WORCESTER, Mass,, Oct. 5 /PRNewswire/ -- Generex Biotechnology Corporation (Nasdaq: GNBT) (www.generex.com) announced today a corporate update in a letter to shareholders from Interim President and Chief Executive Officer, Mark Fletcher, addressing management's strategic initiatives for growth. The letter to shareholders reads as follows:
Since I've taken the position of CEO at Generex, the management team has been working diligently to refine its comprehensive plan for the advancement of our current proprietary drug delivery and immunotherapeutic vaccine platforms as well as the Company's strategic vision for future growth. Over the past twelve months, we have seen significant advancements in both of our platform technologies and we are encouraged by our progress.
Since Generex Oral-lyn™, our proprietary buccal insulin spray product, has been the main focus by many audiences following our Company, I will begin by providing a synopsis of that program as well as providing our vision for the future of this important buccal drug delivery platform. I would, however, like to emphasize that when evaluating our Company, one should not overlook the tremendous potential of our immunotherapeutic vaccine technologies which I will also address here in greater detail.
We are currently in an ongoing Phase III clinical trial of Generex Oral-lyn™ and have reported preliminary outcomes and trends in June of this year suggesting a better "Adverse Event" profile than subjects using injectable insulin as well as no weight gain. In fiscal 2010, the safety and efficacy profile of Generex Oral-lyn™ led the Food and Drug Administration (FDA) to grant us approval for the treatment use of Generex Oral-lyn™ in patients with Type 1 or Type 2 diabetes mellitus under the FDA's "Treatment IND" program and later in that same fiscal year we were permitted to charge for the product to recover costs. Receiving that approval is an important milestone for our Company in that we are the first diabetes-related product to receive an FDA Treatment IND approval and all drugs with that type of approval have historically gone on to achieve full approval from the FDA. We have moved forward with the implementation of this innovative program by enrolling participating health practitioners after securing requisite institutional review board approvals (see www.clinicaltrials.gov for regular updates). I would also like to emphasize that while it is easy to look at some of the high profile pharmaceutical failures related to other non-injectable forms of insulin and just write off Generex Oral-lyn™ as more-of-the-same, the fact is that Generex Oral-lyn™, as opposed to inhaled insulin, does not and cannot go into the lungs. In addition, Generex Oral-lyn™ does not enter (a) the gastrointestinal tract where limited absorption and removal by the liver compromises clinical efficacy, or (b) the nasal cavity where the fragile membrane limits usefulness, or (c) through the skin where extraordinary devices are required. As the route of absorption of Generex Oral-lyn™ is through the epithelial lining of the buccal cavity, the safety and efficacy hurdles facing other forms of non-injectable insulin do not confront our product. Results from countless studies indicate a strong desire among diabetes patients for an easy and safe alternative to insulin injections.
For the future of our buccal drug delivery platform, we intend to pursue a three-pronged approach. First, we intend to complete our Phase III study of Generex Oral-lyn™, which currently has 460 patients enrolled, and then seek FDA and global approvals provided that the data remains consistent with previous data from this and other studies we have conducted. As we move through the remainder of our Phase III trial, we intend to focus our regulatory approval efforts in the United States, the European Union, and Canada. Generex Oral-lyn™ has been approved for sale in India by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. We entered into a Product Licensing & Distribution Agreement with Shreya Life Sciences Pvt. Ltd. (www.shreya.co.in) pursuant to which Shreya is responsible for the marketing, distribution, and sale of Generex Oral-lyn™ in India. The terms of the Indian government approval required that a post-approval marketing surveillance study be undertaken in India. The CDSCO reviewed the protocol in respect of the study and granted permission for the commencement and prosecution of the study. The study, involving as many as 200 subjects, is well underway and is being undertaken and managed by Shreya. Upon completion of the study, the results will be submitted to the CDSCO in support of Shreya's intention to commence commercial distribution of Generex Oral-lyn™ in India.
The second prong to our strategy is to work with strategic partners to further the development and distribution of Generex Oral-lyn™ as well as other applications of our buccal drug delivery platform. Our recent long-term marketing and distribution agreement with Merck, S.A. de C.V. in Mexico for the distribution of one of our proprietary consumer/over-the-counter products, Glucose RapidSpray™ (www.glucoserapidspray.com), is just the beginning of what we believe is a tremendous commercialization opportunity for this platform. We continue to be in discussions with a number of companies with regard to potential strategic relationships in this regard, for Generex Oral-lyn™ as well as other diabetic and energy related pipeline products using the buccal delivery platform technologies.
The third prong to our strategy is to work with other pharmaceutical companies to establish the use of our proprietary liquid formulations that allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using our proprietary RapidMist™ device. By using RapidMist™ as a delivery method, we believe we can extend the patent life of injectable drugs near the end of their patent protection, greatly enhancing the value of those drugs.
For our immunotherapeutic vaccine platform, under development at our wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com), we are confident that fiscal 2011 will be a year of great advancement in these groundbreaking efforts. We believe the vast potential of our breast, prostate, and other AE37 cancer vaccines are unmined gems for our Company. AE37 is used to generate a specific immunological response to cancers expressing the HER2 oncogene. We are in the midst of a Phase II clinical trial in patients with breast cancer and a Phase I trial in patients with ovarian cancer. In addition, we recently completed a Phase I trial in patients with prostate cancer and are making preparations to move into a Phase II trial. We anticipate our Phase II AE37 trial in breast cancer will be completed in fiscal 2011 and, provided that the study data is consistent with data available to date, we intend to work with the FDA on a plan to conduct a Phase III study for this important vaccine.
We have recently looked to augment our team of scientific advisors as we move our development programs and pipeline of products toward commercialization. We intend to take advantage of their experience and expertise to assist our scientific and management teams and provide advice and guidance in refining our science to enable us to capitalize on our Company's promising future. For Generex Oncology, we have brought in Dr. Craig Eagle, the head of the oncology therapeutic area of the global medical group for Pfizer, Inc., as an advisor to help us navigate through the regulatory approval process for AE37 as well to help us in our strategic partnership efforts within the pharmaceutical community. We have also retained the consulting services of Dr. George M. Peoples, presently the Chief of Surgical Oncology at Brooke Army Medical Center in Houston, TX, a Professor of Surgery and the Director & Principal Investigator of the Cancer Vaccine Development Program at Uniformed Services University of the Health Sciences in Bethesda, MD, and the Deputy Director of the United States Military Cancer Institute (www.usmci.org). Dr. Peoples is providing advice and assistance to us with respect to the design and implementation of a Phase III trial of the AE37 vaccine in patients with breast cancer, and acts as a liaison with the FDA regarding the clinical and regulatory development of the vaccine. We also have engaged the services of a world-renowned independent firm used by many major pharmaceutical companies for intellectual property appraisals, to provide an appraisal of our vaccine technology platform.
As I navigate our Company through this transitional period in management, I feel it is important to communicate to our shareholders that management is committed to bringing our rich intellectual property resources to commercial fruition. We continue to work closely with our business development consultants, including Seahawk Capital, which was instrumental in helping us regain our financial footing in 2009. We intend to seek out unique opportunities to generate meaningful near-term revenue streams. We are confident that, together with our board of directors, our in-house scientific team, our scientific and business development advisors, and everyone associated with our Company, we are well-positioned for, and more focused than ever on, achieving our goals.
As I am sure you are aware, we are at a pivotal point in our Company's history and you are faced with an important decision. The price of our common stock is below $1 per share and we face an imminent NASDAQ delisting should our shareholders elect to vote down a proposed reverse stock split. While I fully understand the reservations you may have regarding this proposal and we will continue with our business development strategies without regard to your final decision, management believes that it is in the best interest of our Company and its shareholders to approve the proposal. We believe that by maintaining the NASDAQ listing we will be better able to attract top caliber talent to our Company as well as maintain a stronger standing in the business and financial community. We intend to communicate further on this subject prior to October 15th as we work to position Generex for the future.
In closing, I would once again like to emphasize that each and every employee and all those associated with Generex are dedicated to achieving success. As we forge ahead, I intend to make every effort to guide us toward our promising future. Generex is a company rich in intellectual properties, technologies, and talent, with tremendous growth potential, and together we will realize that potential for the benefit of our Company and its shareholders.
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 flagship product, buccal insulin (Generex Oral-lyn™), which has been approved in India, Lebanon, Algeria, and Ecuador for the treatment of subjects with Type-1 and Type-2 diabetes, 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 immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
Safe Harbor Statement
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," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects," 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 cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. 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|
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