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Pernix Therapeutics Holdings, Inc. Message Board

yyyprionyyy 80 posts  |  Last Activity: Jul 9, 2014 8:22 AM Member since: Jan 13, 2004
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  • 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.'

  • Reply to

    Orchestrated Hit

    by beadkong Jun 9, 2014 7:26 PM
    yyyprionyyy yyyprionyyy Jun 10, 2014 9:48 AM Flag

    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.

  • Reply to

    Shorts are pounding at 80 cents

    by tejdem1 Jun 6, 2014 3:41 PM
    yyyprionyyy yyyprionyyy Jun 7, 2014 10:24 AM Flag

    must be the dark pool and SEC is cracking down.

  • 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

  • yyyprionyyy yyyprionyyy May 23, 2014 2:51 PM Flag

    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.

  • Reply to

    asco news

    by yyyprionyyy May 22, 2014 10:36 AM
    yyyprionyyy yyyprionyyy May 22, 2014 10:37 AM Flag

    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.

  • yyyprionyyy by yyyprionyyy May 22, 2014 10:36 AM Flag

    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

  • Reply to

    Feurstein "PVCT data is meaningless"

    by tejdem1 May 20, 2014 7:32 PM
    yyyprionyyy yyyprionyyy May 21, 2014 8:31 AM Flag

    will get it done today

  • yyyprionyyy yyyprionyyy May 20, 2014 9:27 AM Flag

    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.

  • yyyprionyyy yyyprionyyy May 20, 2014 7:51 AM Flag

    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 ...

  • Reply to

    DR from MD Anderson

    by tejdem1 May 19, 2014 9:24 AM
    yyyprionyyy yyyprionyyy May 19, 2014 10:19 AM Flag

    @DrSapnaPatel awesome
    her data...
    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

    Primary Appointment

    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

  • Monday 5/19 brings cheers for PVCT longs.
    Data going to be relaesed over the weekend..

  • yyyprionyyy yyyprionyyy May 16, 2014 2:10 PM Flag

    BTD is a done deal for PVCT , you clown,

  • yyyprionyyy yyyprionyyy May 16, 2014 2:10 PM Flag

    you keep shorting troll... u will get burned.
    Provectus Rose Bengal is a home remedy for ages. Now modern medicine man can capitalize on Indian Home remedy like Turmeric. Remember c=some clowns tried to patent turmeric?

  • yyyprionyyy yyyprionyyy Apr 11, 2014 8:52 AM Flag

    Liver Metastasis
    •    Phase 1 protocol expansion September 2012 through 2013 into 2014
    •    Orphan drug status April 2011
    •    Phase 1 patient accrual and treatment completed January 2011
    •    Phase 1 study initiated October 2009

    Mechanism of Action

    Moffitt Cancer Center initiates Phase 1 feasibility study to detect immune cell infiltration into melanomas treated by PV-10 in January 2013 into 2014
    In addition to clinical trials, patients enrolled in the compassionate use or expanded access program for PV-10 are also receiving PV-10 treatments.
    In addition to clinical trials, patients enrolled in the compassionate use or expanded access program for PV-10 are also receiving PV-10 treatments.
    In addition to clinical trials, patients enrolled in the compassionate use or expanded access program for PV-10 are also receiving PV-10 treatments.

    How many more in the patients enrolled in the compassionate use ????????? Anyone???

  • We focus on developing our prescription drug candidates PV-10 and PH-10. We are developing PV-10 for treatment of several life threatening cancers including metastatic melanoma, liver cancer, and breast cancer. We are developing PH-10 to provide minimally invasive treatment of chronic severe skin afflictions such as psoriasis and atopic dermatitis, a type of eczema. We believe that our prescription drug candidates will be safer and more specific than currently existing products. All of our prescription drug candidates are in either the pre-clinical or clinical trial stage
      •    Prepare for Breakthrough Therapy Designation request 2013 into 2014
    •    Finalized Phase 2 data October 2012 and September 2013
    •    End-of-Phase 2 FDA meeting April 2010, March 2011, and October 2011
    •    Phase 2 study completed May 2010
    •    Phase 2 treatments completed September 2009
    •    Phase 2 recruitment completed May 2009
    •    Phase 2 study initiated September 2007
    •    Orphan drug status January 2007
      •    Toxicity study research and development for advanced studies 2012, 2013 and into 2014
    •    Phase 2c randomized study final data collection February 2012
    •    Phase 2c randomized study initiated December 2010 and completed August 2011
    •    Phase 2 study completed April 2010
    •    Phase 2 recruitment completed October 2009
    •    Replacement Phase 2 initiated July 2009 due to dose regimen change
    •    Phase 2 study initiated November 2007
    Atopic Dermatitis
      •    Toxicity study research and development for advanced studies 2012, 2013 and into 2014
    •    Phase 2 study completed September 2009
    •    Phase 2 recruitment completed June 2009
    •    Phase 2 study initiated June 2008
    Breast Cancer
      •    Assessing further development 2013 and 2014 in conjunction with Moffitt Cancer Center research
    •    Phase 1 study completed July 2008
    •    Phase 1 initial cohort treatment completed April 2006
    •    Phase 1 study initiated October 2005
    Liver Metasta

    Sentiment: Strong Buy

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