Vaccine

[CarolineC]

http://www.ctvnews.ca/health/canadia...mise-1.1145166

[1rarebird]

Caroline--
Thanks for this post with its accompanying video. I know we are all hoping that one day soon one of these vaccine trials is going to show success in turning the immune system on in a way that it defeats the invading cancer cells. This trial sounds very promising.--bird

['lizbeth]

Yes! Please trial. There are numerous vaccine trials currently. I joined the Walter Reed AE37/GP2 trial. You must enroll within 6 months of finishing Herceptin, this is for early and primary breast cancer survivors. There is a statistical benefit for vacciners, so please consider it.

Other trials are also available. Check clinicaltrials.gov and other sites to find the latest information.

[europa]

Just joined the Walter Reed Vaccine trial. But they have narrowed down who can qualify and who can't. If you are HLA positive you qualify, if you are negative you don't. I did a happy dance and hugged my colleague when I got the news I qualified. I get poked on Monday. SO happy

['lizbeth]

Europa,

Which vaccine are you receiving? AE37, GP2 or E75?

I'm a GP2 vacciner.

Thanks for joining a clinical trial. You Rock!

[JillaryJill]

Just got word that University of Washington, Seattle is accepting 10 candidates for the
Part B, Group 5, Her2 peptide vaccine, plus 2000 mcg Ampligen. 4 mcg, 20 mcg, 79 mcg and 495 mcg have already been tested. I am a little freaked out that they are going from 495 mcg to 2000 mcg in this arm. Does anyone have any thoughts on this? They want me to participate and get my first vaccine this month. Thank you.

[europa]

'lizabeth: I am getting the GP2 too. just got my DCTH(?) test today and will get the vaccine on Wednesday. I don't think they are doing the AE37 anymore as they are no longer accepting HLA negative patients. They found that those patients didn't benefit from the vaccine.

[StephN]

Jill -
I mentioned in another thread that I was in the first phase of that U of W trial. Got the highest dosage, and had NO side effects whatsoever.

They would not go that high if there was not reason to believe that is the effective dose level. The blood of the first round participants is still being analyzed, but there must be enough data that we did not get enough ampligen, and now they know it is safe.

Good luck!

['lizbeth]

Europa,

I'm sorry but I think you have received some misinformation on the AE37 vaccine. It is quite effective. The last report at SABC showed a 43% reduction in recurrence rates.

I did a little snooping and found this:

http://www.abstracts2view.com/sabcs1...hp?nu=P1-13-01

Then I went and checked the company's website and found they are planning on starting a phase III trial for lower expressers this year.

I'm a bit concerned about the rush for the lower expressions market, since I'm historically a higher expresser. I wonder if AE37 gets approved for lower expressors, are the HER2+++ just out of luck?

Anyone else know more about this?

[europa]

'lizbeth: All I know is that the Sibley Memorial Walter Reed vaccine trial is no longer accepting HLA negative patients because they concluded that the vaccine did not benefit them. I had to get blood drawn and tested and I came out positive so I was allowed to enter the trial. When I read the documents on the trial, it seemed that initially those that were HLA negative were randomized to wither A37 vaccine without GM-CSF and or GM-CSF alone. But now, they are only accepting HLA + patients and those either receive the GP2 + GM-CSF or GM-CSF alone.
Perhaps there is another A37 vaccine trial or I missed something in the documents they gave me.

['lizbeth]

Generex Provides an Overview of its Cancer Immunotherapy Product, AE37, and Potential in Early Breast Cancer Given Current and Potential Future Therapies - Wednesday, January 30, 2013

WORCESTER, Mass. and TORONTO, Jan. 30, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) today provided an overview on the early breast cancer competitive status of the lead cancer immunotherapy product, AE37, under development at its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). A detailed update on development plans will be provided during the previously announced conference call scheduled for Thursday, January 31, 2013. Antigen Express is in late Phase IIb clinical development for early stage breast cancer that has provided very encouraging interim results and Phase I testing in prostate cancer has been completed.
The specific advantage of the cancer immunotherapy product AE37 is in early breast cancer by potentially stimulating the immune system to target HER2 (the target for Herceptin's effect) on breast cancer cells at low levels independent of immune type of the person. This follows in the footsteps of one of the most successful therapeutics ever developed for breast cancer (Herceptin), though AE37 potentially addresses an early breast cancer patient population of unmet need several times more common than those treated with Herceptin. In particular, while Herceptin is approved for use in roughly 25% of early stage breast cancer patients with high expression of HER2, it is not approved for the larger group of women (50% of women with early breast cancer) who have lower levels of expression of the target for Herceptin (HER2). Rather than attacking HER2 cancer cells directly as does Herceptin, AE37 works by stimulating the immune system to recognize HER2. The greater sensitivity of the immune system can thereby be brought to bear to recognize and kill cancer cells in this larger low HER2 expressing early breast cancer population. An additional potential advantage is that the immunological memory induced by AE37 means the immune system may continue to scan for and kill HER2 cancer cells long after AE37 treatment has been completed.
Herceptin is approved for metastatic and early stage breast cancer patients. Its 2010 annual sales were nearly $6B. Given that the initial target population for AE37 in early stage breast cancer patients is twice that of Herceptin, AE37 has the potential to achieve blockbuster status.
The potency of AE37 derives from a fragment of the HER2 protein combined with a proprietary modification developed at Antigen Express. While similar fragments of HER2 are also in clinical development for early stage breast cancer patients with low HER2 expression, they lack the potency of AE37. Further, their mechanism of action requires use to be limited to a sub-group of people with a specific genetic immune type. The clinical use of these alternative HER2 immune fragments therefore must exclude roughly half of the women with early breast who would otherwise be eligible. No genetic immune limitation or exclusion from clinical use is required for AE37 treatment. Any market competition in early breast cancer from these alternate HER2 fragments would be limited to the genetic immune sub-group, with AE37 facing no competition in patients excluded from other treatments. Further, additional genetic immune profile testing adds another diagnostic step before a woman with early breast cancer could get a potential new treatment. Any agents requiring additional testing may be at a competitive disadvantage.
Another advantage that sets AE37 apart from other types of related vaccines is that it contains a proprietary modification that is exclusive to Antigen Express. The modification, termed Ii-Key, derives its name from the immune regulatory molecule from which it is derived (Ii protein) and the fact that it functions as a 'key' to deliver its payload (HER2 fragment) to critical components of the immune system that ensure generation of a robust and specific immune response. What makes this modification unique is that it amplifies the vaccine potency of the HER2 fragment without loosing specificity, unlike many non-specific immune stimulants. The Ii-Key modification can be added to many different 'payloads' to generate a specific and robust immune response. Given the increasing interest in cancer immunotherapy, this will be very attractive to companies wishing to 'supercharge' their specific vaccines.
The positive interim data of the AE37 trial have received particular attention given the robust and well-designed nature of the Phase IIb trial. In addition to being the only randomized, controlled and blinded study conducted with this type of HER2 targeted immunotherapy, it is also the largest vaccine therapy study conducted in the adjuvant breast cancer setting to date (330 patients). In recognition of the quality of the trial and encouraging results, the abstract reporting the interim results was recognized with a 2012 American Society of Clinical Oncology (ASCO) Merit Award bestowed by the Conquer Cancer Foundation and the 2012 Scientific Program Committee of ASCO. Further, the FDA has given the company the green light to proceed with submission of a Special Protocol Assessment for the Phase III trial.
Antigen Express is well positioned to execute on its business model, which includes potential out-licensing of additional clinical development of its lead compound in early breast cancer while pursuing additional products using its proprietary immunotherapy Ii-Key technology platform upon which AE37 is based. The advancement of AE37 in breast cancer clinical development will help to validate the company's immune technology platform. Low expression of the HER2 target is widespread among a variety of cancers including breast, prostate, ovarian, lung and cancers of the GI tract suggesting potential future areas for clinical research. Additionally, there are many other cancer targets similar to HER2 for which Antigen Express could design immune targeting compounds as along the linesAE37 targetsHER2.

[Shar]

Is there anyone in Canada that knows how to get into a trial for a vaccine. I am in Edmonton, and have 9 more Herceptin treatments.

[sochnedo]

When I read the documents on the trial, it seemed that initially those that were HLA negative were randomized to wither A37 vaccine without GM-CSF and or GM-CSF alone. But now, they are only accepting HLA + patients and those either receive the GP2 + GM-CSF or GM-CSF alone. ???