Gene therapy naming scheme

Nomenclature scheme for gene products

Approved by the USAN Council
July 2006

I. Scope

Scheme would apply only to non-cellular products produced by insertion of genetic material (transgene) into a vector (virus or plasmid) and where altered genetic material is administered to patients as a biologic drug.

II. Elements of name

Three elements have been identified that are important in distinguishing a gene therapy drug and conveying safety information to the user physician. These include:

1. indication of the drug’s mechanism of action or pharmacologic class. [Note that administration of these gene therapy products frequently results in expression of a biologically active protein];
   
2. the vector used in transfection; and
   
3. complete identification of the genes carried by the vector if there are 1 or 2 transgenes; for vectors containing > 3 transgenes, one or two genes will be chosen to be included in the gene qualifier based on an analysis of the impact that they have on preventing product confusion or conveying safety information.

Additional nomenclature elements would be a fantasy syllable(s) that serves as a unique identifier for the molecular entity and a stem indicating the gene therapy class of products or the ability of the vector to replicate. Based on these elements, the following is proposed:

First word:  corresponds to the gene component

Prefix: Fantasy element to provide unique identification; to contribute to the distinct name

Infix: Element to denote the gene’s mechanism of action (pharmacologic class) such as:

-lim- [immunomodulator]
-tusu- [tumor supression]
-ermin- [growth factor]
-kin- [interleukins]
-cept- [receptors]

Stem:  Element to indicate gene

-gene

Second word: corresponds to the vector component

Prefix: Fantasy element to provide unique identification; to contribute to the distinct name

Infix: Element to denote the type of viral vector such as

-lenti- [lentivirus]
-retro- [other retro viruses]
-adeno- [adenovirus]
-herpa- [herpes virus]
-parvo- [adeno-associated virus (parvovirdae dependovirus)]
-cana- [canarypox virus]
-vari- [vaccinia virus]
-morbilli- [measles (paramyxoviridae morbillivirus)]

Stem: Element to identify type of vector

-vec [non-replicating viral vector]
-repvec [replicating viral vector]
-plasmid [plasmid vector]