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. |
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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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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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:
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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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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. |
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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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. |
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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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. |
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. |
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. |
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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