Founded in 1983 and headquartered in Miramar, Florida, Generex Biotechnology Corporation initially specialized in the delivery of large molecule drugs into the oral cavity via a portable aerosol applicator for use in Canada and the United States, notably offering Generex Oral-lyn, an oral insulin product. The company also had a significant focus on oncology, developing AE37, a synthetic peptide vaccine that had completed Phase IIb clinical trials aimed at stimulating a potent and specific immune response against HER-2/neu oncogenes in breast and prostate cancer patients. Beyond therapeutics, Generex was involved in the development, manufacturing, and distribution of rapid point-of-care in-vitro medical diagnostics for a spectrum of infectious diseases, including HIV, tuberculosis, malaria, and hepatitis, providing both test kits and cassettes.