Lovelace Respiratory Research Institute

Lovelace Biomedical Research Institute

Steven A Belinsky

Devon Dubose

Aaron Badenoch

William A Palmisano

Philip J Kuehl

Michael Burke

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.

Inhalable dry powder cytidine analogue composition and method of use as a treatment for cancer

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-&#x3b1;, PAX5-&#x3b2;, 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-&#x3b1;, PAX5-&#x3b2;, 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-&#x3b1;, PAX5-&#x3b2;, RASSF1A, HLHP, GATA4, GATA5, SFRP1, LAMC2, IGFBP3, H-cadherin, BETA 3, HLHP, and DAPK. Hypermethylation of the promoter region of at least one of p16, MGMT, PAX-&#x3b1;, PAX5-&#x3b2;, RASSF1A, HLHP, GATA4, GATA5, SFRP1, LAMC2, IGFBP3, H-cadherin, BETA 3, HLHP, and DAPK is an indication that the subject is at increased risk of developing cancer for example, non small cell lung cancer.

Gene methylation as a biomarker in sputum

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.

Growing community of inventors

Albuquerque, NM, United States of America

Steven A Belinsky