SOLUBLE HUMAN M-CSF RECEPTOR AND USES THEREOF
Soluble human M-CSF receptor is provided, along with pharmaceutical compositions containing such receptor, kits containing a pharmaceutical composition, and methods of diagnosing and treating diseases and disorders associated with M-CSF such as bone loss in a subject afflicted with an osteolytic disease.
1 . A method of diagnosing cancer comprising the step of:
(a) analyzing a fluid sample from a patient for level of soluble M-CSF receptor, wherein a level of soluble M-CSF receptor above a threshold is correlated with the presence of cancer and a level below said threshold indicates that the patient is unlikely to have cancer.
2 . The method according to claim 1 wherein the fluid sample is selected from the group consisting of urine, plasma, or serum.
3 . A method of determining prognosis in a subject afflicted with cancer comprising the step of:
(a) analyzing a fluid sample from a patient for level of soluble M-CSF
receptor, wherein a level of soluble M-CSF receptor above a threshold indicates that the patient is likely to have a poor prognosis and a level below said threshold indicates that the patient is likely to have a good prognosis.
4 . The method according to claim 3 wherein the fluid sample is selected from the consisting of urine, plasma, or serum.
5 . A method of monitoring cancer therapy in a subject afflicted with cancer comprising the steps of:
(a) analyzing a fluid sample from a patient for level of soluble M-CSF receptor prior to the initiation of treatment with a cancer therapeutic; and
(b) analyzing said fluid sample after the initiation of the treatment with the cancer therapeutic,
wherein a reduction in the level of soluble M-CSF receptor after the initiation of the treatment with the cancer therapeutic indicates the patient is receiving a therapeutically effective dose of the cancer therapeutic.
6 . The method according to claim 5 wherein the fluid sample is selected from the consisting of urine, plasma, or serum.
7 . The method according to claim 1 wherein the cancer is selected from the group consisting of breast, lung, renal, multiple myeloma, thyroid, prostate, adenocarcinoma, blood cell malignancies, including leukemia and lymphoma; head and neck cancers; gastrointestinal cancers, including esophageal cancer, stomach cancer, colon cancer, intestinal cancer, colorectal cancer, rectal cancer, pancreatic cancer, liver cancer, cancer of the bile duct or gall bladder; malignancies of the female genital tract, including ovarian carcinoma, uterine endometrial cancers, vaginal cancer, and cervical cancer; bladder cancer; brain cancer, including neuroblastoma; sarcoma, osteosarcorna; and skin cancer, including malignant melanoma or squamous cell cancer.
8 . The method according to claim 7 wherein the cancer is breast cancer
9 . A method of monitoring menstrual cycle in a female comprising the step of:
(a) analyzing a fluid sample from a female patient for level of soluble M-CSF receptor, wherein a level of soluble M-CSF receptor above a threshold indicates that the patient is likely fertile and a level below said threshold indicates that the patient is likely not fertile.
10 . The method according to claim 9 wherein the fluid sample is selected from the consisting of urine, plasma, or serum.
11 . A kit comprising:
(a) a first antibody that specifically binds to shM-CSFR; and
(b) an M-CSFR standard containing a known quantity of M-CSFR.
12 . A kit according to claim 11 wherein said first antibody is linked to a detectable label.
13 . A kit according to claim 12 wherein said label is an enzyme.
14 . A kit according to claim 13 further comprising a substrate from which said enzyme releases a detectable signal.
15 . A kit according to claim 11 further comprising a second antibody selected from the group consisting of:
a) an antibody that binds to shM-CSFR; and
b) an antibody that binds to said first antibody.
16 . (canceled)
17 . (canceled)
18 . The method according to claim 3 wherein the cancer is selected from the group consisting of breast, lung, renal, multiple myeloma, thyroid, prostate, adenocarcinoma, blood cell malignancies, including leukemia and lymphoma; head and neck cancers; gastrointestinal cancers, including esophageal cancer, stomach cancer, colon cancer, intestinal cancer, colorectal cancer, rectal cancer, pancreatic cancer, liver cancer, cancer of the bile duct or gall bladder; malignancies of the female genital tract, including ovarian carcinoma, uterine endometrial cancers, vaginal cancer, and cervical cancer; bladder cancer; brain cancer, including neuroblastoma; sarcoma, osteosarcoma; and skin cancer, including malignant melanoma or squamous cell cancer.
19 . The method according to claim 5 wherein the cancer is selected from the group consisting of breast, lung, renal, multiple myeloma, thyroid, prostate, adenocarcinoma, blood cell malignancies, including leukemia and lymphoma; head and neck cancers; gastrointestinal cancers, including esophageal cancer, stomach cancer, colon cancer, intestinal cancer, colorectal cancer, rectal cancer, pancreatic cancer, liver cancer, cancer of the bile duct or gall bladder; malignancies of the female genital tract, including ovarian carcinoma, uterine endometrial cancers, vaginal cancer, and cervical cancer; bladder cancer; brain cancer, including neuroblastoma; sarcoma, osteosarcoma; and skin cancer, including malignant melanoma or squamous cell cancer.