Novel retrovirus associated with myelodysplastic syndromes and uses thereof

Abstract

The present invention relates first, to the identification of a novel retrovirus and the novel nucleotide sequences encoding a retroviral polymerase gene (POL nucleotides) associated with the existence of MDS and MDS associated disorders. The present invention further relates to methods for using the MDS associated retroviral nucleotides for the detection of MDS and MDS associated disorders in patient samples. The present invention also relates to methods for using and targeting the MDS associated retroviral POL nucleotides in gene therapy protocols for the treatment of MDS and MDS associated disorders in patients in need of such treatment. The present invention further relates to diagnostic protocols and kits for the detection of MDS and MDS associated disorders in tissue samples.

1 . A method comprising: 
 detecting the presence or absence of a myelodysplastic syndrome associated retrovirus in a biological sample obtained from an individual, and    administering a therapeutically effective amount of an anti-retroviral agent to the individual when the myelodysplastic syndrome associated retrovirus is detected in the biological sample.    
   
   
       2 . The method of  claim 1  wherein the myelodysplastic syndrome associated retrovirus is that isolated from ATCC Deposit No. PTA-2733 or PTA-2734.  
   
   
       3 . The method of  claim 1  wherein the myelodysplastic syndrome associated retrovirus comprises a viral particle size ranging from 40 to 60 nm and a density of 1.14 to 1.16 as measured by a sugar density gradient with the proviso that the virus is not HIV, HTLV or MMTV.  
   
   
       4 . The method of  claim 1  wherein the step of detecting the presence or absence of the myelodysplastic syndrome associated retrovirus in the biological sample comprises detecting the presence or absence of myelodysplastic syndrome associated retroviral nucleic acid specific to the myelodysplastic syndrome associated retrovirus in the biological sample, and the presence of the myelodysplastic syndrome associated retroviral nucleic acid specific to the myelodysplastic syndrome associated retrovirus indicates that the biological sample is infected with the myelodysplastic syndrome associated retrovirus.  
   
   
       5 . The method of  claim 1  wherein the step of detecting the presence or absence of the myelodysplastic syndrome associated retrovirus in the biological sample comprises visually identifying the presence or absence of the myelodysplastic syndrome associated retrovirus in the biological sample, and the presence of viral particles indicates that the biological sample is infected with the myelodysplastic syndrome associated retrovirus.  
   
   
       6 . The method of  claim 1  wherein the step of detecting the presence or absence of the myelodysplastic syndrome associated retrovirus in the biological sample comprises contacting the biological sample with a fragment of an antibody which is capable of detecting the presence of the myelodysplastic syndrome associated retrovirus and determining whether the antibody detected the presence of the myelodysplastic syndrome associated retrovirus.  
   
   
       7 . The method of  claim 6  wherein the antibody capable of detecting the presence of the myelodysplastic syndrome associated retrovirus is capable of detecting a gene product of the myelodysplastic syndrome associated retrovirus.  
   
   
       8 . The method of  claim 1  wherein the step of detecting the presence or absence of the myelodysplastic syndrome associated retrovirus in the biological sample comprises detecting the presence or absence of myelodysplastic syndrome associated retrovirus reverse transcriptase activity, and the presence of the myelodysplastic syndrome associated retrovirus reverse transcriptase activity indicates that the biological sample is infected with the myelodysplastic syndrome associated retrovirus.  
   
   
       9 . The method of  claim 1  wherein the individual is suspected of having myelodysplastic syndrome or chronic leukemia.  
   
   
       10 . The method of  claim 1  wherein the anti-retroviral agent is selected from the group consisting of a cytokine selected from rIFN α, rIFN β, or rIFN γ; an inhibitor of reverse transcriptase, and an non-nucleoside reverse transcriptase inhibitor.  
   
   
       11 . The method of  claim 1  wherein the anti-retroviral agent is a nucleoside reverse transcriptase inhibitor.  
   
   
       12 . A method comprising detecting the presence or absence of a myelodysplastic syndrome associated retrovirus in a biological sample by detecting the presence or absence of myelodysplastic syndrome associated retrovirus reverse transcriptase activity, wherein the presence of the myelodysplastic syndrome associated retrovirus reverse transcriptase activity indicates that the biological sample is infected with the myelodysplastic syndrome associated retrovirus.