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2011

Dr. P.R. Lowenstein

Dr. Maria G. Castro

University of Michigan School of Medicine

Department of Neurosurgery and Cell and Development Biology

Brain Cancer

Grant Amount: $216,000

“PHASE ONE has thus provided the green light to move the dreams of two basic scientists into the challenging arena of clinical trials.” Drs. Pedro Lowenstein and Maria Castro

Highly malignant brain tumors are uniformly lethal. Patients usually survive less than 2 years post-diagnosis, with very few still alive 5 years later. In spite of constant developments in surgery, radiotherapy and chemotherapy a breakthrough for this particularly aggressive cancer has not been yet discovered.

Over the last ten years Drs. Pedro Lowenstein and Maria Castro have developed a novel approach for the treatment of brain tumors. Based on an evolutionary and developmental understanding of the structure and function of the brain immune system, they decided to restitute to the brain those immune cells normally absent from it, as a potential new approach to treat brain tumors. The immune cells normally absent from the brain are those in charge of turning on the anti-tumor immune response. Their absence from the brain helps us explain why normally anti-brain tumor immune responses are ineffective. By attracting those specific immune cells to the brain and the brain tumors, they expect them to identify brain tumor antigens and unleash a therapeutically effective immune attack to eliminate brain tumors.

To achieve this Drs. Lowenstein and Castro have turned adenoviruses which normally can cause lung infections and other diseases into therapeutic agents. They have engineered the viruses to deliver directly to the brain and the brain tumors a protein that will recruit the missing immune cells to the brain to start a clinically effective immune response. As their work uses viruses as agents of treatment to induce immune responses, their therapeutic approach is described as a “combined gene-and immune therapy”. Following more than ten years of development and experimental testing they are now ready to start clinical trials in patients suffering from glioblastoma multiforme.

With very generous support from the PHASE ONE Foundation, they are now on the threshold of starting the first ever clinical trials of this new therapeutic approach for the treatment of deadly highly malignant brain tumors. The proposed trial, which was approved by the Food and Drug Administration on April 7, 2011 is currently undergoing the final evaluations by the Institutional Biosafety Committee, and the Institutional Review Board for Clinical Trials. They expect these evaluations to be finalized within the next few weeks. Once our trial has cleared all necessary Committee reviews, it will be ready to start.
“PHASE ONE has thus provided the green light to move the dreams of two basic scientists into the challenging arena of clinical trials. As the trial starts enrolling patients we will look forward to keeping PHASE ONE abreast of all therapeutic developments. We hope, and for the sake of the patients, we pray, that treating the first patients may represent in Winston Churchill’s prophetic words, Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.