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news.Neotropix, a biotech company developing viruses for the treatment of cancer, has received approval from the FDA to go ahead with human trials of its first cancer treatment candidate, called Seneca valley virus.
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The dose-escalating phase I study will determine if Seneca valley virus (SVV-001) can be systemically administered safely to patients with certain types of advanced neuroendocrine cancers, including small cell lung cancer.
The study will also examine the distribution of the virus in the body, the elimination of it from the body, the immune response to the virus, and whether it affects the patients’ tumors. At the end of the trial, Neotropix intends to select an optimal dose for further clinical studies.
According to the company, SVV-001 has several features that allow it to overcome many of the hurdles classically associated with cancer-killing viral therapies. It can be systemically delivered, shows extremely high specificity towards cancer cells, has a therapeutic index of over one million, and is easy to manufacture.
“Our first product may provide a breakthrough therapy for patients with some of the most serious types of cancer known, such as small cell lung cancer, for which there are few promising therapies under development,” said Dr Paul Hallenbeck, president, chief scientific officer and founder of Neotropix.
SVV-001 is a naturally-occurring virus that specifically kills cancer cells with features similar to those found in many small cell lung cancers. It is the first virus identified for its ability to kill certain types of cancer cells; other viruses have been isolated based on their effects in humans, or their ability to cause disease and only then retro-fitted to kill cancer cells.