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Old 06-04-2013, 08:16 AM   #1
'lizbeth
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Talking NeuVax reduces recurrence by 78.4% over 5 years

NeuVax™ (nelipepimut-S) continues to demonstrate durable response rates

The NeuVax poster presentation entitled: "Biomarker Correlation to Clinical Response in Phase I/II Trials of the Adjuvant Breast Cancer Vaccine, NeuVax (nelipepimut-S or E75)" examined the relationship between in vitro immunologic response (IR) and clinical recurrence (CR) after five years of follow-up in patients with breast cancer. The study looked at the levels of E75 specific T-cells as measured by the dimer assay and correlated the IR with clinical benefit, or lack of recurrence. The dimer assay is a a way of counting E75-specific killer T cells that are induced by the NeuVax vaccine. The vaccine was administered in the adjuvant setting to prevent recurrence in breast cancer patients rendered disease-free following standard-of-care therapy. Evaluable patients (n=187) combined both the SN-33 (node-positive) and SN-34 (node negative) patients from the Phase 1/2 NeuVax trials. In the study, the majority of the recurrences occur in women that had lower absolute levels of NeuVax-specific T cells or more modest increases in their NeuVax-specific T cells.

The study concluded that in completed phase 1/2 trials of NeuVax, patients who exhibit robust in vitro IR have lower recurrence rates. This finding suggests that nelipepimut-specific CTL clonal expansion is a valid biomarker for CR in patients treated with NeuVax. In the SN-33 trial, the 60-month Landmark Analysis demonstrated a 5.6% recurrence rate with NeuVax vs. a 25.9% recurrence rate in the control arm—a recurrence reduction of 78.4%.

"NeuVax works by stimulating the body's own immune system, via cytotoxic T lymphocytes (CTLs), to seek out and destroy micrometastatic cancer cells that may be circulating or deposited in a patient's body after they are deemed clinically disease-free. The data presented today demonstrates there is a correlation between the these NeuVax-specifc CTLs stimulated by the vaccine, and a reduction in recurrence of breast cancer in the women tested," said COL George E. Peoples, MD, FACS, Director, Cancer Vaccine Development Program; Deputy Director, United States Military Cancer Institute; Professor (adjunct), Surgical Oncology, M.D. Anderson Cancer Center; Professor, Surgery, Uniformed Services University; Chief, Surgical Oncology, Brooke Army Medical Center.
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Diagnosed 2007
Stage IIb Invasive Ductal Carcinoma, Pagets, 3 of 15 positive nodes

Traditional Treatment: Mastectomy and Axillary Node Dissection followed by Taxotere, 6 treatments and 1 year of Herceptin, no radiation
Former Chemo Ninja "Takizi Zukuchiri"

Additional treatments:
GP2 vaccine, San Antonio Med Ctr
Prescriptive Exercise for Cancer Patients
ENERGY Study, UCSD La Jolla

Reconstruction: TRAM flap, partial loss, Revision

The content of my posts are meant for informational purposes only. The medical information is intended for general information only and should not be used in any way to diagnose, treat, cure, or prevent disease
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Old 06-09-2013, 11:35 AM   #2
SusanN
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Re: NeuVax reduces recurrence by 78.4% over 5 years

This REALLY looks like something I'd be interested in...I have my 4th treatment tomorrow...need to talk/ask my MO about this... ask if is he has read about it...thank you dear friend!!
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10/18/12 Found pea size lump right breast
11/7/12 Biopsy
12/14/12 Lumpectomy
1/4/13 Rexcision, NO CLEAR MARGINS!! :(
2/11/13 Mastectomy with Expander Placed
2/15/13 INFECTION at Mastectomy site...emergency Surgery!!! Expander removed :(
DX: DCIS, IDC, Stage 2a, 2.7cm, 1/5 nodes positive
ER/PR-, HER2+++
3/28/13 Port placed
4/1/13 Begin 6 Cycles TCH Therapy
4/1/14 Finished Herceptin!!
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Old 06-09-2013, 04:32 PM   #3
jaykay
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Re: NeuVax reduces recurrence by 78.4% over 5 years

It does sound good. I went to their site and it appears they are targeting her2- breast cancers. I took a quick survey and was told that I probably wasn't eligible. Bummer, keep on trying!
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March, 2000: 48, Post menopausal (5 yrs HRT) Left breast, IDC 3mm/DCIS 1.6cm, ER+/PR-/Her2+++, mod differentiated, MIB low, lumpectomy, node neg via SNB, rads=33 Stage 1a
June, 2000: Tamox 4.5 years,Femara for 5 years (end in Jan. 2010)
Sept, 2012: 61, Via mamm, ultrasound, biopsy, right breast, 2.3cm tumor, ER+/PR-/Her2+++, poorly diff, KI67 60-70%
BRCA 1 and 2 negative
October, 2012: Bi Mast with tissue expanders, port placement
Final Path: IDC 2.8cm, DCIS, 1/4 sentinal nodes positive (@#$%). Stage IIB
Nov 29, 2012: Begin TCH/6x/every 3 wks, H for 1 year/every 3 weeks.
March 14, 2013: Finished chemo
April 9, 2013: Begin radiation 28x
May 22, 2013: Finished rads
June 1st, 2013: Started Aromasin for 5 yrs.
July 15, 2013: Switched to Letrozole (Femara). Probably for the rest of my life
October 16, 2013: Exchange surgery
October 31, 2013: Finished Herceptin
December 5, 2013: Port removed
Glad this year is over!
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Old 02-19-2014, 02:21 PM   #4
'lizbeth
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Re: NeuVax reduces recurrence by 78.4% over 5 years

Info on Neuvax taken from:
Here’s Why Galena Pharmaceuticals’ NeuVax Is the Real Deal by Christopher F. Davis



Quote:
in a subpopulation of participants, NeuVax can greatly reduce and eliminate recurrence of breast cancer altogether. NeuVax consists of the E75 peptide derived from HER-2 (human epidermal growth factor receptor 2, which has a 1, 2, or 3 positivity associated with it) combined with the immune adjuvant granulocyte macrophage colony stimulating factor (GM-CSF). Treatment with NeuVax stimulates cytotoxic (CD8+) T cells in our immune system in a highly specific manner to target cells expressing any level of HER-2. Approximately 173,000 women are diagnosed each year with HER-2 positive breast cancer, or around 75 percent of all female breast cancer cases.
Currently, only one-quarter of all breast cancer patients, those with HER2 3+ disease, can receive Herceptin, which is made by Roche. NeuVax targets the remaining patient population whose cancer makes it to remission with the current standard of care but have no available HER2-targeted treatment options to maintain their disease-free status.
Chemically, the science is sound, but I want to talk about the epidemiological science and the data a bit more. The first set of meaningful phase one and two data came out in 2010. In that study, 97 breast cancer patients who had varying degrees of HER-2 positivity were randomized to a treatment (combination NeuVax and standard care) and a control group (standard care only). Figure 1 has the Kaplan-Meier survival curves documenting the data.
Figure 1. Kaplan-Meier survival curves comparing treatment with NeuVax versus control group, Galena Pharmaceuticals, 2010
When we compare the survival curves of the data from that study, there is a marked difference between the two groups, but due to a small sample size, the study did not have adequate power to detect statistically significant differences. In general, we defined statistical significance using p-values, which represent the probability that the observed outcome is completely by chance.
In biostatistics, we generally use the 0.05 cutoff for determining significance. We also use confidence intervals for comparisons. Generally, when a p-value is below 0.05, a confidence interval of the point estimate (such as the relative risk, odds ratio, hazard ratio, etc.) will not contain the null value (which is 1.0 on a relative scale). All of the jargon can be complicated for the lay audience, but is important to have a working knowledge of it when examining clinical data.
So, what you need to know is that the more data points we have, the more power to detect differences. The study only had 97 participants. That’s a very small sample size. The survival curves were visibly different but did not come in below 0.05. The bears cite this as proof it doesn’t work. I fundamentally disagree. Although it was not statically significant with a p-value of 0.12 given the small sample size, most epidemiologists would contend that the results approach significance,and given the small sample size, further study is warranted.
Why? The point estimates are meaningfully different, even though they are not statistically significant. The disease-free status at two years came in at 91 percent for those in the NeuVax group versus 79.5 percent for the control group. At five years, those in the NeuVax group were 85 percent disease free versus 77 percent disease free for the control group. But that’s not all. Where key data exists are in the subset analysis.
The subset analysis: proof is in the pudding

As is often conducted in clinical trials, a subset analysis was performed, looking at all patients that had HER-2 protein positivity, with both 1+ or 2+. They excluded those with HER-2 protein positivity with 3+ because they had received Herceptin treatment and would confound the results.
The subanalysis thus only had 45 patients, which crippled statistical power. Thus something truly impacting the risk for recurrent illness would have to be taking place to have and chance at hitting significance. In lay terms, the data would have to be completely one-sided. I present for your consideration Figure 2, the Kaplan-Meier survival curves for risk of disease recurrence in the subset analysis.
Figure 2. Kaplan-Meier survival curves comparing treatment with NeuVax versus control group among only those patients with HER-2 1+ or 2+, Galena Pharmaceuticals, 2010
Examination of the subset analysis is critical. To the naked eye, we definitely see a difference in the curves. Clearly the NeuVax group is performing better than the control group. What you notice in the figure is a little “HR=0.00.” This refers to the hazard ratio. The hazard ratio is defined as how often a particular event happens in one group compared to how often it happens in another group, over time.
In cancer research, hazard ratios are often used in clinical trials to measure survival at any point in time in a group of patients who have been given a specific treatment compared to a control group. A hazard ratio of 1 means that there is no difference in survival between the two groups. A hazard ratio of greater than 1 or less than 1 means that survival was better in one of the groups. As we see, the hazard was 0.00.
This means there was absolutely no recurrence in the NeuVax group. Thus, not one patient relapsed in the NeuVax compared to 22.2 percent in the control group. Remember the landslide data I mentioned would be need to reach statistical significance? Well the statistics came in with a p-value of 0.035. This hazard ratio and statistical significance held at 24 months and 36 months.
Phase IIb and III trials will determine whether GALE goes to $50 or possibly 50 cents

OK, $50 is a stretch, but not outside the realm of possibility in the biotech/pharmaceutical sector. If the trial flops, the stock will plummet. That’s the risk. If it does well, it gets closer to achieving a Food and Drug Administration approval years down the road. Enrollment is ongoing in the next trial, which will involve many hospitals in many areas of the world. It’s a tall order to set up, which has resulted in a delay, but getting everything in place is necessary to ensure a valid trial.
News releases and data from these trials will move the stock in the coming months and years. Until then, the company can focus on other trials and selling and marketing Abstral to maintain revenues. I believe the company has cash reserves to sustain operations into 2016. By then, the stock could be much a higher, and an offering may take place. That would dilute shares but help raise cash — it remains to be seen. For now, NeuVax seems to be the real deal. It has real potential.

Last edited by 'lizbeth; 02-19-2014 at 02:22 PM.. Reason: clean up text
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Old 01-22-2015, 01:32 PM   #5
TonyaV
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Re: NeuVax reduces recurrence by 78.4% over 5 years

I think it's great that you keep promoting this vaccine that shows huge promise however you have to remember that you actually got the vaccine while there are hundreds/millions of us out here who haven't had access to it. I tried to get into a trial and was turned away on a technicality because it is clear they are now preselects get their subjects in order to pad the results. I fit all the inclusion criteria and the HLA blood typing. I'm angry. So please remember while you are jumping for joy and touting the greatness of Galena Biopharma and Dr. Mittendorf the politics and money behind these trials is still very much alive and well. This vaccine should be available NOW. To all women who need it! We are dying while they make money.
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Old 01-23-2015, 09:13 PM   #6
'lizbeth
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Re: NeuVax reduces recurrence by 78.4% over 5 years

I did not participate in this trial as a patient. I have never received the Neuvax vaccine.

Since the vaccine is not currently approved for the general population Galena Biopharma is not making money on the vaccine. The company is following the clinical trial system to get FDA approval, Phase I - Phase III. I do agree it is a terrible system that patients must die to get a treatment approved. But this company did not create the clinical trial system and the vaccine won't be approved if they don't follow the FDA regulations.

Many women have benefited from participating. I am so happy for them.

I am and will continue to celebrate the progress of a vaccine that reduces the recurrence rate of Her2 positive breast cancer.

If you don't qualify for this clinical trial look for another. I have participated in 6 to advance cancer treatment.
__________________
Diagnosed 2007
Stage IIb Invasive Ductal Carcinoma, Pagets, 3 of 15 positive nodes

Traditional Treatment: Mastectomy and Axillary Node Dissection followed by Taxotere, 6 treatments and 1 year of Herceptin, no radiation
Former Chemo Ninja "Takizi Zukuchiri"

Additional treatments:
GP2 vaccine, San Antonio Med Ctr
Prescriptive Exercise for Cancer Patients
ENERGY Study, UCSD La Jolla

Reconstruction: TRAM flap, partial loss, Revision

The content of my posts are meant for informational purposes only. The medical information is intended for general information only and should not be used in any way to diagnose, treat, cure, or prevent disease
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Old 01-24-2015, 10:27 AM   #7
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Re: NeuVax reduces recurrence by 78.4% over 5 years

Lisbeth, I did qualify for the trial! But they are hand picking their subjects now. This is not a legal practice but it is happening. You can defend it all you want (and for the record I am very excited about the prospect of this vaccine!) but you really need to understand the economics behind this type of trial (phase III) as well as the stake that Galena has in this vaccine especially given there are several in the pipeline. I know for a fact I met all inclusion criteria but they are now tailoring the subjects to make their vaccine more attractive at the end of the trial. I know because I myself have run clinical trials in the past and I know how the system works or rather how it is supposed to work when people aren't on the take. I think you should really listen to the other member here Phil who has also tried to discuss this situation too. Of course I'm going to try for another trial but we all need to be aware of the reality of the system and how it benefits some but puts even more at risk!
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Old 01-24-2015, 11:47 AM   #8
'lizbeth
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Re: NeuVax reduces recurrence by 78.4% over 5 years

I find it very interesting that you just joined and the one and only post that you make is on this old post. When you mentioned Phil I have noticed a trend of the "newly joined" commenting on similar posts.

I do not find you and your comments credible. I do not need to defend Galena Biopharma. They have a legal team that is far more capable than I.

I have a degree in business and 30 years of business experience. I'm very aware of the politics behind the cancer industry and the dirty tricks that people will pull.

I do not know who you are, nor am I interested. However you have made several false statements about me. This negativity reflects on you poorly.
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Old 01-24-2015, 02:30 PM   #9
TonyaV
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Re: NeuVax reduces recurrence by 78.4% over 5 years

Omg! Are you serious? I'm not making any claims about you personally. I just think that instead of pretending that this vaccine is going to be available to us and soon or that we should just blindly enroll in clinical trials without understanding who is really profiting it's important to remember that clinical trials are run by the drug companies at the end of the day. I don't care about your business background. I have a research background. Big deal. It doesn't matter. What does is that on here we have all been diagnosed with some form of Her2. And we ALL want to fight and live! But we cannot blindly tout a Biopharma company without the reality that goes with it because quite honestly some of us will die while we wait for this drug that could save our life. And the only way that this will change is if we rise up and band together to make a change both in terms of how fast a drug is allowed to the market by the FDA but also in how some clinical trials are run! We wouldn't be as far as we are in breast cancer research if people weren't realistic about what is really going on. If they weren't getting angry and taking a stand. That's why I chose one of your posts. You have posted a lot about this vaccine. You have a responsibility to those of us on here to discuss it both a) in a realistic light and b) in a more mature way that doesn't just have you jumping all over those of us who disagree with you. At the end of the day we are all on here for support because we are fighting for our lives - literally! You could be a bit more accepting of other people's points of view as well as be a conduit for change. If you rallied those on here we could have numbers that may make a dent in the system. And every dent we make could mean lives that get to be lived! That lisbeth is what I'm saying. All of this has nothing to do with you personally. But rather with the information you provide. It doesn't have to be so one sided and it can be used as a way to CHANGE the system!
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Old 01-24-2015, 03:49 PM   #10
'lizbeth
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Re: NeuVax reduces recurrence by 78.4% over 5 years

Yes, I'm serious. I've already clarified I have not received the vaccine as you claimed, and I do not find the claim that patients are being handpicked credible, therefore I'm not "defending it".

No one is pretending the vaccine is going to be available soon. The Phase III has just started and will take time.

I do not have a responsibility to discuss it in what you perceive to be a "realistic light". I shared the information so that those on the Her2support board could see what was coming up in the pipelines, just like I shared many other clinical trials for many other companies.

It appears that you are the one jumping all over me. I do not need to be angry to make a positive change. I believe the best way to save lives is to support the research that the vaccines companies are providing, and to support the research other biopharma companies are providing.

Luckily for early stage Her2 breast cancer the overall survival numbers are quite good so the number of women dying is very small. Realistically speaking the vaccine will be likely be approved within the next few years and I prefer to invest my time in a way that benefits those that need the CHANGE more, such as those who have recurred or were diagnosed with Stage IV.

Last edited by 'lizbeth; 01-24-2015 at 04:09 PM.. Reason: typo
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Old 01-24-2015, 04:33 PM   #11
TonyaV
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Re: NeuVax reduces recurrence by 78.4% over 5 years

Wow! I came here for support and discussion. You're seriously insane! It makes me sad that people like you are on these support boards because you just bully the rest of us!
You concentrate on positivity? Yea right! And as far as concentrating on those who need more help like those stage IV or who have a recurrance, duh? That's what I'm saying too just not in such an unrealistic way. I just watched - while going through chemo - my mother die of her2 recurrance. So I have every right to be upset and to want to try and change the system so others don't have to watch their mom/wife/daughter die unnecessarily!
And you're right I am a new member but I'm also about to be an ex- member because of you. I've seen you get into it with others on here. You're NOT helping anyone with your unrealistic portrayals and your bullying of those of us who don't see things the way you do.
So fine tout your clinical trials without all the facts (I've worked behind the scenes and I know) but just remember while you do that women are dying and they have loved ones dealing with those losses. And you can argue all you want but they are preselects for their subjects for phase III and they are padding the results. How else do you think they are going to make money on a vaccine that is also in the pipeline elsewhere. You really need to do more research.
And please don't bother replying I don't need anymore of your negative defensiveness. If this is the kind of place that lets people like you bully new members just because we have a different view and are trying to start a discussion then forget it. You can have this support blog. I certainly don't need to be bullied over the Internet just because I wanted to point out something you have left out of your little "ads" for Biopharma.
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Old 01-24-2015, 04:39 PM   #12
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Re: NeuVax reduces recurrence by 78.4% over 5 years

I do not agree that anyone who posts here has an obligation to post in a certain way or from a particular point of view. Nor do I agree that anyone here has the obligation to engage in advocacy of any kind.

We all have the same underlying disease. This is a support group, and we're here to help each other if we can. Personal attacks are not helpful, because they lead to bickering and bickering leads to stress that no one needs.

It's possible to educate and to put forth one's point of view about touchy subjects without making it about a particular person.

It's okay to be angry about the trial, Tonya, but it's not 'lizbeth's fault that you were not accepted, so please don't take it out on her. You can talk about your frustration with how trials are run without making it personal.

Welcome to the group.
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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 01-24-2015, 10:16 PM   #13
StephN
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Re: NeuVax reduces recurrence by 78.4% over 5 years

Tonya,

I am very sorry to learn you lost your mother to this terrible disease. Naturally you would want to do what you can for yourself and take advantage of any possible cure out there. Do you have any idea as to what in your case would make you less likely to do well in that vaccine trial? Is it your family history? It sounds as if someone does owe you an explanation of your rejection for this trial.
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"When I hear music, I fear no danger. I am invulnerable. I see no foe. I am related to the earliest times, and to the latest." H.D. Thoreau
Live in the moment.

MY STORY SO FAR ~~~~
Found suspicious lump 9/2000
Lumpectomy, then node dissection and port placement
Stage IIB, 8 pos nodes of 18, Grade 3, ER & PR -
Adriamycin 12 weekly, taxotere 4 rounds
36 rads - very little burning
3 mos after rads liver full of tumors, Stage IV Jan 2002, one spot on sternum
Weekly Taxol, Navelbine, Herceptin for 27 rounds to NED!
2003 & 2004 no active disease - 3 weekly Herceptin + Zometa
Jan 2005 two mets to brain - Gamma Knife on Jan 18
All clear until treated cerebellum spot showing activity on Jan 2006 brain MRI & brain PET
Brain surgery on Feb 9, 2006 - no cancer, 100% radiation necrosis - tumor was still dying
Continue as NED while on Herceptin & quarterly Zometa
Fall-2006 - off Zometa - watching one small brain spot (scar?)
2007 - spot/scar in brain stable - finished anticoagulation therapy for clot along my port-a-catheter - 3 angioplasties to unblock vena cava
2008 - Brain and body still NED! Port removed and scans in Dec.
Dec 2008 - stop Herceptin - Vaccine Trial at U of W begun in Oct. of 2011
STILL NED everywhere in Feb 2014 - on wing & prayer
7/14 - Started twice yearly Zometa for my bones
Jan. 2015 checkup still shows NED
2015 Neuropathy in feet - otherwise all OK - still NED.
Same news for 2016 and half of 2017. Boring ...
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