e17521 Background: Lung cancer accounts for the largest percentage of cancer in adults in North America. Non-small cell lung cancer (NSCLC) accounts for 85-90% of all lung cancers with a death rate of 85%. Early diagnosis is the only chance of a cure when surgery or chemo-radiotherapy can be performed. Chest X-ray is the routine first diagnostic step but is not confirmatory. The purpose of this study was to further validate DR-70 utility in lung cancer early detection considering the relatively high sensitivity of this test. Onko-Sure is a regulatory approved blood test for detection/monitoring of lung cancer treatment/recurrence. It measures the accumulation of fibrin/fibrinogen degradation products in the serum using anti-DR-70 antibody. Methods: A total of 239 serum samples were retrospectively obtained from a serum bank and were tested with DR-70. There were two arms: healthy controls (n= 120) and biopsy-confirmed lung cancers (n= 119) including: small cell lung cancer (SCLC) (n=7) and NSCLC (n=112). The NSCLC included adenocarcinoma (n=65), squamous carcinoma (n=37), large cell lung cancer (n=4) and others (n=6). The data were analyzed to find the optimal cut point, sensitivity and specificity of DR-70. Results: The sensitivity and specificity of 63% and 87.5% were achieved, respectively (cut-point of 1.2 ug/ml). For SCLC, the sensitivity and specificity of 57.1% and 82.5% were achieved (cut-point: 1.1 ug/ml). For NSCLC, the sensitivity and specificity of 65.2% and 87.5% were achieved (cut-point: 1.2 ug/ml). Among the subcategories of NSCLC, DR-70 showed the highest sensitivity for acinar cell carcinoma (81.8%). Furthermore, DR-70 showed sensitivity of 59.5%, 70.4, 66.7 and 70% for stages I, II, III, and IV. Conclusions: Chest X-Ray is the routine first step in lung cancer detection with the sensitivity of 78.3%. It is not confirmatory and it can miss lesions smaller than 1 cm. These findings are promising and highlight DR-70 test as an additional first line diagnostic tool that can potentially replace X-ray to increase the diagnosis sensitivity as early as stage I. An enhanced ability to diagnose NSCLC in an early stage (I/II) should significantly improve prognosis, treatment options and survival rate for patients with lung cancer.

2012-02-01·Journal of Clinical Oncology

A new strategy for the early detection of colorectal cancer recurrence.

作者: Motamed-Khorasani, Afsaneh ; Etemadi, Hooman ; Small-Howard, Andrea Lee

416 Background: Several biological markers have been tested for colorectal cancer (CRC) including CEA; however, they are of limited use for recurrence diagnosis due to low sensitivity. Almost 50% of CRC cases experience recurrence and more than 50% of them have low values not detectable by CEA. Therefore, an effective marker for detection of recurrence will vastly increase the quality of life and survival rate. Onko-Sure is an FDA-cleared blood test that is used for the monitoring of treatment/recurrence of CRC. This ELISA assay measures the accumulation of Fibrin/Fibrinogen Degradation products in the serum using an antibody against the DR-70. The goal of this study was to determine whether the combined usage of DR-70 and CEA will improve the sensitivity for detecting recurrences. Methods: A total of 75 serum samples were retrospectively recruited through a serum bank in two arms including the confirmed healthy control (n=39) and biopsy-confirmed recurrent CRC (n=36) groups. For each patient, the serum sample was tested for DR-70 and CEA concentrations. Results: The results showed sensitivity of 75% and specificity of 58.97% for DR-70 and CEA combined. The cut points were calculated as 1.3ug/ml for DR-70, and 3 or 5ng/ml for CEA for non-smokers and smokers; respectively. For the combined analysis, if either CEA or DR-70 was positive, the test was considered positive and if both tests were negative, the result was considered negative. The sensitivity for the combined test was much better than that of each of the markers alone (35% higher than that of CEA). Conclusions: The combined usage of DR-70 and CEA in monitoring of CRC recurrence showed a significant clinical advantage in terms of sensitivity over each marker alone. Improvement in detection of recurrence has important implications to patient treatment options and prognosis. Should an IVD increase early detection of CRC recurrence when used adjunctively with other available diagnostic markers, the annual deaths due to CRC recurrence could be reduced due to the increase in early detection and the survival rate of those early detections.

2012-02-01·Journal of Clinical Oncology

A novel, cost-effective strategy for the screening of colorectal cancer with higher patient compliance.

作者: Motamed-Khorasani, Afsaneh ; Small-Howard, Andrea Lee

407 Background: Routine screening methods for colorectal cancer (CRC) have poor patient compliance and low sensitivity for early stages. The sensitivity rates are 19, 71, 76, and 83% for Fecal Occult Blood test (FOBT), stool DNA test, colonoscopy/sigmoidoscopy, and double-contrast barium enema; respectively. Biological markers have also been tested including CEA (sensitivity of 38.7%); however, its utility in CRC screening is limited due to low sensitivity. Onko-Sure is an FDA-cleared blood test for monitoring of CRC treatment/recurrence. It measures the accumulation of Fibrin/Fibrinogen Degradation products in the serum using anti-DR-70antibody. The objective was to determine whether DR-70 and CEA combination can improve the sensitivity such that it can be used as a cost-effective alternative to current screening methods yet with a higher patient compliance. Methods: A total of 564 serum samples were retrospectively obtained from a serum bank in two arms: confirmed healthy control (n=298) and biopsy-confirmed CRC (n=266) groups. The samples were tested for DR-70 and CEA. Results: The results showed sensitivity of 58.2% and specificity of 59.83% for DR-70 and CEA combined. The sensitivity for the combined test was 55.5% higher than that of CEA alone. A consistent improvement of sensitivity for the combined usage relative to CEA alone was observed with an increase of 73%, 108%, 58% and 18% in CRC stage I, II, III and IV; respectively. The sensitivity of the combined test was 48%, 47%, 57% and 98% for stages I, II, III and IV. Conclusions: Combining DR-70 and CEA tests showed a significant clinical advantage in CRC screening over using each marker alone. The sensitivity improvement was highest for stages I/II, which has important implications in patient treatment options, prognosis and survival rate due to this early detection. With a 3 times higher sensitivity for early stage CRC compared to using FOBT, this approach should improve the CRC early stage diagnosis. Such early stage detection is less likely using routine approaches for CRC screening because of low sensitivity and low patient compliance.

项与 Radient Pharmaceuticals Corp. 相关的新闻（医药）

2011-08-12

·BioSpace

Radient Pharmaceuticals' Onko-Sure(R) Cancer Test Available Through NeoloMed BioSciences

TUSTIN, CA--(Marketwire - August 11, 2011) - Radient Pharmaceuticals Corporation "the Company" or "Radient" (OTCQX: RXPC) (PINKSHEETS: RXPC), a developer and marketer of In Vitro Diagnostic (IVD) cancer tests, today announced it has signed a lab partner agreement with New Jersey-based diagnostics laboratory, NeoloMed BioSciences Inc. Onko-Sure® is a non-invasive cancer blood test which has received FDA clearance for colorectal cancer monitoring during treatment and for post-treatment recurrence monitoring. Onko-Sure® has also received regulatory approval outside of the US as a general cancer tumor marker, as well as for lung cancer detection, treatment and recurrence monitoring. Within the next two weeks, NeoloMed BioSciences will begin offering Radient's Onko-Sure® cancer test to its networks of physicians' offices and hospitals in its region including New Jersey, Connecticut, Delaware, Pennsylvania, Washington, D.C., Virginia, and Maryland. NeoloMed BioSciences is a CLIA certified and CAP accredited, consultative clinical testing laboratory. The lab's services range from routine patient testing with a focus on oncology-related indications, to more specialized testing. NeoloMed BioSicences' customers include physicians and their patients, hospitals and managed care plans, pharmaceutical and biotechnology companies, and contract clinical research organizations. NeoloMed BioSciences has been offering flow cytometry, karyotype, and FISH analysis oncology tests. Onko-Sure® is the first cancer blood test that NeoloMed will integrate into its oncology diagnostics offerings. NeoloMed's CEO, Dr. Faribouz Payvandi, commented, "We have been looking to expand our menu of oncology diagnostics that provide valuable information for doctors and their patients. Onko-Sure® is the first blood test we've chosen to offer. Backed by compelling published clinical data and FDA clearance, we believe it will provide a very beneficial new diagnostic tool for doctors tracking disease treatment and recurrence for their colorectal cancer patients." "Our goal is to significantly expand the availability of Onko-Sure® throughout the US and to work with regional and national diagnostics labs in doing so. We are pleased to work with NeoloMed BioSciences, which is focused in oncology diagnostics and serves a region in which we seek greater market penetration," stated Radient Chairman and CEO, Mr. Douglas MacLellan. For more information regarding NeoloMed BioSciences, please visit . For additional information on Radient Pharmaceuticals Corporation and its products visit: or e-mail info@radient-pharma.com. For Investor Relations contact Dilek Mir at: ir@radient-pharma.com or 714-881-0244. The following table is intended to provide the latest information on Radient's business metrics. ---------------------------------------------------------------------------- RPC's Business Metrics ---------------------------------------------------------------------------- Cash on hand: $940,000* *Approximate amount as of August 10,2011 ---------------------------------------------------------------------------- Shares Outstanding: 198 million* *Approximate number as of August 10, 2011 and there are 200 million shares fully authorized. ---------------------------------------------------------------------------- Outstanding Warrants & Options: 111 million* *Approximate number as of August 10, 2011 ---------------------------------------------------------------------------- About Radient Pharmaceuticals: Headquartered in Tustin, California, Radient Pharmaceuticals Corporation is dedicated to saving lives and money for patients and global healthcare systems through the deployment of its FDA-cleared In Vitro Diagnostic Onko-Sure® cancer test kit for colorectal cancer treatment and recurrence monitoring. The Company's focus is on the discovery, development and commercialization of unique high-value diagnostic tests that will help physicians answer important clinical questions related to early disease state detection, treatment strategy, and the monitoring of disease progression or recurrence. To learn more about our company, products, and potentially life-saving cancer test, visit . Forward-Looking Statements: Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The statements contained in this document include certain predictions and projections that may be considered forward-looking statements under securities law. These statements involve a number of important risks and uncertainties that could cause actual results to differ materially including, but not limited to, the performance of joint venture partners, as well as other economic, competitive and technological factors involving the Company's operations, markets, services, products, and prices. With respect to Radient Pharmaceuticals Corporation, except for the historical information contained herein, the matters discussed in this document are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. Digg this Bookmark with del.icio.us Add to Newsvine Technorati: in vitro diagnostics oncology cancer labs clinical reference labs CLIA colorectral cancer

合作

2011-07-13

·BioSpace

Radient Pharmaceuticals Issues Corporate Report

TUSTIN, CA--(Marketwire - July 13, 2011) - Radient Pharmaceuticals Corporation "the Company" or "Radient" (OTCQX: RXPC) (PINKSHEETS: RXPC), a developer and marketer of In Vitro Diagnostic (IVD) cancer tests, announced today it has issued a Corporate Report. This 12-page document provides an overview of Radient's business, its products, its markets, its strategy, and its finances. Investors or interested parties may view and download the report at the Company's website at: Corporate Report. Douglas MacLellan, Radient's CEO indicated this new Corporate Report highlights investment catalysts in 5 key areas of Radient's business. These catalysts include the Company's: Recent Focus on IVD Business Multiple Revenue Stream Opportunities Building Marketing & Distribution Channels for Approved Indications Plan To Introduce IVDs for New Indications in US In Conjunction with CLIA Certified Labs Intellectual Property Portfolio For additional information on Radient Pharmaceuticals Corporation and its products visit: or e-mail info@radient-pharma.com. For Investor Relations contact Dilek Mir at: ir@radient-pharma.com or 714-881-0244. The following table is intended to provide the latest information on Radient's business metrics. ---------------------------------------------------------------------------- RPC's Business Metrics ---------------------------------------------------------------------------- Cash on hand: $1.4 million* *Approximate amount as of July 11, 2011 ---------------------------------------------------------------------------- Shares Outstanding: 177 million* *Approximate number as of July 11, 2011 and there are 200 million shares fully authorized. ---------------------------------------------------------------------------- Outstanding Warrants & Options: 111.1 million* *Approximate number as of July 11, 2011 ---------------------------------------------------------------------------- About Radient Pharmaceuticals: Headquartered in Tustin, California, Radient Pharmaceuticals Corporation is dedicated to saving lives and money for patients and global healthcare systems through the deployment of its FDA-cleared In Vitro Diagnostic Onko-Sure® cancer test kit for colorectal cancer treatment and recurrence monitoring. The Company's focus is on the discovery, development and commercialization of unique high-value diagnostic tests that will help physicians answer important clinical questions related to early disease state detection, treatment strategy, and the monitoring of disease progression or recurrence. To learn more about our company, products, and potentially life-saving cancer test, visit . Forward-Looking Statements: Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The statements contained in this document include certain predictions and projections that may be considered forward-looking statements under securities law. These statements involve a number of important risks and uncertainties that could cause actual results to differ materially including, but not limited to, the performance of joint venture partners, as well as other economic, competitive and technological factors involving the Company's operations, markets, services, products, and prices. With respect to Radient Pharmaceuticals Corporation, except for the historical information contained herein, the matters discussed in this document are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. Digg this Bookmark with del.icio.us Add to Newsvine Technorati: in vitro diagnostics oncology cancer investors analyst report CLIA colorectal cancer

2010-08-11

·BioSpace

Radient Pharmaceuticals to Present Its Onko-Sure(R) In Vitro Diagnostic Cancer Test at Vietnam Medi-Pharm Expo 2010 August 18-21

TUSTIN, CA--(Marketwire - August 11, 2010) - Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC) announced today it will present its Onko-Sure in vitro diagnostic (IVD) cancer test to distribution partners at the annual Vietnam International Medical, Hospital and Pharmaceutical exhibition -- Vietnam Medi-Pharm Expo, held August 18-21 at the Tan Binh International Exhibition & Convention Center in Ho Chi Minh City, Vietnam. RPC will present at Booth 112 in Hall 3 of the exhibition and convention center. "The Vietnam Medi Pharm Expo in Ho Chi Minh City is the most prestigious specialized exhibition in Vietnam, with participation from hundreds of local and foreign organizations, groups and enterprises," commented Dr. Nguyen Quoc Trieu, Minister of Health for Vietnam. "The exhibition offers a premier venue for the medical circle to showcase their latest advancements, achievements, modern technologies, new medicines and healthcare and treatment services." Douglas MacLellan, Chairman and CEO of RPC, also commented saying, "We are committed to expanding commercialization efforts for Onko-Sure® in Asia and ASEAN partner countries healthcare markets. Vietnam is an important growth market for RPC and our goal is to leverage this event to increase product sales and distribution in Asia and other ASEAN member states this year." Target ASEAN states for RPC include Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam. The total population for ASEAN is approximately 580 million people or 8.7% of the world population. In 2009, this region's combined nominal gross domestic product (GDP) exceeded more than USD $1.5 trillion, and as a single country, ASEAN ranks as the 9th largest economy worldwide in terms of GDP. RPC's Onko-Sure IVD cancer test is a simple, non-invasive, patent-pending and regulatory-approved in vitro diagnostic (IVD) test used for the detection and monitoring of the treatment and/or recurrence of various types of cancer. The test enables physicians and healthcare professionals to effectively detect and/or monitor certain types of cancers by measuring the accumulation of Fibrin and Fibrinogen Degradation Products (FDP) in the blood. FDP levels rise dramatically with the progression of cancer. Onko-Sure® is cleared by the US FDA for the treatment and/or recurrence monitoring of colorectal cancer and by Health Canada for the detection, treatment and/or recurrence monitoring of lung cancer. For more information visit . RPC Contact Information: For additional information on Radient Pharmaceuticals, ADI and its portfolio of products visit the Company's corporate website at . For Investor Relations information contact Kristine Szarkowitz at IR@Radient-Pharma.com or 1.206.310.5323. About Radient Pharmaceuticals: Headquartered in Tustin, California, Radient Pharmaceuticals is dedicated to saving lives and money for patients and global healthcare systems through the deployment of its Onko-Sure® In Vitro Diagnostic cancer test. The company's focus is on the discovery, development and commercialization of unique high-value diagnostic tests that help physicians answer important clinical questions related to early disease detection; treatment strategy; and the monitoring of disease progression, prognosis, and diagnosis to ultimately improve patient outcomes. Radient Pharmaceutical's current Onko-Sure cancer test is used to guide decisions regarding patient treatment, which may include decisions to refer patients to specialists, perform additional testing, or assist in the selection of therapy. To learn more about our company, people and potentially life-saving cancer test, visit . Forward-Looking Statements: Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The statements contained in this document include certain predictions and projections that may be considered forward-looking statements under securities law. These statements involve a number of important risks and uncertainties that could cause actual results to differ materially including, but not limited to, the performance of joint venture partners, as well as other economic, competitive and technological factors involving the Company's operations, markets, services, products, and prices. With respect to Radient Pharmaceuticals Corporation, except for the historical information contained herein, the matters discussed in this document are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. Radient Pharma Contact: Kristine Szarkowitz Director-Investor Relations Email Contact (Tel: ) 206.310.5323 Digg this Bookmark with del.icio.us Add to Newsvine Technorati: pharmaceuticals in vitro diagnostics oncology cancer anti-aging skin care investors

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