WORCESTER, Mass. and TORONTO, June 16, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT) (www.generex.com) today issued a synopsis of the update on the clinical and regulatory program for Generex Oral-lyn™, the Company's proprietary buccal insulin spray product, provided at the annual meeting of the Company's stockholders held in New York City on June 8, 2011.
At that meeting, the current status, clinical study plans, and major market registration pathway for Generex Oral-lyn™ were presented. Dr. James H. Anderson, Jr., MD, FFPM, FACE, Generex's Senior Scientific Advisor, outlined the reorganization within the Company's medical/regulatory group.
Generex received written guidance from the US Food and Drug Administration (FDA) in late May in response to data submitted on Generex Oral-lyn™. There were no safety issues identified in the clinical trials, nor safety questions raised by the FDA. The FDA did not express any concerns about the RapidMist™ delivery device. There were a variety of questions about preclinical, clinical, toxicology, manufacturing, and regulatory and product labeling issues related to the wide variety of formulations and prior protocol changes that were made historically. Generex's new medical/regulatory team has already responded to the FDA, and is in the process of providing the additional information requested for complete clarification. The FDA guidance placed no limitations or restrictions on the types of patients included or trial designs of current or future clinical studies.
Generex clinical trial 084 in patients with type 1 diabetes will be closed to allow a final data analysis to guide future clinical trial plans. Interim results demonstrated that the type 1 patients treated with Generex Oral-lyn™ maintained metabolic control (hemoglobin A1c) over the 12 month duration of the trial. The recently completed Prevoral trial demonstrated that the use of Generex Oral-lyn™ resulted in significant postprandial (after meal) blood glucose reductions in obese patients with impaired glucose tolerance.
The Company's new clinical development plan for Generex Oral-lyn™ will focus on rapid registration in the North American major markets, with its rapid absorption and sharp peak in plasma insulin concentration mimicking normal insulin secretion, and Generex Oral-lyn™'s short duration of activity reducing the potential for hypoglycemia. Studies will include a key activity/effect (pharmokinetic/glucodynamic) study using the final formulation and a series of small, well-designed phase 3 studies (potentially conducted as one study with multiple arms). It is anticipated that these studies would be completed during 2013. A consensus meeting with the FDA to obtain agreement with the clinical plan and submission data package is planned this year to insure timely regulatory agency review and positive marketing approval.
Generex will also focus on studies that will measure Generex Oral-lyn™'s ability to provide metabolic benefits that cannot be achieved with subcutaneously injected insulin such as prolonged reduction of over-production of glucose by the liver. The additional, added-value, market expansion work will be done concurrently.
Dr. Anderson also discussed plans to add shareholder value by expanding the portfolio of diabetes care pharmaceuticals beyond diabetes and insulin. The first agreement announced on June 8, 2011 is with Amarantus BioSciences, Inc. (AMBS.OB) (www.amarantus.com) which recently acquired technology rights from the University of Massachusetts Medical School for the development of a peptide biomarker (MANF) associated with early stress in the insulin producing cells (beta cells) of the pancreas. This biomarker has the potential to allow earlier detection of beta cell damage providing the possibility of blocking the development clinical diabetes and its complications by earlier treatment. The National Institutes of Health (NIH) and Juvenile Diabetes Research Foundation (JDRF) have conducted diabetes prevention trials using small doses of injected or ingested insulin to block the immune system's attack on the insulin producing cells in the pancreas. However, they have not had an early, specific way to determine a patient population most at risk of developing type 1 diabetes. The MANF biomarker may identify the right people to treat at the earliest stage of the development of diabetes. Generex Oral-lyn™ may be the best way to deliver the small amounts of insulin needed to block the immunologic destruction of the beta cells in otherwise healthy children and young adults without causing hypoglycemia.
Generex will also enhance collaboration with its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com), in developing early identification of markers of immune system activation associated with the immunologic destruction of the beta cells, which may lead to immune system therapy that could prevent the development of diabetes.
As resources and opportunities allow, Generex will seek to maximize the benefits and value of the Generex RapidMist™ drug delivery system for delivering new drugs, new proteins, and new enzymes for improved treatment of diabetes and other diseases.
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. The Company's buccal insulin spray product, Generex Oral-lyn™ is in Phase III clinical trials at several sites around the world. 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 in immunotherapy. One of its platform technologies 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. Risks and uncertainties relating to the proposed reverse stock split include the risks that (1) Generex will not meet the standards for listing its common stock on a national stock exchange; and (2) Generex will not meet or sustain the minimum share price requirement of a national stock exchange. 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