but payment will be $0
what a joke
Gale Avg Vol 2M x $4 = $8M dollar trade. still peanuts for big boys looks like Rookies are training on Gale
well, since this is unmet need, FDA would approve it, BLA would be just BS
by that time GALE will be already $80
The Real Reason behind ABstral Growth and revenues because 99.9% Phase III will fail so they want to leech through Abstral story
one should learn from them
oh i hear Santa knocking the door , he will sue me
if the data is good penny stock GNBT will bought by ROCHE/LILLY/GSK while Gale will be dumped.
If the data is poor, GALE will catchup with GNBT at $0.02 where the foools can buy more....fools like Rich Steffens have suffered huge losses in the breast boob companies
as a matter of fact this is much more superior than AE75
The GP2 vaccine works in much the same way as the E75 vaccine. Like E75, the GP2 peptide is 9 amino acids long and binds to MHC class I molecules to stimulate CD8-positive T cells; thus, the vaccine works only in patients who are positive for HLA-A2 or HLA-A3. In contrast, the AE37 peptide, which is longer than the E75 and GP2 peptides, binds to MHC class II molecules and stimulates CD4-positive T cells, thereby eliciting a more robust immune response. Although MHC class II peptides can be HLA-restricted, AE37 is a promiscuous peptide, meaning that blood cells of almost any HLA type can present it. In addition, the AE37 peptide is paired with the Ii-Key protein, which enhances the presentation of the peptide to the immune system.
Both the GP2 and AE37 vaccines are being investigated in an ongoing phase II trial to determine whether the individual vaccines can prevent the recurrence of node-positive or high-risk node-negative breast cancer. Patients are sorted into groups depending on their HLA status and then randomly assigned to receive the appropriate vaccine plus GM-CSF or GM-CSF alone (as the control).
The AE37 trial’s planned interim analysis revealed that at a median of 22 months, the recurrence rate in the vaccinated patients was 10.3%, whereas the recurrence rate in the control group receiving only GM-CSF was 18.0%. The difference represents a 43% reduction in recurrence rate.
“These data are encouraging,” Dr. Mittendorf said. “Obviously, we need longer follow-up, and we need to finish accrual in the trial, but the data suggest that it is reasonable to look forward to investigating the AE37 vaccine in a phase III setting.”
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.
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.
11/18/2013 Antigen Express AE37 Breast Cancer Vaccine Update
Primary Efficacy Analysis Initiated for Phase II Study of Novel Immunotherapeutic
WORCESTER, Mass. and TORONTO, Nov. 18, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (GNBT) today announced that it has reached a pre-specified point in the ongoing Phase II trial of its AE37 breast cancer vaccine to initiate its primary efficacy analysis. The drug is a novel immunotherapeutic cancer vaccine being developed by the Company's wholly-owned subsidiary, Antigen Express, Inc. . A previously released positive interim analysis showed a strong trend toward reduced relapse in breast cancer patients receiving the AE37 vaccine.
The immunotherapeutic vaccine AE37 is designed to stimulate a robust immune response against the HER2 protein, which is expressed in a large percentage of patients with breast and other cancer types. While the highly successful drug Herceptin is approved for use only in patients whose tumors express the highest levels of HER2 (roughly 25% of patients), AE37 is targeted to patients whose cancers express even low levels of the HER2 protein. Not surprisingly, the interim analysis showed that AE37 appeared to perform best in those patients who did not receive Herceptin. It is particularly this patient population of low HER2 expressing cancer patients that represents one of the largest areas of unmet need among breast cancer patients.
The Phase II trial involves the use of 15 sites in the US and Europe and is being conducted under a company-sponsored Investigational New Drug Application (IND). The planned analysis will compare disease free survival in AE37-treated versus control patients. The trial is a single-blinded, controlled, and 1:1 randomized study in patients who have been recently diagnosed with node-positive or high-risk node-negative breast cancer and received standard-of-care therapy. As the largest cancer vaccine trial conducted to dat
synthetic stuff ? IMUC NWBO MACK ring a bell ?
The results of the Phase-I/II trials with NeuVax do not portend success in the ongoing Phase-III trial; specifically, the very small sub-group of booster-vaccinated patients showed a small and arguable DFS benefit over unvaccinated patients at the 24 and 36 month timepoints, but showed no benefit at 60 months. It must be noted that the hurdle for success in the ongoing Phase-III trial will be even higher by virtue of the inclusion of a positive control (GM-CSF).
Clarity and transparency are critical prerequisites to biotech credibility and investment. Deciphering NeuVax's development history and results requires a considerable investment of time and effort that still leaves many unanswered questions. When companies conduct business and present data in a manner that confounds analysis, it's time to step back and re-evaluate. "They're looking for the number of recurrences," Peoples said. "The highest risk of recurrence is in the first two to three years. The end point [Galena] and the FDA decided on was the recurrence rate at the end of three years. Hopefully, we'll see a much lower recurrence rate among the vaccine patients compared to the control group." and "Overall, the phase 2 trial was successful with a 50% reduction in recurrence but failed by a single recurrence from being statistically significant.
Pumpers working overtime over the weekend that too end of year holiday season.... someone is desperate.... ?
Gale daily 5% swing, who shorted at $4.20 todays gets the prize
no buyers then block will move to $4.0 -- any buyers ????
no buyers then block will move to $3.95 -- any buyers ????
no buyers then block will move to $3.88 -- any buyers ????
why do you think neuvax is different or what makes them different from imuc and nwbo
what about ACHN ARIA PSDV and the list doesn't stop
have you missed this post
"Overall, the phase 2 trial was successful with a 50% reduction in recurrence but failed by a single recurrence from being statistically significant"
Read more under the thread " bagholders in denial phase 2 failed statistical significance " by nightrader666
A reminder to the phase II failure
Will we hear the same recurrence in Phase 3 ?
reasonable soon meaning 1 year or after Street looks at the numbers ?