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Vical Incorporated Message Board

  • nakedna nakedna Nov 12, 2012 1:24 PM Flag

    Shock & Awe

    Over a year ago during a conference call Vijay mentioned that Vical hopes the results of the phase 3 trial achieve more than simple FDA approval. He said Vical was looking past approval to marketing and demonstrating as great a competitive advantage as possible.

    It occurs to me that a lot of free publicity could be important in grabbing market share, especially when off-label use is factored in. Let's face it.....a 30% response rate would be terrific for this tough disease but it's not likely to grab headlines when 70% of patients don't achieve a clinical response. This statistic unfortunately ignores one of immuno-therapy's major strengths....the prevention of new metastases.

    A 1 cm lesion contains about a billion cancer cells. That's a lot of work for the immune system to handle, especially considering the lesion isn't static but is rapidly increasing in size and those billion cells are producing cytokines to turn off an effective immune response. Destroying a new microscopic metastasis on the other hand is a much simpler matter but success doesn't help your response rate stats. Since typically it's new metastaces spreading to vital organs that kills you, preventing this should have a major impact on survival.

    Imagine the excitement that would be produced if A-7 doubles or triples DTIC's median survival. Imagine how many headlines this could generate. Yervoy grabbed major headlines with only a 4 month improvement.

    And imagine how many other solid tumor cancer patients would be making appeals to their oncologists for a treatment with the mild side effects of A-7 and the vastly improved Quality of Life compared to traditional chemo's side effects.

    From a marketing perspective, when the public first finds out about A-7, it's the survival advantage we want them buzzing about not the response rate. With the new timeline for results, we will have complete 3 year survival statistics up and ready for reporting and they could be really eye opening.

    Sentiment: Strong Buy

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    • Yes, and I've been positive on VICL for years, but am now worried about competitive advantage. The Celgene news today for Abraxis drug looks promising. VICL really has to have great results.

      "Some analysts had viewed the price paid by Celgene for Abraxis as excessively high; but subsequent positive results of the drug in lung cancer, melanoma, and now pancreatic cancer, suggest the price may have been justified.

      In October the company released results of a late-stage clinical trial showing patients with melanoma lived for a longer period without getting worse than those who received the chemotherapy dacarbazine.

      Analysts say the drug will probably need to show that it also improves overall survival in patients with melanoma if it is to be competitive with Bristol-Myers Squibb's (BMY.N) Yervoy and Roche Holding AG's (ROG.VX) Zelboraf."

      Sentiment: Hold

      • 1 Reply to kdbutler1999
      • Read the whole article at Cancer Gene Therapy about multiple mechanisms of action (MOA), adverse events for other therapies, and enhancement of T cell response.

        Melanoma accounts for a minority of skin cancer diagnoses but at the same time results in the great majority of skin cancer deaths. Incidence trends have steadily increased for the last several decades to a 2012 estimate of over 76 000 diagnoses and 9000 deaths in the United States alone.1 Encouragingly, two new therapeutic options were recently approved based on survival benefits, the small molecule vemurafenib (Zelboraf), which targets the BRAFV600E mutation,2 and the monoclonal antibody ipilimumab (Yervoy), which binds to and blocks CTLA-4 (CD152).3 Unfortunately, these new therapies are also associated with an increased risk of adverse events, and further investigation is needed to identify additional therapies as well as combinational approaches. It is encouraging then that the momentum towards new treatment options continues with other therapeutics in advanced clinical trials, among these velimogene aliplasmid (Allovectin).4

    • I'll take shock.......great post

    • You don't have to worry about them buzzing on the response rate. Just check out the phase 2 results

1.09-0.01(-0.91%)Nov 21 4:00 PMEST

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