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'lizbeth · 08-11-2013, 12:42 PM

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."

08-11-2013, 12:42 PM	#12
'lizbeth Senior Member Join Date: Apr 2008 Location: Sunny San Diego Posts: 2,214	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."