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Generex Biotechnology, and their wholly owned subsidiary Antigen Express, are developing promising new drugs to treat diabetes, as well as synthetic peptide vaccines targeting HER2/neu cancer and pandemic flu. The flagship product for Generex is Oral-lyn buccal insulin. Antigen Express' leading vaccine is the AE37 HER2/neu synthetic peptide vaccine to prevent breast cancer recurrence. I am not qualified to offer investment or medical advice, and make no claims that I am an expert in these areas. I am a layman and a shareholder in this company. The left side of Pipeline Review holds blogs regarding Generex and Antigen Express, while the right side offers items of due diligence mixed with my analysis which may be of interest to others seeking to learn about Generex's pipeline. If the left side only shows the latest blog, click on the word home to view them all.

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Thursday, September 13, 2012

Generex's AE37 Vaccine Press Release Appears Off Target

I'm someone so clumsy that I'd be better off throwing an apple at an arrow, as opposed to an attempt at shooting an arrow at an apple. There's a better chance that I'd shoot the arrow at my foot, or straight up in the air, so I'd only split my head. The wiser move is to simply eat the apple, and forget the arrow. Generex, and their wholly owned subsidiary Antigen Express, appear equally clumsy when it comes to writing press releases detailing the latest data that researchers are presenting for their novel AE37 HER2/neu peptide vaccine. I'm joking a bit, so I hope the good folks at Generex have a sense of humor. Yet, their follies in this area are true.

The latest example of the reporting of interim efficacy results for AE37 in a company press release that are actually lower than the lead researcher's findings came a few hours ago. Here's a quick look. The following sentence is from Generex's press release dated today, where they provide details of a study abstract that will be presented at the ASCO Breast Cancer Symposium this Friday:

While the study showed an overall reduction of 42% in the risk of relapse in all patients of the study who received the vaccine, the reduction in the risk of relapse was 66% in patients with low expression of the HER2 oncoprotein who were classified as having triple negative breast cancer.

That's impressive data, although the actual results are even better. The lead author of the study is Dr Elizabeth Mittendorf from MD Anderson. The following two sentences are from the study abstract:

"After a median follow-up of 22.3 months, the disease-free survival (DFS) rate in the VG is 90.3% vs 81.1% in the CG (p=.46), a 49% risk reduction."

"The DFS rate in the VG of TNBC patients is 83.3% vs 47.6% in the CG (p=.23), a 68% risk reduction."

Generex reports that there was a 42% risk reduction for relapse in all patients who received the vaccine (VG) in the latest interim look at the ongoing study, but the true risk reduction as stated in the abstract is 49%. Generex also reports that there was a 66% risk reduction for relapse in subjects classified as having triple negative breast cancer (TNBC), but the true risk reduction as stated in the abstract is 68%. Here's a link to the press release, and a link to the abstract.

In June, during the ASCO Annual Meeting, Generex's AE37 vaccine was the topic of discussion in a podium presentation titled "From bench to bedside: The use of the li-Key technology to improve helper peptides for clinical use in cancer vaccines". The report highlights earlier interim results for the same ongoing study as discussed today. At the time, Generex issued a press release informing of the presentation, and the following sentence described key data:

With a median follow-up of 22 months in breast cancer patients, Kaplan Meier projections estimate recurrence rates of 10% in vaccinated patients versus 17% in the control group, a risk reduction of 41%.

Once again, that's impressive data. However, Generex also misreported the true findings. The lead author of this report is Dr Tim Vreeland from the San Antonio Military Medical Center. The following sentence reveals the actual data from his presentation:

With a median f/u of 22 months, Kaplan Meier projections estimate recurrence rates of 10.3% in the VG compared to 18% in the CG; a 43% risk reduction

Generex reported that there was a 41% risk reduction for relapse in all patients who received the vaccine up to that time period, with recurrence rates of 10% in the AE37 group vs. 17% in the control group. Dr Vreeland actually reported a 43% risk reduction, with a relapse rate of 10.3% in the AE37 group vs. 18% in the control group. Here's a link to Generex's press release from June, and a link to the actual abstract.

If we go back a little further in time, say to 2009, we may recall this press release from Generex that came one day after an errant corporate update for this same Phase II study. This press release came on the heels of the first look at early efficacy findings, as were presented at the San Antonio Breast Cancer Symposium in December 2009:

Generex Clarifies Previous Announcement of Breast Cancer Study Interim Results

WORCESTER, Mass., Dec 15, 2009 (GlobeNewswire via COMTEX News Network) -- On December 14, 2009, Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com) issued a press release announcing the presentation of interim results from a Phase II efficacy study of a novel immunotherapeutic vaccine being developed by its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com), at the 32nd Annual San Antonio Breast Cancer Symposium (www.sabcs.org).

That press release stated that "only half the number of patients in the treatment arm of the study relapsed compared to those not receiving the vaccine," and that "the results presented at the conference were those observed in patients 13.5 months after treatment." Those statements were incorrect. In fact, as COL George Peoples, MD reported to the symposium, at a median follow-up of 13 months, there were NO relapses in patients receiving the AE37 immunotherapeutic vaccine for breast cancer (0 of 49 patients) while relapses were observed in the control group (5 of 71 patients).

The ultimate goal of the study is to demonstrate that, after a follow-up period of 24 months, the relapse rate in the AE37 group of the study is less than half the relapse rate in the control group. The interim results of this study reported by COL Peoples clearly show that the study is on track to achieve that positive endpoint.

Putting 2009 aside, if we just went with the recent information provided by Generex's press releases, we would assess that the study is going well, with a risk reduction of relapse for all subjects staying relatively even, improving from 41% to 42%, as additional subjects are enrolled into the study. From the abstracts, we can see that the risk reduction was factored at a higher 43% in June, and has since improved to 49%.

What's the difference between a 42% risk reduction in relapse vs. 49%? The difference is an extra few early stage breast cancer patients who are participants in this remarkable study that will continue to lead healthy lives, all because Generex and Antigen Express have done an extraordinary job in creating a revolutionary cancer vaccine, even if they struggle with media relations. Generex and Antigen Express may trip on a pebble, such as writing a press release, yet they appear ready to move what was thought to be the toughest of all mountains, CURING CANCER!