Generex Biotechnology (OTCQB:GNBT) quietly released an 8K SEC filing on May 1st. In this "Current Report" they note:
Generex Biotechnology Corporation (the "Company") has received Special Access Programme authorization from the Therapeutic Products Directorate of Health Canada for a patient-specific, physician-supervised treatment of Type-1 Diabetes Mellitus with Generex Oral-lyn™, the Company's proprietary oral insulin spray product. Health Canada's Special Access Programme [SAP] provides access to non-marketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable.
The filing states that a Type 1 patient will be allowed access to Oral-lyn. Her Doctor will record her therapuetic response to Oral-lyn and alert the Director. Investors in Generex hope that positve results may lead to an expansion of the program.
With this development, Generex Oral-lyn is continuing with its positive momentum at a time the inhalable sector is in decline due the discontinuation of development of inhalable insulin devices by Eli Lilly (LLY) and Novo Nordisk (NVO) and the lung fuction decline and more recent lung cancer concerns raised by Pfizer (PFE) and Nektar's (NKTR) Exubera. These hightened pulmonary safety concerns have brought strong doubt on the efforts of Mannkind (MNKD) in developing it's own inhalable insulin device. Only Generex's Oral-lyn is a fine mist liquid spray where all absobtion takes place in the inner lining of the buccal cavity with no deposition into the lungs.
What this Special Access Programme [SAP] Authorization from Health Canada illustrates is that current treatment for this Type 1 patient have either failed, were unsuitable, or are unavailable. It is interesting to note that this SAP prgram is allowing the patients Doctor to prescribe Oral-lyn to fill an unspecified and unmet need. This SAP is evidence that current standard insulin injectables, pens or pumps have failed to help this patient. Through this special program, the patients doctor specifically turned to Generex Oral-lyn and Health Canada approved the treatment.
In one SEC filing, we may find evidence not only of Oral-lyn's superiority vs inhalable insulin, but potentially of it's superiority vs current approved treatment options for a specific Type 1 subgroup. This is encouraging news for Generex and their shareholders, as the microcap biotech continues with recruitment in North America for Oral-lyn's worldwide Phase III trial.