Chemistry: analytical and immunological testing – Composition for standardization – calibration – simulation,... – Protein or peptide standard or control
Reexamination Certificate
2001-06-28
2004-09-21
Le, Long V. (Department: 1641)
Chemistry: analytical and immunological testing
Composition for standardization, calibration, simulation,...
Protein or peptide standard or control
C436S547000, C435S007210, C435S091100, C435S242000, C424S133100, C424S134100, C424S139100, C424S146100
Reexamination Certificate
active
06794192
ABSTRACT:
The present invention relates to an isolated target sequence. In particular the present invention relates to a method for the diagnosis of a disease or a predisposition to a disease by screening for the presence of the target sequence. More in particular, the present invention relates to the diagnosis of a disease or a predisposition to disease associated with scarring and/or fibrosis. In accordance with the present invention, examples of disease associated with scarring and/or fibrosis include (but are not necessarily limited to): lung fibrosis, atherosclerosis, cardiovascular disease, dermal and corneal scarring and/or fibrosis following infection, trauma, surgery or thermal injury, scleroderma and other connective tissue disorders, fibrosis of the heart, chronic obstructive pulmonary disease, muscle fibrosis, kidney fibrosis, chronic dermal ulceration and lipodermatosclerosis, lung fibrosis (of any origin), post-surgical and idiopathic adhesions, inflammatory conditions of the skin (including Lichen and associated conditions), ageing and all ageing-associated degenerative disorders (including ageing of the skin), liver fibrosis of any ethiology (including viral and non-viral hepatitis), liver cirrhosis, chronic pancreatitis, chronic thyroiditis, calcinosis (of any origin), conditions whose pathogenesis is related to the deposition/modelling of a connective matrix (including cancer). In addition, the present invention relates to a kit for diagnosis for susceptibility or predisposition to a number of disorders, including disorders associated with scarring and/or fibrosis, and to components for inclusion in said kit. The present invention relates to the use of the isolated target sequence to evaluate and/or screen for agents capable of interacting with same. The present invention further provides a means for the directed treatment of such disease states.
BACKGROUND TO THE INVENTION
The incidence of some diseases associated with scarring and/or fibrosis is a significant drain on resources in both developing and developed nations. By way of example, some diseases associated with scarring and/or fibrosis may manifest themselves in the form of atherosclerosis and cardiovascular disease. These diseases are of particular relevance to public health. By way of example, it has been estimated that atherosclerosis leads to approximately 500,000 deaths from coronary artery disease and 150,000 deaths from stroke (Ml) every year in the United States (American Heart Association, 1996). It is now known that atherosclerosis is the principal cause of myocardial infarction, stroke, and peripheral vascular disease, accounting for nearly half of all mortality in developed countries.
The costs for both national and international public health programmes attempting to deal with the consequences of these diseases are substantial. It would therefore be desirable to provide a means for screening individuals to identify those who are predisposed to disease associated with scarring and/or fibrosis and especially to identify to which scarring and fibrotic diseases they are susceptible.
At present, treatment of diseases associated with scarring and/or fibrosis can be effective in slowing the progression of the disease, but only after the disease has been diagnosed. However, such treatments are seldom capable of reversing the effects of the disease once it has set in. Prophylactic treatment of the general population is expensive and a significant drawback is that such treatments are not targeted to the needs of the individual and may be either redundant or even counterproductive. In some cases adverse side effects may be experienced from prolonged exposure to inappropriate prophylactic treatments.
The progression of certain diseases associated with scarring and/or fibrosis such as atherosclerosis, may involve the accumulation/proliferation of smooth muscle cells (SMCs) which elaborate extracellular matrix macromolecules which are largely collagenous in nature. The progression of atherosclerosis from thrombosis to myocardial infarction (MI) can lead to tissue injury which may result in both scar tissue turnover and fibrous tissue formation. Although the process of normal would repair after tissue injury results in the proliferation of fibroblast cell, the differentiation of fibroblasts into myofibroblasts can mark an early event in the development of tissue fibrosis. The prolonged presence of myofibroblasts at an infarct site may also likely to produce an imbalance in extracellular matrix proteins and proteases, which may exacerbate hypertrophic scars and wound formation.
It would be desirable to have a method for diagnosis of disease associated with scarring and/or fibrosis and/or a predisposition to disease associated with scarring and/or fibrosis that solves or at least ameliorates the disadvantages associated with the prior art.
It would also be advantageous to be able to identify new therapeutic targets which would facilitate the identification with increased accuracy of those individuals having a predisposition or increased susceptibility to diseases associated with scarring and/or fibrosis which are associated with an accumulation/proliferation of smooth muscle cells (SMCs) and/or a prolonged presence of myofibroblasts at a disease site. In this way, suitable therapy could then be put into place before the effects of such a disease sets in.
SUMMARY ASPECTS
The present invention relates to methods for inter alia identifying and/or diagnosing the presence or absence of one or more target sequences in a sample taken from an individual. In particular, these methods relate to screens to determine the presence or absence of a target sequence. The methods of the present invention may also be used to determine the relative position of multiple target sequences in a sample taken from an individual order to provide a risk profile for that individual. The identified target sequence may be used to diagnose a disease associated with scarring and/or fibrosis and/or predisposition to a disease associated with scarring and/or fibrosis by correlating the identified target sequence with inherited genetic factors and/or phenotypic traits. The identified target sequence may also be used as a target for the discovery of agents (such as modulators) which may be effectively used to prevent or delay or treat a disease associated with scarring and/or fibrosis or a predisposition to a disease associated with scarring and/or fibrosis associated with these target sequence.
In a broad sense, the present invention relates to an assay method for detecting the presence of a target sequence presented as SEQ ID No 1 or an analogue thereof wherein the assay method comprises a means for detecting said target sequence.
DETAILED ASPECTS OF THE INVENTION
According to a first aspect of the present invention, there is provided an isolated target sequence wherein the target sequence is presented as SEQ ID No 1.
In this embodiment, typically the target sequence is taken from an individual or is in a sample taken from an individual. In this embodiment, typically the individual is a human.
In this embodiment, typically the target sequence is associated with (e.g. located in or on) cells that express a smooth muscle phenotype.
In a highly preferred aspect, the target sequence is associated with (e.g. located in or on) actin intermediate filaments.
In a highly preferred aspect, the target sequence is associated with (e.g. located in or on) a smooth muscle cell and/or a myofibroblast and/or a myoepithelial cell.
According to a second aspect of the present invention there is provided a moiety, such as an antibody, capable of recognising a target sequence wherein the target sequence is presented as SEQ ID No 1.
According to a third aspect of the present invention there is provided an assay method for detecting the presence of a target sequence in a cell or tissue sample from an individual, wherein the target sequence is presented as SEQ ID No 1, and wherein the assay method comprises:
(i) contacting the cell with a moiety, such as an antibody, capab
Parums Dinah
Phillips Stephen Charles
Ridden John
Cheu Jacob J.
Le Long V.
Pfizer Inc.
Raymer Gregory P.
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