Neotropix(TM), Inc., a biotechnology company developing oncolytic viruses for the treatment of
cancer, announced today that the FDA has approved its Investigational New
Drug (IND) application for its first cancer drug candidate, Seneca Valley
Virus (SVV-001).
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' tumors. At the end of the trial, Neotropix intends to select
an optimal dose for further clinical studies.
SVV-001 has several features which 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 1 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. "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."
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.
Advantages of SVV-001 compared to other oncolytic viruses or
chemotherapeutics:
-- Targets and recognizes certain tumor cells with no impact on normal
cells.
-- Not inhibited by any component of human blood and pre-existing
antibodies are not found in humans.
-- Demonstrates cancer-killing specificity 10,000 times higher than that
of traditional chemotherapeutics.
-- No overt toxicity at doses one million times higher than effective
doses in mice.
-- Small in size, which enables better penetration and spread in solid
tumors, thereby eradicating tumors more efficiently.
"Neotropix is dedicated to discovering virotherapies that hold great
promise for treating cancer. The company's expertise will enable us rapidly
develop SVV-001 toward registration and approval. In the coming years, we
plan to develop several additional viruses and bring them into clinical
trials," said John Neefe, MD, Senior Vice President of Clinical Development
for Neotropix.
Cancer is the second leading cause of death in the United States. 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 tumors
but leaving normal cells largely unaffected.
About Neotropix
Based in Malvern, Pa., Neotropix(TM), Inc. is a biotechnology company
dedicated to the development of oncolytic viruses for the treatment of
cancers with significant unmet clinical need. The company discovers native
and engineered viruses with tumor-selective properties, and utilizes them
to develop technology, discover new cancer targets, and develop treatments
for aggressive cancers. The company is conducting research on Seneca Valley
Virus, a novel systemically-deliverable oncolytic virus for the treatment
of small cell lung cancer and other neuroendocrine cancers. For more
information, visit neotropix.
Neotropix, Inc.
neotropix