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Provectus Biopharmaceuticals, Inc. Message Board

  • darrell-v@hotmail.com darrell-v Feb 24, 2014 4:59 PM Flag

    corperate UPDATE

    plans for pvct per company presentation:
    Oncology (PV-10)
    – Melanoma: finish development with FDA for approval via BTD or
    otherwise, TGA, Immunology studies (MOA) via Moffitt Cancer Center
    – Liver: Meet with FDA, begin Phase 2/3
    – Continue expanded and compassionate use programs
    – Investigate new indications
    – Look to secure regional licensees (with Japan, or Korea, or Other
    parts of Asia) ahead of other territories (chiefly Europe/US) with
    major pharmaceutical company
    • Dermatology (PH-10)
    – Report Phase 2C results, End-of-Phase 2 FDA meeting, Tox work
    – Continue MOA studies via leading research facility
    – Complete pharmaceutical licensure talks at appropriate valuation
    • Corporate Governance
    - List on a national exchange (NASDAQ or NYSE Euronext) when
    appropriate
    30

    ---------------------------------------------------------------
    There is a strong patent portfolio, which includes the
    following recent announced patents:
    – “Combination of Local and Systemic Immunomodulative
    Therapies for Enhanced Treatment of Cancer,” which
    covers a method of treatment of cancer that comprises
    administering a therapeutically effective amount of an
    intralesional chemoablative pharmaceutical composition
    in combination with a therapeutically effective amount of
    a systematic immunomodulatory anticancer agent.
    – “Process for the Synthesis of 4,5,6,7-tetrachloro-3’,6’-
    dihydroxy-2’,4’,5’,7’-tetraiodo-3Hspiro[
    isobenzofuran-1,9’-xanthen]-3-one(Rose Bengal)
    and Related Xanthenes ,” which details a new process for
    the manufacture of Rose Bengal and related iodinated
    xanthenes in high purity.
    – “Medicaments for Chemotherapeutic Treatment of
    Disease,” which provides detailed protection of the
    Company’s investigational oncology drug PV-10, an
    injectable formulation of Rose Bengal
    ------------------------------------------------------
    Strategy:
    ? First indications being targeted are psoriasis and atopic
    dermatitis (eczema), both of which are available for outlicensing.
    ? It is planned to then develop PH-10 for all inflammatory
    dermatoses.
    • Characteristics:
    ? 0.001% to 0.01% Rose Bengal topical gel
    ? Hydrogel for direct application to skin
    ? Activated by ambient (green) light
    • Advantages:
    ? Robust positive response comparable to competitors, but
    also with little or no systemic uptake and negligible side
    effects.
    ? No substantial rebound after 4 weeks (unlike steroids). No
    immuno-suppressant characteristics and no skin thinning
    evident. Potential for repeated use.
    24
    Advantages (cont.):
    – No detectable vehicle effects
    – Unique lack of toxicity
    – No prolonged photosensitivity
    • Goal:
    – Final product to allow patient to self treat as necessary
    • Clinical Status:
    – Phase 2C RCT psoriasis study with vehicle, 2x, 5x, 10x
    drug
    – Report Phase 2C results, End-of-Phase 2 FDA meeting,
    Tox work
    – Continue MOA studies via leading research facility
    • BizDev Status: Licensure talks underway
    -------------------------------------------------------
    • Melanoma
    ? Finish development with FDA for approval via BTD
    and/or AA, TGA, Immunology studies (MOA) via
    Moffitt Cancer Center.
    • Liver
    ? Next step is to complete the expanded Phase 1 trial
    ? Meet with FDA, begin Phase 2/3
    • Continue with expanded and compassionate use
    programs and investigate new indications
    --------------------------------------------------------
    utpatient setting
    ? No pre-treatment or post-treatment care required
    ? Well-tolerated intratumoral injections
    ? no co-treatment needed
    ? Minimal adverse impact on quality of life
    • Treatment Decision
    ? Medical or Surgical Oncologist
    • Treatment Delivery
    ? Performed by Interventional Oncologist
    • Anticipated Reimbursement
    ? Chemotherapy
    ? Procedure
    • Potential driver of adoption
    19
    PV-10: Treatment (minimally invasive)
    and Commercial Channel
    -----------------------------------------------------------
    Phase 1 trial
    – Single, direct injection of PV-10 into tumor
    – 2 groups low/high dose of 3 tumors each
    – Follow for 28 days using CT and functional MRI
    – Follow 9 to 15 months PET/CT; continued to follow
    thereafter
    • Trial Results
    – 5 HCC tumors: substantial ablation with sustained
    regression, no disease per PET/CT at 9-15 month check-up
    – 1 Colorectal (met): substantial ablation with sustained
    regression, no disease at 9-15 month check-up per PET/CT,
    other large bystander mets regressing as well
    • Amended and expanded the scope of PV-10-LC-01 to include
    safety and efficacy in up to 24 additional patients
    • Follow-up trial: Phase 2/3 for accelerated approval, PV-10 +
    Sorafenib vs Sorafenib, RCT, survival endpoint
    18
    PV-10: Liver Tumor Treatment
    ----------------------------------------------
    PV-10: Moffitt Cancer Center
    Single Injection May Revolutionize Melanoma Treatment, Moffitt Study
    Shows
    • The initial study appears in PLOS ONE, an open-access, peerreviewed
    online journal.
    • In the initial study, researchers injected a single dose of PV-10 into
    mice with melanoma. The result was a significant reduction in the
    skin cancer lesions, as well as a sizable reduction in melanoma
    tumors that had spread in the lungs. The researchers said the dye
    solution appeared to produce a robust anti-tumor immune
    response and may be safer than existing immunological agents.
    • “Various injection therapies for melanoma have examined over the
    past 40 years, but few have shown the promising results we are
    seeing with PV-10,” said Shari Pilon-Thomas, Ph.D., assistant
    member of Moffitt’s Immunology Program.
    • “We are currently in the middle of our first human clinical trial of
    PV-10 for advanced melanoma patients. In addition to monitoring
    the response of injected melanoma tumors, we are also measuring
    the boost in the anti-tumor immune cells of patients after
    injection,” explained Amod A. Sarnaik, M.D., assistant member of
    Moffitt’s Cutaneous Oncology Program.
    -----------------------------------------------------------------
    PV-10: Systemic Effect
    Combination of PV-10 Immuno-chemoablation and Systematic anti-
    CTLA-4 Antibody Therapy in Murine Models of Melanoma
    • Intermittent intralesional exposure to PV-10 in Phase 2 testing
    (limited to 4 doses over 14 weeks) resulted in locoregional disease
    control (CR+PR+SD) in 69% of patients.
    • PV-10 is highly effective when all existing tumor is accessible for
    injection, providing rapid reduction in tumor burden (both in animal
    models and clinically in cancer patients).
    • Tumor ablation with PV-10 induces tumor-specific immunity.
    • Rapid, permanent local ablation in combination with induction of
    tumor-specific immunity afforded by PV-10 comprises a uniquely
    powerful approach that may be complementary to many systematic
    therapies, while its distinctive adverse effect profile and
    pharmacology minimizes potential for drug interaction.
    • For visceral or other inaccessible disease, the combination of PV-10
    with CTLA-4 blockade has important potential for synergy.
    • Apparent toxicity of high dose 9H10 markedly reduced the effect of
    both 9H10 alone and the combination of PV-10 + 9H10, although
    the combination remained more effective than 9H10 alone at the
    high dose.
    -------------------------------------------------------------
    • Completed Phase 2 trial in May 2010
    – 80 subjects in the US and Australia (7 sites)
    – Possible retreat after 8, 12, 16 weeks, Interim data for 20 and 40
    subjects after 6 months, 12 month follow-up
    – ORR, PFS, Imaging of visceral metastases, Quality of life
    – Well tolerated and elicited a robust response in a majority of
    subjects
    – Bystander responses noted for cutaneous and visceral mets
    – Adverse Events include photosensitivity, locoregional injection site
    reactions (blisters, oedema and injections site pain) not grade 4 or 5
    • As noted in the press release on December 18, 2013, the Company will
    communicate guidance of pathway to approval of PV-10.
    • Established path to Provisional Approval with TGA.
    • Presented PV-10 Phase 2 final data for metastatic melanoma at
    European Society for Medical Oncology (ESMO) 2012 Congress in Vienna
    – October 2012.
    • Presented PV-10 data at ECCO 2013 in Amsterdam – September 2013.
    ----------------------------------------------------------------
    Strategy: Demonstrate broad spectrum efficacy for multiple
    cancer indications
    • 10% Rose Bengal solution
    – Direct injection into solid tumors
    – Simple and effective ablative impact
    – May stimulate immune system response
    • Lead clinical trial: Recurrent melanoma (orphan status,
    Accelerated path or BTD, TGA)
    • Background trials
    – Breast carcinoma Phase 1 (completed)
    – Liver/mets Phase 1 (completed), Orphan status, Amended
    and expanded the scope of PV-10-LC-01 to include safety
    and efficacy, Planning Phase 2/3
    – Expanded and compassionate use programs
    – Immunology study of bystander response
    – New indications (pancreatic cancer; bladder cancer
    ----------------------------------------------------------
    Rose Bengal: Unique Compound
    • Rose Bengal is a small molecule Fluorescein derivative attributed to Gnehm
    1882.
    • No known toxicity - therapeutics benefit unrealized until sufficient quantities
    administered. (Ito. A and Watanabe H. paper).
    • PV-10 is a sterile, non-pyrogenic solution of Rose Bengal Disodium (10% RB)
    for intralesional injection.
    • Unique dual mode of action – chemoablative effect and immunomodulatory:
    1) Kills cancer tumors that it is injected into; selectively transits (passes
    through) the cell membrane and accumulates in lysosomes forcing
    cell death (no biochemical action or effect).
    2) Attracts tumor-specific T-cells; up-regulating immune effect,
    allowing systemic effect on bystander legions. As tumor burden is
    reduced, immune system is enhanced (possible to obtain this
    systemic effect simply by treating lesions locally).
    • PV-10 has no known resistance; unlike other oncology drugs. Can continue to
    be used even after recurrence if occurs in first place. Kills cancer cells and
    enlists the immune system to kill whatever cancer cells remain elsewhere in
    the body.
    • PH-10 photosensitive effect. Apparent local down-regulating action on
    aberrant immune expression in skin.
    • PH-10 has no substantial rebound after 4 weeks, unlike steroids. No systemic
    immune-suppressant characteristics and no skin thinning.
    -----------------------------------------------------------
    Clinical progress a catalyst for increased valuation
    – Oncology: Melanoma approvable pathway (via FDA, TGA),
    Breakthrough Therapy Designation application for PV-10
    for melanoma, Liver Phase 2/3, Compassionate use
    program, Immunology studies via Moffitt Cancer Center,
    Tampa, Florida
    – Dermatology: Licensure off completed Phase 2 and Phase
    2C trials, Tox work, MOA work via leading research facility
    • Emphasis now on establishing paths to licensure, broadening
    clinical applications and expanding business development
    3

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