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Moore K.N.,University of Oklahoma | Tian C.,Gynecologic Oncology Group Statistical Center | McMeekin D.S.,University of Oklahoma | Thigpen J.T.,University of Mississippi Medical Center | And 2 more authors.
Cancer | Year: 2010

Background: This study evaluated whether progression-free interval (PFI) following primary chemotherapy (PCT) was predictive of overall survival (OS) after second-line chemotherapy in advanced/recurrent endometrial cancer (EC). Methods: This is a pooled analysis of patients who recurred after PCT and were treated with second-line chemotherapy on Gynecologic Oncology Group trials. PFI-1 measured from initiation of PCT to recurrence or treatment-free interval (TFI) measured from completion of PCT to initiation of second-line chemotherapy was evaluated in relation to clinical outcomes. Results: A total of 586 patients treated on 5 phase 3 PCT protocols were included. Baseline factors in primary setting associated with clinical outcome after PCT were also predictive of OS after second-line chemotherapy, including race, Gynecologic Oncology Group performance status, grade, and prior radiation therapy (P <.01). PFI-1 was the most significant factor predictive of survival after second-line chemotherapy, with a 30% reduction in the risk of death for PFI-1 >6 months compared with ≤6 months (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.59-0.84 [P <.0001]) and median OS after second-line chemotherapy of 10 versus 5 months. A total of 275 patients treated on 9 phase 2 second-line chemotherapy protocols were also evaluated, and TFI >3 months was associated with a 25% reduction in the risk of death (HR, 0.75; 95% CI, 0.57-0.97 [P =.030]) and median OS after second-line chemotherapy of 10 versus 7 months compared with TFI a;circ3 months. The tumor response to second-line chemotherapy was 9.6% versus 5.8%; the difference was not statistically significant. Conclusions: Time to recurrence after PCT is predictive of survival after recurrence in advanced/recurrent EC. However, there is no evidence that this variable can be used in selecting salvage chemotherapy. Cancer 2010. © 2010 American Cancer Society. Time to recurrence after primary chemotherapy is predictive of survival after recurrence in advanced endometrial cancer. However, there is no evidence that this variable provides significant prognostic information or can be used in selecting salvage chemotherapy. Copyright © 2010 American Cancer Society.


Dalton H.J.,University of Texas M. D. Anderson Cancer Center | Fiorica J.V.,First Physicians Group Gynecologic Oncology | Edwards R.P.,University of Pittsburgh | Benjamin I.,Arizona Cancer Center | And 9 more authors.
Anticancer Research | Year: 2014

Background/Aim: An in vitro chemoresponse assay may aid effective therapy selection in epithelial ovarian cancer (EOC). This study explores changes in chemoresponse between paired primary and recurrent EOC tumors. Patients and Methods: Results from metachronous tumors were examined in 242 patients. Changes in in vitro chemoresponse, measured by the area under the dose response curve (AUC) between paired tumors were assessed. Results: A significant increase in AUC was identified in most first-line therapies over time. No significant difference was observed in most recurrent therapies. When the elapsed time between occurrences was <17 months, no difference was observed for any recurrent therapies, and half of first-line therapies exhibited significant increases in AUC. When ≥17 months, all 7 therapies showed significant increases. Conclusion: These results suggest an increase in chemoresistance over time, which is more pronounced for first-line therapies. This is consistent with clinical observations and suggests the biologic concordance between assay results and response to chemotherapy.


PubMed | Arizona Cancer Center, Florida Atlantic University, Precision Therapeutics, Abington Memorial Hospital and 7 more.
Type: Journal Article | Journal: Anticancer research | Year: 2014

An in vitro chemoresponse assay may aid effective therapy selection in epithelial ovarian cancer (EOC). This study explores changes in chemoresponse between paired primary and recurrent EOC tumors.RESULTS from metachronous tumors were examined in 242 patients. Changes in in vitro chemoresponse, measured by the area under the dose response curve (AUC) between paired tumors were assessed.A significant increase in AUC was identified in most first-line therapies over time. No significant difference was observed in most recurrent therapies. When the elapsed time between occurrences was <17 months, no difference was observed for any recurrent therapies, and half of first-line therapies exhibited significant increases in AUC. When 17 months, all 7 therapies showed significant increases.These results suggest an increase in chemoresistance over time, which is more pronounced for first-line therapies. This is consistent with clinical observations and suggests the biologic concordance between assay results and response to chemotherapy.


News Article | November 29, 2016
Site: www.marketwired.com

VANCOUVER, BC--(Marketwired - November 28, 2016) - Med BioGene Inc. ("MBI") (TSX VENTURE: MBI) today wishes to announce the next phase in its corporate history. After extensive good-faith negotiations, MBI and Helomics Corporation (formerly known as Precision Therapeutics, Inc. or PTI) ("Helomics") have agreed to restructure their relationship. Effective immediately, the two companies have signed a Settlement Agreement which terminates the original licensing agreement put in place in 2011 by prior MBI management and relieves MBI of all the encumbrances associated with this agreement. These included, but were not limited to: Going forward, MBI is free to seek new licensing partners for not only the original MBI intellectual property but also the product enhancements made by PTI and, subsequently, Helomics. These included eliminating the need to use frozen tissue samples in favour of a liquid reagent transfer agent. In addition, MBI and its future licensees have the option to make use of the enhanced Helomics laboratory procedures for the actual processing of patient tissue specimens. Helomics has agreed to provide a license to MBI for the GeneFX Lung® product, covering all improvements made to the original MBI intellectual property by both PTI and Helomics during the term of the original licensing agreement. This represents an unrestricted grant of the work product resulting from two years of effort by PTI/Helomics to qualify and position MBI's intellectual property into a commercially-viable product, GeneFX Lung®. Furthermore, Helomics has agreed to forgive any and all indebtedness and royalty setoffs which would otherwise impact Med BioGene's ability to offer an unencumbered product proposition to new licensees. This has a cash value to MBI of US$1.15M which would otherwise have been deducted from royalty streams due to MBI. Helomics has agreed to very favorable royalty terms for its components of the evolved GeneFX Lung® product, and will provide a cash payment to MBI as part of the restructuring. Lastly, Helomics has agreed, in detailed terms, to support MBI's efforts to secure new licensees between now and the end of April 2017. These support services will be provided without any additional expense to MBI unless the work performed by Helomics exceeds specified hourly thresholds. All of these benefits to MBI are included in the terms and conditions of the final Settlement Agreement which terminates the original relationship between MBI and Helomics. MBI is immediately beginning the process of pursuing new licensing relationships for the GeneFX Lung® product. Taken as a whole, MBI management believes this new agreement is in the long term interests of the company and welcome the opportunity to continue working with Helomics personnel under this revised arrangement. As it previously announced, Helomics has initiated a corporate realignment that will shift the focus of its clinical products business while expanding into the clinical research market. This arrangement makes best use of their experience and expertise while freeing MBI to expediently seek a new sales and marketing partner with the capabilities and commercial plan it believes will be best suited to leverage the inherent value of GeneFX Lung®. MBI is a life science company based in Vancouver, British Columbia that is currently focused on managing the license and rights to GeneFX® Lung, a prognostic genomic based test procedure. MBI's common shares are listed for trading on the Exchange. For more information, please visit www.medbiogene.com This news release contains forward-looking statements and forward-looking information (together, "forward-looking statements") within the meaning of applicable Canadian and United States legislation. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements include those risks set out in the Company's public documents filed on SEDAR at www.sedar.com. Although the Company believes that the assumptions and factors used in preparing the forward-looking statements are reasonable, undue reliance should not be placed on these statements, which only apply as of the date of this news release, and no assurance can be given that such events will occur in the disclosed times frames or at all. Except where required by law, the Company disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. The TSX Venture Exchange has neither approved nor disapproved of the contents of this press release. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release


News Article | November 24, 2016
Site: www.newsmaker.com.au

According to Stratistics MRC, the Global Cancer/Tumor Profiling market is expected to grow from $23.04 billion in 2015 to reach $78.69 billion by 2022 with a CAGR of 19.2%. Increasing cases of cancer and the need for therapy are the major factors influencing the market growth. Moreover, high investments in R&D, technological developments, and demand for safer medicines are the factors fostering the market growth. However, low awareness among clinicians about options and potential of cancer profiling are the major challenges for this market. By application, personalized medicines segment leads the market globally with the biggest market share and is expected to grow with a high CAGR during the forecast period.  The growth is attributed by unique characteristics of this segment in examining and prognosis of cancer disease. North America commands the market due to the presence of leading cancer profiling industry leaders. Asia Pacific is expected to witness huge growth due to raising incidence of cancer in this region. Some of the key players in global Cancer/Tumor profiling market include Agendia Nv, Biotheranostics, Boreal Genomics, Inc., Caris Life Sciences, Genomic Health, Inc., Illumina, Inc., Life Technologies Corporation, Nanostring Technologies, Neogenomics Laboratories, Oncopath Laboratory, Oxford Gene Technology Ltd, Precision Therapeutics, Inc., Proteome Sciences Plc, Rational Therapeutics, and Ribomed Biotechnologies. Applications Covered: • Biomarker Discovery • Diagnostics • Personalized Medicine • Prognosis • Research Applications Technologies Covered: • Fluorescence/Chromogenic In Situ Hybridization • Immunohistochemistry • Microarray • Next-Generation Sequencing • Quantitative PCR Regions Covered: • North America o US o Canada o Mexico • Europe o Germany o France o Italy o UK  o Spain      o Rest of Europe  • Asia Pacific o Japan o China o India o Australia o New Zealand o Rest of Asia Pacific • Rest of the World o Middle East o Brazil o Argentina o South Africa o Egypt What our report offers: - Market share assessments for the regional and country level segments - Market share analysis of the top industry players - Strategic recommendations for the new entrants - Market forecasts for a minimum of 7 years of all the mentioned segments, sub segments and the regional markets - Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations) - Strategic recommendations in key business segments based on the market estimations - Competitive landscaping mapping the key common trends - Company profiling with detailed strategies, financials, and recent developments - Supply chain trends mapping the latest technological advancements


News Article | December 1, 2016
Site: www.newsmaker.com.au

The increasing prevalence of various types of cancer and the growth of the aging population are the major factors driving the growth of the noninvasive cancer diagnostic and technologies market. Noninvasive cancer diagnosis technologies are used to identify breast, lung, blood, and other cancers. Noninvasive diagnostics is a process for the detection of disease through minimal incisions into the body. Noninvasive cancer diagnostic technologies provide fast and convenient procedures for noninvasive early detection of cancer and provide a valuable aid to the clinician and increased comfort to the patient. These technologies reduce the mortality rate by providing treatment in the early stage of the disease. The global noninvasive cancer diagnostics and technologies market is categorized based on types of cancer, techniques, and end users. Based on types of cancer, the report covers solid tumors, blood cancer, lung cancer, breast cancer, and others. Based on techniques, the market comprises immunochemistry/immunoassay, molecular diagnostics, clinical chemistry, and others. Based on end users the market covers medical device manufacturing companies, hospitals, clinics, oncology labs, government and private research institutes, academic institutes, and pharmaceutical companies. North America has the largest market for noninvasive cancer diagnostic and technologies, followed by Europe. This is due to the increasing prevalence of cancer, growth of research in oncology, rising demand for noninvasive cancer diagnostic technologies, mounting awareness among people about various forms of cancer and their treatment, and an improved healthcare infrastructure in the region. The noninvasive cancer diagnostics and technologies market in Asia is also expected to experience a high rate of growth in the next few years. This is due to the evolution of research and development activities on cancer, increasing government support in the form of funding, growing awareness about various noninvasive diagnostic technologies, and improving healthcare infrastructure in the region. In addition, growing populations and economies in developing countries, such as India and China are expected to impact growth in the noninvasive cancer diagnostics and technologies market in Asia. Technological advancement in cancer detection technologies, the increasing prevalence of cancer, a growing aging population, rising obesity, escalating demand for noninvasive cancer diagnostic technologies, rising awareness among people toward cancer and its treatment, and growing research and development activities in cancer diagnostic and treatment technologies are the key drivers for the global noninvasive cancer diagnostics and technologies market. However, high cost of diagnostic procedures and stringent regulatory requirements obstruct the growth of the global noninvasive cancer diagnostics and technologies market. Increasing numbers of mergers and acquisitions, rapid product launches, and a rise in number of collaborations and partnerships are some of the latest trends that have been observed in the global noninvasive cancer diagnostics and technologies market. Some of the major companies operating in the global noninvasive cancer diagnostics and technologies market are Precision Therapeutics, Affymetrix Inc., Gen-Probe Incorporated, AVIVA Biosciences Corporation, A&G Pharmaceutical, BIOVIEW Inc., Quest Diagnostics Incorporated, Digene Corporation, and Laboratory Corporation of America Holdings. Key geographies evaluated in this report are:


Plamadeala V.,Precision Therapeutics | Huang S.,Precision Therapeutics | McCreary S.M.,Precision Therapeutics | Reitze N.J.,Precision Therapeutics | And 6 more authors.
Applied Immunohistochemistry and Molecular Morphology | Year: 2014

A formalin-fixed paraffin-embedded tissue-based prognostic assay to assess the risk for recurrence in stage II colon cancer has recently been clinically validated. This study describes the analytical performance and quality control measures of the assay. The reportable range was determined to be [-1.129, 1.414] in risk score units. The accuracy was evaluated with a split sample comparison within the production lab and between the production lab and a reference lab. The concordance between the replicates within the production lab was 79% (95% confidence interval, 64%-91%). There was no evidence of bias, and the concordance was 78% (95% confidence interval, 61%-90%) between the labs. The lab-to-lab concordance was further evaluated by simulating risk scores from the full reportable range. The simulation suggested a higher concordance. The sensitivity study demonstrated that the percentage of tumor tissue did not impact the risk score and that RNA concentration of 9.5 ng/μL was a conservative determination of the analyte lower limit of quantification. From the precision study, the repeatability and reproducibility estimates were 0.1267 and 0.0548 in risk score units, respectively. Furthermore, multifaceted quality control measures were implemented, such as proper tissue processing steps, high-risk and low-risk controls, nontemplate control, and a gene expression-based classifier to evaluate the cDNA amplification kit, a key reagent in the assay. In conclusion, this study demonstrates the strong analytical performance of the assay and further supports its use as an objective standardized prognostic test for stage II colon cancer. © 2013 by Lippincott Williams and Wilkins.


Suchy S.L.,Precision Therapeutics | Landreneau R.J.,University of Pittsburgh | Schuchert M.J.,University of Pittsburgh | Wang D.,Precision Therapeutics | And 2 more authors.
Cancer Biology and Therapy | Year: 2013

Purpose: Pemetrexed is the only FDA approved treatment for mesothelioma and is a second line agent for treatment of non-small cell lung carcinoma (NSCLC). Pemetrexed is inhibited by folate and its analogs, which are components of many culture media, making it challenging to study pemetrexed in vitro. In order to accurately evaluate pemetrexed's effects in vitro, the protocol for a standard chemosensitivity assay, the ChemoFx drug response marker, had to be modified. Experimental Design: Novel rinse and media change steps were assessed and then added to the assay protocol in order to observe pemetrexed activity. The intraday and interday stability of pemetrexed were also established under the adapted protocol. Then, the modified protocol was used to examine pemetrexed in 65 ex vivo lung cancer specimens. Results: Substituting 5% RPMI + EGF for BEGM allowed pemetrexed to exert its anticancer activity in the ChemoFx DRM. ChemoFx classified 6.2% of the lung specimens as responsive, 9.2% as intermediate responsive and 84.6% as non-responsive to pemetrexed. Conclusions: Adapting the ChemoFx protocol allowed for the accurate evaluation of pemetrexed anticancer activity in ex vivo lung specimens. ChemoFx evaluation may provide an indication of a patient's clinical response to the drug prior to pemetrexed treatment. Having this information when treatment options are being considered could avoid wasted time, unnecessary costs and needless side effects that are the result of an inappropriate chemotherapy regimen. © 2013 Landes Bioscience.


Grendys Jr. E.C.,Florida Gynecologic Oncology and Regional Cancer Center | Fiorica J.V.,First Physicians Group Gyn Onc | Orr Jr. J.W.,Florida Gynecologic Oncology and Regional Cancer Center | Holloway R.,Florida Hospital Cancer Institute | And 4 more authors.
Clinical and Translational Oncology | Year: 2014

The objective of this review is to summarize recent scientific and medical literature regarding chemoresponse assays or chemotherapy sensitivity and resistance assays (CSRAs), specifically as applied to epithelial ovarian cancer. A total of sixty-seven articles, identified through PubMed using the key words "in vitro chemoresponse assay," "chemo sensitivity resistance assay," "ATP," "HDRA," "EDR," "MiCK," and "ChemoFx," were reviewed. Recent publications on marker validation, including relevant clinical trial designs, were also included. Recent CSRA research and clinical studies are outlined in this review. Published findings demonstrate benefits regarding patient outcome with respect to recent CSRAs. Specifically, analytical and clinical validations, as well as clinical utility and economic benefit, of the most common clinically used CSRA in the United States support its use to aid in making effective, individualized clinical treatment selections for patients with ovarian cancer. © 2014 The Author(s).


PubMed | Precision Therapeutics
Type: Journal Article | Journal: Cancer biology & therapy | Year: 2013

Pemetrexed is the only FDA approved treatment for mesothelioma and is a second line agent for treatment of non-small cell lung carcinoma (NSCLC). Pemetrexed is inhibited by folate and its analogs, which are components of many culture media, making it challenging to study pemetrexed in vitro. In order to accurately evaluate pemetrexeds effects in vitro, the protocol for a standard chemosensitivity assay, the ChemoFx drug response marker, had to be modified.Novel rinse and media change steps were assessed and then added to the assay protocol in order to observe pemetrexed activity. The intraday and interday stability of pemetrexed were also established under the adapted protocol. Then, the modified protocol was used to examine pemetrexed in 65 ex vivo lung cancer specimens.Substituting 5% RPMI + EGF for BEGM allowed pemetrexed to exert its anticancer activity in the ChemoFx DRM. ChemoFx classified 6.2% of the lung specimens as responsive, 9.2% as intermediate responsive and 84.6% as non-responsive to pemetrexed.Adapting the ChemoFx protocol allowed for the accurate evaluation of pemetrexed anticancer activity in ex vivo lung specimens. ChemoFx evaluation may provide an indication of a patients clinical response to the drug prior to pemetrexed treatment. Having this information when treatment options are being considered could avoid wasted time, unnecessary costs and needless side effects that are the result of an inappropriate chemotherapy regimen.

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