Study Using the Medpulser Electroporation System With Bleomycin to Treat Head and Neck Cancer

Electroporation therapy is a tumor-specific ablative treatment modality with the potential to
manage local tumors without the potentially undesirable side effects of systemic chemotherapy
agents or radiotherapy. Surgical resection of solid tumors often leaves subjects with
significant organ dysfunction and/or permanent disfigurement requiring reconstructive
surgery. In contrast, electroporation therapy may offer equivalent disease control to
conventional surgery with lessened need for reconstructive surgery. Electroporation therapy
may also provide economic benefits over conventional surgical and or radiation procedures
through reduced operating theatre costs, hospital stays and post treatment interventions. The
ability to shrink or eliminate local tumors with the MedPulser® System when used in
conjunction with intralesional Bleomycin is an important new possible treatment for the
conservative local management of SCCHN and provides a possible alternative treatment option
to surgical excision in the management of cancer.

Inclusion Criteria:

1. The presence of primary oral cavity, primary pharyngeal, primary laryngeal, salivary
gland, limited recurrent and second primary tumors must be confirmed by histological
examination of a tissue sample (e.g., biopsy) obtained within 2 months of the subject
receiving the study treatment.

2. The length of the longest diameter of the study lesion must be < 5 cm and the
calculated treatment volume (tumor volume plus a 0.5 cm margin around the tumor) for
the study lesion [where treatment volume = 0.5 (a+1) (b+1)2 and where a = length of
the longest diameter (cm), b = the next longest diameter perpendicular to "a" (cm)]
must be < 60.0 cm3.

3. Age: 18 years or older.

4. Male or female.

5. Men and women of childbearing potential must be using Investigator prescribed
contraceptive methods while undergoing protocol related therapy.

6. Baseline performance status: ECOG 0-2:

- Grade 0: Fully active, able to carry on all pre-disease performance without
restriction.

- Grade 1: Restricted in physically strenuous activity but ambulatory and able to
carry out work of a light or sedentary nature, e.g., light house work, office
work.

- Grade 2: Ambulatory and capable of all self-care, but unable to carry out any
work activities. Up and about more than 50% of waking hours.

7. Life expectancy of at least 6 months.

8. Subjects must sign a written Informed Consent prior to receiving any study procedures
or treatments.

Exclusion Criteria:

1. Subjects with tumors suspected of involving a 50% or greater encasement of a blood
vessel as measured by magnetic resonance imaging (MRI) or computed tomography (CT)
scan.

2. Subjects with tumors having bone invasion.

3. Subjects with hypersensitivity to bleomycin.

4. Subjects who have received or will exceed a total lifetime dose of bleomycin greater
than 400 units.

5. Subjects deemed unsuitable for general anesthesia.

6. Subjects with a significant history of emphysema or pulmonary fibrosis.

7. Subjects with indwelling cardiac pacemakers who cannot tolerate a period with
pacemaker turned off.

8. Subjects with a history of uncontrolled cardiac arrhythmia.

9. Women who are pregnant, or are nursing. Women must have a negative pregnancy test
(urine pregnancy tests are acceptable) within 7 days of study treatment.