Neotropix receives FDA approval for cancer trials
be in the offering after Neotropix received FDA approval to begin
clinical trials of a drug candidate that offers new drug treatment
hope for advanced cancers.
The treatment 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.
The drug candidate, Seneca Valley Virus (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.
When compared to other oncolytic viruses or chemotherapeutics, SVV-001 has been shown to target and recognize certain tumour cells with no impact on normal cells.
In addition, SVV-001 was found not to be inhibited by any component of human blood and pre-existing antibodies are not found in humans.
SVV-001 has also demonstrated cancer-killing specificity 10,000 times higher than that of traditional chemotherapeutics with no overt toxicity at doses one million times higher than effective doses in mice.
"Seneca Valley Virus has the potential to be safer and more effective than treatments currently available or even on the horizon, and may help treat some of the most commonly diagnosed cancers among American men and women," said Paul Hallenbeck, president, chief scientific officer and founder of >Neotropix.
Cancer is the second leading cause of death in the US. The American Cancer Society predicts that, in this country alone, nearly 600,000 people will die from cancer in 2006.
Harnessing the natural properties of oncolytic viruses to fight cancer is known as "virotherapy," a treatment that holds great promise for treating cancer because oncolytic viruses selectively infect and replicate in cancer cells, destroying tumours but leaving normal cells largely unaffected.
The dose-escalating Phase I study will determine if 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' tumours. At the end of the trial, Neotropix intends to select an optimal dose for further clinical studies.
"Neotropix is dedicated to discovering virotherapies that hold great promise for treating cancer," said John Neefe, senior vice president of Clinical Development for Neotropix.
"We plan to develop several additional viruses and bring them into clinical trials."
