Big blocks of PVCT like 20000 and 2500 going thru silently at asking price of .80. what's going on?
Any news coming ?
6:17 am Provectus Pharma data presented at ESMO 2014 Congress show ablative, bystander effects of PV-10; data enables design of Phase 3 RCT for melanoma (PVCT) : Co announced that data on its investigational agent PV-10 for intralesional treatment of locally advanced cutaneous melanoma was featured in a poster presentation on Sep 28, 2014 during the European Society For Medical Oncology 2014 Congress in Madrid, Spain.
The presentation showed that PV-10 elicits a high rate of response in injected tumors through its ablative effect, and additionally, that the durability of response as well as the bystander response in uninjected tumors implicate an additional immunologic mechanism secondary to ablation.
Tumors were no longer detectable (complete response or CR) in 26% of the study population. This response was particularly evident in patients who had all existing lesions injected with PV-10 (i.e., All Lesions Treated subgroup, 50% CR; Confidence Interval: 31-69%). These 28 patients had as many as 20 lesions confined to the skin, and experienced a mean PFS of 9.8 months. For an additional 26 patients who had all their disease treated with the exception of 1-2 designated, untreated bystander lesions, mean PFS was 8.9 months. +
These data from this subgroup analysis support the potential of PV-10 as a single agent and provide a rationale for a PV-10 phase 3 randomized controlled trial in locally advanced melanoma patients.
does anybody care for Melanoma cure? PVCT sure does. Not A scam. Ask Moffit docs
Sentiment: Strong Buy
Novartis (NVS) announced that the FDA has granted Breakthrough Therapy Designation to its pipeline candidate, CTL019.
Novartis is evaluating CTL019, an experimental chimeric antigen receptor (CAR) therapy, for the treatment of pediatric and adult patients suffering from relapsed/refractory acute lymphoblastic leukemia (r/r ALL).
CTL019 uses CAR technology to reprogram a patient's own T cells to look for cancer cells which express specific proteins, called CD19. Once reprogrammed, the T cells (called CTL019 after reprogramming) are released into the patient's blood so as to proliferate and bind to the targeted CD19+ cancer cells and destroy them.
The filing was submitted by the University of Pennsylvania's Perelman School of Medicine. We note that the university has an exclusive global agreement with Novartis to research, develop and commercialize personalized CAR T cell therapies for the treatment of cancers. The university is currently conducting phase I/II trials on CTL019.'
PVCT management can issue .005 cent dividend to catch the shorts. They can borrow money from big Pharmas to negate the naysayers... The naked shorts have to come out of hiding to pay the dividends to those stockholders. That will be fun.
Extreme volatility today ?
How many drugs can have results like obliterate_cancer said
“Among the 54 patients in both of these subgroups (i.e., patients who had all of their disease monitored in the study), CR (Complete Response) was achieved in 232 of 363 injected lesions (64% CR).” without side effects. None.
what is this? Confidential treatment has been requested for portions of Exhibit 99.2
PVCT can go to India and China and get data faster the results without sideeffects tell the story and FDA logic does not make sense. what other is even equivalent? Tell me one for melanoma?
Further data may cause the Agency to revisit this decision at a later date. In the notification letter the FDA stated, “We have reviewed your request and while we have determined that treatment of ‘locally advanced cutaneous melanoma’ meets the criteria for a serious or life-threatening disease or condition, the preliminary clinical evidence you submitted does not indicate that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
It is hard to believe the logic. PV-10 does not have side effects . all the other drugs do.. and that is not significant? Big pharmas are influencing FDA decision. It is time for PVCT to their business to India and China and forget about getting anything done in the US. I bet PVCT will move their business elsewhere.
Six of eight patients had metastatic disease refractory to previous ipilimumab, anti-PD-1 and/or vemurafenib therapy. Peripheral blood was collected pre-treatment, at the time of resection and four weeks after PV-10 injection.
Results showed treatment with PV-10 led to pathological complete response (pCR) in post-treatment biopsies of both PV-10-injected and uninjected bystander lesions in four of the eight patients, and all eight exhibited at least partial regression of the injected lesion. IL PV-10 was associated with an increase in circulating cytotoxic CD3 /CD8 T cells (paired t test, p=0.008).
“What’s really powerful about these results is that patients responded even after being refractory to the latest drugs including ipilimumab, anti PD-1 and/or vemurafenib,” said Wachter, adding it was unprecedented for a small molecule ablative agent to have this kind of immune system activity detectable in the peripheral blood of patients.
Both abstracts will be featured in the Poster Highlights Session, Melanoma/Skin Cancers, on June 2, 2014 during the American Society of Clinical Oncology (ASCO) Annual meeting in Chicago, Illinois.
PV-10 data for break through therapy designation application highlighted by ASCO 21 May 2014
by ecancer reporter Janet Fricker
Half of patients with locally advanced cutaneous melanoma who had all their lesions injected with the investigational agent PV-10 achieved a complete response, reports a subgroup analysis of an open label phase 2 study.
The sub-group analysis, released as an ASCO abstract (May 14, 2014), provides the basis for the pending breakthrough therapy designation application for PV-10 submitted to the FDA in March 2014.
PV-10, a 10% solution of Rose Bengal that was originally used as an agent to stain necrotic tissue in the cornea, has been developed to selectively target and destroy cancer cells without harming surrounding healthy tissue, minimizing the potential for side effects.
Between October 2007 and May 2010, 80 patients with Stage IIIB-IV melanoma received up to four treatment cycles of intralesional (IL) PV-10.
Altogether up to 10 cutaneous or subcutaneous target lesions and up to 10 additional non-target lesions received IL PV-10 at day 0 and could receive up to three further treatment cycles at weeks 8, 12 and 16 if tumour remained.
Furthermore, up to two ‘bystander’ lesions were identified that underwent biopsy to confirm melanoma, but did not receive treatment.
The subjects, recruited from seven centres in the USA and Australia, all had locally advanced disease refractory to a median of six previous interventions.
In the current abstract, Sanjiv Agarwala, from St. Luke's Hospital and Health Network, Bethlehem, Pennsylvania, explored the subgroup of 54 patients from the phase 2 study who were able to have most or all of their lesions injected, leaving out patients with more advanced disease where substantial numbers of lesions went untreated from the analysis.
Results showed that for 28 patients who had all their existing melanoma lesions injected with PV-10 (i.e. had no uninjected lesions) the overall response rate was 71% (CI
Rose Bengal is old science in India. They use it in Ayurvedic medicine for ages. The Idiots will never understand and will call it "New" science. Idiots.
The small sample population, if extrapolated to the population, reflects a very high %age of success with no adverse effects or death. How do you take that into account. Every other failed BTD had much higher failure rates.
Adam Feuerstein @adamfeuerstein · 4h
$PVCT ringing opening bell at NYSE. Must mean Rose Bengal is blockbuster skin cancer drug. Why else would NYSE allow CEO to press a button?
I wish more Cancer docs can talk openly about breakthru medical cures withour fear and stick with the facts.
This will keep guys like Adam Feurstein challenged ...
Melanoma oncologist at MD Anderson Cancer Center. I specialize in uveal melanoma as well as melanoma of the skin and mucous membranes. Tweets are my own.
Present Title & Affiliation
Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
Director of Online Media, Department of Melanoma Medical Oncology, Houston, TX