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Generex Announces Results Of Annual Stockholders' Meeting

Stocks in this article: GNBT

WORCESTER, Mass. and TORONTO, June 20, 2012 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB:GNBT) announced today the results of the Company's annual meeting of stockholders held on June 19, 2012.

At the annual meeting of stockholders, the following directors were elected to serve on the Board of Directors until the next annual meeting of stockholders: John Barratt, Brian McGee, Nola Masterson, Mark Fletcher, Dr. James H. Anderson, Jr., MD, and Dr. Eric Von Hofe, PhD.  Stockholders also ratified the appointment of MSCM LLP as the Company's independent registered public accounting firm for the year ending July 31, 2012.

The powerpoint presentation from the annual meeting will be available on the Generex website beginning at 4 p.m. EDT today.

The Company also announced today that Dr. James T. Symanowski, PhD has joined the Antigen Express AE37 breast cancer vaccine working group as a consultant oncology biostatistician to provide advice and assistance in respect of the on-going Phase II clinical trial of the vaccine and the transition into a pivotal Phase III trial.

Dr. Symanowski received his PhD in statistics from Iowa State University and gained over 16 years of statistical experience in the pharmaceutical industry.  He was senior research advisor at Eli Lilly and Co. and worked in both the laboratory and clinical settings.  He was the principal statistician supporting clinical development of gemcitabine, pemetrexed, and enzastaurin in a variety of tumor types.  Notably, he was extensively involved with the efforts leading to the regulatory approvals for the use of pemetrexed in the treatment of malignant pleural mesothelioma and non-small cell lung cancer, and for the use of gemcitabine in the treatment of ovarian and breast cancers.  After joining Nevada Cancer Institute in 2006, Dr. Symanowski collaborated with investigators throughout the institution and provided statistical support in the laboratory, translational, clinical, and population sciences areas of research.  Since joining Desert Research Institute in 2012, he has continued to collaborate with investigators involved with health sciences.  Dr. Symanowski also consults with external investigators and has served on several NIH grant review panels and on external Advisory Boards and Data and Safety Monitoring Boards.

Statisticians are key members of any clinical investigation team.  Their participation at the beginning of the study design and conduct process can mean the difference between a successful study and a study that fails to demonstrate that a "good" drug or treatment is safe and effective.  The statistician's contributions to the study design include identifying the most efficient design, one that is inclusive of all of the study's aims, that has an appropriate interim monitoring plan, and most importantly, the correct sample size (number of patients to be studied).  The statistician provides valuable assessments of the "end point" selection by considering the subjective versus objective measurements, the inclusion of multiple endpoints (such as safety and efficacy), and the categorization of primary versus secondary endpoints.  The statistical analysis plan, which has to be designed before the study begins, is a vital part of the clinical plan that allows medical investigators, regulatory officials, and ethical review boards to judge the scientific, regulatory, and ethical value of the planned study.  Dr. Symanowski will expertly fulfill all of these requirements to insure the highest quality Phase 3 protocol for the Antigen Express AE37 immunotherapeutic breast cancer vaccine.

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