Abstract: An embodiment of the present invention provides for a dry powder pharmaceutical composition suitable for dispersion in an aerosol for inhaled administration to a patient with cancer, the composition comprising: a cytidine analogue including salts, solvates, hydrates, and esters thereof; and a pharmaceutically acceptable excipient together forming the dry powder pharmaceutical composition suitable for dispersion in the aerosol for administration via inhalation to the patient with cancer. Another embodiment provides for a method of making the composition and a further embodiment provides for a method a treating a patient in need thereof with the composition.

Abstract: An embodiment of the present invention provides for a dry powder pharmaceutical composition suitable for dispersion in an aerosol for inhaled administration to a patient with cancer, the composition comprising: a cytidine analogue including salts, solvates, hydrates, and esters thereof; and a pharmaceutically acceptable excipient together forming the dry powder pharmaceutical composition suitable for dispersion in the aerosol for administration via inhalation to the patient with cancer. Another embodiment provides for a method of making the composition and a further embodiment provides for a method a treating a patient in need thereof with the composition.

Abstract: The present invention provides for a method to monitor the health of a subject. The method includes obtaining a test sample from the patient. A first probe specific for a CpG promoter region of a biomarker selected from p16, MGMT, PAX-?, PAX5-?, RASSF1A, HLHP, GATA4, GATA5, SFRP1, LAMC2, IGFBP3, H-cadherin, BETA 3, HLHP, and DAPK is provided to the sample. The probe contacts the test sample. The DNA of interest from the test sample is isolated. A second stage probe specific for a second CpG promoter region of a biomarker selected from p16, MGMT, PAX-?, PAX5-?, RASSF1A, HLHP, GATA4, GATA5, SFRP1, LAMC2, IGFBP3, H-cadherin, BETA 3, HLHP, and DAPK is provided to the sample to form a second stage PCR product. The DNA is analyzed for hypermethylation of the promoter region for at least one of p16, MGMT, PAX-?, PAX5-?, RASSF1A, HLHP, GATA4, GATA5, SFRP1, LAMC2, IGFBP3, H-cadherin, BETA 3, HLHP, and DAPK.

Abstract: A system and method for predicting the health of a subject comprising obtaining nucleic acid sequence data about the subject. Identifying at least one polymorphic risk marker associated with a change in promoter methylation of a gene associated with lung cancer; and predicting the health of the subject from a presence of at least one polymorphic risk marker identified and kits associated therewith.

Abstract: The present invention provides for a method to monitor the health of a subject. The method includes obtaining a test sample from the patient. A first probe specific for a CpG promoter region of a biomarker selected from p16, MGMT, PAX-?, PAX5-?, RASSF1A, HLHP, GATA4, GATA5, SFRP1, LAMC2, IGFBP3, H-cadherin, BETA 3, HLHP, and DAPK is provided to the sample. The probe contacts the test sample. The DNA of interest from the test sample is isolated. A second stage probe specific for a second CpG promoter region of a biomarker selected from p16, MGMT, PAX-?, PAX5-?, RASSF1A, HLHP, GATA4, GATA5, SFRP1, LAMC2, IGFBP3, H-cadherin, BETA 3, HLHP, and DAPK is provided to the sample to form a second stage PCR product. The DNA is analyzed for hypermethylation of the promoter region for at least one of p16, MGMT, PAX-?, PAX5-?, RASSF1A, HLHP, GATA4, GATA5, SFRP1, LAMC2, IGFBP3, H-cadherin, BETA 3, HLHP, and DAPK.

Abstract: A molecular marker-based method for monitoring and detecting cancer in humans. Aberrant methylation of gene promoters is a marker for cancer risk in humans. A two-stage, or “nested” polymerase chain reaction method is disclosed for detecting methylated DNA sequences at sufficiently high levels of sensitivity to permit cancer screening in biological fluid samples, such as sputum, obtained non-invasively. The method is for detecting the aberrant methylation of the p16 gene, O 6-methylguanine-DNA methyltransferase gene, Death-associated protein kinase gene, RAS-associated family 1 gene, or other gene promoters. The method offers a potentially powerful approach to population-based screening for the detection of lung and other cancers.

Abstract: A method for genetic testing relating to chronic obstructive pulmonary disease (COPD), including testing for a single nucleotide polymorphism within the metal loproteinase-9 gene, an exon 6, codon 279 Gln/Arg polymorphism, where in presence of the variant polymorphism, particularly homozygous presence, is predictive of susceptibility to COPD. Further provided are methods of selecting patients for specific therapies and methods of drug development and discovery for treatment and prevention of COPD.

Abstract: PAX5 alpha and PAX5 beta and other genes as markers for cancer detection. A PCR-based technique of methylated CpG island amplification, followed by representational difference analysis, for identifying genes methylated in human cancer. The genes PAX5 alpha and PAX5 beta, novel loop helix loop protein, and a novel gene 2, and beta3 genes when methylated serve as markers for detecting, monitoring, diagnosing and prognosticating breast, colon, and lung cancer in humans. Amplification methods, including primer sequences for methylation specific polymerase chain reaction, are disclosed.

Abstract: A molecular marker-based method for monitoring and detecting cancer in humans. Aberrant methylation of gene promoters is a marker for cancer risk in humans. A two-stage, or “nested” polymerase chain reaction method is disclosed for detecting methylated DNA sequences at sufficiently high levels of sensitivity to permit cancer screening in biological fluid samples, such as sputum, obtained non-invasively. The method is for detecting the aberrant methylation of the p16 gene, O 6-methylguanine-DNA methyltransferase gene, Death-associated protein kinase gene, RAS-associated family 1 gene, or other gene promoters. The method offers a potentially powerful approach to population-based screening for the detection of lung and other cancers.