical trials run by the U.S. National Library of Medicine at the National Institutes of Health ("NIH"), at https://clinicaltrials.gov/ct2/show/study/NCT02288897?term=Provectus%2C+PV-10&rank=6&show_locs=Y#locn.
Dominic Rodrigues, Chairman of the Company's Board of Directors, said, "Provectus has had a longstanding commitment to understanding quality of life issues in order to better design our clinical trials. We believe the endpoints of our pivotal Phase 3 trial for locally advanced cutaneous melanoma, like progression-free survival and complete response rate, are congruent with the findings of this quality of life study that highlight patients' emotional and physical challenges, which owe to their persistent, visible disease."
Mr. Rodrigues added, "We are grateful to our regulatory partners at FDA, Therapeutic Goods Administration, Agenzia Italiana del Farmaco, Bundesinstitut für Arzneimittel und Medizinprodukte, Agence Nationale de Sécurité du Médicament et des Produits de Santé, and Comisión Federal para la Protección contra Riesgos Sanitarios for working with Provectus to achieve clinical trial authorization in their respective countries for this important trial, and to enable the Company to continue the drug development work required to advance delivery of accessible and affordable healthcare around the globe via PV-10, the first small molecule oncolytic immunotherapy for melanoma."
About In-Transit Melanoma
According to the current NCCN Guidelines for Patients(R), Melanoma, Version 1.2016(2) , Stage III in-transit melanoma is when cancer cells have spread into lymph vessels near the first tumor but not into nearby lymph nodes. Melanoma that has spread to a small area of skin near the first tumor is called satellite metastasis. Non-metastatic recurrence is melanoma that has come back after treatment but has not spread to distant parts of the body. According to the NCCN Guidelines for Melanoma, version 1.2018(3) , under Treatment for Stage III In-transit Disease, "[t]he tumor burden, time course of appearance, and duration of in-transit disease is variable. In some patients, in-transit lesions remain confined to a region of the body for many years. This may occur in isolation or in combination with other sites of metastatic disease. A major concern in patients in which in-transit disease occurs in isolation is the high probability of subsequent development of visceral metastasis."
MM on the IV suggested a mini "pump and dump" via the market makers, shorting the stock and dumping it in early January. What you think?
any idea how many warrants resulted from the ratchet? I believe the most was 250mm.
Why is the RATCHET tied to volume?
Mokyo Toe, you mentioned the ratchet warrants. They kick in at ~.053 however must the SP close that day or can they be converted as soon as the SP hits that price?
Do you know how many outstanding ratchet warrants are out there?
Vorlon with a 6 month extension what makes you so confident a deal can be had this year / couple weeks?
Yeah it means the share price went to $1.03
If they submit the protocol by Sep 30th, and start Nov 1st, that will fall within the 90 days of the MOU. fingers crossed.
this chart show 1.02 resistance. Where do you get 1.05?
http://www.stockta.com/cgi-bin/analysis.pl?symb=PVCT&cobrand=&mode=stock
how long does it take a third party company to check / review a protocol? Anyone know?
more like, lack of, and there is the problem. The SP will not remain over a dollar if things continue. This is an .80 - 90 cent stock
Dont worry fellas i will sell tomorrow, and when I do the SP will soar.
Tom, if I was you, i would lower my stink bid to the low 70's. IMO that is where we are headed.
I would hold on to your shares. Let them turn into long term shares. What is important is the end game. Just my 2 cents
we have seen this type of movement before. Lets see how it holds up.
lets see if if holds. Market closes at 1 today
several minutes ago there were over 124K shares on the ask @$1. We are going to need a lot of buying to get past $1. Since then that number has been cut in half.
I am not saying they are sitting back. However, material events need to happen. The market does not care about how well the drugs work. If they did we would not be sitting at .87 cents.
Vorlon, on April 17th 2014 institutional ownership was 6.1% on scottrade. As of today (and since the up listing) it shows up at 6.8%. Not much of an increase. I don't believe the funds have really stepped in.
Snidely, that may or many not happen. IMO there are several things that can happen to affect the SP over the next 6 months
- A China deal and / or
- A India deal
- A buyout offer
- Combo agreements
There are also events like
- The announcement of phase 3 enrollment for PV-10 melanoma
- The announcement of phase 2 liver start
- Any positive Moffitt results (or other clinics)
If management sits back and twiddles their thumbs until next year, then yes we will eventually be delisted and the SP will fall into the abyss.
Thanks Vorlon. I will sit back and give them to December. Management does not have to strike a deal before the start of Phase 3. Even the sites (China, India) can be introduced half way through the phase 3 trial.
You are correct about Peter's comments and the PR wording. However, as you know, you can not hang your hat on any of that. We have been through this before. As a result I remain skeptical.
I have been long for well over 3 years. Should of taken some off the table when it hit $5 - $6. But I did not. I am in it for the long term.