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Theodore Cohen  

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  • Dendreon's Provenge: A Major Focus At The European Cancer Congress 2013 [View article]
    Thanks for your input, William...always appreciated.

    The combination of Provenge and Xtandi is an interesting one. There has been at least one case where sequencing the two treatments has resulted in an undetectable PSA for the patient involved. I covered this in an earlier article.

    http://seekingalpha.co...

    We await the initiation of Dendreon's trial sequencing the two agents.

    Ted
    Sep 18, 2013. 04:22 PM | Likes Like |Link to Comment
  • Dendreon's Provenge: A Major Focus At The European Cancer Congress 2013 [View article]
    After everything that's happened, everything you say would be nice to see.

    Ted
    Sep 18, 2013. 01:24 PM | Likes Like |Link to Comment
  • Dendreon's Provenge: A Major Focus At The European Cancer Congress 2013 [View article]
    You answer may come, in part, when we learn more about any ROW partnership established to market Provenge in Europe.

    Ted
    Sep 17, 2013. 10:11 AM | Likes Like |Link to Comment
  • Dendreon's Provenge: A Major Focus At The European Cancer Congress 2013 [View article]
    Congrats to Johnson & Company, you mean.

    Ted
    Sep 17, 2013. 09:02 AM | Likes Like |Link to Comment
  • Dendreon's Provenge: A Major Focus At The European Cancer Congress 2013 [View article]
    Dendreon Announces Marketing Authorization for PROVENGE(R) in the European Union

    SEATTLE--(BUSINESS WIRE)-- September 17, 2013 — Dendreon Corporation (DNDN) today announced that the European Commission has granted marketing authorization for PROVENGE® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or sipuleucel-T) dispersion for infusion in the European Union for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. This final decision by the EC follows recent positive opinions from both the European Medicines Agency (EMA) Committee for Advanced Therapy and the Committee for Medicinal Products for Human Use (CHMP) recommending that PROVENGE be granted marketing authorization in the EU.

    The marketing authorization provides approval for the commercialization of PROVENGE in all 28 countries of the EU as well as Norway, Iceland and Liechtenstein.

    John H. Johnson, chairman, president and chief executive officer of Dendreon said, "The marketing authorization of PROVENGE in the EU represents an important achievement for Dendreon. As the first personalized immunotherapy approved for the treatment of mCRPC in Europe, PROVENGE may help extend the lives of appropriate prostate cancer patients."

    "With sipuleucel-T, we have the potential to create a new treatment paradigm in advanced prostate cancer, with the integration of this novel therapy to harness a patient's own immune system to fight their cancer," said Prof. Karim Fizazi, M.D., Ph.D., Head of the Department of Cancer Medicine, The Institut Gustave Roussy, Villejuif, and Full Professor in Oncology, the University of Paris, France.

    The European marketing authorization for PROVENGE was granted based upon data from three randomized, placebo-controlled, multi-center Phase III studies, which enrolled 737 patients. In the pivotal Phase III IMPACT study, an improvement in overall survival (OS) was observed, with a median survival of 4.1 months longer in patients who received PROVENGE versus those who received placebo (HR=0.775, 95%-CI 0.614, 0.979, P =0.032). Similar effects were observed in the two supportive studies.

    "This milestone demonstrates the importance of providing a new therapeutic option with a differing mechanism of action than other approved treatments for appropriate prostate cancer patients in the EU," said Mark Frohlich, executive vice president of research and development and chief medical officer of Dendreon. "We continue to enroll patients in the EU open-label study, and plan to have a presence at the upcoming European Cancer Organization (ECCO) and European Society for Medical Oncology (ESMO) conferences."
    Sep 17, 2013. 08:41 AM | 3 Likes Like |Link to Comment
  • Vical's Herpes Vaccine: An Update [View article]
    You'll have to contact the company directly for more information, Kyle.

    Ted
    Sep 17, 2013. 07:34 AM | Likes Like |Link to Comment
  • Vical's Herpes Vaccine: An Update [View article]
    Kyle,

    I don't have direct knowledge of Vical's intent, but their public comments on electroporation appear pretty straightforward. I am aware that Vical explored various electoporation devices in the past, but abandoned them a couple of years ago because they worked no better than the company's own Vaxfectin adjuvant. Their conclusions, which seemed to put a definitive end to Vical's electroporation research, were presented at the DNA Vaccines conference in 2011 and summarized in the following press release:

    http://bit.ly/1aOBk5R.

    So, the lack of efficient DNA vaccine delivery appears to be a myth perpetuated by the electroporation companies. It's not that electroporation doesn't work. It's just that electroporation is cumbersome, expensive, uncomfortable for the patient, and unnecessary if the vaccine is properly dosed and properly formulated. After all, the most advanced DNA vaccine to date - the only one to reach Phase 3 - is the Vical/Astellas CMV vaccine ASP0113, which seems to work fine without electroporation.

    Hope that's helpful,

    Ted
    Sep 16, 2013. 06:52 PM | 1 Like Like |Link to Comment
  • Dendreon's Provenge: A Major Focus At The European Cancer Congress 2013 [View article]
    Hi, Adam. And thanks for the Tweets (you and Brad). As they say, there is no such thing as bad publicity.

    Yeah, repositioning my resources...a definite BUY signal on Dendreon. BTW, is Brad still sore at me because of the loss he took on his one share?

    Be well. Happy New Year to you and the family.

    Ted
    Sep 16, 2013. 06:42 PM | 2 Likes Like |Link to Comment
  • Dendreon's Provenge: A Major Focus At The European Cancer Congress 2013 [View article]
    Excellent question.

    No, I think they have a management team that is up to the job. But they have a lot of headwinds, not the least of which is the restricted label. And they need to move quickly to reduce the cost of goods sold and the cash burn. Being up against the JNJ marketing machine doesn't help.

    Be well.

    Ted
    Sep 16, 2013. 05:58 PM | Likes Like |Link to Comment
  • Dendreon's Provenge: A Major Focus At The European Cancer Congress 2013 [View article]
    Tax considerations and the desire to reposition resources elsewhere. I have been adding all summer to positions in GILD and REGN.

    Ted
    Sep 16, 2013. 04:40 PM | Likes Like |Link to Comment
  • Dendreon's Provenge: A Major Focus At The European Cancer Congress 2013 [View article]
    Don't assume anything, Wheaton.
    Sep 16, 2013. 04:05 PM | Likes Like |Link to Comment
  • Dendreon's Provenge: A Major Focus At The European Cancer Congress 2013 [View article]
    I sold my few remaining shares to use the tax loss against gains in other biotech stocks that have performed better this year (e.g., CELG).

    Ted
    Sep 16, 2013. 10:37 AM | 1 Like Like |Link to Comment
  • Dendreon's Provenge: A Major Focus At The European Cancer Congress 2013 [View article]
    Thanks. It's an interesting confluence of events...this conference and the possible release of information on EU approval (which could occur at any time).

    Ted
    Sep 16, 2013. 09:43 AM | 1 Like Like |Link to Comment
  • Vical's Herpes Vaccine: An Update [View article]
    Thanks, RP...but not, I haven't been following that sector, nor that issue. Sorry.

    Ted
    Sep 16, 2013. 09:41 AM | Likes Like |Link to Comment
  • Dendreon's Provenge: A Major Focus At The European Cancer Congress 2013 [View article]
    There is no denying it will be a positive.

    Ted
    Sep 16, 2013. 07:47 AM | 1 Like Like |Link to Comment
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