Hi!!
This experiment was revealed on June 21, 2004, and as you can see in
the following page this therapy is in its earliest stages:
"'The results of these first animal studies are very promising, and
while we don't yet have a target date for our first human trial, our
entire team is working hard to make this treatment available to cancer
patients as soon as possible,' said Halas, the Stanley C. Moore
Professor in Electrical and Computer Engineering and professor of
chemistry. 'We have licensed the technology to the Houston-based firm
Nanospectra Biosciences Inc., which will obtain the necessary
approvals and funding for human trials.'
###
This research was funded by the National Science Foundation under both
an STTR grant to Nanospectra Biosciences and a National Nanotechnology
Initiative grant to Rice's Center for Biological and Environmental
Nanotechnology."
From "ScienceDaily: Nanoshells Cancer Treatment Proves Effective In
First Animal Test":
http://www.sciencedaily.com/releases/2004/06/040622020433.htm
This article leads me to research at the site of Nanospectra
Biosciences Inc.; this is what I found at their main page:
"Eliminating Cancer Using AuroLase? Therapy:
Nanospectra Biosciences, Inc. is developing a therapeutic medical
device which incorporates a new class of microparticles to selectively
destroy solid tumors. These AuroShell? microparticles (also known as
nanoshells) are delivered systemically and then activated by a
near-infrared laser, resulting in the thermal destruction of the tumor
and the blood vessels supplying them without significant damage to
healthy tissue.
AuroShell? microparticles were developed at Rice University in the
1990s. Nanospectra commenced operations in 2002 to commercialize
applications using these unique materials. In addition to the
elimination of solid tumors, potential applications of AuroShell?
microparticles include cancer detection, the rapid, sensitive
detection of biomolecules and biodefense agents, surface-enhanced
Raman scattering, the treatment of macular degeneration, laser tissue
welding, microfluidic devices, and optical protection."
From "Nanospectra Biosciences, Inc.":
http://www.nanospectra.com
There is also an AuroLase page where you can read the following:
"While AuroLase? Therapy can be used to destroy nearly all solid
tumors, we plan to conduct our first clinical trial in patients with
head and neck cancer.
We currently intend to seek FDA approval to commence a human trial for
the treatment of head and neck cancers in 2006. Other cancer
applications will be developed after these initial trials."
From "Nanospectra Biosciences, Inc. -- AuroLase? Cancer Therapy":
http://www.nanospectra.com/Aurolase.htm
Before continue with this company (which is conducting the research
and managing the funds) I wnat to make a stop here and go to the FDA's
approval times.
This new therapy is on its first stages, and according to the FDA's
development and approval process it takes in average 12 to 15 years
for an experimental therapy or drug to be available for patients since
its discovery, see the following chart:
"The Drug Discovery, Development and Approval Process":
http://www.fdareview.org/graphics/graph1.jpg
The good new is that the 6 years period of discovery and preclinical
testing is practically accomplished. Nanospectra Biosciences is
requesting approval to start the Phase I of the clinical trials, so
this stage is not started yet. This means that there is another 6 to 9
years (if all goes right) to have this therapy available for US
patients.
You asked "It's all very positive, but no one's using it for humans,
at least that I can find. Why not? What are the risks? What are the
specific scientific/technical challenges that must be solved?", the
problem is that there are no answers for these questions, unless
someone has conducted illegal trials on humans. These answers must be
found during the approval process, and no one single step can be
skipped.
If you want to know more about this approval process see:
"The Drug Discovery, Development and Approval Process - FDAReview.org,
a project of The Independent Institute":
http://www.fdareview.org/approval_process.shtml
For an in depth lecture about this subject see the following multipage article:
"Approval Process for New Cancer Treatments - National Cancer Institute":
http://www.cancer.gov/clinicaltrials/learning/approval-process-for-cancer-drugs/page1
You can read in one of these pages the following:
"New treatments can be legally marketed in the United States only
after approval by the U.S. Food and Drug Administration (FDA).
Approval is the final stage of a multi-year process of study and
testing to establish that the new treatment is safe and effective for
the proposed use ...
A cancer treatment rarely receives approval for general use against
cancer. Instead, a treatment is approved for use in treating a
specific stage of a particular kind of cancer, for which it has been
tested in patients. The specific approved use is called an indication.
The indication is described in the labeling for the drug or biologic,
which consists of a printed insert included in the treatment's
packaging. The insert also describes in detail the chemical
composition of the treatment, how it works in the body, and the
possible adverse effects of taking it."
From "Approval Process for New Cancer Treatments - National Cancer Institute":
http://www.cancer.gov/clinicaltrials/learning/approval-process-for-cancer-drugs/page5
But there is a chance to accelerate the process (how much it could be
accelerated is not determined):
"Accelerated approval is the short-hand term for the process by which
the FDA quickly conducts its review of new treatment applications
while also putting new safeguards in place. Accelerated approval is
based on surrogate endpoint judgments: the FDA can grant marketing
approval to drugs and treatments that, according to certain
indicators, prove they are likely to have beneficial effects on a
disease or condition, even before such direct benefits have been shown
clinically. Accelerated approval does not mean that additional
clinical trials are not needed or that the FDA stops gathering
information about the effects of the drug; a follow-up study is
required to demonstrate activity by more conventional endpoints."
FRom "Approval Process for New Cancer Treatments - National Cancer Institute":
http://www.cancer.gov/clinicaltrials/learning/approval-process-for-cancer-drugs/page4#Accelerated
Approval
The following article add more info regarding speeding up the approval process:
"Part II: Drug Development and Approval (Updated)":
http://www.plwc.org/portal/site/PLWC/menuitem.169f5d85214941ccfd748f68ee37a01d/?vgnextoid=2a2141eca8daa010VgnVCM100000ed730ad1RCRD
Note that some red lights are shinning, the following articles gives
you an idea about this:
"FDA Moves Cancer Cures into the Slow Lane - AEI - Short Publications"
By Scott Gottlieb, M.D.:
http://www.aei.org/publications/pubID.21820,filter.all/pub_detail.asp
"Nanotechnology Presents R&D Quandary for FDA":
http://www.asq.org/qualitynews/qnt/execute/displaySetup?newsID=724
Back to Nanospectra Biosciences, Inc. and its research, they are
receiving funds from the National Science Foundation to continue
development of a
nanoshell-based cancer therapy. They receive funds as part of a SBIR program.
"What is the SBIR Program?
The Small Business Innovation Research (SBIR) Program is a highly
competitive three-phase award system which provides qualified small
business concerns with opportunities to propose innovative ideas that
meet the specific research and research and development needs of the
Federal Government."
From "Frequently Asked Questions -- Small Business Innovation Research
(SBIR) Program":
http://www.ed.gov/programs/sbir/faq.html
Press releases let us know that other funds was received recently:
"Houston ? September 27, 2006 ? Nanospectra Biosciences, Inc. today
announced that the Texas Emerging Technology Fund (?TETF?) has awarded
$1,250,000 to fund the clinical development of Nanospectra?s AuroLase?
cancer therapy. The TETF will receive a warrant to acquire Common
Stock in connection with the award."
http://www.nanospectra.com/Nanospectra%20Texas%20ETF%20Announcement%202006-09-27.pdf
"Houston ? November 2, 2006 ? Nanospectra Biosciences, Inc. today
announced that it has sold $1.7 million of Series A Preferred Stock,
including the conversion of previously issued notes into Series A
Preferred Stock. Including the $1.25 million investment by the Texas
Emerging Technology Fund, the total funding raised to date in 2006 by
Nanospectra is $3.0 million. The proceeds will fund the initial
clinical trial of AuroLase? cancer therapy in head and neck cancer."
http://www.nanospectra.com/Nanospectra%20Series%20A%20Pfd%20Closing%202006-11-2.pdf
Summing up, the only conclusion we can getis that until this new
treatment accomplishes the FDA's approval process it will not be
available for US patients. This process takes several years and the
clinical trials with humans are not started yet,so the expected delay
is 6 to 9 years. This process can be accelerated but this is
supposition only. The goal of the approval process is to answer the
questions you asked, since it is not started yet no accurate answer
can be given.
The AuroLase treatment is promising but its effectiveness and safety
must be proved.
For more info regarding this new "nanotherapy" see:
"Nanotechnology Now - Best of Nanotechnology - 2003 Awards. Best Discoveries.":
http://www.nanotech-now.com/2003-Awards/Best-Discoveries-2003.htm
"Immunonanoshells for Selective Photothermal Therapy and Nanoshells
for Combined Cancer Therapy and Imaging in Vivo":
http://www.azonano.com/news.asp?newsID=1659
"Nanoshells Revolutionary New Form of Cancer Therapy":
http://www.azonano.com/news.asp?newsID=186
Search strategy:
fda cancer nanoshells
fda cancer nanoshells approval
sbir phase
aurolase fda trial
I hope this helps you. If you find something unclear or incomplete do
not hesitate to use the clarification feature to request further
assistance on this subject.
Best regards,
livioflores-ga |
