- To: LINHILLIS@aol.com
- Subject: Re: [MOL] Some more info
- From: GW0123 <GW0123@aol.com>
- Date: Thu, 11 Dec 1997 18:54:24 EST
- Organization: AOL (http://www.aol.com)
Here Diana
This is the article You Wanted
F.D.A. Approves New Drug
c The Associated Press
BETHESDA, Md. (AP) - Dr. Raj Puri injected mice with an experimental ``smart
bomb'' for cancer and watched as huge tumors disappeared from their bodies
within a few weeks.
Puri discovered the potential cancer therapy in a tiny, little-known
laboratory at the Food and Drug Administration - and now the government has
given his invention to an Illinois biotechnology company that hopes to begin
testing it in people with killer brain tumors and kidney cancer late next
year.
The saga is unusual because the FDA is supposed to regulate drugs, not invent
them - and if this interleukin-13 therapy ultimately works in people, NeoPharm
Inc. will need FDA permission to sell it.
And it comes at a time when the FDA's biotechnology laboratories are
threatened by budget cuts.
``Should they be discovering drugs? I don't think that's their job,'' said
Alan Goldhammer of the Biotechnology Industry Organization, one of several
trade groups that successfully pushed legislation to block the FDA from using
$10 million a year in industry fees to fund the labs.
But Dr. William Govier, NeoPharm's chief executive, says his company may have
saved $100 million in drug-development work by merely licensing the FDA's
discovery.
The collaboration ``is a shining example of what should work,'' Govier said.
``We don't have the scientists on board with these skills. This is truly
cutting-edge science.''
Puri's discovery was a surprise. He had run out of the immune system cells
needed for an experiment and out of curiosity stuck breast cancer cells under
the microscope instead.
Covering them were receptors for an immune substance called interleukin-13.
Amazed, he analyzed brain tumors, kidney tumors and the AIDS-related Kaposi's
sarcoma - and the solid tumors had large clusters of these magnet-like
receptors, while healthy cells had very few.
IL-13 travels straight to the receptors and latches on. Puri essentially
discovered a potential guided missile: Attach a cancer-killing drug to the
IL-13 and the substance should carry the chemotherapy straight inside the
tumor.
A string of studies published in distinguished medical journals showed it
works in test tubes. Then Puri tried treating sick mice. His eyes widened with
excitement as he displayed for a reporter autopsy photos that show untreated
mice covered in bloody tumors from Kaposi's sarcoma next to healthy-looking
treated mice.
``We've had tumors that were about 20 percent the body weight of the animal to
completely disappear,'' he said.
Puri asked longtime cancer researcher Dr. Waldemar Debinski of Pennsylvania
State University to develop the tumor toxin, made from bacteria, that is
attached to IL-13. Debinski said his separate experiments suggest low doses of
the resulting drug can destroy - in mice - incurable brain tumors called
glioblastomas.
Drugs that work in mice don't necessarily work in people.
Still, ``it is quite a significant finding,'' said Debinski, who envisions
testing people with brain tumors within a year. In addition, NeoPharm plans
human testing against killer kidney cancer.
Discovering potential drugs and licensing them to companies is routine for the
research-driven National Institutes of Health, but it's unusual for a
regulatory agency. The FDA has licensed its own discoveries to 27 companies,
mostly laboratory tests important in determining the safety and effectiveness
of medical treatments. If the IL-13 drug ultimately works, it could become the
first medicine sold through this project - and Puri would get royalties.
Consequently, ``there's a real fire wall'' to ensure Puri has no say in the
regulation of NeoPharm, said Mark Elengold, who oversees Puri's branch of FDA.
But labs like Puri's are in for some downsizing because of the new law that
will phase out by 2001 the $10 million a year they once got from industry,
rolling them back to 1992 spending levels.
That has Elengold worried: The labs are where his employees learn how
medicines function at the molecular level so they can, for instance, predict
unforeseen side effects before allowing a new drug to sell.
``When you know what the risks are yourself - you didn't just read about them
- you know when to say no,'' Elengold explained.
As for discovering a new drug, ``that was serendipity,'' stressed Puri, whose
main job is helping approve medicines. ``To regulate cutting-edge research,
you have to get your hands dirty. ... When you do that, who knows what you'll
find?''
AP-NY-12-09-97 0125EST
