Oncogene Science, Inc.

Applied Bio Technology

E.i. Dupont De Nemours and Company

Bayer Corporation

Siemens Healthcare Diagnostics Gmbh

Walter P Carney

Sara J McKenzie

Robert Allan Weinberg

Peter J Hamer

Gail P Mazzara

Allan Lipton

Jonathan H Morgan

Suhail M Ali

Paula Jean Marks

Debra Ann Petit

Kim Leitzel

Sheryl Brown-Shimer

Karen Pierce

James Elting

Leticia Morris

The present invention describes clinically and medically important methods of examining, screening over time, and monitoring the outcome of a cancer patient who is undergoing treatment or therapy for his or her disease. More specifically, the invention provides a method of monitoring the progression of disease, or the effectiveness of cancer treatment, in a cancer patient by measuring the levels of one or more analytes of the plasminogen activator (uPA) system, namely, uPA, PAI-1 and the complex of uPA:PAI-1, in a sample taken from the cancer patient, preferably, before treatment, at the start of treatment, and at various time intervals during treatment. As a result of performing the method, an increase or elevation in the levels of one or more of the PA system analytes in the cancer patient compared with the levels one or more of the respective PA system analytes in normal control individuals serves as an indicator of cancer advancement or progression and/or a lack of treatment effectiveness for the patient.

Assays for cancer patient monitoring based on levels of analyte components of the plasminogen activator system in body fluid samples

The present invention describes clinically and medically important methods of monitoring the outcome of a cancer patient who is suffering from disease or who is undergoing treatment or therapy for his or her disease. More specifically, the invention provides a method of monitoring the progression of disease or cancer treatment effectiveness in a cancer patient by measuring the level of the extracellular domain (ECD) of the epidermal growth factor receptor (EGFR) in a sample taken from the cancer patient, preferably, before treatment, at the start of treatment, and at various time intervals during treatment, wherein a decrease in the level of the ECD of the EGFR in the cancer patient compared with the level of the ECD of the EGFR in normal control individuals serves as an indicator of cancer advancement or progression and/or a lack of treatment effectiveness for the patient. As another aspect of determining disease outcome and survival, the invention further provides assessing both EGFR and HER-2/neu levels, in combination, in a patient sample. A finding of decreased levels of EGFR concomitantly with elevated or increased levels of HER-2/neu relative to control levels indicates poor outcome and short time to progression.

Assays for cancer patient monitoring based on levels of epidermal growth factor receptor (EGFR) extracellular domain (ECD) analyte, alone or in combination with other analytes, in body fluid samples

This invention relates to a substantially purified p100 which is a human neu related protein having a molecular weight in the range from about 97,000 daltons to about 115,000 daltons which corresponds substantially to the extracellular domain of the human neu gene product, said protein being detectable in a biological fluid. In another embodiment this invention relates to assays for detecting this protein. Finally, this invention also concerns monoclonal antibodies which are capable of binding to p100.

Detection and quantification of neu related proteins in the biological fluids of humans

This subject of this invention is the detection, quantitation of ras p21 proteins in body fluids, tissues, or cells. Specifically, this invention concerns detecting and quantitating normal and mutated ras p21s from normal subjects, subjects suspected of having preneoplastic disease or subjects known or suspected of having neoplastic (cancer) disease. This invention also concerns the detection and quantitation of the ras p21 proteins into the three families of ras proteins designated Ha, Ki and N in body fluids and tissues.

Detection, quantitation and classification of ras proteins in body fluids and tissues

Detection of neu p185 in cell lysates

Detection, quantitation and classification of ras p21 proteins in body fluids, tissues, or cells is described. Specifically, this disclosure concerns detecting and quantitating normal and mutated ras p21s from normal subjects, subjects suspected of having preneoplastic disease or subjects known or suspected of having neoplastic (cancer) disease. This invention also concerns the detection and quantitation of the ras p21 proteins into the three families of ras proteins designated Ha, Ki and N in body fluids and tissues.

Detection, quantitation and classification of RAS proteins in body

Detection and quantification of neu related proteins in the biological

Antibodies reactive with normal and oncogenic forms of the ras p21 protein. The antibodies are secreted by hybridomas obtained by immunizing mice with the Ha ras p21 protein containing the arginine mutation at position 12 of the protein. The antibodies and immunoreactive fragments thereof of useful for detection, diagnosis, quantitation, staging and classification of normal and activated ras p21s in normal tissues, malignant and premalignant lesions.

Antibodies reactive with normal and oncogenic forms of the ras p21

Monoclonal antibodies reactive with oncogenic and activated ras p21 proteins containing aspartic acid or valine at position 13 and unreactive with normal ras p21 proteins containing glycine at position 13. The antibodies are secreted by hybridomas obtained by immunizing mice with synthetic peptides corresponding in amino acid sequence to positions 5-19 or normal ras p21 proteins, except having aspartic acid or valine in place of glycine at position 13 and except for the addition of cysteine at the amino terminal end of the peptide. The antibodies and immunoreactive fragments are useful in the diagnosis, staging and classification of malignant and premalignant lesions.

Monoclonal antibodies against activated ras proteins with amino acid

Monoclonal antibodies reactive with oncogenic and activated ras p21 proteins containing glutamic acid, arginine or valine at position 12 and unreactive with normal ras p21 proteins containing glycine at position 12. The antibodies are secreted by hybridomas obtained by immunizing mice with synthetic dodecapeptides corresponding in amino acid sequence to positions 5-16 of normal ras p21 proteins, except having glutamic acid, arginine or valine in place of glycine at position 12. The antibodies and Fab fragments thereof are useful for diagnosis, staging and classification of malignant and premalignant lesions.

Monoclonal antibodies reactive with activated and oncogenic ras p21

Monoclonal antibodies reactive with normal and oncogenic forms of the ras p21 protein. The antibodies are secreted by hybridomas obtained by immunizing mice with the Ha ras p21 protein containing the arginine mutation at position 12 of the protein. The antibodies and immunoreactive fragments thereof of useful for detection, diagnosis, quantitation, staging and classification of normal and activated ras p21s in normal tissues, malignant and premalignant lesions.

Monoclonal antibodies reactive with normal and oncogenic forms of the

Monoclonal antibodies reactive with oncogenic and activated ras p21 proteins containing aspartic acid or valine at position 13 and unreactive with normal ras p21 proteins containing glycine at position 13. The antibodies are secreted by hybridomas obtained by immunizing mice with synthetic peptides corresponding in amino acid sequence to positions 5-9 of normal ras p21 proteins, except having aspartic acid in place of glycine at position 13 and except for the addition of cysteine at the amino terminal end of the peptide. The antibodies and immunoreactive fragments are useful in the classification of malignant and premalignant lesions.

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Brighton, MA, United States of America

Walter P Carney