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-   -   Sign Petition to Stop Delay of the GP2 Vaccine (https://her2support.org/vbulletin/showthread.php?t=62307)

phil 12-07-2014 05:20 PM

Sign Petition to Stop Delay of the GP2 Vaccine
 
Many of us have been excited about the stats for the GP2 vaccine - 100 % of the her2 pts in the first 12 phases of testing have not had any re-occurrence for up to 3 yrs so far. results should be presented at San Antonio this week.
What many do not know is that some of the players in the development -a military foundation , and a military doctor have sued the pharma co. ( the doc wants 500,000$$) and are delaying the start of phase III trials . Go to " Our Her2Cancer Struggle " on Fb or Inspires Metastatic BC Advocacy , also on FB for the legal details .
Please Sign and Pass ON - you will Save Lives !

https://www.change.org/p/director-ma...cancer-vaccine

phil 12-07-2014 05:22 PM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
2 phases of testing , not 12. feels like 12 with this fda. I think the lawsuit prevented the docs at md Anderson from filling all Phase II slots and from starting Phase III.

phil 12-07-2014 05:23 PM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
sorry again , Inspired MBC Advocacy

Carol Ann 12-07-2014 06:15 PM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
Thanks for posting this here, Phil. It is already on our HER2 support Facebook page, a bunch of us have seen it there and signed it, but not everyone is on Facebook so now more of us can see it and sign. :)

Carol Ann

rhondalea 12-07-2014 06:20 PM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
For those who want to read more about this, I obtained a copy of the arbitration award and the order denying the motion to set aside that award, along with a copy of the current appeal docket (to show the current status).

Order:
https://www.dropbox.com/s/9uz2fqhm4k...rwell.pdf?dl=0

Docket:

https://www.dropbox.com/s/0x5noaii3s...ocket.pdf?dl=0

I will try to keep the second link updated so that anyone who is interested in the progress of the appeal can refer to it. I signed the petition, but I have little hope that they'll pay it any heed at this point. The monetary stakes are too high, and it seems they've failed to count the cost in lives.

thinkpositive 12-08-2014 07:29 AM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
Phil,

Thanks for posting this. I just signed the petition. Hopefully, this trial can move forward quickly. Amazing that it always seems to come down to money when the focus should be on saving lives.

Take Care

KaiM 12-08-2014 10:38 AM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
Signed. Thanks Phil!

'lizbeth 12-08-2014 11:21 AM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
Gosh, looks like this is already over and settled. Fascinating how ugly the cancer business can get, especially when there is so much money coming in from charities and government.

And the IRS has reported that Norwell, Inc. just received a grant for almost $245,000 to study GP2 less than 2 months ago.

Not only that but the vaccine is most effective for our type of cancer, the higher expressors. I will share that in a different post.

I will also share when there is information available about a Phase III for GP2.

rhondalea 12-08-2014 11:34 AM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
Unfortunately, the Qualifying Therapeutic Discovery Project Grant reference above was awarded in 2009:

http://www.irs.gov/Businesses/Small-...State-of-Texas

The appeal of the arbitration award in THE HENRY M. JACKSON FOUNDATION FOR THE
ADVANCEMENT OF MILITARY MEDICINE, INC. v. NORWELL, INC is ongoing:

https://www.dropbox.com/s/0x5noaii3s...ocket.pdf?dl=0

No final determination has been entered by the appellate court.

Edited to add: If there's sufficient interest, I can download the appeal documents from PACER and stick them in my Dropbox for viewing.

'lizbeth 12-08-2014 12:37 PM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
Well Rhondalea, it is so wonderful that you and Phil developed a new interest in the GP2 vaccine after all these years of my posting news.

I do so hope that the co-founder of the vaccine Dr. Peoples isn't getting his technology stolen away after all these years of effort without adequate compensation. That seems to be such a risk in this industry, one works hard to advance treatment, makes a discovery and then has to work to keep it from being stolen away.

Phil, what is the latest on Prop 303? Have you heard from anyone who was able to benefit from the new legislation?

lkc Gumby 12-08-2014 02:11 PM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
signed ! Thank you Phil

sassy 12-08-2014 02:41 PM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
Signed! Thanks Phil!

Rhonda, I'll PM you about the appeal documents.

michka 12-09-2014 12:46 AM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
Signed! Michka

Vicky 12-10-2014 09:57 AM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
Signed!

Thanks for posting it here for us all to see!

JillaryJill 12-12-2014 08:54 AM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
signed. Thanks Phil

phil 12-15-2014 12:25 PM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
no news on prop 303 , but then i am far away in boston. as it advances it sends amessage not only to slow fda but to pharma - remember our RTT testimony exposed how little comp use kaiser permanente gives - probably no different than most pharma .
i started hearing about gp2 around sept. when dr. mittendorf published data . mbrs of our Our Her2Cancer Struggle started researching , posting there and started a petition . lizbeth and rhondalea - you should definitely join us on fb and coordinate activism with shannon . you all talk the right activist talk .
the info i have seen does not picture dr. peoples as a co-founder . info i have says norwell pharma was looking for funding - very difficult with any new drug / but especially with vaccines - which dont think bring the Billions annually that drugs like herceptin do , for ex. and may take longer to develop.
so norwell approaches HJF and HJF gives $$ , providing Dr. P . leads study . he was also working on 2 other vaccines . . problems came up w/ HJF , dr. p. in charge - as norwell saw it ( later court case validated many of their concerns) - delays in phase II . so norwell asked hjf to remove dr. p. , - conflict of interest w/ other compettive / time consuming vaccines he was working on .Dr. P. agreed to leave if he got 500,000$ . norwell said no, offered stock options in stead. dr. p. says no. norwell tries to drop hjf but they have trial paerwork norwell needs and hjf sues for breach of contract . norwell wins , and " co -incidentally " dr. p. retires from military and goes to work for larger pharma co. , galena , working on one of those vaccines, neuvax . seems like hjf failed to fill all phase II slots , and that their suing also would delay a potentially breakthrough her2 tx. it sure seems like some shady stuff going on - i say : just get to the table and settle -NOW !! and get this trial back on track - to at least finish phase II by end of 2015. i have heard hjf say it will take " several more yrs " , just for phase II ! lives are at stake. i suspect that they all will not be in a rush - none of their family probably have metastatic her2 . i want an investigation from congress - who chartered hjf ( like they did fda ) . i am calling my reps .

'lizbeth 12-15-2014 07:42 PM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
Gosh Phil - that sounds like some crazy rambling. I don't think you have all the facts straight. I'm sure this will get all straightened out. I'm a little busy working on other projects that will affect a larger number of cancer patients.

The vaccine isn't even in trials for metastatic breast cancer. It is for prevention of recurrence with primary breast cancer. It might not even be for Her2 3+. Many of the companies are going for the larger lower expressor market.

George Peoples is my hero! Thanks to him there are 3 vaccine trials in study currently. Awesome man. There is a reason it is called GP2, wouldn't that be naming the vaccine after the co-discoverer?

Anyway, I'm not interested in joining you.

phil 12-16-2014 09:46 AM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
crazy rambling -? here's the court case below that HJF/ Dr. P. lost , read ( and talk with shannon on our fb page ) and decide for yourselves. i did say " info I have seen ". which does not include Dr. P.'s side of story . is he a researcher ? - in the lab with test tubes , working at earliest stages of development of this vaccine ? or a dr. hired to run trials ? there is a difference. maybe 500,000$ is a standard fee for this in the private sector - here he is , in our military , working with hjf , a supposed non profit. did hjf bite off more than they cold chew ? i don't know - thse are just educated guesses on my part , but not crazy rambling ... seems investigatory material to me - is norwell pharma an angel in all this ? dr. mittendorf ? , i dont know - but court case speaks for itself .
i think any delay is definitely worth our pt rights attention .
perhaps most importantly - dr. mittendorfs research says it DOES work best in high her2 overexpression of 3.0 or greater . to get this vaccine thru phase II by end of 2015 and into expanded testing is my goal . to be tried as soon as possible on met. pts in remission . i am sorry you choose not to join us .

https://www.dropbox.com/s/9uz2fqhm4k...rwell.pdf?dl=0

'lizbeth 12-16-2014 10:27 AM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
I confirmed on clinicaltrials.gov that our GP2 trial doesn't even have a primary end point until December 2015 for Phase II.

I do not know why you are giving the impression that the trial is not ongoing. It is fully enrolled, the clinical trial staff is still collecting data. Patients are still being contacted in follow up. There is currently no delay. Everything is on schedule. The end point really depends more on when the patients enrolled into the trial, and not on anything that anyone outside the trial does.

My understanding is Peoples is both a co-discoverer and a primary investigator. Although that may change. Very juicy stuff. I found it interesting reading.

I do not need to join you - I joined the study. And that is why it will get through phase II by the end of 2015.

Not because of some petition or court case.

It all comes down to the patients who support the studies. I've enrolled in 6 clinical trials to advance standard of care.

If someone truly wants to join me in advancing cancer vaccines - there is currently a Phase II enrolling for Neuvax, which is the first generation vaccine, for us higher expressors.

https://www.clinicaltrials.gov/ct2/s...=neuvax&rank=1

When the post Herceptin trial starts I will share that information.

AND when the phase III for AE37 and GP2 starts, which are the 2nd generation vaccines, I will share that information as well.

Thanks to the other former and current breast cancer patients who understand the critical importance of joining a clinical trial - to get them to full enrollment as quickly as possible.

No Phil I choose not to join you. I have other more effective ways to advance standard of care.

rhondalea 12-16-2014 11:09 AM

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 
Note to Phil: I just realized that when I uploaded the order, I forgot to run text recognition. It's fixed now, so if you need to copy and paste from it, you won't have a problem.

On the GP2 trial:

https://www.clinicaltrials.gov/ct2/s...erm=gp2&rank=1

I don't think clinicaltrials.gov tells the whole story. Recruiting was terminated prematurely (pages 17-25 of the order). The order assigns responsibility for trial completion to Norwell if Norwell so chooses. Of course, pending the appeal, the trial is funded with vapor--there is no money. Here's the relevant paragraph at the end of that section:

Quote:

Since we have determined that the enrollment requirements of the May 7, 2009 agreement have not been met [emphasis supplied], and since HJF has not notified the Panel that it would do so after receiving the objection of Norwell, it would be unfair to require Norwell to continue to pay HJF under the License Agreement to fund the GP2 clinical trial for further enrollment which may now be undertaken by Norwell. Therefore, Norwell will be relieved of its Clinical Trial Financial Support obligation under 3.6 of the License Agreement and any unpaid delay fees under Section 17 of the First Amendment and Section 5 of the Second Amendment. Norwell will be free to pursue the GP2 clinical trial on an independent basis.


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