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generex biotechnology corp (GNBT) Key Developments

Generex Biotechnology Corp. Auditor Raises 'Going Concern' Doubt

Generex Biotechnology Corp. filed its 10-K on Oct 03, 2014 for the period ending Jul 31, 2014. In this report its auditor, Meyers Norris Penny LLP - MNP LLP, gave an unqualified opinion expressing doubt that the company can continue as a going concern.

Generex Biotechnology Corp. Collaborates with University Health Network for Buccal Insulin Project

Generex Biotechnology Corporation announced that it has entered into a collaboration with University Health Network (UHN) pursuant to which UHN's Centre for Molecular Design and Preformulations (CMDP) will spearhead the Company's buccal insulin refinement project. The goal of the project is to increase the insulin bioavailability of Generex Oral-lyn(TM), the Company's proprietary buccal insulin spray product, thereby reducing the number of puffs required to achieve effective prandial metabolic control for patients with diabetes. This research will ensure the product is more attractive to patients and prospective commercialization partners.

Generex Announces Publication of AE37 Prostate Cancer Vaccine Study

Generex Biotechnology Corporation announced publication of a follow-up study from a Phase I clinical trial of the immunotherapeutic agent AE37 in patients with prostate cancer. The study demonstrates an association between a specific immune response generated by AE37 and improved overall survival. The compound is being developed by Antigen Express, Inc. a wholly-owned subsidiary of Generex, for multiple cancer indications. The publication, entitled, "AE37 peptide vaccination in prostate cancer: identification of biomarkers in the context of prognosis and prediction, " appears in the peer-reviewed journal Cancer Immunology, Immunotherapy, a forum for new concepts and advances in basic, translational, and clinical cancer immunology and immunotherapy (online publication July 23, 2014). While a prior study showed that AE37-immunized patients had better overall and disease-free survival as a group than would be expected from their disease status, the current study shows that patients with the strongest immunological response did the best. In particular, both the presence of AE37-induced T cells in peripheral blood as well as a robust delayed type hypersensitivity (DTH) response elicited by AE37 correlated significantly with overall survival. The authors point out the importance of CD4+ T cells in developing a good DTH response. AE37 was developed using the Antigen Express Ii-Key technology platform that ensures robust, specific CD4+ T cell activation. The current report expands upon prior studies on the results of a Phase I trial of AE37 in patients with prostate cancer. AE37 is also the subject of a controlled, randomized Phase II trial to prevent recurrence in patients who have had breast cancer. That study has shown an encouraging trend toward preventing relapse, particularly in patients with low levels of HER2 expression and in triple negative patients. The search for reliable biomarkers is a key priority in the emerging field of cancer immunotherapy. The current study makes important contributions toward that aim while supplying compelling data for the further developmental of AE37.

Generex Biotechnology Corp. Announces Antigen Express AE37 Breast Cancer Vaccine Abstract Presentations at American Society of Clinical Oncology 2014 Annual Meeting

Generex Biotechnology Corporation announced that two abstracts in respect of results of the on-going Phase II study of a novel cancer vaccine designed to prevent relapse in patients who have had breast cancer will be presented at 2014's American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago from May 30 to June 3, 2014. The abstracts, entitled "Primary analysis of prospective, randomized, single-blinded phase II trial of AE37 vaccine vs GM-CSF along administered in the adjuvant setting to high risk breast cancer patients" and "Immunogenic Comparison of Recurrent and Non-Recurrent Breast Cancer Patients Undergoing AE37 Peptide Vaccine Therapy", will be poster presentations on June 2 from 8:00 am CDT to 11:45 am CDT. The immunotherapeutic AE37 is designed to work indirectly by stimulating the patient's immune system to recognize and kill cancer cells. An advantage of the compound is that it potently activates a subclass of immune cells, known at CD4+ T cells, without sacrificing tumor target specificity. This subclass has been shown to be critical in generating a robust, long-lasting and effective immune response. AE37 consists of a fragment of the tumor-associated HER2 protein modified by a proprietary platform technology developed by Antigen Express scientists.

Generex Biotechnology Corp. Proposes Amendment to Restated Certificate of Incorporation

Generex Biotechnology Corp. at its annual general meeting to be held on may 22, 2013, share holders proposed to approve an amendment to restated certificate of incorporation to effect, at any time prior to December 31, 2015, a reverse stock split of common stock at an exchange ratio to be determined and to proportionately reduce the number of shares of the common stock authorized for issuance (the implementation of the reverse stock split, ratio and timing of which will be subject to the discretion of the Board of Directors).


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