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Cooperative Research and Development
Frederick National Lab's Biopharmaceutical Development Program is, for the time
being, the only manufacturer of a monoclonal antibody that proved effective in clinical
trials and is being made available to affected children nationwide through an ongoing
NCI clinical trial. The antibody, ch14.18, was shown to be effective against high-risk
neuroblastoma, a cancer of nerve tissue that is relatively rare but one of the most
common in young children. In a large clinical trial in 2010, the antibody proved
effective, in combination with other drugs, in extending survival rates. Because
the drug combination was so effective, the trial was modified to allow all enrolled
children to receive the medication. As a bridge to commercialization, Frederick
National Lab is meeting the immediate need for the antibody, while at the same time
transferring the technology to a commercial pharmaceutical manufacturer, United
Therapeutics Corp., under an NCI Cooperative Research and Development Agreement
(CRADA).
Get more information about the Biopharmaceutical Development Program.
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Collaboration yields commercial products.
Early in the AIDS epidemic it became evident that blood transfusion was a major
route of exposure with greater than 5000 people/year becoming infected with the
AIDS virus from blood transfusions. In 1984, soon after HIV-1 was discovered and
adapted to growth in cell culture, virus infected cells were transferred to contractor
scientists in what was later to become the AIDS Vaccine Program (AVP) at Frederick
National Lab, for the large scale production of viruses to be used in the development
of diagnostic blood tests. By the end of the first year, 131 lots of purified HIV-1
derived from >12,400 liters of cell culture were prepared. Accomplishing this task
was facilitated by critical unique technical infrastructure capabilities and expertise
at the Frederick National Lab (originally developed for the large scale propagation
and production of retroviruses for cancer related studies) and the flexibility and
rapid response capabilities afforded by the FFRDC organization. The Frederick National
Lab scientists provided large quantities of virus, virus-infected cells and technology
to the private companies that had received licenses to prepare HIV-1 assays. As
a result of this close interaction between the FFRDC contractor staff and the private
companies, commercial diagnostic assays were approved by the FDA within 11 months
of receipt of the virus infected cells at Frederick National Lab. Use of these assays
to detect and discard blood from infected individuals resulted in rapid decrease
of blood transfusion associated infections to less than 500/year.
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Nanotechnology Gives Failed Cancer Drugs a Second Life
The Nanotechnology Characterization Laboratory, part of the NCI Alliance for Nanotechnology
in Cancer, is leading the way in medical applications of nanotechnology, including
diagnostics, imaging technologies, and targeted cancer therapeutics. NCL is a national
resource and knowledge base for all cancer researchers to assist in the regulatory
review of nanotechnologies intended for cancer therapies and diagnostics. By providing
the critical infrastructure and characterization services to researchers across
the country, NCL accelerates the transition of basic nanoscale particles and devices
into clinical applications to help cancer patients. In collaboration with the U.S.
Food and Drug Administration and the National Institute of Standards and Technology,
the NCL has developed protocols for the thorough characterization of nanoparticles,
making them suitable for clinical studies. The laboratory accepts proposals from
investigators nationwide and has fully characterized more than 280 nanoparticles,
five of which have been approved by the FDA for human clinical studies. Current
projects include reformulating cancer drugs that previously failed clinical trials
because of excessive toxicity or other issues. For example, tumor necrosis factor,
a potent killer of cancer cells, was shelved after clinical trials showed it was
too toxic and unsafe for human use. NCL worked with CytImmune Sciences Inc., which
reformulated this therapy with nanoparticles, causing it to zero in on tumors and
spare the rest of the body from ill effects. The drug was recently approved by the
FDA for Phase II human trials.