FDA issues written guidance to Generex on Oral-lyn

Generex Oral-lyn is an experimental liquid formulation of regular recombinant human insulin spray that is delivered to the buccal mucosa using the RapidMist device.

In its guidance the FDA has not raised any questions on safety issues related to the clinical trials of the formulation.

Moreover, the FDA guidance placed no limitations or restrictions on the types of patients included or trial designs of current or future clinical studies.

Generex plans to conclude its clinical trial 084 evaluating patients with type 1 diabetes to allow final analysis to guide future clinical trial plans.

Generex intends to register in the North American markets, as part of its new clinical development plan for Oral-lyn.

The studies include an activity/effect (pharmokinetic/glucodynamic) study utilizing the final formulation and a series of small, well-designed Phase 3 studies (potentially conducted as one study with multiple arms).

Generex will also focus on studies that will measure 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 company plans to strengthen its collaboration with its wholly-owned subsidiary Antigen Express that may lead to the development of immune system therapy for diabetes.

Generex will also seek to further develop RapidMist drug delivery system to deliver new drugs, new proteins and new enzymes totreatdiabetes and other diseases.