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All, it looks like Dendreon is moving onward to get Provenge approved by the
FDA. The press release also mentions some on-going clinical trials which you
will have to search for at www.clinicaltrials. gov (I would guess that
ProACT would be the most likely "fit". )
Take care,
Howard

Dendreon Completes Submission of Biologics License Application for PROVENGE
SEATTLE (November 2, 2009) - Dendreon Corporation (Nasdaq: DNDN) today
announced that it has completed the submission of the amended Biologics
License Application (BLA) for PROVENGER (sipuleucel- T), the Company's lead
investigational product, to the U.S. Food and Drug Administration (FDA).
Dendreon is seeking licensure for PROVENGE for men with metastatic
castrate-resistant prostate cancer (CRPC). If approved by the FDA, PROVENGE
would represent the first product in the new therapeutic class known as
active cellular immunotherapies.
The amended BLA includes data from the IMPACT (IMmunotherapy for Prostate
AdenoCarcinoma Treatment) trial, which was conducted under a Special
Protocol Assessment agreement with the FDA. The IMPACT study met its
pre-specified primary endpoint demonstrating a statistically significant
improvement in overall survival in men with metastatic CRPC.
"With the BLA submission complete, we have taken an important step towards
reaching our goal of bringing a new therapy to men with advanced prostate
cancer
," said Mitchell H. Gold, MD, president and chief executive officer of
Dendreon. "We look forward to working with the FDA to potentially make
PROVENGE the first active cellular immunotherapy to be licensed in the
United States."
PROVENGE is available through several ongoing clinical trials, including
openACT, an open label trial enrolling men with metastatic CRPC, ProACT
(PROstate cancer Active Cellular immunoTherapy) , and NeoACT (NEOadjuvant
Active Cellular immunotherapy) . For more information regarding these
studies, visit www.clinicaltrials. gov.
about PROVENGE
PROVENGE is Dendreon's investigational product candidate for men with
advanced prostate cancer and may represent the first in a new class of
active cellular immunotherapies (ACIs) specifically designed to engage the
patient's own immune system against cancer. PROVENGE and other ACIs are
uniquely designed to use live human cells to engage the patient's own immune
system with the goal of eliciting a specific long-lasting response against
cancer.
about Prostate Cancer
According to the American Cancer Society, prostate cancer is the most common
non-skin cancer in the United States and the third most common cancer
worldwide. More than one million men in the United States have prostate
cancer. An estimated 192,280 new cases are expected to be diagnosed in 2009.
Approximately 27,360 men are expected to die this year from the disease.

Post Edited (zufus) : 11/2/2009 12:17:58 PM (GMT-7)

Posted 11/2/2009 12:53 PM (GMT -7)
Zufas, can you give me a good layman's understanding of what it means to be hormone refractory? Seen the term used rarely, don't really understand its use or implication.
Age: 57, 56 dx, PSA: 7/07 5.8, 7/08 12.3, 9/08 14.5, 10/08 16.3
3rd Biopsy: 9/08 - 7/7 Positive, 40-90% Cancer, Gleason 4+3
Open RP: 11/08, Rht nerves saved, 4 days in hospt, on catheters for 63 days, 5th one out 1/09
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos margin
Post Surgery  PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Latest: 7/9 met 2 rad. oncl, 7/9 cath #6 - blockage, 8/9 2nd corr surgery, 8/9 cath #7 out  38 days, 9/9 - met 3rd rad. oncl., mapped  9/9, 10/1 - 3rd corr. surgery - SP cath/hard dialation, 10/5 - began IMRT SRT - 39 sessions/72 gys.

Posted 11/2/2009 1:13 PM (GMT -7)
Homone Refractory Prostate cancer is homone independent. Meaning prostate cancer cells that do not need testosterone or dihydrotestosterone to grow. HRPC is the deadliest form of prostate cancer as it no longer responds to hormone therapies.

Tony
Age 47 (44 when Dx)
Pre-op PSA was 19.8 : Surgery at The City of Hope on February 16, 2007
Gleason 4+3=7, Stage pT3b, N0, Mx
Positive Margins (PM), Extra Prostatic Extension (EPE) : Bilateral Seminal vesicle invasion (SVI)
Hormone Therapy May '07 to September '09 ~ Currently off.
IMRT radiation for 38 Treatments ending August 3, '07
Current PSA (October 7, 2009): <0.1

My journey is at: www.caringbridge.org/visit/tonycrispino

My InfoLink page is at Tony's Prostate Cancer InfoLink Page

STAY POSITIVE!

Post Edited (TC-LasVegas) : 11/2/2009 1:17:02 PM (GMT-7)

Posted 11/2/2009 1:17 PM (GMT -7)
Tony, does it start out working, then later ceases to respond? Or do the cells just not respond at all? If they work for a while, then are we talking about weeks, months, or years?
Age: 57, 56 dx, PSA: 7/07 5.8, 7/08 12.3, 9/08 14.5, 10/08 16.3
3rd Biopsy: 9/08 - 7/7 Positive, 40-90% Cancer, Gleason 4+3
Open RP: 11/08, Rht nerves saved, 4 days in hospt, on catheters for 63 days, 5th one out 1/09
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos margin
Post Surgery  PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Latest: 7/9 met 2 rad. oncl, 7/9 cath #6 - blockage, 8/9 2nd corr surgery, 8/9 cath #7 out  38 days, 9/9 - met 3rd rad. oncl., mapped  9/9, 10/1 - 3rd corr. surgery - SP cath/hard dialation, 10/5 - began IMRT SRT - 39 sessions/72 gys.

Posted 11/2/2009 1:29 PM (GMT -7)
This isn't 100% clear. Many agree that prostate cancer inherently comes with HRPC cells. But for many, when cells mutate and multiply they become more so. Hormone therapy is not a cure for prostate cancer, but rather a control system for prostate cancer. There are many ways to tweak a therapy using many drugs to try to get a response from the cancer. Abiraterone for example is based on the premise of bringing androgen supply for the cancer to absolute zero levels. But it still will fail eventually.

How long someone can benefit from HT is unpredictable on a case by case basis. But it is usually years. How long it may work does have some dependancy of the Gleason grade of the cancer and also the amount of spread. Men with disease spread to lymph nodes or bone usually will not fare as well as someone with more locally advanced spread such as my case.

Tony
Age 47 (44 when Dx)
Pre-op PSA was 19.8 : Surgery at The City of Hope on February 16, 2007
Gleason 4+3=7, Stage pT3b, N0, Mx
Positive Margins (PM), Extra Prostatic Extension (EPE) : Bilateral Seminal vesicle invasion (SVI)
Hormone Therapy May '07 to September '09 ~ Currently off.
IMRT radiation for 38 Treatments ending August 3, '07
Current PSA (October 7, 2009): <0.1

My journey is at: www.caringbridge.org/visit/tonycrispino

My InfoLink page is at Tony's Prostate Cancer InfoLink Page

STAY POSITIVE!

Post Edited (TC-LasVegas) : 11/2/2009 1:37:01 PM (GMT-7)

Posted 11/2/2009 1:34 PM (GMT -7)
Tony, thanks for the good info, that's the best explanation I have heard yet. I don't know if this is a fair term for HT or not, so please set the record straight, I have heard some refer to HT as a stall, not a cure. Is that in line with what you said above, or just a poor choice of a word?
Age: 57, 56 dx, PSA: 7/07 5.8, 7/08 12.3, 9/08 14.5, 10/08 16.3
3rd Biopsy: 9/08 - 7/7 Positive, 40-90% Cancer, Gleason 4+3
Open RP: 11/08, Rht nerves saved, 4 days in hospt, on catheters for 63 days, 5th one out 1/09
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos margin
Post Surgery  PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Latest: 7/9 met 2 rad. oncl, 7/9 cath #6 - blockage, 8/9 2nd corr surgery, 8/9 cath #7 out  38 days, 9/9 - met 3rd rad. oncl., mapped  9/9, 10/1 - 3rd corr. surgery - SP cath/hard dialation, 10/5 - began IMRT SRT - 39 sessions/72 gys.

Posted 11/2/2009 1:41 PM (GMT -7)
It's in line with what I said, but just a layman's term. For many, a delay is all they need.

Tony
Age 47 (44 when Dx)
Pre-op PSA was 19.8 : Surgery at The City of Hope on February 16, 2007
Gleason 4+3=7, Stage pT3b, N0, Mx
Positive Margins (PM), Extra Prostatic Extension (EPE) : Bilateral Seminal vesicle invasion (SVI)
Hormone Therapy May '07 to September '09 ~ Currently off.
IMRT radiation for 38 Treatments ending August 3, '07
Current PSA (October 7, 2009): <0.1

My journey is at: www.caringbridge.org/visit/tonycrispino

My InfoLink page is at Tony's Prostate Cancer InfoLink Page

STAY POSITIVE!

Posted 11/2/2009 3:13 PM (GMT -7)
Understood, Tony, meant no disrepect with the use of the term. Thanks for your explanations
Age: 57, 56 dx, PSA: 7/07 5.8, 7/08 12.3, 9/08 14.5, 10/08 16.3
3rd Biopsy: 9/08 - 7/7 Positive, 40-90% Cancer, Gleason 4+3
Open RP: 11/08, Rht nerves saved, 4 days in hospt, on catheters for 63 days, 5th one out 1/09
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos margin
Post Surgery  PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Latest: 7/9 met 2 rad. oncl, 7/9 cath #6 - blockage, 8/9 2nd corr surgery, 8/9 cath #7 out  38 days, 9/9 - met 3rd rad. oncl., mapped  9/9, 10/1 - 3rd corr. surgery - SP cath/hard dialation, 10/5 - began IMRT SRT - 39 sessions/72 gys.

Posted 11/2/2009 4:30 PM (GMT -7)
No disrespect seen. What you heard is correct.

Tony
Age 47 (44 when Dx)
Pre-op PSA was 19.8 : Surgery at The City of Hope on February 16, 2007
Gleason 4+3=7, Stage pT3b, N0, Mx
Positive Margins (PM), Extra Prostatic Extension (EPE) : Bilateral Seminal vesicle invasion (SVI)
Hormone Therapy May '07 to September '09 ~ Currently off.
IMRT radiation for 38 Treatments ending August 3, '07
Current PSA (October 7, 2009): <0.1

My journey is at: www.caringbridge.org/visit/tonycrispino

My InfoLink page is at Tony's Prostate Cancer InfoLink Page

STAY POSITIVE!

Posted 11/2/2009 7:29 PM (GMT -7)
Tony explained such, to make it very simple: when your normal hormone therapies of LHRH drugs (lupron-zoladex, eligard, trelstar etc.) and casodex and its equals, stopping working to control your psa, then you can figure you are getting into HRPCa (hormone refractory prostate cancer), it refracts from being useful against PCa. One premise that my onco-doc whom went to school with Dr. Labrie, is that these various drugs and agents we use, can kill the older established PCa cells, but they do not seem to stop the 'stem cells' and thus PCa continues to be an uphill fight. If someone figures out how to dump the PCa stem cells, then we should be able to find patients with new hope.

There are drugs that can work against HRPCa, the question is how long and how effective and what side effects...there are more choices than the uro-docs will bring to your attention either out of ignorance or other reasons that I won't elaborate on. The onco-docs know this territory much better, but may or may not use a wide variety of options or have maybe their own personal thing (bias) on certain drugs. I have mentioned this is the twlight zone, and jungle before. Another reason for multiple opinions, even with onco-docs or even specialist PCa onco-docs from the "A" list...they don't all agree on the same protocols, either.

Post Edited (zufus) : 11/3/2009 6:43:25 PM (GMT-7)

Posted 11/2/2009 8:24 PM (GMT -7)
That I fully agree with. You could put Lebowitz, Scholz, Meyers, Strum on the same case and get more opinions than doctors. The key is having an oncologist versed in many protocols and armed with an open mind. LHRH agonists, 5-AR inhibitors, anti-androgens, Keto, Nilandron, DES, Abiraterone, etc. are all hormonal therapies. Once they fail, then Docetaxyl chemo therapy, perhaps with Provenge, Satraplatin, MDV3100, and many other experimentals, may eventually be used, sometimes re-establishing the effectiveness of the HT drugs. Thus making a complex set of combinations that could work well for a patient.

Provenge is a bit tricky, but Provenge ventures into the bodies own immune system and is personalized in every case to the patient. Blood is drawn, cancer cells, white blood cells and antibodies are extracted and processed into a therapy concoction that is then re-introduced into the patient in hope of jump starting an effective immune system response to the cancer. During an interview with Dendreon, and a marketing firm, I was told about how difficult it is to make Provenge. Right now only one Dendreon facility is able to do it. Anybody that was in the study had to come in several times over many weeks to receive the doses. The samples all had to be flown back to the lab and processed, then flown back to the center administering it.

www.dendreon.com/pipeline/sipuleucel_t/

Many of the top oncologists are hopeful to use it before the disease becomes refractory to see it's benefits there as well. I have a Leibowitz video where he expressly believes that using it on HRPC cancer after failed chemo is the primary reason that it added only 4 months (average) to the lives of the trial patients. Like Abiraterone, he would like to see the drug used earlier in the treatment phases. He will get his chance soon enough.

Tony
Age 47 (44 when Dx)
Pre-op PSA was 19.8 : Surgery at The City of Hope on February 16, 2007
Gleason 4+3=7, Stage pT3b, N0, Mx
Positive Margins (PM), Extra Prostatic Extension (EPE) : Bilateral Seminal vesicle invasion (SVI)
Hormone Therapy May '07 to September '09 ~ Currently off.
IMRT radiation for 38 Treatments ending August 3, '07
Current PSA (October 7, 2009): <0.1

My journey is at: www.caringbridge.org/visit/tonycrispino

My InfoLink page is at Tony's Prostate Cancer InfoLink Page

STAY POSITIVE!

Post Edited (TC-LasVegas) : 11/2/2009 8:44:48 PM (GMT-7)

Posted 11/2/2009 8:33 PM (GMT -7)
Sounds very complicated to me.
Age: 57, 56 dx, PSA: 7/07 5.8, 7/08 12.3, 9/08 14.5, 10/08 16.3
3rd Biopsy: 9/08 - 7/7 Positive, 40-90% Cancer, Gleason 4+3
Open RP: 11/08, Rht nerves saved, 4 days in hospt, on catheters for 63 days, 5th one out 1/09
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos margin
Post Surgery  PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Latest: 7/9 met 2 rad. oncl, 7/9 cath #6 - blockage, 8/9 2nd corr surgery, 8/9 cath #7 out  38 days, 9/9 - met 3rd rad. oncl., mapped  9/9, 10/1 - 3rd corr. surgery - SP cath/hard dialation, 10/5 - began IMRT SRT - 39 sess/72 gys cath #8 33 days, 11/2- SP Cath #9 in place