{"id":47056,"date":"2004-03-25T00:00:00","date_gmt":"2004-03-25T06:00:00","guid":{"rendered":"https:\/\/www.unmc.edu\/newsroom\/2004\/03\/25\/gene-therapy-being-used-in-cystic-fibrosis-study-at-unmc-thenebraska-medical-center\/"},"modified":"2022-08-29T10:42:05","modified_gmt":"2022-08-29T15:42:05","slug":"gene-therapy-being-used-in-cystic-fibrosis-study-at-unmc-thenebraska-medical-center","status":"publish","type":"post","link":"https:\/\/www.unmc.edu\/newsroom\/2004\/03\/25\/gene-therapy-being-used-in-cystic-fibrosis-study-at-unmc-thenebraska-medical-center\/","title":{"rendered":"Gene therapy being used in cystic fibrosis study at UNMC\/The\n\nNebraska Medical Center"},"content":{"rendered":"

The University of Nebraska Medical Center and its hospital partner,<\/p>\n

The Nebraska Medical Center, have been selected as one of 12 sites participating<\/p>\n

in a study using gene therapy techniques to treat cystic fibrosis (CF),<\/p>\n

a genetic disease affecting approximately 30,000 children and adults in<\/p>\n

the United States.<\/p>\n

With cystic fibrosis, a defective gene causes the body to produce abnormally<\/p>\n

thick, sticky mucus that clogs the lungs and leads to chronic, life-threatening<\/p>\n

lung infections. These thick secretions also obstruct the pancreas, preventing<\/p>\n

digestive enzymes from reaching the intestines to help break down and absorb<\/p>\n

food. The chronic lung infections are responsible for shortening the life<\/p>\n

expectancy for CF patients to a median of approximately 33 years. In addition,<\/p>\n

many CF patients eventually develop diabetes.<\/p>\n

Cystic fibrosis is really a difficult disease to treat because so many<\/p>\n

organs are affected, said John Colombo, M.D., professor and chief of the<\/p>\n

pediatric pulmonology section in the UNMC pediatrics department and a pediatric<\/p>\n

pulmonologist for The Nebraska Medical Center. Its a great honor for<\/p>\n

us to participate in this study. Were excited to be able to help in the<\/p>\n

development of a potentially major new treatment for our CF patients. It<\/p>\n

is exciting because it is one of the first therapies actually targeted<\/p>\n

to treat the underlying defect.<\/p>\n

CF is caused by a defect in a single gene. The CF gene tells cells how<\/p>\n

to make a molecule called the CFTR protein, which is needed to keep the<\/p>\n

proper water balance in the bronchial tubes and in linings of other internal<\/p>\n

organs so they remain wet and clean. With CF patients, the CFTR gene has<\/p>\n

the wrong instructions and cells cant make a CFTR protein that works properly.<\/p>\n

Without this protein, the lung airways can become blocked with mucous secretions,<\/p>\n

which can lead to severe, recurring respiratory infections.<\/p>\n

Gene therapy, also called gene transfer, is an experimental procedure<\/p>\n

that is being developed to treat a variety of diseases, including CF, by<\/p>\n

putting normal copies of genes into cells that need them. Because genes<\/p>\n

are located inside cells, transferring new genes from the outside of a<\/p>\n

cell to the inside of a cell requires help.<\/p>\n

In this study, a very small and simple virus, called AAV, has been<\/p>\n

engineered in the laboratory to contain a normal copy of the CFTR gene.<\/p>\n

AAV is not known to make people sick.<\/p>\n

The AAV genes are taken out of the virus and a normal copy of the CFTR<\/p>\n

gene is put in their place. This new gene combination is then put back<\/p>\n

inside the virus. The combination of AAV and the CFTR gene that is being<\/p>\n

tested in the current study is called tgAAVCF.<\/p>\n

Once the virus has infected the cells lining the bronchi (the branching<\/p>\n

airways within the lungs), the cells own machinery makes good CFTR from<\/p>\n

the good copies of the gene supplied by the virus and will continue to<\/p>\n

do so for the life of the cell.<\/p>\n

Over the next several months, UNMC and The Nebraska Medical Center hopes<\/p>\n

to enroll about 10 patients into the study, Dr. Colombo said. The study<\/p>\n

provides for a total enrollment of 100 patients nationally. Two patients<\/p>\n

have already been enrolled at the medical center and have started receiving<\/p>\n

treatments.<\/p>\n

Participants in the study will visit the CF center at the medical center<\/p>\n

eight times. During two of these visits, participants will receive either<\/p>\n

tgAAVCF or a placebo.  Participants will not know during the treatment<\/p>\n

if they are receiving the active drug or the placebo.<\/p>\n

A nebulizer will be used to turn the drug or the placebo into an aerosol,<\/p>\n

which participants will breathe in through their mouths. By breathing in<\/p>\n

through their mouths, the drug or placebo will enter the airways in the<\/p>\n

lungs. Once the drug enters the airway, it enters cells.<\/p>\n

We are hoping that the normal copy of the CFTR gene carried by the<\/p>\n

drug will provide the cell with the right instructions to make properly<\/p>\n

functioning CFTR protein and thus result in more normal mucous secretions,<\/p>\n

Dr. Colombo said.<\/p>\n

Two patients enrolled in The Nebraska Medical Center\/UNMC study are<\/p>\n

Kate Howard, 16, of Sioux City, Iowa, and Chad Humston, 17, of Giltner,<\/p>\n

Neb. Both participated in a news conference held at the Medical Center.<\/p>\n

Cystic fibrosis is a disease that reminds you that its there every<\/p>\n

day, said Lonnel Howard, Kates mother. Kate has never had one day of<\/p>\n

normal living. We are so excited to have Kate participating in this study.<\/p>\n

It represents hope for the future for all CF patients.<\/p>\n

 In an earlier Phase II study of the drug, Dr. Colombo said it<\/p>\n

was determined that the drug appeared safe and didnt cause any serious<\/p>\n

side effects. In addition, patients realized a statistically significant<\/p>\n

improvement in lung function at 30 days after treatment in that study.<\/p>\n

The phase II study has now been published in the February issue of Chest,<\/p>\n

a leading scientific journal. It served as the basis for the current study,<\/p>\n

a Phase IIb study, which is being conducted by Targeted Genetics Corporation<\/p>\n

of Seattle, the company that manufactures the CF drug, and the Cystic Fibrosis<\/p>\n

Foundation.<\/p>\n

 Gene therapy is one of the most exciting areas of scientific<\/p>\n

research, Dr. Colombo said. It is a potential mode of therapy for any<\/p>\n

disease with a genetic basis, so that can encompass lots of diseases, including<\/p>\n

several forms of cancer. The use of gene therapy in CF is probably the<\/p>\n

biggest breakthrough weve seen since the CF gene was discovered in 1989.<\/p>\n

 Currently, UNMC and The Nebraska Medical Center are participating<\/p>\n

in two other gene therapy studies, said Ernie Prentice, Ph.D., associate<\/p>\n

dean for academic affairs. These studies deal with breast cancer and prostate<\/p>\n

cancer.<\/p>\n

We have seen a marked increase in the number of gene therapy protocols<\/p>\n

at UNMC in the last year, Dr. Prentice said, and we anticipate that we<\/p>\n

will continue to see an increase in gene therapy studies in the future.<\/p>\n

 The CF gene therapy study is being administered nationally by<\/p>\n

Childrens Hospital and Regional Medical Center in Seattle. For more information<\/p>\n

on the study, call (402) 559-9256.<\/p>\n<\/div><\/div>","protected":false},"excerpt":{"rendered":"

The University of Nebraska Medical Center and its hospital partner, The Nebraska Medical Center, have been selected as one of 12 sites participating in a study using gene therapy techniques to treat cystic fibrosis (CF), a genetic disease affecting approximately 30,000 children and adults in the United States. With cystic fibrosis, a defective gene causes […]<\/p>\n","protected":false},"author":79,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-47056","post","type-post","status-publish","format-standard","hentry","category-uncategorized","department-press-release"],"yoast_head":"\nGene therapy being used in cystic fibrosis study at UNMC\/The Nebraska Medical Center<\/title>\n<meta name=\"description\" content=\"The University of Nebraska Medical Center and its hospital 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