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generex biotechnology corp (GNBT) Key Developments

Generex Biotechnology Corp. Provides Update on Antigen Express Phase II AE37 Breast Cancer Vaccine Trial

Generex Biotechnology Corporation announced that results of the last pre-specified analysis of data from a Phase II study of a novel cancer vaccine designed to reduce the risk of relapse in patients who have had breast cancer corroborate qualitatively prior results from the primary analysis conducted in January of 2014. The company plans to disclose the results from the Phase II clinical trial at this year's American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago from May 29 to June 2, 2015. The ASCO Annual Meeting is the premier annual oncology symposium, bringing together more than 25,000 oncology professionals from a broad range of specialties. An abstract in respect of the results of the Phase II trial has been submitted to the ASCO Annual Meeting; per ASCO rules, the contents of those abstracts are embargoed pending the meeting. The recent analysis is based on data from 301 patients, making this the large controlled and randomized trial of a breast cancer vaccine conducted to date. Similar to prior analyses, high-risk patients who are ineligible to receive the drug Herceptin (e.g., triple negative breast cancer) appear to benefit from AE37. Triple negative breast cancer patients in particular represent a population of significant unmet need. The immunotherapeutic AE37 is designed to work indirectly by stimulating the patient's immune system to recognize and kill cancer cells. An advantage of AE37 is that it potently activates a subclass of immune cells, known at CD4+ T cells, to recognize the tumor-specific HER2 protein. This subclass of T cell 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 Corporation Announces Collaboration on Medicinal Cannabis

Generex Biotechnology Corporation announced that it has entered into a non-binding Letter of Intent (LOI) to license the company's proprietary RapidMist(TM) drug delivery technologies to CannScience Innovations Inc. (CannScience) for the delivery of medicinal cannabis derived products into the bloodstream through the buccal membrane. The RapidMist(TM) drug delivery platform administers medications directly into the mouth as a metered dose spray for rapid absorption by the buccal mucosa. Generex's most advanced product in development using RapidMist(TM) is Generex Oral-lyn(TM) for the treatment of diabetes mellitus. This co-development arrangement with CannScience is intended to develop products initially for the Canadian medical cannabis market. The LOI contemplates a significant royalty stream to Generex. Costs to develop, manufacture, and commercialize the products will be borne by CannScience.

Generex Announces Presentations Correlating Immunological Response with Reduced Recurrence in Phase II Study of AE37 Breast Cancer Vaccine in Patients at the American College of Surgeons

Generex Biotechnology Corporation announced two presentations demonstrating that the extent of the immunological response triggered by its novel proprietary cancer immunotherapeutic AE37 vaccine correlated with a reduction of relapse in breast cancer patients. The presentations are being made at the American College of Surgeons Clinical Congress 2014, being held October 26--30, 2014 in San Francisco, CA. The AE37 cancer vaccine is designed to elicit a specific immunological response targeting the HER2 cancer-associated protein. The Company previously reported a strong trend toward reduced relapse in patients with lower levels of HER2 expression who received the AE37 vaccine; i.e., in patients who are not eligible for the drug Herceptin (which also targets the HER2 protein). In particular, the most favorable results were observed in patients with triple negative breast cancer. Patients with this type of cancer are not eligible for either Herceptin or hormone therapy and thus constitute one of the areas of unmet need among breast cancer patients. The first study, entitled "Biomarker Correlation to Clinical Response in a phase II Trial of the HER2 Peptide Vaccine (AE37+GM-CSF)", by Schneble et al, is being given as a podium presentation. In that study, the extent of the local reaction to the vaccine as well as the presence of specific T cells in the blood that had been specifically activated by AE37 was measured. The study found that for patients who had a more robust response to the vaccine there was a significantly reduced incidence of relapse compared to those who developed weaker responses. The second presentation, entitled "Clinical benefit and safety of boosting the HER2 peptide vaccine (AE37+GM-CSF) in the adjuvant setting to prevent breast cancer recurrence", also by Schnebel et al, assessed the impact of AE37 booster immunizations on reducing the risk of recurrence. The study concludes that the trend toward reduced relapse is strongest in patients who have received boosters. Taken together, the newly reported studies provide important new data correlating immunological response to AE37 with clinical response. The new studies are based on patient data from a controlled, randomized and single-blinded phase II trial assessing the efficacy of the AE37 vaccine in patients with early stage breast cancer. The conclusions corroborate prior results from a phase I trial of AE37 in patients with prostate cancer. Immunological response data from that trial similarly showed a trend toward improved disease-free and overall survival in patients who developed a more robust response to the AE37 vaccine.

Generex Biotechnology Corp. Presents at BIO-Europe 2014, Nov-03-2014

Generex Biotechnology Corp. Presents at BIO-Europe 2014, Nov-03-2014 . Venue: Portalhaus Messe Frankfurt, Strasse der Nationen, 60327 Frankfurt, Germany.

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.


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