Treatment Use of Generex Oral-lyn™ in Patients With Diabetes

This is an open-label Treatment IND for the use of Generex Oral-lyn™ in patients with
serious or life-threatening Type 1 or Type 2 diabetes mellitus that have no satisfactory
alternative therapy available for treatment of diabetes, and who are not eligible to
participate in the ongoing pivotal clinical trial (Protocol GEN-084-OL).

This Treatment IND provides for treatment use of Generex Oral-lyn™ under a treatment
protocol. This program is open to anyone who meets the inclusion and exclusion criteria.
There are no oral or injectable medications contraindicated for this study. Patients may or
may not be on long-acting insulin. They will continue their current treatment on entry into
the study.

Inclusion Criteria:

- Patients with Type 1 or Type 2 diabetes mellitus (according to ADA and/or WHO
classification) and have therefore, by current definition of the condition, evidence
of risk to organ damage (such as neuropathy, nephropathy, retinopathy); During the
Treatment Phase patients will receive oral insulin spray for prandial use, while
maintaining their current basal injectable therapy. Patients will continue their
current treatment on entry into the Treatment IND .

- There is no satisfactory alternative treatment available. You are unable to or cannot
take the current injectable insulin therapy for control of your glucose levels (such
as visually impaired or presence of skin disorders) and other methods of controlling
your diabetes are not adequate at present.

- Willing to give written informed consent prior to admission into the Treatment IND.

- Age of subjects enrolled in the treatment protocol shall be greater than or equal to
12 years*. *18 years where required by site

Exclusion Criteria:

- Have positive pregnancy test, or is a breast feeding woman, or a woman not using an
adequate method of contraception;

- Have an active oral lesion(s) and/or active disease involving the oral cavity.