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

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.

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

sorry again , Inspired MBC Advocacy

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

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.

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

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

Signed. Thanks Phil!

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.

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.

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?

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

signed ! Thank you Phil

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

Signed! Thanks Phil!

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

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

Signed! Michka

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

Signed!

Thanks for posting it here for us all to see!

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

signed. Thanks Phil

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 .

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.

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

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.

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:

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

I'm going in Feb for my booster and draw. My nurse said everything is running normally

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

I hope it stays that way for the patients who are enrolled. It may be there were sufficient supplies to cover those who were in the program. It may also be that there is action behind the scenes to keep things running for the current enrollees until the court decides or there is a settlement. But the order isn't just an order or a history of the case, it's also a history of the vaccine trial itself, and until this is settled, GP2 is limping.

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

Europa,

Sounds like much ado about nothing. It hasn't affected me in the clinical trial. I enrolled after the lawsuit and did the entire trial.

I doubt that this has much to do with the GP2 trial.
I'm sure this ties back to the discussion about the KRAS variant. I had no idea it would stir up such a ta-do. I was just sharing information that I hoped would advance standard of care.

Post all you want. The GP vaccine trial is moving forward despite the postings. Happy to have participated.

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

For the record, Phil did not participate in the discussion of the KRAS-variant study, and I doubt he even followed the thread, because it's not his area of interest.

I first heard about this petition on the Facebook site, so I logged into PACER, downloaded the order and the current appellate docket, and I made them available to anyone who had an interest in a more detailed understanding of the current status of the GP2 vaccine.

For myself, I do not care about the vaccine because I am not a trial participant. For those who want an opportunity to try the vaccine, I care deeply, which is why I signed the petition, even though I'm not confident it will help given the amount of money at stake in the litigation.

This is the second time you've made a totally baseless accusation about my motivations, 'lizbeth. Don't do it again.

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

I think that every participating hospital received enough supplies for the number of participants to complete Phase II. That is what I was told. The only thing that gets sent out to Walter Reed is blood to see how people are responding to the vaccine.
I do know that my hospital has yet to hear if there will be a phase III. Looks like that part is kind of in limbo. The whole situation sounds sad and completely bureaucratic to me. But thankfully those that are enrolled will continue to benefit from the phase II.

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

That makes sense, europa. The hospital where I'm doing the metformin study has a closet full of five years' worth of giant pill bottles.

Norwell won't be in a position to put anything into play until it has all the documentation from the HJF, but the language of the arbitration award indicates it is eager to forge ahead with GP2 research. I have no idea how Norwell will deal with the premature termination of recruiting in Phase II, but the sooner the case is settled, the sooner it can patch the holes and get on with the research. Then it will be onward to Phase III.

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

thanks for confirmation that enrollment requirements were not met , and i have heard that hjf still has data paperwork that norwell needs . . all info that should be looked into - i am neither pro norwell nor anti - hjf/dr p. - but pro - stage iv pt. none of these entities have the sense of urgency that stage iv requires - their lack of urgency is nothing personal , just their timetable is not ours. if they had an immediate family mbr w/ strong her2 overexpression - at dx or metastatic - they would be pushing for as quick a process as possible.
i dont think you have to fill very slot to move on to phase III, hopefully these entities wil settle and get going on to next phase .

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

Signed. Thanks Phil.

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

I too am a participant in the GP2 vaccine trial and have been told to continue to come (last month and again in April 2015) to complete my booster shots. I was also aware that down at MD Anderson they did fill all the slots for their portion of the trial...that being said, I am not sure about the legal responsibilities of studies to continue with the enrolled subjects once they have started?

I strongly feel that there are different ways to advocate. Whether you try to enroll yourself to contribute and move studies along or whether you raise awareness and organize to be heard or put pressure on companies or the public are just different ways to go about it. I think we all want the same in the end: A cure and access for all to get it!
I think you all are such effective and strong resource to all of us,...keep up the fight on ALL levels and thank you!

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

Wow Carol Ann, as long as I've been a member I didn't know there was a Facebook page. Just asked to become a member of the group. Can anyone explain what this lawsuit is about?

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

I'm not Carol Ann, but...

The Facebook page is new. europa started it the last time this site went down for several days so we'd all have somewhere to go if it happened again. Anyone else who is interested and who hasn't seen the post about it can look it up on Facebook with "Her2support." Currently, there are 84 members.

As for explaining the lawsuit, it might make more sense if you read the original order linked in an earlier thread. The bottom line is an agreement that didn't work out quite as anyone planned, followed by a disagreement about who owes what to whom. For details, though, the order is the best source.

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

Norwell won the appeal ! The Federal Appeals Court threw out the Henry " Scoop " Jackson Foundations' appeal in very succinct fashion . Now we will see if HJF will expeditiously turn over the data to Norwell so the Phase III trial can begin : http://www.ca4.uscourts.gov/Opinions...d/141580.U.pdf

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

Great news Phil!!!!!

Keep up the good work!

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

fyi - just saw this on another blog and thought I would pass it along. good news for the GP2 vaccine? http://www.ca4.uscourts.gov/Opinions...d/141580.U.pdf

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

Wanted to clarify that the previous post refers to the court decision in favor of Norwell on 1/8/15 :-)

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

Signed

Paul

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

I am trying to contact Norwell directly about this to try and get new info. I can't find them online though, which is very weird. Does anyone know the best way to reach them?

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

last I heard , after losing 2 court cases , HJF was still dragging out turning over data , and Dr. P is gone to Galena Pharma. will update when I get more info.

Re: Sign Petition to Stop Delay of the GP2 Vaccine
 

That's the last I heard too but it looks as is Norwell is no longer in business from the research I've done: http://www.corporationwiki.com/Texas.../39290919.aspx