Generex Announces Results of Annual Stockholders' Meeting Company announces addition of oncology biostatistician to Antigen Express AE37 breast cancer vaccine working group; provides update on EOP2 meeting
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.
Mark Fletcher, Generex President & Chief Executive Officer, stated: "We are pleased that an individual with the qualifications, expertise, and experience of Dr. Symanowski in the field of clinical oncology statistics has joined our AE37 breast cancer vaccine working group. We will look forward to availing ourselves of his advice and assistance as we move the clinical and regulatory program forward."
The Company previously announced that an End-of-Phase II meeting with the United States Food and Drug Administration ("FDA") had been scheduled for June 18, 2012 in respect of the AE37 immunotherapeutic breast cancer vaccine under development at the Company's wholly-owned subsidiary, Antigen Express, Inc. In response to a comprehensive pre-meeting package submitted by Antigen Express of technical and pre-clinical data, Phase I and Phase II studies of AE37, as well as a discussion of a proposed Phase 3 clinical trial design, Antigen Express received multiple comments, questions and suggestions from the FDA on June 15, 2012 regarding the vaccine, technical specifications, and proposed plans for the pivotal Phase III trial of the vaccine. While agreeing in principle with the Phase III study design, the FDA provided a detailed list of issues and items they would like included in the final Phase III study design primarily related to the patient trial population who are low HER2 expressors (the category of breast cancer patients for whom no other vaccine therapy currently exists). In agreement, the Antigen Express AE37 breast cancer vaccine working group determined, that to insure the most productive meeting outcome, the best course of action was to postpone the End-of-Phase II meeting in order to afford the company an opportunity to provide comprehensive and detailed responses to these additional FDA comments as an addendum to the previously submitted package. The company expects to submit the addendum to the FDA within the next 60 days and to reschedule the meeting before the end of this year.
The Antigen Express efforts in respect of an End-of-Phase II meeting, with a view to transitioning into a pivotal Phase III trial, follow on (i) the recent establishment of a Scientific Advisory Board in respect of the AE37 breast cancer vaccine comprised of key thought and opinion leaders in the clinical study of breast cancer treatments, and (ii) the report of encouraging interim results of the Phase II trial earlier this month at the annual meeting of the American Society of Clinical Oncology (ASCO).
About Generex Biotechnology Corporation
Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist™ device. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T-helper stimulation technologies in immunotherapy. One technology focuses on modification of peptides with Ii-Key to increase potency while a second relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T-helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
Cautionary Note Regarding Forward-Looking Statements
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
SOURCE Generex Biotechnology Corporation