Wednesday, October 22, 2008

FDA approves Orphan Drug Status for revolutionary cancer drug for children

LOS ANGELES, Oct. 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 groundbreaking 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 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 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 http://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
barry@cureourchildren.org
Phone: 310-355-6046
Fax: 310-454-9592
http://www.cureourchildren.org
source: eReleases

Want to know more about Ewing's Sarcoma? This is our suggested book available for purchase:

Autobiography of a Face by Lucy Grealy


Synopsis:
"I spent five years of my life being treated for cancer, but since then I've spent fifteen years being treated for nothing other than looking different from everyone else. It was the pain from that, from feeling ugly, that I always viewed as the great tragedy of my life. The fact that I had cancer seemed minor in comparison."

At age nine, Lucy Grealy was diagnosed with a potentially terminal cancer. When she returned to school with a third of her jaw removed, she faced the cruel taunts of classmates. In this strikingly candid memoir, Grealy tells her story of great suffering and remarkable strength without sentimentality and with considerable wit. Vividly portraying the pain of peer rejection and the guilty pleasures of wanting to be special, Grealy captures with unique insight what it is like as a child and young adult to be torn between two warring impulses: to feel that more than anything else we want to be loved for who we are, while wishing desperately and secretly to be perfect.

Buy this book at Barnes & Noble

Read an Excerpt:

Chapter One
Luck
KER-POW!

I was knocked into the present, the unmistakable now, by Joni Friedman's head as it collided with the right side of my jaw. Up until that moment my body had been running around within the confines of a circle of fourth-grade children gathered for a game of dodge ball, but my mind had been elsewhere. For the most part I was an abysmal athlete, and I was deeply embarrassed whenever I failed to jump bravely and deftly into a whirring jumprope, ever threatening to sting if I miscrossed its invisible boundaries, like some science-fiction force field. Or worse, when I was the weak link yet again in the school relay race. How could one doubt that the order in which one was picked for the softball team was anything but concurrent with the order in which Life would be handing out favors?

Not that I considered myself a weak or easily frightened person; in more casual games I excelled, especially at wrestling (I could beat every boy but one on my street), playing war (a known sneak, I was always called upon to be the scout), and in taking dares (I would do just about anything, no matter how ludicrous or dangerous, though I drew the line at eating invertebrates and amphibians). I was accorded a certain amount of respect in my neighborhood, not only because I once jumped out of a secondstory window, but also because I would kiss an old and particularly smelly neighborhood dog on the lips whenever asked. I was a tomboy par excellence.

But when games turned official under the auspices of the Fleetwood Elementary Phys-Ed Department, everything changed. The minutea whistle appeared and boundaries were called, I transformed into a spaz. It all seemed so unfair: I knew in my heart I had great potential, star potential even, but my knowing didn't translate into hitting the ball that was coming my way. I resigned myself early on, even though I knew I could outread, outspell, and outtest the strongest kid in the classroom. And when I was picked practically last for crazy kickball or crab relays, I defeatedly assumed a certain lackadaisical attitude, which partially accounts for my inattention on the day my jaw collided with Joni Friedman's head.

Maybe I was wondering whether Colleen's superiority at dodge ball would be compromised by her all-consuming crush on David Cassidy, or maybe some other social dilemma of prepubescence ruled that days game. I do know that the ball I was going for was mine. I hadn't even bothered to call it, it was so obvious, and though it was also obvious that Joni was going to try to steal it away from me, I stood my ground. The whistle to stop playing began to blow just as the ball came toward us, toward me. I leaned forward and Joni lunged sideways, and suddenly all thoughts about Colleen's social status or Joni's ethics were suddenly and sharply knocked out of me.

I felt the force of our collision in every one of my atoms as I sat, calm and lucid though slightly dazed, on the asphalt. Everyone was running to get on line. I assume Joni asked me how I was, but all I remember is sitting there among the blurred and running legs, rubbing the right side of my jaw, fascinated by how much pain I was in and by how strangely peaceful I felt. It wasn't the sensation of things happening in slow motion, which I had experienced during other minor accidents; it was as if time had mysteriously but logically shifted onto another plane. I felt as if I could speculate and theorize about a thousand different beautiful truths all in the time it would take my lips to form a single word. In retrospect, I think it's possible I had a concussion.

My jaw throbbed. Rubbing it with my hand seemed to have no good or bad effect: the pain was deep and untouchable. Because the pain was genuinely unanticipated, there was no residue of anxiety to alter my experience of it. Anxiety and anticipation, I was to learn, are the essential ingredients in suffering from pain, as opposed to feeling pain pure and simple. This alien ache was probably my first and last experience of unadulterated pain, which perplexed me more than it hurt me.

"Are you all right, dear?"

Interrupted in my twilight, I looked up to see Mrs. Minkin, who was on playground duty that afternoon. She fell into the category of "scary" adults, and from there into the subcategory of adults "with cooties." In her plaid wool skirts and thick makeup, luridly ugly to schoolchildren's eyes, Mrs. Minkin was not someone to whom I was willing to admit distress.

"I'm fine, thank you."

And I was fine: as quickly as it had happened, the sharp ache in my jaw receded and my sense of self transported itself back to the playground. I quickly stood up and brushed myself off The looming issue now was how far back in line I would have to stand because of this bothersome delay. By the time I was back in the classroom I had forgotten the incident entirely.

I was reminded of it again that evening as I sat on the living room rug earnestly trying to whip up a book report I had been putting off for two weeks. Now, to my grave dismay, the report was due the very next day. Gradually I became aware of possible salvation: I had a toothache. This wasn't as welcome a reason for staying home from school as a cold or a fever because it would entail a visit to the dentist. Had it been only a minor toothache I'd probably have preferred to suffer the wrath of my teacher rather than my mother's inevitable agitation, but now that I had noticed the ache it seemed to be worsening steadily.


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