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Dendreon $DNDN DowN but not DoNe ... sipuleucel-T (Provenge)


A Custom Vaccine to Fight Prostate Cancer

Prostate cancer can be stubborn. It can be prolific in its ability to spread and grow. But you already know this—particularly if you’ve been fighting a very nasty form of the disease that will claim the lives of nearly 30,000 men in 2014. “For men with aggressive metastatic prostate cancer that has spread to the bones or other locations in the body, it can be very disheartening. Especially if they are battling stage 3 or 4 castrate-recurrent prostate cancer that no longer responds to hormone therapy,” says Clif Vestal, M.D., a cancer specialist with USMD Prostate Cancer Center.

“Provenge is a custom vaccine made specifically for each patient using his white blood cells. The vaccine stimulates the man’s immune system to kill prostate cancer cells,” says Dr. Vestal. “We all know that our immune system fights off colds, the flu and other viruses that make us ill. But because cancer cells begin as normal, healthy cells, the immune system doesn’t recognize them as a threat to the body. Provenge works around this by stimulating the immune system to recognize and fight certain proteins that are specific to cancer cells.” 

“The main benefit of Provenge is it can help men with advanced prostate cancer live longer,” Dr. Vestal says. “And that is very important.”

Provenge is covered by Medicare and many private health insurance providers. When it was first approved by the Federal Drug Administration and made available in 2010, it sparked spirited discussion and debate among prostate cancer advocates. Its most vocal critic—Marie Huber, a high-profile Cambridge University-educated biochemist turned New York hedge fund analyst—was discredited when it was learned that she had falsified documents and failed to disclose she had a financial interest in the failure of Provenge. The Securities and Exchange Commission learned she had purchased $236,000 worth of options in Dendreon—the Seattle-based company that manufactures Provenge—betting that its stock price would drop during the controversy. In December 2013, she was fined by the SEC and barred from the securities industry for six months.

Now that the dust has settled, Provenge is providing men with another important treatment option. In fact, the National Comprehensive Cancer Network Prostate Panel lists sipuleucel-T (Provenge) as a category 1 recommendation for first-line treatment of asymptomatic patients with castration-resistant prostate cancer, and a 2a recommendation for second-line treatment for minimally symptomatic patients.

“Provenge can also help men prepare for chemotherapy since it helps boost the immune system,” says Dr. Vestal. “Most importantly, Provenge is another tool in our arsenal that we can use to help men live longer—even in the face of very aggressive metastatic prostate cancer.”
Read Full Article :  http://www.usmdpcc.com/news-custom-vaccine-to-fight-prostate-cancer.php
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Abstract:
   Results: The median time of enzalutamide therapy was 5.4 months (range: 1-13). In our cohort of 19 patients: 1 case showed radiographic full regression of metastatic lesions in bone, lung and lymph nodes. Another case showed radiographic full regression of bony metastatic lesions. 2 other cases – showed a partial regression radiographically of bony metastatic disease. 13 cases showed stable disease according to RECIST-criteria. The remaining 2 patients were deceased due to progression of mCRPC. The patients with full and partial response were in the lowest quartile of our cohort as defined as a PSA ≤ 3.87 ng/ml. On the contrary, all cases of progression and death were documented in highest (last) quartile as defined by a PSA level more than 84 ng/ml. Conclusions: Our experience demonstrates a promising effect using sequential sipuleucel-T immunotherapy followed by enzalutamide for mCRPC. To our knowledge this will be the first case of complete radiographic regression of lung, bone, and extensive lymph node disease.
Read full Abstract: http://meetinglibrary.asco.org/content/134803-144
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Dendreon Corporation (NASDAQ:DNDN) continues to see momentum in Provenge with strong KOL support and successful meeting with European Association of Urology (EAU). More than 70% of physicians agreed that Provenge should be used prior to Zytiga and Xtandi in mCRPC. http://www.fdaheadlines.com/dendreon-corporation-nasdaqdndn-presents-additional-data-for-provenge/#sthash.mpqQaaR5.dpuf

There seems to be broad consensus that Provenge should be first in line. The real question then is, “What should come second, Xtandi or Zytiga?” http://prostatesnatchers.blogspot.com/2014/02/xtandi-enzalutamide-star-of-10th-annual.html

Dr. Piezconka - Time to Chemotherapy Following Treatment with Sipuleucel-T: Data from PROCEED
#ASCO14 - Poster: Time to chemotherapy following treatment with sipuleucel-T: Data from PROCEED
http://ampofny.com/news/article/dr.-piezconka-time-to-chemotherapy-following-treatment-with-sipuleucel-t-data-from-proceed


However, if I am asked a slightly different question—“What type of new technology has the greatest potential for saving lives?”—my answer will always be the same for every patient: Immune therapy. MARK SCHOLZ, MD & RALPH H. BLUM http://prostatesnatchers.blogspot.com/2013/03/what-is-most-exciting-new-treatment-for.html
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As of this posting stock Price is @ $2.28
Latest Short interest data is in the neighborhood of 43M as of June 30th 2014 http://www.nasdaq.com/symbol/dndn/short-interest
here are some key stock statistics via http://finance.yahoo.com/q/ks?s=DNDN+Key+Statistics

Time and tide wait for no man. - Geoffrey Chaucer

"There is a tide in the affairs of men, Which taken at the flood, leads on to fortune. Omitted, all the voyage of their life is bound in shallows and in miseries. On such a full sea are we now afloat. And we must take the current when it serves, or lose our ventures." William Shakespeare