vaccine trial
 

Went up to Baltimore to Union Medstar hospital and was bled to see if I was a candidate for the Walter Reed vaccine trial. They called today and I'm (I think what she said)HAL2 positive, so I'm not able to join the trial. Are there any others?

Thanks Valleygirl

Re: vaccine trial
 

Valleygirl,

Not HAL2 positive? Did you mean Her2?

Re: vaccine trial
 

This seems interesting. I was in the GP2 arm of the Walter Reed and I was HLA2 positive. sandraGA was negative and received AE37.

my understanding is Phase III is only enrolling lower expressors of HER2, the former 3Ns (Triple Negs) who test HER2+ and HER2++

when was your last infusion of Herceptin?

Re: vaccine trial
 

Hi lizbeth,

My last Herceptin was June 25th. I was really excited about this, what a disappointment.

Re: vaccine trial
 

I started the vaccine trial here at Sibley about 4 months ago...maybe 6 months ago. I was tested for HLA + or -. I was told that they are only enrolling HLA + patients because they have concluded that HER2+ patients that are HLA - don't benefit from the vaccine. this is what I was told. If you are HER2- and HLA- they put you in the AE37 arm. If you are positive and either HER2+ or - they put you in the GP2 arm.

Re: vaccine trial
 

HLA A2- folks do not have a strong response to cancer, organs from others, or stings and bites. The vaccine, AE37 in designed to "more vigoriously" stimulate our bodies to produce antibodies to fight in these situations. The GP2 vaccine, which is also a peptid vaccine, does a good job for HLA A2+ folks, but not for neg ones.

I could not get into a trial at Mayo because they were only looking at the GP2 vaccines with two different additives to increase effectivity. Then I found the Walter Reed study which had both vaccines. That was one of the best days of my life. I traveled 525 miles each way to do the trial and I would do it again in a heart beat.

Please do your best to get into one of these trials. You will never regret it. When I entered the trial you only had a 30 day window from your last Herceptin treatment. They want you to be disease free.

Sandra

Re: vaccine trial
 

Hi Sandra in Ga
Can you tell me who your contact is at Walter Reed. I went up to Baltimore on Wednesday and was bled, Friday they called and said I wasn't a candidate because I was HLA positive. I had such high hopes for this vaccine.

Thanks Denise

Re: vaccine trial
 

Denise,
I am not sure if the study I am in is still recruiting. I did not go to Walter Reed. There were several locations nationwide with one being in Winston-Salem NC at Wake Forest Medical Center. However, I had a wonderful study nurse and I am certain she will talk with you. Her name is Robin Petro and her number is 336-713-4788. If I were you, I would give her a call and she should be able to share valuable information with you. (Tell her I gave you her name and number.)

Here is the trial info and it looks to me like they are still active. http://clinicaltrials.gov/ct2/show/N...cine%22&rank=1
I do know they have been approved for phase III and are tageting a wider population this time. I do not know the details of this.

I am keeping my fingers crossed for you!!!! Do not give up. Keep looking until you find one that fits your needs. That is the secret.

Sandra

Re: vaccine trial
 

6/12/2013 Generex Announces Interview of MD Anderson's Dr. Elizabeth Mittendorf, Principal Investigator on Company's AE37 Phase IIb Breast Cancer Efficacy Trial

Unique abilities of AE37 to activate immune system highlighted

WORCESTER, Mass. and TORONTO, June 12, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (GNBT) today announced an interview given by Dr. Elizabeth Mittendorf, M.D., Ph.D. Dr. Mittendorf is the Principal Investigator of the Company's AE37 clinical trial to test the ability of the novel immunotherapeutic agent to prevent relapse in patients who have had HER2-expressing breast cancer, the largest Phase IIb peptide clinical trial conducted to date. AE37 is being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). The interview was conducted by Oncology TV at this year's Annual Meeting of the American Society of Clinical Oncology (ASCO), held in Chicago from May 31 to June 4. The interview can be viewed online at:

http://www.oncology.tv/Videos/TabId/79/VideoId/474/ASCO-2013-Elizabeth-A-Mittendorf-MD-PhD-HER2-Peptide-Vaccine.aspx

The interview of Dr. Mittendorf, Assistant Professor, Department of Surgical Oncology, Division of Surgery, The University of Texas MD Anderson Cancer Center, gave an overview of this year's ASCO presentations on AE37, as well as where the breast cancer vaccine fits into the field of cancer immunotherapy. She noted that cancer immunotherapy in general was much more in the limelight at this year's conference. She described the two distinguishing features of AE37 that set it apart from other types of cancer vaccines. Firstly, the vaccine is designed to stimulate CD4+ T helper cells, which are key in generating a more robust anti-tumor immune response. Secondly, the vaccine includes a proprietary modification that increases its potency. The studies that were part of this year's ASCO meeting confirm these unique properties. Dr. Mittendorf was also noted that this vaccine addresses patients with any level of HER2 expression, unlike other HER2-targeted therapies. Currently, patients with low HER2 expression represent a patient population of significant unmet need (representing 50% of all breast cancers).

The updates this year built upon interim results of the Company's controlled, randomized Phase IIb clinical trial of AE37 presented at last year's ASCO meeting. Those presentations demonstrated a clear trend toward reduced relapse in breast cancer patients who had received AE37. One of the studies this year showed that while some patients developed a hypersensitivity reaction (urticarial response), they appeared to have a stronger all-around immune response to the AE37 vaccine. Interestingly, no relapses have been observed in this population of patients. A second presentation demonstrated that repeated AE37 boosters could be safely given to patients to further augment and extend the initial anti-tumor immune response observed with AE37.

The primary efficacy analysis of Phase IIb data from the Antigen Express breast cancer study is expected prior to the end of 2013. Mark Fletcher, Generex President & Chief Executive Officer, commented: "Based on the outstanding interim results announced at ASCO 2012, we are looking forward to qualitatively similar results with greater statistical robustness when data is evaluated later this year, which will leave Antigen Express well-positioned to secure a partnership for a Phase III trial." Antigen Express has been encouraged by the US Food and Drug Administration to submit a protocol for the Phase III trial, which the Company is in the process of preparing under the auspices of a Special Protocol Assessment (SPA), whereby the FDA declares the design, clinical endpoints, and statistical analyses acceptable for FDA approval.

Finally, Dr. Mittendorf pointed to the possible real benefit of combining AE37 with other agents, such as immune checkpoint inhibitors. In particular, inhibitors of PD-1 (programmed cell death protein 1) or CTLA-4 (Cytotoxic T-Lymphocyte Antigen 4) have been shown to essentially take the brakes off the immune system, allowing it to more effectively combat tumor cells in a general way. As AE37 activates the immune system to specifically attack tumor cells, essentially "stepping on the gas", it is an exciting hypothesis to try combining them. It should be noted, however, that patients treated with AE37 alone also appear to have "taken the brakes off" the immune system to an extent.

http://www.antigenexpress.com/news_r...asp?NewsID=194

Re: vaccine trial
 

Anyone know about the vaccine trial at the University of Pennsylvania with Dr. Czerniecki?

Denise

Re: vaccine trial
 

Note the Phase IIb says there is a clear trend of effectiveness with AE37, and in the robust responders there have been NO recurrences.

I don't know abou twhat works for your nurse SandraGA, but not having a recurrence works for me!

Valleygirl,

Here is my nurses' email for the Walter Reed AE37 & GP2 trial. You can email her and double check the status:

sherri.thomas.ctr@amedd.army.mil

Re: vaccine trial
 

6/5/2013 Generex Announces ASCO Presentations of AE37 Vaccine Data; Potential Leading Immunotherapy Option for Breast Cancer Patients

Treatment Regimen Targets All HER2 Expressing Patients, including those 50% of patients for whom no therapies are available

WORCESTER, Mass. and TORONTO, June 5, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (GNBT) today announced two presentations showing the strengths of AE37 as a viable and promising treatment option for patients who have had breast cancer. The compound is being developed by its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). The two presentations were made at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago from May 31 to June 4.

The two presentations focused on the safety and long-term immunity that can be achieved with AE37 treatment. The first presentation, "Risk factors for development of delayed urticarial reactions in the phase II trial of HER2 peptide vaccines plus GM-CSF versus GM-CSF alone in high-risk breast cancer patients to prevent recurrence", by Alfred Trappey et al, reports on cumulative safety data from the ongoing Phase II efficacy study. The maximum toxicities observed (allergic reactions) occur very infrequently, are easily managed, and have no long-term consequences. In addition, they were observed both in the control arm of the study as well as in the peptide arm, indicating that they were associated with the GM-CSF adjuvant rather than the peptide. The demonstrated safety of AE37 in this larger Phase II patient population confirms prior observations from earlier previous Phase I studies.

"I am very pleased with the progress Antigen Express has made over the years, particularly with the AE37 vaccine program," stated Richard Purcell, Chief Operating Officer of Antigen Express. "The AE37 data continues to track positively, as shown by the immunological and safety results presented in Chicago this week. Given the buzz, excitement, and significant focus on immunotherapy at ASCO this year, a big pharma partnership is a realistic expectation for the Company in the near future."

The second presentation extended results from a published 2013 ASCO abstract, ("Effect of immunization with Ii-Key modified HER2 (776-790) peptide vaccine (AE37) on immunologic responses in prostate cancer patients", by Sonia Perez et al) showing that AE37 induced immunological responses for longer time periods than have been observed with any other peptide vaccines used for breast cancer. In particular, the recent presentation "Booster inoculations of the AE37 peptide vaccine enhance immunological responses in a phase II study", by Eleftheria Anastasopoulou et al, showed that administration of AE37 as a booster for up to two years after the initial therapy further increased the level of specific anti-tumor immunity that could be observed in patients. Not only can the specific immune response be maintained but is even augmented by subsequent dosing.

The strong safety profile and superior immunogenicity set AE37 apart, both from other types of immunotherapy as well as other peptide immunotherapies targeting breast cancer. Combined with highly encouraging interim results, showing a reduction of relapse in patients treated with AE37 in a controlled, randomized Phase II efficacy trial, these latest studies support ongoing plans the Company has for a pivotal Phase III registration trial.

"Several distinct products are being developed with the Antigen Express Ii-Key technology and are at various stages of development," said Joe Moscato of Company consultant Seahawk Capital Partners, Inc. "Our attendance at ASCO 2013 gave Antigen Express the opportunity to initiate and continue discussions with multiple interested prospective big pharma partners and collaborators. The different products have applicability in diseases such as breast cancer, prostate cancer, ovarian cancer, influenza, and HIV. Interim data from October of 2011 suggested efficacy in our AE37 breast cancer vaccine, enhanced with our proprietary Ii-Key/HER2 antigen hybrid, has helped to validate Antigen Express' Ii-Key technology overall." Mr. Moscato went on to say: "The Ii-Key hybrid technology allows tumor-associated or foreign antigens, like viral antigens, to potently enhance the immune system's ability to recognize and destroy cancerous or virus-infected cells bearing any of the targeted antigens, as well as generate immunological memory. We are committed to finding alliances and partners to work together on the best clinical trial programs for each distinct product and, as the end of this year approaches, and new data is unveiled in our late-stage Phase IIb breast cancer trial, we are looking to have sufficient positive data to attract and finalize key partnerships and collaborations."

Re: vaccine trial
 

http://www.clinicaltrials.gov/ct2/re...=Open&no_unk=Y

I see about 14 vaccine trials on clinicaltrials.gov

The PRESENT trial has only a 30 day window, and is only for lower expressors. That is trial #10 on the list. Perhaps a Phase II is still open at some locations. E75 is showing about a 43% reduction in recurrence rates.

I'm only familiar with AE37, E75, and GP2 (personal experience) vaccines. I see several new vaccines in a Phase I at one location. So if they are close, or you are willing to travel they could be possibilities.

If you are HLA-A2+ you should be eligible for the GP2, and according to clinicaltrials.gov - it is still in PhaseII and open.

I don't know about the Pennsylvania location vaccine, but would be eager to learn more about it. It might have come up before, but I don't recall.

There must be an opportunity for a vaccine trial for you. Totally worth it with the lowered recurrence rates.

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Thanks lizbrth for all the info! penniesinaction.org this is the website where I found the info but can't find on the clinical trial pages.

Re: vaccine trial
 

http://www.ncbi.nlm.nih.gov/pubmed/22252842

Oh the pennies in action has been discussed before. I've forgotten the details but here is a journal article in pub med.

Re: vaccine trial
 

hi.
I am also in the GP2 arm of the trial due to having tested HLA2-positive,. I am enrolled at MD Anderson in Houston and as far as I know they are still looking for participants for it.

Re: vaccine trial
 

I asked the San Antonio Med Ctr nurses for the latest status of the clinical trials and here is my understanding of what is open for Her2 3+ (which is us, the Her2+++).

Walter Reed Vaccine trial:

"If a patient is HER2 3+ and HLA A2+ then she would qualify for the study. If she is Her2 3+ and HLA A2-she would NOT qualify for the study. Don't forget there are several other inclusion/exclusion criteria that she may have not met. Also, there are only 3 sites open to enrollment at this time due to the trial being almost fully enrolled and Walter Reed is not one of them. It is us at SAMMC, MD Anderson in Houston and I can't remember the 3rd at this time, but I will ask and let you know.

At this time you can still enroll for AE37 at MD Anderson. They are looking to close the trial to enrollment by the end of the year." (this is the Phase II HER2 3+ HLA A2- group).

So it appears that the "not qualifying" is based on full enrollment at specific sites.

Re: vaccine trial
 

Hey, 'lizbeth! No recurrance is what I am all about!!!

When I had my scare in Dec. with a couple of spots on my right lung, I called my study nurse and she emphatically stated she was sure they were nothing ~ and she was right!

Sandra

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Sandra you've been quiet lately. Is it flower season?

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anyone doing these....NCT00195091 or NCT00393783