Radient Pharmaceuticals Corporation, a pharmaceutical company, engages in the research, development, manufacture, and marketing of diagnostic and skin care products. It offers ONKO-SURE, a proprietary in-vitro diagnostic cancer test, which is used for the detection and/or monitoring of lung, breast, stomach, liver, colon, rectal, ovarian, esophageal, cervical, trophoblastic, thyroid, malignant lymphoma, and pancreatic cancers. The company also has interests in the Combined Immunogene Therapy, a cancer vaccine therapy technology, which is used to build the body’s immune system and destroy cancer cells. In addition, it provides Elleuxe brand of anti-aging skin care products, including hydrating firming cream, renergie hydrating cleanser, intense hydrating cleanser, visable renewing hydrating softener, and smoothing renewing eye moisturizer. The company sells its products through distributors to hospitals, clinical laboratories, clinics, and other health care organizations primarily in the United States, Canada, Chile, Europe, India, Korea, Taiwan, and Vietnam. It has a collaborative agreement with the Mayo Clinic. The company was formerly known as AMDL, Inc. and changed its name to Radient Pharmaceuticals Corporation in September 2009 to reflect its new corporate direction and branding statements. Radient Pharmaceuticals Corporation was founded in 1988 and is headquartered in Tustin, California. RXPC - Investors Social Network
Colorectal Cancer
Colorectal cancer, commonly known as bowel cancer, is a cancer caused by uncontrolled cell growth (neoplasia), in the colon, rectum, or vermiform appendix.[citation needed] Colorectal Cancer is clinically distinct from anal cancer, which affects the anus.
Colorectal cancers start in the lining of the bowel. If left untreated, it can grow into the muscle layers underneath, and then through the bowel wall. Most begin as a small growth on the bowel wall: a colorectal polyp or adenoma. These mushroom-shaped growths are usually benign, but some develop into cancer over time. Localized bowel cancer is usually diagnosed through colonoscopy.
Invasive cancers that are confined within the wall of the colon (TNM stages I and II) are often curable with surgery, For example, in England over 90% of patients diagnosed at this stage will survive the disease beyond 5 years. However, if left untreated, the cancer can spread to regional lymph nodes (stage III). In England, around 48% of patients diagnosed at this stage survive the disease beyond five years. Cancer that has spread widely around the body (stage IV) is usually not curable; approximately 7% of patients in England diagnosed at this stage survive beyond five years.
Colorectal Cancer is the third most commonly diagnosed cancer in the world, but it is more common in developed countries. Around 60% of cases were diagnosed in the developed world. GLOBOCAN estimated that, in 2008, 1.24 million new cases of colorectal cancer were clinically diagnosed, and that this type of cancer killed 610,000 people. (Taken From Wikipedia Colorectal Cancer )
Onko-Sure® Overview
How Onko-Sure® Works: While the production of Fibrin and Fibrinogen Degradation Products (FDP) is restricted in healthy individuals, FDP are over produced by cancer cells, which release proteolytic enzymes such as plasmin and thrombin. Current assays for FDP usually measure a specific FDP component, such as D-dimer, as a representative of this group; whereas the Onko-Sure® test detects the full complement of FDP. Onko-Sure® acts as a “barometer for cancer” by simultaneously measuring the multiple FDP species that may be underestimated by other tests.
Assay Description: Standard sandwich-type Enzyme-Linked ImmunoSorbent Assay (ELISA). Antigen is captured from human serum samples by an affinity-purified rabbit anti-DR-70® (FDP) antibody that is immobilized in the wells of a standard 96-well assay plate. After appropriate washing, the antigen captured from the serum sample is complexed by a peroxidase-labeled detection antibody to form an immuno-sandwich. The bound enzyme conjugate is quantitatively measured with TMB substrate. Immediately after stopping the enzymatic reaction, the absorbance of the solution is read at 450 nm.
Lung Cancer
Lung cancer is the leading cause of death due to cancer in Canada and on average, 450 Canadians are diagnosed with lung cancer every week.1 It is expected that One in 11 men and one in 16 women will develop lung cancer during his/her lifetime, and one in 13 men and one in 18 women will die from it.1
Based on the SEER Cancer Statistics Review in the period of 1975-2007, the distribution of lung cancers based on histology included: non-small cell lung cancer (NSCLC) (85-90%), small-cell lung cancer (SCLC) (10-15%), sarcoma (0.2%), and other types of lung cancer including bronchial carnoids and cancer of supporting lung tissue (0.1%). Non-small cell lung cancers include: squamous and transitional cell lung carcinomas (19.8%), lung adenocarcinoma (37.5%), and large cell carcinomas (3.3%).
While trends indicate a slight decrease in the incidence of lung cancer in men, there has been an increase in the number of lung cancer cases in women. NSCLC is a common cancer with an approximately 85% death rate and the only chance of a cure for these patients is in the early stages that surgery or chemoradiotherapy can be performed. In general, most lung cancers are diagnosed in late stages, due in part to lack of effective screening procedures. For lung cancer, early detection and/or identification of recurrence with prompt treatment can lead to a better survival rate and quality of life for the patients.
Lung Cancer Diagnosis
Upon learning of a patient’s symptoms, a healthcare provider often formulates a list of possible diagnoses and questions the patient with regard to symptoms, medical and surgical history, smoking, work history, life style, overall health and medications. This is generally followed by a chest X-ray to determine the cause of the respiratory symptoms. In the majority of the patient, a magnetic resonance imaging (MRI) or computed tomography scan (CT scan) of the chest further defines the problem. However, none of these imaging techniques are confirmatory and the only way to confirm lung cancer is histological assessment of the cells or tissue taken by semi-invasive or invasive techniques. Sputum testing may be performed, where cells in the sputum can be examined to see if they are cancerous. Following treatment, patients often undergo regular check-ups, including physical exams, blood tests, chest X-rays, CT scans and bronchoscopy to evaluate the treatment’s efficacy and to monitor for potential lung cancer recurrence.
Imaging techniques can only monitor the macroscopic changes of the tumor mass and often the tumor size changes are detected only after several cycles of therapy.3-5 On the other hand, tumor markers can reflect the activity and metabolism of the cancer cells and can be evaluated as predictive factors either alone or in combination with other histopathological, biochemical and clinical variables.6
Tumor Markers for Lung Cancer
Several biological tumor markers have been tested for lung cancer including: Carcinoembryonic Antigen (CEA), Cytokeratin 19 Fragment Antigen 21-1 (CYFRA21-1), Neuron Specific Enolase (NSE) and Tumor Pyruvate Kinase (TU M2-PK). The blood tests available to determine the concentration of these markers have low sensitivity and are of limited use for lung cancer diagnosis.7 The use of TU M2-PK has been under investigation and has a potential for clinical oncopulmonology, however, because of its low specificity, further studies are needed for its use in NSCLC patients.7
DR-70 is the only other available tumor marker cleared by Health Canada for the detection and treatment and/or recurrence monitoring of lung cancer. Onko-Sure® is a simple, non-invasive, regulatory-approved in vitro diagnostic (IVD) blood test used for the detection of lung cancer and monitoring changes in the level of the marker in response to treatment. It was cleared by Health Canada in 1998. It is an ELISA-based assay that measures the accumulation of Fibrin/Fibrinogen Degradation Products (FDP) in the serum using a polyclonal antibody against the DR-70 tumor marker. The use of this tumor marker can result in possible increased effectiveness in the clinical evaluation of surgical resections in lung cancer patients and also in monitoring of recurrence of lung cancer during the 5-year window post-treatment in lung cancer survivors. In addition, the expected reduction in non-essential invasive diagnostics can lead to benefits for both the individual patient and the healthcare system. Onko-Sure Web Site
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