For
Immediate Release:
FDA Approves Orphan Drug Status for Revolutionary
Cancer Drug for Children
LOS ANGELES, Calif.
– October 20, 2008 – The Cure Our
Children Foundation, a nonprofit charitable foundation dedicated to children,
announced today that the U.S. Food and Drug Administration (FDA) has approved
the Orphan Drug Designation of the foundation’s unique drug product for children
with Ewing’s Sarcoma cancer. The efforts
to develop this drug were made possible by the generous volunteers and researchers
in private industry and at two universities.
Orphan Drug status allows for
recognition of the potential viability of a drug therapy while providing a
variety of benefits during the drug approval process. These benefits include waivers of certain FDA
fees, the availability of government grants, and FDA attention and assistance
during the review process.
This ground-breaking new drug
combines two modern technologies: biotechnology and nanotechnology. This incredible technology is analogous to
the concept of a Trojan Horse, and is expected to have very far reaching
implications for other cancer treatments.
The product consists of cell matter that is modified to have the same
genetic code as the cancer cells, but that matter is not viable food for the tumor
cells. The cell matter is then placed in
a nanotechnology formulation which allows the matter to migrate through the
body’s own vessels directly to the tumor cells.
When the tumor cells uptake the matter, they cannot reproduce, and they
die. Key elements of this drug technology are:
·
Fewer side effects may be possible
·
The drug is directed only at the tumor cell and not at healthy cells
·
The product is so small that it migrates right through blood vessels
and cell walls
·
This technology may be applied to other diseases in the future that
have a genetic component
The
President of the foundation, Barry Sugarman, a 30-year veteran executive and
consultant in the pharmaceutical industry, and father of a son who has survived
Ewing’s Sarcoma, will continue the development
of the drug product by raising money from individuals and foundations.
The
Cure Our Children Foundation identifies important under-researched children's
issues and devotes extensive resources to educate and guide parents,
professionals, government and the public.
The foundation website at www.cureourchildren.org
receives thousands of website visits every month. The results of the research are provided as a
public service, and are supported by donations to the foundation. The foundation has a number of other research
projects underway that will continue to benefit children and families.
Contact: Barry Sugarman, B.S.ENGR., President, The
Cure Our Children Foundation, mailto:barry@cureourchildren.org , Phone: 310-355-6046, Fax: 310-454-9592,
http://www.cureourchildren.org
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