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az4peaks2 posted:
Bayer's blockbuster Alpharadin may roil fast-changing prostate cancer field
September 26, 2011 — 8:40am ET | By John Carroll

The experimental prostate cancer drug Alpharadin took center stage at the big EMCC meeting in Stockholm, with researchers reporting that they had suspended a registration trial after castration-resistant patients taking the alpha radiation drug lived significantly longer with less pain and fewer side effects. The independent monitoring board called for the early unblinding of the study so that everyone in the study could benefit from the therapy and analysts were quick to dub the treatment a potential game changer in the fast-changing prostate cancer market.
Investigators for Algeta and Bayer say that the treatment extended overall survival by 44 percent, with patients living a median average of 14 months compared to 11.2 months in the placebo arm. The treatment also delayed painful bone metastases. Alpha particles can demolish cancer cells far more effectively than standard radiation therapies. Because they have a very narrow target range, down to a few millionth of a meter, it's possible to pinpoint tumors without devastating healthy tissue - significantly easing side effects. "This appears to be an important study using a highly targeted form of radiation to treat prostate cancer that has spread to the bones," says Professor Gillies McKenna, Cancer Research UK's radiotherapy expert.
Just weeks ago the FDA announced that the agency would put Alpharadin on the regulatory fast track, slashing six months off of the review time as analysts widely expestpoct a swift approval. The drug is expected to hit peak sales of $1.7 billion on all indications. Bayer signed up for a global development deal on Alpharadin back in 2009. Algeta hung on to an option for up to 50/50 co-promotion and profit-sharing in the USA.
TheStreet's Adam Feuerstein, who has been closely following Exelixis 's experimental prostate cancer therapy cabozantinib, astutely notes that the new data on Alpharadin could spell trouble for the rival program. Exelixis wants to mount a pivotal study on endpoints related to pain and bone scan resolution. Regulators, Feuerstein observes, may now insist that the investigators also focus on overall survival--a classic goal in registration studies for cancer drugs--now that Alpharadin has set the bar higher. The new data could also complicate things for Amgen, which is planning to seek an FDA OK to use Xgeva to delay the spread of prostate cancer to the bone without supporting data on added survival times.
- see the Bayer release -





http://www.fiercebiotech.com/press-releases/alpharadin-significantly-improves-overall-survival-patients-castration-resi?utm_medium=nl&utm_source=internal
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Fairwind responded:
"The drug is expected to hit peak sales of $1.7 billion on all indications"

That tells you all you really need to know...

"Investigators for Algeta and Bayer say that the treatment extended overall survival by 44 percent, with patients living a median average of 14 months compared to 11.2 months in the placebo arm."

'LIVING"?? Living how? In a hospice hooked up to a morphine pump?
 
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az4peaks2 replied to Fairwind's response:
Hi Fairwind, - I submitted the previous Post, without comment (and with the authors name prominently stated, because I don't personally know whether the contents are accurate or not.

However, after 30 years as a Medical Administrator and 13 years of PCa medical literature research of my own, I am knowledgeable enough to know that the early suspension of an active Medical Study, when accompanied by the offer of the experimental drug and/or treatment to the "patient CONTROL group" (those NOT receiving it) usually indicates that seemingly significant benefits were found to be present in the reported results.

When evidence is considered sufficient, it is considered unethical to NOT take such action. As the story indicates, it is usually an independent monitoring group that makes such a RECOMMENDATION, based upon preliminary results submitted for their review. Those who are actively involved then make the final call, since they are most directly informed and it is their reputations on the line.

Although I have no personal knowledge, other than what is contained in the article, I thought the positive statements it contains (highlighted in this bold print below) warranted its wider distribution to those with advanced Prostate Cancer (PCa), who may be interested in the status of FDA action and the seemingly favorable Study results to date. If so, they can keep track of its further activity.

Your negative and discouraging comments offer NO supportive data to your personal opinions expressed and UNFAIRLY, in my opinion, detract from the hope that it MAY provide for their future.

I will continue to retain my own judgment as to its impact, until more FACTS are known, rather than to depressingly rail at the unknown. - John@newPCa.org (aka) az4peaks

Bayer's blockbuster Alpharadin may roil fast-changing prostate cancer field
September 26, 2011 By John Carroll

"The experimental prostate cancer drug Alpharadin - - -, with researchers reporting that they had suspended a registration trial after castration-resistant patients taking the alpha radiation drug lived significantly longer with less pain and fewer side effects.

The independent monitoring board called for the early unblinding of the study so that everyone in the study could benefit from the therapy - - -.

Investigators for Algeta and Bayer say that the treatment extended overall survival by 44 percent, with patients living a median average of 14 months compared to 11.2 months in the placebo arm. The treatment also delayed painful bone metastases.

"This appears to be an important study using a highly targeted form of radiation to treat prostate cancer that has spread to the bones," says Professor Gillies McKenna, Cancer Research UK's radiotherapy expert.

Just weeks ago the FDA announced that the agency would put Alpharadin on the regulatory fast track, slashing six months off of the review time - - - -.
 
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Fairwind replied to az4peaks2's response:
Sorry John, but extending the life of a terminal cancer patient by a few months is not a "breakthrough" in my opinion..It might be a breakthrough for the company that holds the patent, but not for the patient. Last years "breakthrough" treatment Provenge delivered about the same results as Alpharadin and it's introduction was accompanied by an equal and similar publicity campaign. A quick check on the status of Provenge today reveals the bloom has faded from that rose...http://www.medscape.com/viewarticle/750610
 
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An_240348 replied to Fairwind's response:
Fairwind,

Your knowledge regarding statistics and clinical trials is flawed. There are only 3 or 4 cancer drugs in history which showed a greater than 4 months "MEDIAN survival advantage" as Provenge did. Furthermore, Provenge was not compared to a true placebo but to a group of patients who received Provenge at a later point in time (Frozen Provenge, or Frovenge). So please do not spread misinformation.
 
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Fairwind replied to An_240348's response:
The link I posted speaks for itself. I did not write it..

Then there is the $100,000 cash up front problem...
 
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az4peaks2 replied to Fairwind's response:
Hi Fairwind, - This is what happens when a Poster comments on a subject about which he has no knowledge. The question isn't whether this is a "breakthrough" or not, but whether you have any real basis for your original disparaging comments about the contents of the article I posted (without comment).

It had no relationship to Provenge, but when you know nothing about the Poduct involved, it seems unfair and not very pertinent to change the topic to an unrelated product, and to base your derision on information that is totally unassociated with the topic of the original article.

If you want to talk about Provenge's problems, start your OWN thread and don't detract from what was a simple informational based Post!

But, I will let others judge the reliability and veracity of your comments and explanations. I am happy to have them compare our responses and explanations to make such a judgment. - John@newPCa.org (aka) az4peaks


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