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Old 02-29-2008, 10:07 AM   #1
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Prostate Cancer Vaccine

Hello All,

Does anyone have any information on PC Vaccine approval by FDA?. Signed: A friend in need.

 
Old 02-29-2008, 11:10 AM   #2
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Re: Prostate Cancer Vaccine

Quote:
Originally Posted by TheDave1 View Post
Hello All,

Does anyone have any information on PC Vaccine approval by FDA?. Signed: A friend in need.
I had not heard of this but just looked into it. The company is Dendreon and the drug is Provenge. Unfortunately, it was not approved by the FDA- that happened sometime in the first part of last year.

However, there is another drug being evaluated now by a company called GTx.
Preliminary results are favorable. You can read about that by looking for the company. I think its stock symbol is gtxi.

 
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Old 02-29-2008, 11:30 AM   #3
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Re: Prostate Cancer Vaccine

Quote:
Originally Posted by TheDave1 View Post
Hello All,

Does anyone have any information on PC Vaccine approval by FDA?. Signed: A friend in need.
Hi Dave1,

The only PC vaccine that is a candidate for approval by the FDA in the near future that I know about is Provenge.

I attended the hearing last year (as a survivor - hearings are open to the public) in which the advisory committee voted in favor of Provenge on safety and efficacy grounds, but the FDA exercised its authority to not grant accelerated approval for the drug, based on concerns about the adequacy of the evidence. Instead, they elected to wait until at least interim results were available from a key, large clinical trial. Those results were expected in about a year from the hearing, which would project the date to about early this summer. A lot of us are hoping the results will support approval, but they may not, and another alternative is that the FDA may decide to wait until complete results are available.

We were also hoping that another vaccine would be successful. It was known as satraplatin, and early clinical observations were favorable. Accelerated approval by the FDA was not granted last year, following the advisory committee's advice that results were not clearly favorable enough to warrant accelerated approval. I also attended that hearing (again as a survivor), and I agree with the advisory committee's and FDA's positions. Months later, later results from the trial were disappointing and the company stopped the trial and work on the drug, as I understand it.

Provenge will be very expensive, in the $40,000 to $60,000 range for a set of infusions.

Could you give us some background on the need? There are probably some other good options available.

Jim

Last edited by IADT3since2000; 02-29-2008 at 11:36 AM. Reason: Added sentence about folding of satraplatin project.

 
Old 02-29-2008, 11:46 AM   #4
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Re: Prostate Cancer Vaccine

Quote:
Originally Posted by daff View Post
I had not heard of this but just looked into it. The company is Dendreon and the drug is Provenge. Unfortunately, it was not approved by the FDA- that happened sometime in the first part of last year.

However, there is another drug being evaluated now by a company called GTx.
Preliminary results are favorable. You can read about that by looking for the company. I think its stock symbol is gtxi.
Hi daff,

I think you are referring to GVAX, being developed by Cell Genesys. Do you know if the company plans to bring it to the FDA this year?

Here's what I know about it. It was put on the fast track for approval review in 2006. It involves a GM-CSF mechanism, as does Provenge and Leukine, but operates differently. There are two phase III clinical trials evaluating GVAX for men with androgen independent (in other words, refractory) prostate cancer who are also metastatic. The trial known as VITAL-1 involves more than 600 patients, with interim results projected for the first half of this year and final results in 2009. The trial known as VITAL-2 is aiming at about 600 patients. In a phase 2 trial, GVAX median survival was about 35 months compared to about 18.9 months for those on docetaxel plus prednisone.

Did any other key facts strike you when you read about the company?

Jim

 
Old 02-29-2008, 01:24 PM   #5
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Re: Prostate Cancer Vaccine

Quote:
Originally Posted by IADT3since2000 View Post
Hi daff,

I think you are referring to GVAX, being developed by Cell Genesys. Do you know if the company plans to bring it to the FDA this year?

Here's what I know about it. It was put on the fast track for approval review in 2006. It involves a GM-CSF mechanism, as does Provenge and Leukine, but operates differently. There are two phase III clinical trials evaluating GVAX for men with androgen independent (in other words, refractory) prostate cancer who are also metastatic. The trial known as VITAL-1 involves more than 600 patients, with interim results projected for the first half of this year and final results in 2009. The trial known as VITAL-2 is aiming at about 600 patients. In a phase 2 trial, GVAX median survival was about 35 months compared to about 18.9 months for those on docetaxel plus prednisone.

Did any other key facts strike you when you read about the company?

Jim
I think this is a different one. What I read was about a company named GTx, Inc. A few days ago it made an announcement that toremifene citrate 80 mg meets primary and key endpoints in its Phase III trial. The company said results show a 50% reduction in the incidence of androgen deprivation induced osteoporosis related vertebral fractures.

Since you've been involved in much of this type of ongoing research, I'd suggest you check out the company's website to read the fairly lengthy news release on this. It does expect to file a new drug application by this summer.

 
Old 02-29-2008, 02:09 PM   #6
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Re: Prostate Cancer Vaccine

Quote:
Originally Posted by daff View Post
I think this is a different one. What I read was about a company named GTx, Inc. A few days ago it made an announcement that toremifene citrate 80 mg meets primary and key endpoints in its Phase III trial. The company said results show a 50% reduction in the incidence of androgen deprivation induced osteoporosis related vertebral fractures.

Since you've been involved in much of this type of ongoing research, I'd suggest you check out the company's website to read the fairly lengthy news release on this. It does expect to file a new drug application by this summer.
Yes - it's not the same, and very interesting! Thanks for pointing it out!

This is definitely a drug to watch, and it appears the FDA advisory committee hearing will be held later this year. This could be a drug I would use for my own case to help handle side effects when I'm on the LHRH-agonist drug, which is Lupron for me.

Jim

 
Old 03-12-2008, 06:24 PM   #7
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Re: Prostate Cancer Vaccine

I stumbled across Bellicum Pharmaceuticals and their development of a vaccine for prostate cancer and thought I would add it to this thread. BP-GMAX-CD1 is a genetically-modified autologous cell-based vaccine that is in late stage preclinical development and is scheduled to enter phase 1/2 clinical trials in early 2008, pending FDA authorization. So, unless a person qualifies for the trial, it's a long way from commercialization. The founder of Bellicum is Dr Kevin Slawin, the doc that removed my prostate.

 
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