generex biotechnology corp (GNBT) Key Developments
Generex Presents Data Correlating Immune Response with Reduction of Relapse in AE37 Phase II Breast Cancer Trial at AACR 2015
Apr 21 15
Generex Biotechnology Corp. announced presentation of data from the on-going Phase II clinical trial of the AE37 breast cancer vaccine correlating local immune response to a reduction in relapse. AE37 is being developed by Antigen Express Inc., a wholly-owned subsidiary of Generex. The abstract entitled 'Correlation of robust local reactions prompting GM-CSF dose reduction to clinical response in a Phase II trial of the AE37+GM-CSF HER2 peptide vaccine' by Julia Greene, et al was presented at the Clinical Trials in Progress session of the AACR on April 20. The goal of the study was to establish the importance of the local reaction to immunization with AE37. The controlled, randomized and single-blinded trial is comparing the ability of AE37 plus the adjuvant GM-CSF versus the GM-CSF adjuvant alone to reduce recurrence of breast cancer in early stage patients. The study found that those patients receiving AE37 who had the large responses (requiring reductions in the amount of GM-CSF) had a relapse rate of 5.9% versus a rate of 14.2% in those who did not require dose reduction. This indicates that a robust stimulation of the immune system by AE37, as evidenced by the need for dose reduction, results in positive anti-cancer activity. The AE37 vaccine is designed to activate critical components of the immune system to combat cancer cells. Prior analyses have shown a trend toward reduction of relapse in patients receiving the vaccine, particularly those who are not eligible for the cancer drug Herceptin as well as those with triple negative breast cancer. The current results add to prior studies both from the ongoing Phase II trial as well as a completed Phase I study of AE37 in patients with prostate cancer showing robust yet specific immunological responses together with almost negligible toxicity. The distinguishing feature of AE37 is its ability to specifically activate CD4+ T helper cells, which govern both the quality and magnitude of an immune response to a novel target.
Generex Biotechnology Corporation Announces Resignation of John P. Barratt as Member of Board of Directors
Apr 8 15
Generex Biotechnology Corporation announced the resignation of John P. Barratt as a member of the company's Board of Directors. For medical reasons, Mr. Barratt has made the decision to take full retirement from his myriad corporate responsibilities. The resignation from the company’s Board of Directors will take effect on April 30, 2015.
Generex Biotechnology Corporation Provides Update on Buccal Insulin Formulation Enhancement Project
Mar 12 15
Generex Biotechnology Corporation provided an update on the status of the buccal insulin formulation enhancement project for the company's proprietary Generex Oral-lyn buccal insulin spray product. As previously announced, Generex has engaged the Center for Molecular Design and Preformulations (CMDP) at University Health Network with the goal of enhancing the Generex Oral-lyn formulation to make it more attractive to patients and prospective commercialization partners by increasing the bioavailability of insulin in the product and reducing the number of puffs required to achieve effective prandial metabolic control for patients with diabetes. Generex has entered into a Research Service Agreement with the University of Guelph pursuant to which the University will conduct a study of the relative bioavailability of the enhanced formulation in dogs in the University's Comparative Clinical Research Facility. Dogs proffer ease of administration and the results of the biochemical analyses of the blood are expected to approximate the impact of the product in humans. Allowing a direct comparison with the canine studies the University undertook of the original formulation of Generex Oral-lyn for proof of concept, safety, and toxicity, the new dog study will allow a rapid assessment of the added value of the improved formulation.
Generex Biotechnology Is Considering Various Alternatives
Mar 6 15
Management of Generex Biotechnology Corp. (OTCPK:GNBT) is seeking various alternatives to ensure that they can meet some of their operating cash flow requirements through financing activities, such as private placement of the common stock, preferred stock offerings and offerings of debt and convertible debt instruments as well as through merger or acquisition opportunities. In addition, management is actively seeking strategic alternatives, including strategic investments and divestitures.
Generex Biotechnology Corp. Provides Update on Antigen Express Phase II AE37 Breast Cancer Vaccine Trial
Feb 17 15
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.