Fears of gene-therapy DNA passed to next generation statistically unfounded: Penn geneticist's estimates affect FDA gene-therapy policy

Ever since gene therapy was introduced almost ten years ago, there's been much apprehension about genes from the disabled viruses used in the therapies inserting their own genetic material into a recipient's reproductive cells. The fear is that viral DNA could reach sperm or egg cells and potentially the genome of subsequent generations. Deciding on an acceptable level of this potential insertion has remained a contentious issue in setting policies for gene-therapy trials. The Federal Drug Administration (FDA) has proposed that a desirable limit would be no more than 1 insertion in about every 6,000 sperm cells, or individuals.

To help put this level into context, Haig Kazazian, MD, professor of genetics at the University of Pennsylvania School of Medicine estimated the natural incidence of gene insertions. He found that naturally occurring insertions in sperm cells were 100 times more common than the suggested FDA limit. His report is published in the June issue of Nature Genetics.

"There's a lot of concern about insertions of viral or other DNA from exogenous somatic gene therapy into gametes that could be passed on to the next generation," says Kazazian. "The FDA has been concerned about allowing studies where there was a chance of this." Kazazian's estimates -- along with other considerations -- were sufficiently convincing that the FDA no longer absolutely requires investigators to analyze gametic insertion before approving gene-therapy studies.

The major cause of naturally occurring genomic insertions is retrotransposons, so-called jumping genes. These are sequences of genetic material that are capable of duplicating and randomly reinserting themselves into the genome. Protein-coding sequences of retrotransposons are quite similar to some bacterial sequences, so are thought to be very old and therefore also important from an evolutionary standpoint.

Based on data found in the scientific literature and the Human Gene Mutation

Contact: Karen Young Kreeger
University of Pennsylvania School of Medicine

Page: 1 2

Related biology news :

1. Fears of second-hand smoke confirmed
2. Fears grow over mad elk disease
3. Fears over ICSI largely groundless say fertility experts
4. Single virus tracing sets the stage for new infection-fighting drugs and gene-therapy strategies, Science authors say
5. Ageing gene could be passed on via X chromosome
6. Genes passed from crops to weeds persist for generations
7. Phase II trials of second-generation antisense cancer drug planned following successful early study
8. Disruption of protein-folding causes neurodegeneration, mental retardation
9. Double-segment periodicity underlies odd segment generation in centipedes
10. Gene defects found in age-related macular degeneration
11. UNC scientists discover molecular pathway leading to nerve growth and regeneration

Post Your Comments:

(Date:6/14/2017)... PARIS , June 15, 2017  IBM (NYSE: IBM ... the international tech event dedicated to developing collaboration between startups ... on June 15-17. During the event, nine startups will ... deliver value in various industries. ... in the international market, with a 30 percent increase in ...
(Date:5/6/2017)... 2017 RAM Group , Singaporean ... breakthrough in biometric authentication based on a ... to perform biometric authentication. These new sensors are based ... by Ram Group and its partners. This sensor will ... chains and security. Ram Group is a next ...
(Date:4/17/2017)... NXT-ID, Inc. (NASDAQ: NXTD ) ("NXT-ID" or the "Company"), ... Report on Form 10-K on Thursday April 13, 2017 with the ... The ... section of the Company,s website at http://www.nxt-id.com  under "SEC Filings," ... 2016 Year Highlights: Acquisition of ...
Breaking Biology News(10 mins):
(Date:10/12/2017)... ... 12, 2017 , ... They call it the “hairy ball.” ... depiction of a system of linkages and connections so complex and dense that ... computer science at Worcester Polytechnic Institute (WPI) and director of the university’s bioinformatics ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... announced today that they have entered into a multiyear collaboration to identify and ... researchers with additional tools for gene editing across all applications. , Under the ...
(Date:10/12/2017)... ca (PRWEB) , ... October 12, 2017 , ... ... the Surgical Wound Market with the addition of its newest module, US Hemostats ... $1.2B market for thrombin hemostats, absorbable hemostats, fibrin sealants, synthetic sealants and biologic ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... analysis platform specifically designed for life science researchers to analyze and interpret ... Rosalind Franklin, who made a major contribution to the discovery of the ...
Breaking Biology Technology:
Cached News: