Breakout Alert: Generex Biotech GNBT Seeking FDA Approval

Finally there is life in the penny stock of Generex Biotechnology Corp. (OTC: GNBT) after the Breast Cancer Vaccine makers made three seperate announcements.  GNBT stock currently trading up 17.84% at 0.109 on more than 5x the 10 day aveage volume after the Company announced an End-of-Phase II meeting has been scheduled with the FDA in respect of the Phase II clinical trial of the AE37 Breast Cancer Vaccine being undertaken by Generex Biotech’s wholly-owned subsidiary, Antigen Express, Inc.

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GNBT Stock Chart

52-Week High
(Jan 17, 2012): 0.28
52-Week Low
(Dec 8, 2011): 0.08

Avg Vol (3 month): 685,411
Avg Vol (10 day): 420,157

The meeting has been scheduled for June 18, 2012 with FDA regulatory management staff in the Office of Cellular Tissues and Gene Therapies in the Center for Biologics Evaluation and Research.  Antigen Express has provided the FDA with a comprehensive and detailed package regarding the AE37 breast cancer vaccine, the on-going Phase II clinical trial, and the company’s plans for a transition into a pivotal Phase III trial.

Furthermore, the Company presented a podium presentation at the Annual Meeting of the American Society of Clinical Oncology (ASCO) on June 4, 2012 in Chicago, IL. The abstract entitled “From bench to bedside: The use of the li-Key technology to improve helper peptides for clinical use in cancer vaccines” was presented during a session on Developmental Therapeutics – Clinical Pharmacology and Immunotherapy. This abstract was recognized with a 2012 Conquer Cancer Foundation of ASCO Merit Award bestowed by the Conquer Cancer Foundation and the 2012 Scientific Program Committee. The merit award program was established to recognize high quality clinical and scientific advancements.

And second presentation at ASCO entitled: ‘An assessment of disease features and immune response in breast cancer patients that did not recur after receiving HER2 peptide, AE37 vaccine in a randomized phase II trial‘ by Diane Hale, et al, was presented June 2 in the Breast Cancer – HER2/ER session at ASCO. The presentation compared the immunological response in patients who relapsed versus those who did not. The parameters examined included T cell proliferation and cytokine expression, delayed-type hypersensitivity (DTH) and presence of T regulatory cells.

For more information about the above, visit Generex website here or the Antigen Express website here.

Bottom Line: The penny stock of Generex Biotech, GNBT, was on our list of penny stocks to watch in December and had an 8 week rally from 0.076 to 0.277, a gain of 264.47%. These new announcements and the June 18th meeting could send GNBT into the level we always thought it could trade at, the uber-level by being a buyout candidate with its Breast Cancer Vaccine by one of the Biotech Giants.

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