J
medicine forum Guru
Joined: 29 Apr 2005
Posts: 612
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 Posted: Sun Jun 18, 2006 10:47 pm Post subject:
Re: endostatin ?
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J W wrote:
| Quote: | Does anyone know anything about ths drug (endostatin)? Is it approved
and available in USA or in clinical tials anywhere for colon cancer?
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Stories seem to vary.
http://www.findarticles.com/p/articles/mi_m0ISW/is_2001_April/ai_72297200
Nearly three years ago, the New York Times touted the wonders of the
anti-angiogenesis drug Endostatin on its front page. Consequently, the
stock of EntreMed, manufacturer of the drug, went through the roof. At the
time, I wrote: "The hopes of millions of cancer patients have been raised,
cruelly in my opinion. I deplore the cynical manipulation of the hopes and
fears of cancer patients by self-interested individuals." Now, the first
clinical results with Endostatin have been reported and they are
underwhelming.
In November, researchers from three cities presented data from their Phase
I clinical trial. In Boston, 19 patients with advanced disease were
treated, but 12 had to be taken off the study due to disease progression,
and 5 more withdrew voluntarily. That left 2 patients still receiving the
treatment. The results in the two other locations were no better.
"Some patients benefited, but many did not," said one of the
investigators, laconically. The best results were seen in a 50-year-old
man with cancer of the jaw, which shrank by 62%, and a pancreatic tumor
that shrank by 19%. In five other cases, the disease appeared to stabilize
for a while. Scientists pointed out that blood flow through the tumors had
become "less robust" and that the chemicals involved in blood vessel
creation had diminished as patients were given increasing doses of the
drug.
Advocates of anti-angiogenesis tried to spin straw into gold. The results,
they said, were "tremendously promising." The Washington Post gushed that
"the findings...augur well for more elaborate series of tests scheduled to
begin next year." Imagine if complementary and alternative medicine got
the same kid gloves treatment from the media. Then, even minor responses
could be covered favorably in the New York Times! Incidentally, Wall
Street isn't buying. The stock of EntreMed has plunged to one-fifth of
what it was in its heyday.
http://www.webmd.com/content/article/29/1728_63768.htm
Nov. 9, 2000 (Amsterdam, Netherlands) -- Researchers gave a thumbs-up to
one of the most eagerly awaited cancer drugs -- a genetically engineered
protein that may prevent tumors from developing a blood supply and
thriving.
The drug, called endostatin, interferes with the ability of small tumors
to recruit cells to build blood vessels. Without those blood vessels, the
cancer can't grow or spread to other parts of the body.
But while the studies showed that endostatin was not harmful and did have
some cancer-fighting activity, doctors cautioned that even in the best
scenarios, endostatin will not reach the nation's pharmacies or hospitals
for at least eight years. The preliminary studies were announced here at a
meeting of cancer experts.
On all fronts, endostatin succeeded, the researchers say, but most
importantly, in the area of safety. "If you are going to have a drug that
has to be taken for long periods of time -- and that is probably going to
be the case with endostatin -- it cannot have serious side effects," says
James Thomas, MD, assistant professor of medicine at the University of
Wisconsin Medical School in Madison.
No significant side effects were seen in any of the 61 patients in the
three studies, two of them sponsored by the National Cancer Institute and
the third sponsored by drug manufacturer EntreMed of Rockville, Md.
"There were a couple of cases of rash that went away," Thomas said. There
also were a few cases of infection, which were cleared with antibiotics.
As far as fighting cancer goes, one of the Houston patients, a 58-year-old
man with malignant melanoma, experienced some reductions in skin tumors.
And another patient achieved more than a 50% reduction in a head and neck
tumor. Researchers from one of the other studies also reported two minor
responses to the drug.
Researchers will tweak existing studies, and new ones will get under way.
In fact, the University of Amsterdam will begin a study next week in which
patients will wear an infusion pump that continuously delivers the drug.
All the patients in the endostatin study were suffering from end-stage
cancer, says James Abbruzzese, MD, professor of medicine at the University
of Texas M.D. Anderson Cancer Center in Houston. They all had progressive
disease, and none were on any other active medication. All had taken one
to 10 previous regimens of anticancer drugs, but the therapies failed to
stop disease.
http://www.clinicaltrials.gov/ct/show/NCT00004229?order=2 Phase I
completed
http://www.clinicaltrials.gov/ct/show/NCT00004872?order=3 Phase 1
completed
http://www.clinicaltrials.gov/ct/show/NCT00262327?order=1 Phase 1 China No
longer recruiting.
Phase I measures more for toxicity.
That's all I could find at http://www.clinicaltrials.gov/
J |
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