RETRANSMISSION: Generex Receives Regulatory Clearance To Introduce Oralin For Use By Diabetic Patients In Ecuador.TORONTO--(BUSINESS WIRE)--Oct. 1, 1998--Generex Biotechnology Corporation (the "Company") (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB:GNBT) announced today that it has received permission to introduce Oralin, the Company's oral insulin formulation for the initiation of the Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trials and use by the medical community in Ecuador. Permission was granted by the Ministry of Public Health, Sanitarian sanitarian /san·i·tar·i·an/ (san?i-tar´e-an) one skilled in sanitation and public health science. san·i·tar·i·an n. A public health or sanitation expert. Control Department of Quito, Ecuador. With this regulatory clearance the Company expects that Oralin will be initially targeted to approximately 200 diabetic patients in order to evaluate the product's efficacy and safety. The Company will closely monitor the patients to accumulate data (daily glucose levels and monthly hbA1c levels) for its overall worldwide clinical program in order to facilitate registration in other jurisdictions. The Company expects to obtain a permanent registration of Oralin in Ecuador within the next 120 days. The Company has been working closely with the Academy of Sciences in Ecuador for the purpose of introducing Oralin to Ecuador and other Andean Pact Andean Pact A regional trade pact that includes Venezuela, Colombia, Ecuador, Peru, and Bolivia. countries (Bolivia, Chile, Colombia, Peru and Venezuela, and has been assisted by Dr. Jaime Guevara Aguirre, Principal Investigator Noun 1. principal investigator - the scientist in charge of an experiment or research project PI scientist - a person with advanced knowledge of one or more sciences of the Instituto de Endocrinologia Metabolismo Y Reproduccion in this effort. Generex Biotechnology Corporation is engaged in the development of drug delivery systems and technologies related to proteinic pharmaceuticals. To date, the Company has focused on developing a platform technology to orally administer large molecule drugs which, historically, have been required to be administered by injection or intravenously in·tra·ve·nous adj. Abbr. IV Within or administered into a vein. n. A drug, nutrient solution, or other substance administered into a vein. . Oralin is the Company's first application of its platform technology. Preliminary screenings, however, have shown that the technology is appropriate for a broad range of other molecule drugs. Notice: This release contains, and oral statements made from time to time by Company representatives concerning the subject matter hereof may contain, so-called "forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. ". These statements can be identified by introductory words such as "expects", "plans", "will", "estimates", "forcasts", "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 the Company's growth strategy, operating and financial goals, plans relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc regulatory submissions and approvals and development programs. Many factors may cause actual results to differ from the Company's 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. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. |
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