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Old 12-07-2014, 05:20 PM   #1
phil
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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
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Old 12-07-2014, 05:22 PM   #2
phil
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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.
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Old 12-07-2014, 05:23 PM   #3
phil
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

sorry again , Inspired MBC Advocacy
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Old 12-07-2014, 06:15 PM   #4
Carol Ann
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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
__________________
July 24, 2013: "Infected" Right Nipple and benign cyst removed, pathology report revealed Paget's, DCIS, and ILC 1.25 cm, ER+/Pro+/HER2 equivocal, Grade 2 under benign cyst, previous diagnostic mammo/ultrasound said I was perfectly healthy in both breasts.

Aug 18, 2013: MRI report says Left breast is perfectly healthy "consistent with previous studies".

Sept 2013: I insist on a bilateral mastectomy anyway. Too nervewracking to let left breast remain with higher risk after 3 cancers in right, nipple in right is already gone anyhow.

Sept 18, 2013: Bilateral mastectomy, 11 right nodes removed, ALL negative BUT -- ER+/PRO+/HER2+ tumor, 1.0 cm, Grade 2 found in a piece of "grossly unremarkable" breast tissue from prophylactic mastectomy of left breast, no nodes removed.

Oct 25, 2013: 13 left side nodes removed, ALL negative, Stage 1 across the board, NO RADS needed, YAAAAY! Port also installed.

Nov 25, 2013 Begin 6 rounds TCH.

March 10, 2014 Just finished 6th and LAST Chemo today, YAAAAAY!

March 24, 2014 Echocardiogram to make sure I'm still good for Herceptin every 3 weeks.

March 31, 2014 Echo results NORMAL, first Herceptin all by itself. Now if only my eyes would stop streaming from the Taxotere ... :)

April 21, 2014 Started Arimidex and therapy for "mild" lymphedema in left hand and arm

May 2014 Therapy completed, I have sleeves and gloves for both arms, a Flexi touch lymph pump to hook up to for an hour every day, and I've become an arm bandaging expert. :)

June 2014 Begin Fosamax to prevent osteoporosis; bone scan revealed osteopenia

Nov 17, 2014 FINAL Herceptin!

Dec 4, 2014 My right thigh muscle has been extra achy for days ... I discover a blister rash cluster on the side of my right thigh while taking a shower. Port appointment cancelled until Dec 17, my doc is working me in tomorrow afternoon to see me and the rash. My muscle at least feels less achy.

Dec 5, 2014 Yep, I have shingles. Boo! I start acyclovir and also have a prescription for a painkiller just in case for over the weekend.

Dec 17, 2014 Port is OUT!

January 2016 Shingles again and this time it started where my left breast (where the hidden HER2+++ tumor was!) used to be. My onc nurse got me a same day appointment to see my doc when I called and told her I had a rash on the site. The antiviral meds are working once again, though, so that is good news. :)
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Old 12-07-2014, 06:20 PM   #5
rhondalea
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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.
__________________

2/6/09 Core needle biopsy: negative; Mammos through 2010: no change
3/30/11 Pea-sized lump in left breast at site of prior biopsy; mammo negative, sonogram not so much
4/14/11 Core needle biopsy: negative for cancer
5/18/11 Excisional biopsy 1.2 cm tumor, LVI, positive margin; ER+60%,PR+20%,HER2/CEP17 5
6/15/11 BMX: Left DCIS & LH; Right ADH; SNB: 2/3 nodes: 1.4 cm and 1 mm; ALND L1&2: 0/10; Stage IIa, Grade 3
7/14/11 CT/Bone scans NED; MUGA 66%
7/19/11 Biweekly dd AC w/Neulasta; done 8/30/11
9/13/11 Transfusion (Hemoglobin 8.6); MUGA 64%
9/20/11 Start Taxol + Herceptin; Taxol done 12/6/2011; continue Herceptin until 9/4/2012
12/27/11 Radiation - 6 weeks; 2/27/2012 - DONE! Yayyyy!
2/29/12 Start Tamoxifen 20 mg/day; continue until 2/28/17
5/16/12 Start five-years Metformin trial
6/19/12 MUGA 61%
8/21/12 Brain MRI NED (head still hurts, brain still fogged)
9/4/12 Herceptin done!
9/6/12 Port out!
7/11/13 Aricept 5mg for cognitive impairment; increased to 10mg as of 8/23/13; back to 5mg 12/2013
5/2014 Add Namenda 7mg
9/2014 Stop Aricept and Namenda; Neuropsychological evaluation
10/24/14 Start cognitive rehabilitation therapy
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Old 12-08-2014, 07:29 AM   #6
thinkpositive
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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
__________________
8/2013 Diagnosed IDC Left Breast ER-/PR-/HER2+ Stage 3C, DCIS ER+/PR+/HER2- Right Breast (54 yr)
8/2013 PET/CT scan shows mass in uterues and suprclavicular nodes
8/20/13 Begin 6 rounds TCH chemo, Perjeta added for rounds 4-6
9/2013 After 1st round of chemo, mass in neck and breast no longer able to feel
11/2013 Hysterectomy, mass from PET/CT scan not cancer (adenomylosis)
12/2013 Finished chemo
1/2014 Double mastectomy with chest expanders
1/2014 Pathology report from surgery and SNB show complete pathological response!
3/2014 Finish IMRT radiation
8/2014 Fat transfer to radiated breast
8/2014 Completed 1 yr of Herceptin
10/2014 exchange surgery expanders removed implants placed
6/2015 3D nipple and areola tattoos
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Old 12-08-2014, 10:38 AM   #7
KaiM
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

Signed. Thanks Phil!
__________________
9/11 - dx 3 mnths after giving birth to my 2nd child. (not a clogged milk duct) ER/PR- HER2+++
10/11 - Initially staged at 2b after unilateral mastectomy
11/11 - CT scan 4 weeks later found spots on bones and liver (crap!) Stage 4
12/11 - starting TCH
5/12 - STABLE. stoping TCH after 6 months and continuing Herceptin with Tykerb and Xgeva
8/12 - STABLE, but I'm calling it NED because all they see is bone scaring!
11/12 - STABLE
2/13 - STABLE
6/13 - STABLE
9/13 - STABLE
12/13 - STABLE
3/14 - STABLE
6/14 - STABLE
9/14 - STABLE
12/14 - STABLE
...Continue Herceptin and daily Tykerb and scans every 4 months
1/16 - STABLE
Mom to Audrey (8 yrs) and Hudson (4)

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Old 12-08-2014, 11:21 AM   #8
'lizbeth
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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.
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Old 12-08-2014, 11:34 AM   #9
rhondalea
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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.
__________________

2/6/09 Core needle biopsy: negative; Mammos through 2010: no change
3/30/11 Pea-sized lump in left breast at site of prior biopsy; mammo negative, sonogram not so much
4/14/11 Core needle biopsy: negative for cancer
5/18/11 Excisional biopsy 1.2 cm tumor, LVI, positive margin; ER+60%,PR+20%,HER2/CEP17 5
6/15/11 BMX: Left DCIS & LH; Right ADH; SNB: 2/3 nodes: 1.4 cm and 1 mm; ALND L1&2: 0/10; Stage IIa, Grade 3
7/14/11 CT/Bone scans NED; MUGA 66%
7/19/11 Biweekly dd AC w/Neulasta; done 8/30/11
9/13/11 Transfusion (Hemoglobin 8.6); MUGA 64%
9/20/11 Start Taxol + Herceptin; Taxol done 12/6/2011; continue Herceptin until 9/4/2012
12/27/11 Radiation - 6 weeks; 2/27/2012 - DONE! Yayyyy!
2/29/12 Start Tamoxifen 20 mg/day; continue until 2/28/17
5/16/12 Start five-years Metformin trial
6/19/12 MUGA 61%
8/21/12 Brain MRI NED (head still hurts, brain still fogged)
9/4/12 Herceptin done!
9/6/12 Port out!
7/11/13 Aricept 5mg for cognitive impairment; increased to 10mg as of 8/23/13; back to 5mg 12/2013
5/2014 Add Namenda 7mg
9/2014 Stop Aricept and Namenda; Neuropsychological evaluation
10/24/14 Start cognitive rehabilitation therapy
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Old 12-08-2014, 12:37 PM   #10
'lizbeth
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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?
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Old 12-08-2014, 02:11 PM   #11
lkc Gumby
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

signed ! Thank you Phil
__________________
Linda

Dxed Stage IIIC May 05, 12 pos nodes
er/pr -neg,Her -pos
LVI
Right partial mast & partial axillary dissection-June14,2005
Right modified mast-no clear margins- June 30, 2005
DD AC x4
Taxotere X4 with Herceptin
Rads x 35( 5 fields )
Left prophylactive mast( atypia & hyperplasia found ),
put on Tamoxifen x 1 yr; D/ced due to endometrial thickening
bilateral recon (saline implants)May 06
Nipple recon July 06
metformin 2010
removal of implants due to severe encapsulation, insertion of gummies 2013
Reclast Q yr
NED!!!
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Old 12-08-2014, 02:41 PM   #12
sassy
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

Signed! Thanks Phil!

Rhonda, I'll PM you about the appeal documents.
__________________
Rhonda (Sassy)
dx age 45
DX 2/15/05 Stage IIb (at surgery)restaged IIIa
Left mast .9cm tumor 5 of 14 nodes
Triple Positive
4 DD A/C
12 Taxol/Herceptin
33Rads
Strange infect mast site one year aft surg, hosp 1 wk
Herceptin for total of 18 months
Lupron Monthly 4 yrs
Neurontin for aches, pains and hot flashes(It works!)
Ovaries removed 11/09 stop Lupron and Neurontin
Arimidex 6 yrs (tried Femara, no SE improvement)
Tried Exemestane-hips got so bad could hardly walk
Back to Arimidex for year seven
Zometa 2X Annual for 7years, Lasix
Stop Arimidex 5/13
Stop Zometa 7/13-Bi-lateral Stress Fractures in Femurs from Zometa
5/14 Start Tamoxifen
3/15 Stem cell transplant to stimulate femur bone growth/healing
5/15 Complete fracture of right femur/Titanium rods both femurs
9/16 Start Evista stopTamoxifen
13 YEARS NED!
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Old 12-09-2014, 12:46 AM   #13
michka
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

Signed! Michka
__________________
08.2006 3 cm IDC Stage 2-3, HER2 3+ ER+90% PR 20%
FEC, Taxol+ Herceptin, Mastectomy, Radiation, Herceptin 1 year followed by Tykerb 1 year,Aromasin /Faslodex

12.2010 Mets to liver,Herceptin+Tykerb
03.2011 Liver resection ER+70% PR-
04.2011 Herceptin+Navelbine+750mg Tykerb
06.2011 Liver ned, Met to sternum. Added Zometa 09.2011 Cyberknife for sternum
11.2011 Pet clear. Stop Navelbine, continuing on Hercpetin+Tykerb+Aromasin
02.2012 Mets to lungs, nodes, liver
04.2012 TDM1, Ned in 07.2012
04.2015 Stop TDM1/Kadcyla, still Ned, liver problems
04.2016 Liver mets. Back on Kadcyla
08.2016 Kadcyla stopped working. mets to liver lungs bones
09.2016 Biopsy to liver. no more HER2, still ER+
09.2016 CMF Afinitor/Aromasin/ Xgeva.Met to eye muscle Cyberknife
01.2017 Gemzar/Carboplatin/ Ibrance/Faslodex then Taxotere
02.2017 30 micro mets to brain breathing getting worse and worse
04.2017 Liquid biopsy/CTC indicates HER2 again. Start Herceptin with Halaven
06.2017 all tumors shrunk 60% . more micro mets to brain (1mm mets) no symptoms
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Old 12-10-2014, 09:57 AM   #14
Vicky
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

Signed!

Thanks for posting it here for us all to see!
__________________
3-16-11 dx IDC 4.4 cm tumor, right breast,HER-2 neu 3+++, Stage III
3-25-11 PET scan shows 3 mets to liver and 1 to spine, Stage IV
4-12-11 start clinical trial of TDM1 infusion 1x every 3 weeks.
6-14-11 CT scan after 3 cycles shows NO liver spots, reduced spinal met from 18mm to 13mm and right breast mass from 4.4 to 4.2 cm.
8-12-11 Mastectomy rt. breast.
10-11 scans reflect stable cancer
12-11 MRI reveals area of concern in brain, CT scan reveals 3mm spot on lung. Watch and wait and rescan in a few weeks. Round 13 TDM1 complete.
2-21-12 Scans reveal progression in lungs with 4 new small mets. Officially off tdm1. Start halaven and radiation for single brain met, 1 spot in spine.
3-13 stereotactic radiosurgery for single brain met.
5-31-12 Halaven stopped due to low blood counts. Start tamoxifen and cont. Herceptin 1x3 weeks.
7-11-12- brain mri shows shrinking brain met and no new lesions. Cont. Herceptin and Tamoxifen
10-2-12 Stable tumor markers. Continue Herceptin and Tamoxifen
4-9-13 progression in lymph node under arm and new lung spots. Stop Tamoxifen. Add Xeloda to Herceptin.
6-10-13 Stereotactic radiosurgery to two new brain mets. Stop Xeloda due to lung mets progression. begin Tykerb 7-2-13.
10-29-13 Begin radiation to my lungs and one lymph node under my arm. Stop Tykerb until completion and then recommence.
1-31-14 Progression in lungs. Oophorectomy performed.
2-18-14 Begin Arimidex and continue Herceptin
7-7-15 progression with spots on colon, in pelvic region, and in lungs. Begin Taxotere, Perjeta and Herceptin.
11-15 Switch to weekly Taxol, and continue with Perjeta and Herceptin.
12-23-16 PET scan shows Complete Response with no new spots. Continue on with TPH indefinitely.
3-16-16 Still no evidence of disease, break from Taxol. Continue on with Perjeta and Herceptin.
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Old 12-12-2014, 08:54 AM   #15
JillaryJill
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

signed. Thanks Phil
__________________
DX November 2010
Brain MRI, CT of lung, liver, bone, all clear
Double Mastectomy w/expanders December 1, 2010
ER- PR- Her2+++, grade 3, 12 positive nodes out of 15
Stage IIIc
Started TCH/Chemo December 31, 2010
6 rounds TCH
Herceptin every 3 weeks for a year
33 rounds of TomoTube radiation, to chest wall, neck, skin and lymph area
September, 2011, MRI to lower spine, hips, DX bulging disk, L4 & L5, pain not from cancer
Expanders removed, implants in Dec 1, 2011
Finished Herceptin, December 21, 2011
August 2012, CT of chest and abdomen, all ok
Enrolled in MC1136 Phase I Peptide Vaccine Trial at Mayo Clinic, Rochester, Minnesota
March 2013, First Vaccine
April 2013, 2nd Vaccine
May 2013, 3rd Vaccine
June 2013, 4th Vaccine
July 2013, 5th Vaccine
August 2013, 6th Vaccine Done!
September 2013, Mayo visit, Echo results 68, vaccine did not effect my heart! Blood work normal.
January 31, 2013, Mayo visit, Echo normal
February 23, 2014, Numb lips on right side, Brain MRI, normal!
June, 2015, Finished the trial at Mayo Clinic. Feels good!
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Old 12-15-2014, 12:25 PM   #16
phil
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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 .
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Old 12-15-2014, 07:42 PM   #17
'lizbeth
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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.
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Old 12-16-2014, 09:46 AM   #18
phil
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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
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Old 12-16-2014, 10:27 AM   #19
'lizbeth
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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.
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Old 12-16-2014, 11:09 AM   #20
rhondalea
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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.
__________________

2/6/09 Core needle biopsy: negative; Mammos through 2010: no change
3/30/11 Pea-sized lump in left breast at site of prior biopsy; mammo negative, sonogram not so much
4/14/11 Core needle biopsy: negative for cancer
5/18/11 Excisional biopsy 1.2 cm tumor, LVI, positive margin; ER+60%,PR+20%,HER2/CEP17 5
6/15/11 BMX: Left DCIS & LH; Right ADH; SNB: 2/3 nodes: 1.4 cm and 1 mm; ALND L1&2: 0/10; Stage IIa, Grade 3
7/14/11 CT/Bone scans NED; MUGA 66%
7/19/11 Biweekly dd AC w/Neulasta; done 8/30/11
9/13/11 Transfusion (Hemoglobin 8.6); MUGA 64%
9/20/11 Start Taxol + Herceptin; Taxol done 12/6/2011; continue Herceptin until 9/4/2012
12/27/11 Radiation - 6 weeks; 2/27/2012 - DONE! Yayyyy!
2/29/12 Start Tamoxifen 20 mg/day; continue until 2/28/17
5/16/12 Start five-years Metformin trial
6/19/12 MUGA 61%
8/21/12 Brain MRI NED (head still hurts, brain still fogged)
9/4/12 Herceptin done!
9/6/12 Port out!
7/11/13 Aricept 5mg for cognitive impairment; increased to 10mg as of 8/23/13; back to 5mg 12/2013
5/2014 Add Namenda 7mg
9/2014 Stop Aricept and Namenda; Neuropsychological evaluation
10/24/14 Start cognitive rehabilitation therapy
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