A Phase III Multicenter Study of Intratumoral/Interstitial Therapy With TransMID™ Compared to Best Standard of Care in Patients With Progressive and/or Recurrent, Non-Resectable Glioblastoma Multiforme

Inclusion Criteria:

1) Male or female at least 18 years of age 2) Histological results confirming GBM are
available 3) Progressive GBM (≥ 25% increase in contrast enhanced tumor CSA compared to
the nadir or smallest previous measured CSA) and/or recurrent GBM after conventional
treatment, including surgery (biopsy or debulking surgery) and/or radiation therapy and/or
chemotherapy 4) Pre-study MRIs used to determine current progression and/or recurrence of
GBM are available to the Investigator and for independent confirmation of progression
and/or recurrence 5) Patient is not considered a candidate for resection 6) If female of
child-bearing potential, a reliable method of contraception must be combined with a
negative pregnancy test before entering the study (female patients must be willing to use
contraception for 2 months after the last treatment with TransMID™). Male patients must
be willing to use a barrier method of contraception for up to 2 months after the last
treatment with TransMID™ 7) Able and willing to follow instructions and comply with the
protocol 8) Provide written informed consent prior to participation in the study 9)
Karnofsky Performance Scale Score 70-100 10) Tumor characteristics: i) must be unifocal;
and ii) must be unilateral and supratentorial; and iii) lesion must have a diameter (on
contrast-enhanced MRI) ≥1.0 cm and ≤4.0 cm

Exclusion Criteria:

1) Anticipated life expectancy of less than 3 months 2 Infratentorial or intraventricular
tumors 3) Presence of satellite tumors 4) Chemotherapy within 30 days prior to study entry
or nitrosoureas or Mitomycin-C containing therapy within 42 days prior to study entry 5)
External Beam irradiation within 60 days prior to study entry or stereotactic (gamma
knife) radiosurgery within 90 days prior to study entry 6) Tumor surgery, tumor debulking
or other neurosurgery within 5 days prior to study entry 7) Previous administration of
TransMID™ 8) Previous enrollment in this study 9) Regional therapy including
administration of biodegradable polymer wafers containing carmustine within 90 days prior
to study entry or brachytherapy within 12 calendar months prior to study entry 10)
Significant liver function impairment - AST or ALT > 2 times the upper limit of normal,
total bilirubin > upper limit of normal 11) Hepatitis B surface antigen positive or
positive Anti-Hepatitis C antibodies, or previous history of infectious Hepatitis (except
previous Hepatitis A infection) 12) Significant renal impairment (serum creatinine > 1.7
mg/dL or 150 µmol/L) 13) Coagulopathy (prothrombin time [PT] or activated partial
thromboplastin time [APTT] >1.5 times control) 14) Thrombocytopenia (platelet count < 100
x 103/μL or 100 x 109/L) 15) Granulocytopenia (absolute neutrophil count (ANC), < 1 x
103/μL or 1.0 x 109/L) 16) Severe acute infection 17) Medical condition that is considered
an unacceptable anesthetic risk 18) Evidence of a mass effect on CT or MRI with more than
a 5 mm midline shift and/or nausea, vomiting, reduced level of consciousness or clinically
significant papilledema 19) Nursing or pregnant females. A pregnancy test will be
performed on all females who are of child-bearing potential 20) Use of any investigational
product and/or participation in another clinical research study within the last 30 days
prior to study entry