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Ae37 vaccine clinical trial

Ae37 vaccine clinical trial

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AE37, an Ii 11:00 Clinical Development of a Modified, Self-Potentiating HER2 Peptide Vaccine in Breast and Prostate Cancer Patients

T1 - Results of the first phase I clinical trial of the novel Ii-key hybrid preventive HER-2/neu peptide (AE37) vaccine

com) (OTCQB: GNBT) announced today presentation of data from the on-going Phase II clinical trial of the AE37 breast cancer vaccine correlating local immune response to a reduction in relapse

Generex Biotechnology Corporation today announced presentation of additional results from a recently completed Phase I clinical trial of its novel immunotherapeutic peptide AE37 in prostate cancer patients

Vaccine: AE37 Company: The trial aims to show a reduction in cancer relapse after two years compared with patients not AE37 - 10 promising therapeutic vaccines

Peoples will supervise the on-going Phase II clinical trial of the Company's breast cancer vaccine, provide advice and assistance to the Company in respect of the design and implementation of a Phase III trial of the vaccine, and liaise with the Food and Drug Administration regarding the clinical and regulatory development of the vaccine

Generex Biotechnology Corporation has announced publication of a follow-up study from a Phase I clinical trial of the immunotherapeutic agent AE37 in patients with prostate cancer

AE37 in clinical trials The AE37 investigative vaccine has been tested in a prospective Phase 2 clinical trial (NCT00524277) involving 298 women with HER2-positive breast cancer who were clinically disease-free and who either had cancer cells in lymph nodes (called “node-positive”) or nodes that had a high risk of cancer cells (“high-risk node-negative”)

Only about 20 percent of breast cancer patients have high levels of HER2 in their tumors that are required for Herceptin to work

Shumway served as the Principle Investigator for six breast cancer vaccine trials single-blinded phase II trial of AE37 Breast Cancer Vaccine Targets HER2 The breast cancer trial used a peptide vaccine, known as AE37, to target HER2

Expert opinion: Clinical trials have shown the AE37 vaccine to be safe and capable of generating peptide-specific, durable immune responses

from the Phase II clinical trial at this year's Generex Announces Collaboration with Merck to Evaluate KEYTRUDA® (pembrolizumab) in Combination with AE37 in Patients with Triple-Negative Breast Cancer Background: AE37 is a Ii-Key hybrid of the HER2 peptide AE36 (HER2 776-790), which stimulates peptide-specific T cells

We have recently reported that preexisting levels of IFNɣ in response to AE36 might serve as a predictive factor for immunological and clinical responses to vaccination with AE37, the Ii-Key hybrid peptide of HER2 776-790 (AE36) in prostate cancer patients

3% among women inoculated with the vaccine compared to 18% of women in the control group

preexisting immunity in prostate cancer patients vaccinated with the HER-2 hybrid peptide (AE37), during a phase I clinical trial

The presentation, “ Correlation of HER2/neu Antibody Response to Clinical Response in a Phase II Trial of the AE37+GM-CSF HER2 Peptide Vaccine,” demonstrated that antibody response, not necessarily absolute levels of HER2-specific antibody, allowed relapse in enrolled patients

, a wholly-owned subsidiary of Generex, for multiple cancer indications

This phase II trial of the AE37 vaccine shows no benefit in the intention-to-treat population

Generex Subsidiary Antigen Express To Present AE37 Cancer Vaccine Phase 2 Clinical Data At 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium The AE37 cancer vaccine has also completed a Phase 1 trial in prostate cancer demonstrating appropriate dosing and immune activation similar to that seen in the breast cancer trials

The clinical development of vaccines for HER2 AE37 vaccine [Li-Key hybrid HER2 rates ranging from 43 to 80% makes vaccine clinical trial design particularly Generex Biotechnology Corporation announced that its wholly-owned subsidiary, Antigen Express, Inc

Background: Our Cancer Vaccine Development Program has performed phase I and II clinical trials using immunogenic peptides from the HER2/neu protein

com) has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the United States and Canada), through a wholly-owned subsidiary, to evaluate Antigen’s AE37 cancer vaccine in combination with AE37 represents the only HER2-based peptide vaccine currently being studied in a randomized trial and its use is not restricted to patients with a particular type of human leukocyte antigen (HLA) peptide

The results of this Phase II clinical trial were presented at the 2012 Breast Cancer Symposium

Given the increasing interest in cancer immunotherapy, this will be very attractive to companies wishing to 'supercharge' their specific vaccines

Generex Biotechnology Corporation today provided an update to the clinical development & regulatory strategy for its cancer vaccine, AE37

Areas covered: This article reviews preclinical investigations as well as findings from completed and ongoing Phase I and Phase II clinical trials of the AE37 vaccine

We have completed the active phase of a prospective, randomized, multi-center, phase II trial of the AE37 vaccine in the adjuvant setting

Researchers at the MD Anderson Cancer Center in Houston developed a vaccine, called AE37, that trains the body's immune system to attack a common piece found on breast cancer tumors, a protein called HER2, which helps tumors grow

We conducted the first phase I trial of an Ii-Key/HER-2/ neu (776–790) hybrid peptide vaccine (AE37) with recombinant granulocyte macrophage colony-stimulating factor as adjuvant in patients with HER-2/ neu + prostate cancer

' AE37 Cancer Vaccine Featured in Scientific American - read this article along with other careers information, tips and advice on BioSpace clinical trials conducted outside the EU / EEA that are linked to European paediatric To determine if the AE37 + GM-CSF vaccine reduces the recurrence rate in AE37 is a novel Ii-Key Hybrid-based HER-2/neu Peptide Vaccine designed to train the immune system, independent of HLA-type, to track down cancer cells throughout the body and destroy them

Recent immunotherapy trials in prostate cancer have indicated that active immune responses can be achieved with therapeutic cancer vaccines, providing long-term clinical benefit for cancer patients [2, 3]

The Phase 2b breast trial results add to AE37's database on tolerability and safety and have raised the possibility of using AE37 early in prostate cancer therapy

Generex Biotechnology Corporation, a biotech company engaged in the research, development, and commercialization of drug delivery systems and technologies, announced that updated data from the on-going phase II clinical trial of the AE37 breast cancer vaccine under development at the company's wholly-owned subsidiary, Antigen Express, Inc

The AE37 vaccine showed a 43% risk reduction in these patients after 22 months of follow-up in a phase IIb clinical trial

The HER2 peptide AE37 vaccine did not demonstrate a benefit in patients with breast cancer with any degree of HER2 expression

the AE37 vaccine mixed with 125μg of GM-CSF at each vaccination cycle

AE37 is a synthetic cancer vaccine being developed by Antigen Express, Inc

The vaccine still needs further research, but breast cancer experts say the results are promising

According to Generex, AE37 is the only HER2-based peptide vaccine being advanced in a randomized trial

, a wholly owned subsidiary of Generex, for multiple cancer indications

Food and Drug Administration of investigational new drug (IND) status for PolyPEPI 1018

AE37 A breast cancer vaccine already shown to elicit a powerful immune response in women with varying levels of HER2 expression has the ability to improve recurrence rates and is well tolerated in an adjuvant setting, according to new research from a clinical trial led by researchers at the University of Texas MD Anderson Cancer Center

announced the database lock for the primary efficacy analysis of its ongoing AE37 breast cancer vaccine trial

Now there is evidence that therapeutic vaccines actually can work

The positive interim data of the AE37 trial have received particular attention given the robust and well-designed nature of the Phase IIb trial

AE37 (aa:776-790+Ii-Key) is HLA promiscuous whereas E75 (aa:369-377) and GP2 (aa:654-662) are HLA-A2/A3 + restricted

Results from clinical trials demonstrated that prostate cancer vaccines are safe with low toxicity

The immunotherapeutic peptide AE37 is being developed by Antigen Express Inc

Subgroup efficacy evaluation of the AE37 HER2 vaccine in breast The AE37 vaccine is safe and well tolerated and has Clinical trial information An investigational vaccine known as AE37 may reduce the risk of cancer recurrence among women who have been treated for early-stage, triple-negative breast cancer

Prior analyses have shown a trend toward reduction of relapse in patients receiving the vaccine, particularly those who are not eligible for the cancer drug Herceptin as well as those with triple negative breast cancer

Combined clinical trial results of a HER2/neu (E75) vaccine for the prevention of recurrence in high-risk breast cancer patients: U

It builds on previous research showing the vaccine, known as AE37, In the Phase II randomized clinical trial of 201 disease-free The vaccine induces an antibody response to HER2, the target of AE37, and reduces relapse in breast cancer patients

Several early stage trials of HER2 derived peptide vaccines suggest that they may have utility in preventing recurrence and/or progression of cancer

The AE37 cancer vaccine is being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc

The study, entitled "Results from the First Phase I Clinical Study of the Novel Ii-Key/HER-2/neu (776-790) Hybrid Peptide Vaccine in Patients with Prostate Cancer," reports on both the safety and immunological response to the vaccine in patients

The positive interim Phase 2b results, building upon completed pre-clinical and Phase I breast cancer studies, enables Antigen Express to move up the timing of key development and regulatory plans

com), will be presented at the upcoming annual meeting of the MD Anderson Cancer Center

Generex Announces Collaboration with Shenzhen BioScien The clinical trials will be designed and The AE37 vaccine is designed using a Generex Biotechnology reported promising technology and clinical results from its on-going phase II trial of the AE37 breast cancer vaccine being developed by its subsidiary Antigen Express

com) (OTCQB: GNBT) announced today that updated data from the on-going Phase II clinical trial of the AE37 breast cancer vaccine under development at the Company’s wholly-owned subsidiary, Antigen Express, Inc

com), will be presented at the upcoming annual meeting of the A Phase 1 clinical trial sponsored by Treos Bio will soon begin to evaluate the company’s PolyPEPI 1018 cancer vaccine for the treatment of metastatic colorectal cancer (mCRC)

Also I wanted to know Generex Biotechnology reported promising technology and clinical results from its on-going phase II trial of the AE37 breast cancer vaccine being developed by its subsidiary Antigen Express

To determine if the AE37 peptide/GM-CSF vaccine reduces the recurrence rate in HLA-A2-negative, HER2/neu-positive, node-positive or high-risk node-negative breast cancer patients randomized to receive the vaccine versus the immunoadjuvant, GM-CSF, alone

The drug is a novel immunotherapeutic cancer vaccine being developed by the company's wholly-owned subsidiary, Antigen Express Inc

It is designed to stimulate an immune response against the patient's cancer cells, preventing relapse in patients who have been treated for early stage breast cancer

While reading about BC read about trials being on for ae37 a vaccine (I guess) for node positive n her2 positive women

Purpose: Active immunotherapy is emerging as a potential therapeutic approach for prostate cancer

Conclusion: AE37 vaccine is safe and can induce HER-2/neu–specific cellular immune responses in patients with castrate-sensitive and castrate-resistant prostate cancer, thus emphasizing the potential of AE37 to target HER-2/neu for the immunotherapy of prostate cancer

10 was a key date for the CVDP: Phase II of a clinical trial on a peptide called E75 concluded after eleven years

Based on a successful Phase 2 trial, which achieved its primary endpoint of DFS, the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study

The AE37 vaccine is designed to activate components of the immune system to combat cancer cells

title = "Comparison of different HER2/neu vaccines in adjuvant breast cancer trials: Implications for dosing of peptide vaccines", abstract = "We have performed multiple adjuvant clinical trials using immunogenic peptides from the HER2/neu protein (AE37/E75/GP2) plus (GM-CSF) given intradermally to breast cancer patients

The Ii-Key technology in its cancer vaccine design and clinical trial data indicated that the AE37 breast ae37 Canada-headquartered Generex Biotechnology Corporation (OTCQB:GNBT) yesterday announced that its wholly-owned subsidiary, Antigen Express has entered into a license and research agreement with Shenzhen BioScien Pharmaceuticalsto develop and commercialize the Antigen Express AE37 immunotherapeutic vaccine for prostate cancer in China (including Taiwan, Hong Kong, and Macau)

Currently, five of our vaccines, E75, GP2, E39, E39’, and AE37 have been licensed out to industry partners

The Ii-Key technology in its cancer vaccine design and clinical trial data indicated that the AE37 breast Results of the First Phase I Clinical Trial of the Novel Ii-Key Hybrid Preventive HER-2/neu Peptide (AE37) Vaccine “Generex Biotechnology Corporation (www

In this respect, future immunotherapeutic protocols with the AE37 vaccine, could possibly achieve better clinical responses by recruiting patients with a pre-existing immunity to the native peptide

A pilot study in prostate cancer patients treated with the AE37 Ii-key-HER-2/neu polypeptide vaccine suggests that HLA-A*24 and HLA-DRB1*11 alleles may be prognostic and predictive biomarkers for clinical benefit

AE37 We are evaluating this strategy in 2 ongoing adjuvant vaccine trials: also the principal investigator on a phase II clinical trial evaluating the AE37 vaccine; AE37 is also described as a peptide-based vaccine that uses bits of the HER-2/neu protein that are small in size, inexpensive to synthesize and very easy to manipulate, which means that they can be readily formulated into a vaccine that is simple to manufacture in large amounts

The clinical development of vaccines for HER2 AE37 vaccine [Li-Key hybrid HER2 rates ranging from 43 to 80% makes vaccine clinical trial design particularly A new era in anticancer peptide vaccines

A vaccine containing HER2/Neu-derived epitope (amino acids 776-790) linked to li-Key peptide (li-Key/HER2/neu hybrid peptide or AE37), and combined with granulocyte-macrophage colony-stimulating factor (GM-CSF), with potential antineoplastic and immunoadjuvant activities

The United States Military Cancer Institute has conducted the various clinical trials of E75, as well as for two other peptide based vaccines, GP2 and Antigen Express' AE37

Generex Biotechnology has published studies conducted at the Mayo Clinic using the Antigen Express proprietary Ii-Key technology

Antigen Express, Generex’s subsidiary, has used this technology platform in the development of self-potentiating immunotherapeutic vaccines for cancer

45-47 All of the aforementioned studies paved the way for clinical trials of AE37 in patients Generex Biotechnology Corporation, a biotech company engaged in the research, development, and commercialization of drug delivery systems and technologies, announced that updated data from the on-going phase II clinical trial of the AE37 breast cancer vaccine under development at the company's wholly-owned subsidiary, Antigen Express, Inc

The FDA approved the first therapeutic vaccine in April 2010

However, the trial confirms the vaccine to be safe and capable of E75 PHASE II CLINICAL TRIALS COMPLETE Sept

2016 Vaccines in Development Allergy Drug Name Sponsor Indication Development Phase AE37 vaccine Antigen Express breast cancer, prostate cancer Phase II Breast Cancer Vaccine Reduces Cancer Recurrence in Women: Interim Results From Phase 2 Clinical Trial Trend Toward AE37 Vaccine Benefit; Results Presented at SABCS The vaccine, called AE37, is a synthetic hybrid of a peptide derived from the HER2 protein, which is the target of the successful drug Herceptin

results from the first phase i clinical study of the novel ii-key/her-2/neu (776–790) hybrid peptide vaccine in patients with prostate cancer Generex Biotechnology Corporation, a company focused on the research and development of drug delivery systems and technologies, has announced a follow-up study from its Phase I clinical trial of the immunotherapeutic agent AE37 in patients with prostate cancer

" Per trial design in the ongoing Phase II study, patients are being followed for clinical recurrences; data regarding the efficacy of the AE37 vaccine will be reported after a median follow-up of 24 months

clinical trial of the AE37 vaccine clinical trials conducted outside the EU / EEA that are linked to European paediatric To determine if the AE37 + GM-CSF vaccine reduces the recurrence rate in In an early-phase clinical trial that enrolled patients with stage IV breast, ovarian, or non–small-cell lung cancer, Disis and colleagues evaluated multi-epitope vaccines that incorporated MHC class II epitopes

Military Cancer Institute Clinical Trials Group Study I-01 and I-02

"The clinical path forward for AE37 is straightforward, with the Phase III trial designed and ready to be implemented

and TORONTO, April 21, 2015 /CNW/ -- Generex Biotechnology Corporation (www

will be presented at the upcoming annual meeting of the (ASCO)

Antigen Express' novel Ii-Key Hybrid Preventive HER-2/neu Peptide Vaccine (AE37) is an "off-the-shelf" cancer immunotherapy product candidate that is easier and less costly to produce than comparable cell-based approaches

The doses for both AE37 and GM-CSF In a phase I clinical trial, we provided immune Generex Provides Update on Antigen Express Phase II AE37 Breast Cancer Vaccine Trial

Generex Biotechnology has signed a clinical trial collaboration agreement through its Antigen Express division to combine its cancer vaccine AE37Read More AE37 peptide vaccination in prostate cancer: a 4-year immunological assessment updates on a phase I trial

AE37's use "is not restricted to patients with a particular type of human leukocyte antigen peptide," the company noted

A clinical trial began here yesterday at the Walter Reed Army Institute of Research, where 75 participating healthy adults were vaccinated with a Zika virus vaccine that the institute’s scientists AE37 represents the only HER2-based peptide vaccine currently being studied in a randomized trial and its use is not restricted to patients with a particular type of human leukocyte antigen (HLA) peptide

In fact, no fewer than 14 vaccine platforms are currently being used in literally dozens of clinical trials to test cancer vaccines, including peptides/proteins, recombinant vectors, tumor cells, and dendritic cells/antigen-presenting cells

E75 was discovered in the mid-1990s, and Peoples has taken it through consecutive stages of development -- pre-clinical, clinical and human trials

Therapeutic vaccines are meant to combat existing disease rather than offer lasting protection against infection, as traditional vaccines do

However, the trial confirms the vaccine to be safe and capable of We evaluate patients who required dose reductions and compare them to those who did not in our three peptide vaccine trials to Our Cancer Vaccine AE37 (aa:776 Abstract Aim

Finally, cancer vaccines may have limited clinical tumor response in metastatic cancer Peoples GE, Holmes JP, Hueman MT et al

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

1 “The goal of the vaccine is to prime the immune system to recognize and attack the HER2 protein that is found in some breast cancers

This trial represents the first human experience with the Ii-Key modification, and to our knowledge, AE37 is the first peptide vaccine to show potency in the absence of an immunoadjuvant

A breast cancer vaccine already shown to elicit a powerful immune response in women with varying levels of HER2 expression has the ability to improve recurrence rates and is well tolerated in an adjuvant setting, according to new research from a clinical trial led by researchers at the University of Texas MD Anderson Cancer Center

There is an unmet need for predictive biomarkers in cancer immunotherapy

AE37 is capable of eliciting HER-2/neu-specific immune responses, even without the use of an adjuvant

The AE37 cancer vaccine has also completed a Phase 1 trial in prostate cancer demonstrating appropriate dosing and immune activation similar to that seen in the breast cancer trials

The research that propelled these vaccines to this stage of development was performed by the Cancer Vaccine Development Program (CVDP) founded and directed since its inception in 2000 by COL George E Peoples, MD, FACS

[17] One vaccine consisted of three MHC class II epitopes derived from the HER2 protein’s extracellular domain (ECD)