After years of testing, the FDA finally granted approval to test the therapy on humans.

An investigational brain cancer drug made with disabled polio virus and manufactured at the Frederick National Lab has won breakthrough status from the Food and Drug Administration (FDA) to fast-track its further refinement and clinical testing. 

Breakthrough status is designed to speed the development and approval of candidate therapies that treat serious or life-threatening diseases and show early evidence of outperforming existing treatments. 

A model of the interaction of processed KRAS-FME protein (cyan) with a lipid nanodisc (green and yellow).

A scientific innovation at the Frederick National Lab has opened the way for a new line of experiments in the decades-old quest for a drug to fight cancers triggered by mutant RAS proteins – which underlie one-third of all malignancies, including those of the pancreas, lung, and colon.

Using modified insect cells, a research group at the national lab recently invented a more accurate laboratory replica of a RAS protein, KRAS4b, that can be produced at high grade and in quantities adequate for research studies that were impossible previously.

Portrait of David Lindsay

Over the past 12 months, we’ve grown accustomed to seeing Zika in the news. The virus has been linked to thousands of cases of microcephaly in Brazilian babies. Numerous countries, including the United States, have reported Zika-related deaths. And there is no vaccine available at this time. 

In the face of what has become a global health crisis, the Vaccine Research Center (VRC) at the NIH/National Institute of Allergy and Infectious Diseases (NIAID) responded to a call from Anthony Fauci, Ph.D., head, NIAID, to get a candidate vaccine into human trials by the summer of 2016. 

Representative low and high magnification RNAscope in situ hybridization images from a chronically SIV-infected rhesus macaque (RM) (top panel) and a SIV-negative RM (bottom panel) demonstrating the robust detection of SIV vRNA only SIV-infected, but not in SIV-negative lymphoid tissues. Scale bars = 50 µm.

Frederick National Lab scientists have developed a faster, more accurate way of pinpointing minute pockets of the AIDS virus that can hide out in infected tissue, thus exposing these remnants as targets for more definitive treatment of the infection.

An image of a koilocyte shows human ectocervical cells expressing HPV-16 E5 oncoprotein, and immortalized with HPV-16 E6 and E7 oncoproteins. Formation of koilocytes requires cooperation between HPV E5 and E6 oncoproteins. The cell culture is stained with hematoxylin and eosin. Image courtesy of the National Cancer Institute.

The Frederick National Lab and Moffitt Cancer Center have established a collaboration to research antibody responses against the human papillomavirus (HPV) in males following administration of the Gardasil vaccine. The vaccine prevents HPV infections that can cause a number of cancers, including oral cancers.

In its interagency agreement with the FDA, NCL will apply a filtration method invented by Stephan Stern, Ph.D., for measuring drug release from several nanomedicine products. The method allows for accurate determination of how much of the drug is bound to the nanoparticle, how much is free, and how much is bound to plasma proteins. This image is a cartoon illustration of a drug (middle) released from a nanoparticle (left) and binding a plasma protein (right), all in suspension above a filter, with the filtr

The Frederick National Lab has begun to assist several major pharmaceutical companies in adopting nanotechnologies in early stage drug development, when the approach is most efficient and cost-effective.

For some time, the national lab’s Nanotechnology Characterization Laboratory (NCL) has worked with pharmaceutical companies on reformulating cancer drugs that failed in human clinical trials because of toxicity or other issues. By reformulating the drugs using nanotechnologies, the drugs reentered clinical trials with success.

Girls in Technology scholarship recipient, Celina Paudel, visits the Advanced Technology Research Facility Dec. 7, 2015, and works with Billy Burgan, a scientist in the Cancer Research Technology Program.

Sixteen-year-old Celina Paudel solidified her career interest in biomedical engineering after winning a scholarship through the national Girls in Technology (GIT) program. Then, thanks to Rachel Bagni, she got to see what it really means to be a scientist.

Bagni, Ph.D., head scientist of the Target Biology Group, Cancer Research Technology Program, played the role of mentor for a day to Paudel, who said she was eager to learn about the world of biomedical research. 

Nanotechnology Characterization Laboratory (NCL) staff and European Union Nanomedicine Characterisation Laboratory staff discuss nanomedicine during a recent visit to the NCL.

European nanotechnology experts visited the Nanotechnology Characterization Laboratory (NCL) to observe best practices and methods and to share their own knowledge with NCL scientists as they prepared to launch an NCL-like operation in Europe.

The European Union Nanomedicine Characterisation Laboratory (EU-NCL) plans to open for business in mid-2016 with funding from the European Commission and support from the NCL and organizations in France, Germany, Ireland, Italy, Norway, Switzerland, and the United Kingdom.

The first international RAS Initiative Symposium on Dec. 15–16, 2015, brings hundreds of RAS researchers together at the Advanced Technology Research Facility.

RAS Symposium Draws Hundreds of Attendees

Published: 1/6/2016Tagged:

They call themselves “rasologists”: scientists who study the RAS family of genes and the cancers that can arise due to mutations within them. This field of research is at the heart of some sobering numbers. Almost a third of all human cancers, including 95 percent of pancreatic cancers, are driven by mutated RAS genes. The American Cancer Society estimates there were 48,960 new cases of pancreatic cancer in the United States in 2015 and 40,560 deaths from the disease. A high proportion of lung and colorectal cancers are also driven by mutations in RAS.

George Lountos, Ph.D., with a Rigaku MicroMax-007 HF rotating anode X-ray generator in the Macromolecular Crystallography Laboratory.

A research team of scientists from the National Cancer Institute and the Frederick National Laboratory for Cancer Research recently identified the structure of a key protein of the virus that causes the highly lethal Middle East Respiratory Syndrome. The team is now using that discovery in the search for new drugs.

Pages