To determine the safety and tolerability of the maximum dose for laboratory engineered Herpes
Simplex Virus-1 in patients who would not be eligible for surgical resection of recurrent
glioma To determine the safety and tolerability of the maximum dose for laboratory engineered
Herpes Simples Virus-1 in patients who would benefit from surgical resection of recurrent
M032 is a second-generation oncolytic herpes simplex virus (oHSV) that is conditionally
replication competent; that is, similar to G207, a first generation oHSV, it can replicate in
tumor cells, but not in normal cells, thus killing the tumor cells directly through this
process. Replication of M032 in the tumor itself not only kills the infected tumor cells, but
causes the tumor cell to act as a factory to produce new virus. These virus particles are
released as the tumor cell dies, and can then proceed to infect other tumor cells in the
vicinity, and continue the process of tumor kill. In addition to this direct oncolytic
activity, the virus carries a therapeutic payload--acting as a gene therapy vector, too--and
causes the tumor cell to synthesize and secrete an immunity-stimulating protein called
Interleukin-12 (IL-12) before it is killed. This IL-12 is released and promotes an immune
response against surviving tumor cells, which increases the antitumor effect of the therapy.
The IL-12 that is expressed can also produce an anti-angiogenic effect, by interfering with
the production of new tumor blood vessels necessary to allow tumor growth. Anti-angiogenic
therapies potentially starve the tumor of necessary oxygen and nutrients. Thus, the M032 oHSV
produces three different potential mechanisms for antitumor effects. The virus has also been
genetically-engineered to minimize the production of any toxic effects for the patient
receiving the therapy.
Recurrent Glioblastoma Multiforme,
Progressive Glioblastoma Multiforme,
Anaplastic Astrocytoma or Gliosarcoma
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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