January 4, 2012

Digging Deeper

Some thoughts about OMP's research note:
  • "Because melanoma is a cancer type where drug development has been historically tricky, pharma interest maybe high with suitors lurking around to assess the complexity and feasibility of an FDA endorsed phase III design before pulling the trigger to in-license PV-10 or acquire PVCT." 
    • When the FDA blesses the MM Phase 3 design, the beginning of the end-game will be at hand.
  • "...they also realized that being a diagnostic agent RB was already FDA approved for IV therapy and at much higher doses than what would be needed for cancer. Furthermore, thru decades of use, its safety is well established and all preclinical and animal toxicity studies have already been performed historically and are on-file at the FDA. Now as PVCT proceeds with clinical work in cancer and dermatology indications, their FDA dossier will be significantly easier than if RB was a brand new agent."
    • While competing scientists might well kick themselves, for years to come, for not deducing rose bengal's potential use as an anti-cancer agent, skeptics and critics of management might well kick themselves for not fully realizing the importance of rose bengal's historical safety profile in easing the journey from anti-cancer candidate agent to approved agent.
  • "This dual approach of cell- destruction and immune triggering is very potent."
    • Chemoablative immunotherapeutic
  • "PVCT has approached the FDA with a draft phase III trial design wherein ~300 patients could be treated with PV-10 (or control [standard of care]) for a primary endpoint of modified PFS. Should the trial demonstrate success on PFS the sponsors will apply for accelerated approval of PV-10 but keep the trial running to completion for an overall survival (OS) endpoint. It may be several years until the OS endpoint is achieved but in the meantime PVCT will be able to market the agent under the accelerated approval based on statistically and clinically superior PFS results."
    • Management is pursuing AA as a parallel track [to their Phase 3/SPA track] based on Moffitt's immunology work. OMP's connection of the Phase 3 trial and AA is very interesting to read. Is there a connection? Did OMP accurately state this?
  • "While they admit to pharma/biotech companies interest in partnering the cancer indications of PV-10, we believe that no deal can be struck without PVCT getting a consent from the FDA regarding their phase III trial design."
    • How quickly does Pfizer and/or other big pharma companies initiate discussions with Provectus after the FDA blesses management's Phase 3 trial design?
  • "PV-10 has been tested in both...[HCC and breast]...indications in 6 and 12 patients, respectively in phase I trials. In both trials 10% RB was found to be safe and well tolerated and demonstrated tumor ablation in a majority of patients."
    • Management has not discussed the breast cancer trial much. So it is, again, interesting to see OMP discuss efficacy, which previously only was alluded to by the company (see here).
  • "RB has an "old" agent; the composition of matter patent has expired but PVCT has recently filed a synthesis patent that spells a method to manufacture this agent that is devoid of any impurities and is the only formulation that meets the FDA's ICH guidelines. This patent maybe as robust as a composition of matter patent because without using this synthesis protocol, medicinal grade RB can never be synthesized."
    • Management's IP protection work is undervalued and under-appreciated.
  • "With a cash position of $14.4MM and three large pivotal trials in the design stage (MM, phase 2/3 in HCC versus sorafenib and psoriasis), it seems logical that PVCT will require additional capital imminently, yet management insists that they are well capitalized thru YE2013. This indicates that management has its sight-set on one or more large licensing deals in 2012. The upfront payments from such deals will provide funds for phase III trials to start, and the partners will continue to fund development in a joint venture."
    • Provectus has the $30MM equity line of credit from Lincoln Park Capital and two $50 million shelf filings. The LOE and shelf filings are more effectively used of course (i.e., to minimize dilution) when the share price is [much] higher, which should happen when the company receives an SPA and/or a dermatology license is announced. Management should have sufficient financial resources readily available to conduct its pivotal trials if it so desires.

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