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SAN ANTONIO -- A sentinel lymph node biopsy (SLNB) during surgery that showed no signs of cancer was associated with a low risk for breast cancer recurrence in the axillary (armpit) lymph nodes for patients with large, operable breast tumors and no clinical signs of the cancer in the axillary lymph nodes prior to neoadjuvant (presurgery) chemotherapy, according to data from the GANEA 2 clinical trial presented at the 2016 San Antonio Breast Cancer Symposium, held Dec. 6-10. "Axillary lymph node dissection (ALND), which is an invasive surgical procedure in which many of the lymph nodes in the armpit are removed, is often performed to check whether a patient's cancer has spread outside the breast after neoadjuvant chemotherapy," said Jean-Marc Classe, MD, PhD, head of surgery at the Institut de Cancerologie de l'Ouest René Gauducheau in Nantes, France. "ALND has a high risk for serious complications and long-term sequelae. So we wanted to assess the feasibility and safety of the less invasive procedure of SLNB for patients treated with neoadjuvant chemotherapy for a large breast cancer. "We found that for patients with no proof of cancer in the axillary lymph nodes before neoadjuvant chemotherapy, SLNB during the surgery after neoadjuvant chemotherapy was safe because those who had a negative SNLB and did not have an ALND had a very low risk of an axillary relapse at three years after surgery," continued Classe, who is also professor of oncology at the Medical University in Nantes. "We had expected more axillary lymph node relapses than we observed, so this is very exciting and will hopefully mean that more patients are spared the potential complications of invasive ALND." Classe and colleagues enrolled in the trial 590 patients with large, operable breast tumors who had no cancer in the lymph nodes as determined by axillary sonography with fine needle cytology. All patients received neoadjuvant chemotherapy and then underwent surgery and SLNB. Cancer cells were detected in the SLNB samples from 139 patients. These patients all then underwent ALND. No cancer cells were detected in the SLNB samples from 432 patients. Among these 432 patients, follow-up was available for 416. Median follow-up for these patients was 35.8 months. At three years, disease-free survival in the patients who had no cancer in the SLNB sample and, therefore, did not receive ALND was 94.8 percent. One patient had homolateral axillary lymph node relapse. The other nine relapses were metastatic (n=3) or recurrences in the breasts (n=6). Overall survival was 98.7 percent. "The disease-free and overall survival results we observed for the patients who underwent only an SLNB after neoadjuvant chemotherapy are comparable with the historical survival rates for patients in this situation who have ALND rather than SLNB," said Classe. "Therefore, an ALND could be avoided by patients who have no signs of cancer in the axillary lymph nodes following a sonographic axillary assessment prior to neoadjuvant chemotherapy and SLNB during surgery after neoadjuvant chemotherapy." Classe noted that longer follow-up of the patients is needed to further confirm the safety of SLNB for these patients. This study was funded by a grant from the Institut National du Cancer. Classe declares no conflicts of interest. Title: Sentinel node detection after neoadjuvant chemotherapy in patient without previous axillary node involvement (GANEA 2 trial): follow-up of a prospective multi-institutional cohortPresentation: Wednesday, Dec. 7, General Session 2 - Hall 3, 4:45 p.m. CT To interview Jean-Marc Classe, contact Julia Gunther at julia.gunther@aacr.org or 267-250-5441. The mission of the 2016 San Antonio Breast Cancer Symposium is to produce a unique and comprehensive scientific meeting that encompasses the full spectrum of breast cancer research, facilitating the rapid translation of new knowledge into better care for patients with breast cancer. The Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center at San Antonio, the American Association for Cancer Research (AACR), and Baylor College of Medicine are joint sponsors of the San Antonio Breast Cancer Symposium. This collaboration utilizes the clinical strengths of the CTRC and Baylor and the AACR's scientific prestige in basic, translational, and clinical cancer research to expedite the delivery of the latest scientific advances to the clinic. For more information about the symposium, please visit http://www. .


REDWOOD CITY, Calif., Nov. 29, 2016 /PRNewswire/ -- Genomic Health, Inc. (NASDAQ: GHDX) today announced that it will present seven Oncotype DX® studies at the 39th CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), which is being held December 6-10, 2016. The study findings reinforce...


News Article | December 9, 2016
Site: www.eurekalert.org

SAN ANTONIO -- Breast cancer mortality rates continue to decline in many nations, but a review of mortality trends in 47 countries around the world indicates some significant disparities, particularly in South Korea and some Latin American nations, according to results presented at the 2016 San Antonio Breast Cancer Symposium, held Dec. 6-10. "Breast cancer is by far the primary cancer site in women and, worldwide, represents a quarter of all cancers in women," said the study's lead author, Cécile Pizot, MSc, at the International Prevention Research Institute in Lyon, France. "Comparing mortality trends between countries helps identify which health care systems have been the most efficient at reducing breast cancer mortality." In this study, Pizot and colleagues extracted information on breast cancer deaths from the World Health Organization database and calculated mortality rates over the years 1987-2013, stratifying results according to age groups. Overall, breast cancer mortality declined in 39 out of 47 countries, including the United States and most developed European nations. England and Wales had the sharpest drop in mortality, with a 46 percent decline. Pizot said this trend was to be expected, due to advances in detection and treatment over the past few decades. Latin American nations experienced scattered increases in mortality; for example, Brazil and Colombia saw mortality rates increase in women of all age groups, while in Argentina and Chile mortality rates decreased in all women. South Korea had the most dramatic increase in breast cancer mortality, with an 83 percent increase overall and higher mortality in every age group. However, the breast cancer mortality rate is still lower than the rate in the United States (5.3 per 100,000 women in South Korea compared with 14 per 100,000 women in the United States in the 2011-2013 period). "South Korea has experienced major societal changes since the 1950s and quickly evolved from an agricultural, developing country to a highly industrialized and Westernized country," Pizot said. "Such quick changes might explain the considerable shift in cancer mortality." Other highlights of the study: "This finding underlines the difficulty of isolating a single, common factor that would have a major influence on mortality trends," Pizot said, adding that future research on breast cancer mortality should focus on other facets of breast cancer management, including risk factors, drug therapies, access to care, and the use of multidisciplinary teams. "Differences in health care systems and patient management could explain discrepancies in mortality reduction between similar countries," Pizot said. "However, there is at present little data comparing the management of breast cancer patients across countries." Pizot said a limitation of the study is that data were unavailable for many Latin American, Asian, and African nations. This study was funded internally by the International Prevention Research Institute. Pizot has no conflicts of interest. Abstract Publication Number: P5-08-04 Title: Overview of breast cancer mortality trends in the world Presentation: Friday, Dec. 9, Poster Session 5, 5 p.m. CT The mission of the 2016 San Antonio Breast Cancer Symposium is to produce a unique and comprehensive scientific meeting that encompasses the full spectrum of breast cancer research, facilitating the rapid translation of new knowledge into better care for patients with breast cancer. The Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center at San Antonio, the American Association for Cancer Research (AACR), and Baylor College of Medicine are joint sponsors of the San Antonio Breast Cancer Symposium. This collaboration utilizes the clinical strengths of the CTRC and Baylor and the AACR's scientific prestige in basic, translational, and clinical cancer research to expedite the delivery of the latest scientific advances to the clinic. For more information about the symposium, please visit http://www. . To interview Cécile Pizot, contact Julia Gunther at julia.gunther@aacr.org or 267-250-5441.


Prosigna Provides the Most Prognostic Information of Four Genomic Tests in Head-to-Head Comparison of Early Breast Cancer Node-Negative Patients Over a 10-Year Period SEATTLE, Dec. 12, 2016 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today highlighted study findings relating to the prognostic value of the PAM50-based Prosigna® Breast Cancer Gene Signature Assay in treating breast cancer that were presented at the 2016 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS). Investigators retrospectively evaluated and compared the performance of four multigene expression profiles to predict the risk of Distant Recurrence (DR) in the same large dataset of more than 800 patients from the TransATAC study.  These signatures included Prosigna, Oncotype DX®, EndoPredict® and Breast Cancer IndexSM. For post-menopausal women with node-negative, hormone receptor-positive, HER2-negative early stage breast cancer, the study found that Prosigna provided the most accurate prognostic information of all four multigene expression profiles tested as measured by the statistical measure known as the likelihood ratio.  The study further found that Prosigna also provided the most accurate differentiation between low and high risk patients as compared to the other genomic tests.  Low-risk women as identified by Prosigna had a 3% risk of DR over 10 years, the lowest rates of DR for all genomic tests that were studied.  In contrast, high-risk women as identified by Prosigna had on average a 33% chance of distant recurrence by 10 years. These results support the conclusions of the 2016 evidence-based ASCO guidelines that multi-gene expression signatures provide clinical utility for selection of low risk patients who may be spared adjuvant chemotherapy based upon their outcomes when treated with hormone therapy alone.  Those guidelines gave a strong recommendation for Prosigna, equivalent to the recommendation given for Oncotype Dx and stronger than other tests evaluated by the guideline committee. Additional results from the study demonstrated the potential clinical utility of Prosigna for informing the duration of endocrine therapy by accurately assessing the risk of a patient’s cancer recurring between five and 10 years after diagnosis.  In node-negative patients, Prosigna provided the most prognostic information between 5 and 10 years after diagnosis as measured by the likelihood ratio.  Low-risk women as identified by Prosigna had a 1.4% risk between years 5 and 10, the lowest rates of DR for all genomic tests that were studied. “This important data demonstrates the ability of Prosigna to identify a low risk group of women for whom adjuvant chemotherapy following surgery and extended endocrine therapy in years 5-10 following diagnosis may be of limited benefit,” said Dr. Aleix Prat, MD, Ph.D., from Hospital Clinic in Barcelona, Spain, who was not an investigator on the study. “These results further validate the clinical utility of Prosigna as a superior second generation breast cancer assay that provides oncologists and patients the critical information they need to make informed decisions about their treatment options,” stated Brad Gray, president and chief executive officer of NanoString Technologies. Results of the TransATAC analysis were presented on Friday December 9th by Ivana Sestak Ph.D. in SABCS abstract S6-05, titled Comprehensive comparison of prognostic signatures for breast cancer in TransATAC.  Prosigna’s performance as part of the TransATAC study has been previously published in the Journal of Clinical Oncology (http://ascopubs.org/doi/abs/10.1200/jco.2012.46.1558) and the Journal of the National Cancer Institute (http://jnci.oxfordjournals.org/content/105/19/1504). About the Prosigna® Breast Cancer Prognostic Gene Signature Assay and nCounter® Dx Analysis System The Prosigna Assay provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna Assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score to assess a patient's risk of distant recurrence of disease. The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma. The Prosigna Assay requires minimal hands-on time and runs on NanoString's proprietary nCounter® Dx Analysis System, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision. The nCounter Dx Analysis System is a highly automated and easy-to-use platform that utilizes a novel digital barcoding chemistry to deliver high precision multiplexed assays. The system is available in the multi-mode FLEX configuration, which is designed to meet the needs of high-complexity clinical laboratories seeking a single platform with the flexibility to run the Prosigna Breast Cancer Assay and, when operated in the "Life Sciences" mode, process translational research experiments and multiplexed assays developed by the laboratory. In the United States, the Prosigna Assay is 510(k) cleared for use on the nCounter Dx Analysis System, and is available for diagnostic use when ordered by a physician. The Prosigna Assay has been CE-marked and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark, as well as Canada, Israel, Australia, New Zealand, Argentina, Thailand, South Africa, Turkey and Hong Kong. In the U.S., the Prosigna Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as: (1) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors or (2) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with four or more positive nodes. Other uses of Prosigna or the PAM50 panel in studies as described in this press release are for Investigational Use Only, or Research Use Only. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the clinical utility of the Prosigna Assay, including its ability to outperform certain other diagnostic tests. These forward-looking statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to: risks associated with keeping pace with rapidly changing technology and customer requirements; risks associated with competition in marketing and selling products; risks of increased regulatory requirements; risks associated with maintaining and expanding reimbursement coverage for Prosigna; risks related to the Company’s intellectual property portfolio, as well as the other risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. NanoString Technologies disclaims any obligation to update these forward-looking statements. About NanoString Technologies, Inc. NanoString Technologies provides life science tools for translational research and molecular diagnostic products. The company's nCounter Analysis System has been employed in life sciences research since it was first introduced in 2008 and has been cited in more than 1,350 peer-reviewed publications. The nCounter Analysis System offers a cost-effective way to easily profile the expression of hundreds of genes, proteins, miRNAs, or copy number variations, simultaneously with high sensitivity and precision, facilitating a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The company's technology is also being used in diagnostics. The Prosigna® Breast Cancer Prognostic Gene Signature Assay together with the nCounter Dx Analysis System is FDA 510(k) cleared for use as a prognostic indicator for distant recurrence of breast cancer. In addition, the company is collaborating with multiple biopharmaceutical companies in the development of companion diagnostic tests for various cancer therapies, helping to realize the promise of precision oncology. For more information, please visit www.nanostring.com. The NanoString Technologies logo, NanoString, NanoString Technologies, nCounter, and Prosigna are registered trademarks or trademarks of NanoString Technologies, Inc. in various jurisdictions. Oncotype Dx is a registered trademark of Genomic Health, Inc., EndoPredict is a registered trademark of Myriad Genetics, Inc. and Breast Cancer Index is a service mark of Biotheranostics, Inc.


SEATTLE, Dec. 05, 2016 (GLOBE NEWSWIRE) -- NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced advances in precision oncology using the Prosigna® Breast Cancer Gene Signature Assay and the PAM50 gene signature, the basis for Prosigna, will be presented at the 2016 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS). In addition, numerous customers will be presenting data generated using NanoString’s nCounter® Analysis System, including several involving immuno-oncology. "The volume and impact of the clinical research being presented at the SABCS underscores our commitment to improving the lives of breast cancer patients," said Brad Gray, president and chief executive officer of NanoString Technologies. “These studies demonstrate that our Prosigna Assay can improve decision-making in early-stage breast cancer today, and that a modified companion diagnostic version of this assay has future potential in triple negative breast cancer. The studies also show that our nCounter Analysis System is continuing to grow in prominence as an important tool among breast cancer researchers.” NanoString and its collaborators will present three oral presentations and fourteen posters covering Prosigna/PAM50 and other nCounter-based research at SABCS, which is being held December 6-10, 2016. Following are details for each presentation of data involving Prosigna and the PAM50 gene signature (all times are in Central Standard Time): Additional abstracts and posters demonstrate the diverse applications and robust performance of the nCounter® Analysis System in immuno-oncology and biomarker validation, including: You can learn more about the Prosigna Breast Cancer Gene Signature at booth #525. About the Prosigna® Breast Cancer Prognostic Gene Signature Assay and nCounter® Dx Analysis System The Prosigna Assay provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna Assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score to assess a patient's risk of distant recurrence of disease. The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor tissue previously diagnosed as invasive breast carcinoma. The Prosigna Assay requires minimal hands-on time and runs on NanoString's proprietary nCounter® Dx Analysis System, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision. The nCounter Dx Analysis System is a highly automated and easy-to-use platform that utilizes a novel digital barcoding chemistry to deliver high precision multiplexed assays. The system is available in the multi-mode FLEX configuration, which is designed to meet the needs of high-complexity clinical laboratories seeking a single platform with the flexibility to run the Prosigna Breast Cancer Assay and, when operated in the "Life Sciences" mode, process translational research experiments and multiplexed assays developed by the laboratory. In the United States, the Prosigna Assay is 510(k) cleared for use on the nCounter Dx Analysis System, and is available for diagnostic use when ordered by a physician. The Prosigna Assay has been CE-marked and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark, as well as Canada, Israel, Australia, New Zealand, Argentina, Thailand, South Africa, Turkey and Hong Kong. In the U.S., the Prosigna Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as: (1) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors or (2) a prognostic indicator for distant recurrence-free survival at 10 years in postmenopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with four or more positive nodes. Other uses of Prosigna or the PAM50 panel in studies as described in this press release are for Investigational Use Only, or Research Use Only. For more information, please visit www.prosigna.com. About NanoString Technologies, Inc. NanoString Technologies provides life science tools for translational research and molecular diagnostic products. The company's nCounter Analysis System has been employed in life sciences research since it was first introduced in 2008 and has been cited in more than 1,350 peer-reviewed publications. The nCounter Analysis System offers a cost-effective way to easily profile the expression of hundreds of genes, proteins, miRNAs, or copy number variations, simultaneously with high sensitivity and precision, facilitating a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The company's technology is also being used in diagnostics. The Prosigna® Breast Cancer Prognostic Gene Signature Assay together with the nCounter Dx Analysis System is FDA 510(k) cleared for use as a prognostic indicator for distant recurrence of breast cancer. In addition, the company is collaborating with multiple biopharmaceutical companies in the development of companion diagnostic tests for various cancer therapies, helping to realize the promise of precision oncology. For more information, please visit www.nanostring.com. The NanoString Technologies logo, NanoString, NanoString Technologies, nCounter, and Prosigna are registered trademarks or trademarks of NanoString Technologies, Inc. in various jurisdictions.


LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, announced that interim results from a Phase II clinical trial of Puma’s investigational drug PB272 (neratinib) were presented at the 2016 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) that is currently taking place in San Antonio, Texas. The presentation entitled, “Incidence and severity of diarrhea with neratinib plus intensive loperamide prophylaxis in patients with HER2-positive early-stage breast cancer (EBC): Interim analysis from the multicenter, open-label, phase II CONTROL trial” was presented as a poster presentation. The main adverse event that has been seen to date in clinical trials of neratinib is diarrhea and more specifically grade 3 diarrhea. In the Phase III ExteNET trial of neratinib as extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with adjuvant Herceptin, 95.4% of the patients experienced all grade diarrhea and 39.8% of the patients experienced grade 3 or higher diarrhea (there was one event of grade 4 diarrhea). The CONTROL trial is an international, open-label, phase II study investigating the use of loperamide prophylaxis with or without other agents in the prevention and reduction of neratinib-associated diarrhea and more specifically grade 3 diarrhea. In the trial, patients with HER2-positive early-stage breast cancer who had completed trastuzumab-based adjuvant therapy received neratinib daily for a period of one year. High dose loperamide prophylaxis was given for the first 2 cycles (56 days) of treatment. Initially, the loperamide dosing used was 16 mg on day 1, then 12 mg on days 2 and 3 and then 6-8 mg on days 4-56 (original dosing). The protocol was later amended to simplify the regimen such that patients took 12 mg on days 1-14 and 8 mg on days 15-56 (modified dosing). The CONTROL trial has recently been expanded to include prophylaxis with the combination of loperamide and budesonide, a locally acting corticosteroid that the Company believes targets the inflammation identified in a preclinical model of neratinib-induced diarrhea. The interim analysis of the trial presented in the poster included a total of 135 patients who received neratinib plus loperamide prophylaxis (28 patients taking the original dosing and 107 patients taking the modified dosing) and 40 patients who received neratinib plus loperamide prophylaxis for 2 cycles and budesonide for 1 cycle. The results of the trial showed that the incidence of grade 3 diarrhea for the total 135 patients who received the loperamide prophylaxis was 28.1%. For the 28 patients who received loperamide using the original dosing regimen the grade 3 diarrhea rate was 25.0% and for the 107 patients who received the modified loperamide dosing regimen the grade 3 diarrhea rate was 29.0%. For the patients in the original dosing group, 71% of the patients who experienced grade 3 diarrhea were known to be non-compliant with the loperamide regimen and for the patients in the modified loperamide dosing regimen, 35% of the patients were known to be non-compliant with their loperamide dosing regimen. For the 135 patients who received the loperamide prophylaxis, the median number of grade 3 diarrhea episodes per patient was 1 and the median cumulative duration of grade 3 diarrhea was 3 days. For the 135 patients who received loperamide prophylaxis, 18.5% discontinued neratinib due to diarrhea. For the 40 patients who received the combination of loperamide plus budesonide, the results of the trial showed that the incidence of grade 3 diarrhea was 15.0%. None of the patients who experienced grade 3 diarrhea were non-compliant with the loperamide plus budesonide regimen. The median number of grade 3 diarrhea episodes per patient was 1 and the median cumulative duration of grade 3 diarrhea was 2.5 days. For the 40 patients who received loperamide plus budesonide prophylaxis, 5.0% discontinued neratinib due to diarrhea. Further information is provided in Table 1 below: In the ExteNET trial, higher grade (grade 2 and grade 3) diarrhea occurred early and persisted throughout the duration of the 12-month treatment period. In the CONTROL trial, in both the loperamide prophylaxis and loperamide plus budesonide prophylaxis arms, the results showed that higher grade diarrhea (grade 2 and 3) occurred early but did not typically recur. This is shown in more detail in Figure 1: Treatment Emergent Diarrhea, which is attached to this news release. The grade 3 diarrhea rates seen in the loperamide cohort have increased over what was previously reported in December 2015 (n=50, grade 3 diarrhea rate 16%). During the course of the CONTROL trial there has been an increase in the proportion of patients previously treated with pertuzumab (mainly in the neoadjuvant setting). More specifically in the data reported in December 2015, 18% (9 of 50 patients) had previously received pertuzumab. In the current data set 40% (54 of 135 patients) of the patients in the combined loperamide prophylaxis arms received prior pertuzumab and 55% (22 of 40 patients) received prior pertuzumab in the budesonide arm. For the 54 patients in the loperamide prophylaxis cohort who received prior pertuzumab, the grade 3 diarrhea rate was 35.2% (Table 2). For the 81 patients who did not receive prior pertuzumab, the grade 3 diarrhea rate was 23.5%. For the 22 patients in the budesonide cohort who received prior pertuzumab, the grade 3 diarrhea rate was 13.6%. For the 18 patients in the budesonide cohort who did not receive prior pertuzumab, the grade 3 diarrhea rate was 16.7%. This analysis suggests that prior pertuzumab exposure may have led to a higher rate of grade 3 diarrhea in CONTROL that was not effectively managed by loperamide prophylaxis alone but was more effectively managed by loperamide plus budesonide. Dr. Carlos H. Barcenas, Assistant Professor, Department of Breast Oncology and Associate Medical Director, Breast Cancer Survivorship for the University of Texas MD Anderson Cancer Center, said, “We are pleased to see the reduction in incidence, severity and duration of neratinib-associated diarrhea when using the loperamide prophylaxis and the loperamide plus budesonide prophylaxis. When using either the loperamide prophylaxis or the loperamide plus budesonide prophylaxis there appears to be a reduction in the incidence and severity of grade 3 diarrhea with neratinib. Importantly, the severe grade 2 and grade 3 diarrhea, when using the prophylaxis, appears to be acute, self-limiting and manageable. We look forward to completing the loperamide plus budesonide cohort and to the testing of additional investigational agents as well.” Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, “We are pleased to see the reductions in the incidence of severe neratinib-related diarrhea in the CONTROL trial when using the loperamide and/or loperamide plus budesonide combination. We are further pleased to see the severe diarrhea become more acute, whereby it does not typically recur after the first month.” Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidates—PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2. Further information about Puma Biotechnology can be found at www.pumabiotechnology.com. This press release contains forward-looking statements, including statements regarding the development of the Company’s drug candidates. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing, the Company's dependence on PB272, which is still under development and may never receive regulatory approval, the challenges associated with conducting and enrolling clinical trials, the risk that the results of clinical trials may not support the Company's drug candidate claims, even if approved, the risk that physicians and patients may not accept or use the Company's products, the Company's reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates, the Company's dependence on licensed intellectual property, and the other risk factors disclosed in the periodic and current reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company's Annual Report on Form 10-K for the year ended December 31, 2015. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.


News Article | November 14, 2016
Site: www.marketwired.com

Conference Call to be Held Monday, November 14, 2016 at 5:30pm Eastern Time SEATTLE, WA--(Marketwired - Nov 14, 2016) - Atossa Genetics Inc. ( : ATOS) today announced Third Quarter ended September 30, 2016 financial results and provided an update on recent company developments. Dr. Steve Quay, President and CEO, commented, "We are pleased with our continuing achievements in the Third Quarter 2016, which enabled us to strengthen Atossa's foundation and further our drug development program goals. Our settlement with Besins Healthcare, and our recently completed capital raise provided Atossa with approximately $4 million in additional capital with which to advance our two exciting drug development programs." Dr. Quay added, "We continue to make progress on both of our drug development programs: Our Phase 2 clinical trial of intraductal fulvestrant is proceeding and I am pleased to report that the study has been accepted for presentation at the CTRC-AARC San Antonio Breast Cancer Symposium to be held December 6-10, 2016. We also made strong progress with our proprietary oral endoxifen, which we are developing for breast cancer patients who do not respond to tamoxifen. The initial drug supply for Phase 1 and Phase 2 studies is under development and we'll provide updates as we head towards the clinical studies." Total operating expenses were approximately $1.6 million and $5.4 million for the three months and nine months ended September 30, 2016, respectively, consisting of general and administrative (G&A) expenses of approximately $1.5 million and $5.0 million, respectively and R&D expenses of approximately $85,000 and $404,000 respectively. As a result of the sale of NRLBH, operating expenses related to the NRLBH are presented separately as discontinued operations for the three months and nine months ended September 30, 2015. Operating expenses from continuing operations for the three months and nine months ended September 30, 2016 decreased approximately $2.2 million and $4.9 million, or 57.9% and 47.6% respectively, from approximately $3.8 million and $10.3 million for the three months and nine months ended September 30, 2015, respectively, which consisted of G&A expenses of approximately $2.4 million and $7.2 million, respectively, R&D expenses of approximately $949,000 and $1.9 million, respectively, and selling expenses of approximately $499,000 and $1.2 million, respectively. The decrease in operating expenses is mainly attributed to the 2015 launch of new devices and services which are not being pursued in 2016 and investing more in new R&D programs in the first quarter of 2015 compared to 2016. Net loss for the nine months ended September 30, 2016 was $3.8 million and cash and cash equivalents were approximately $4.4 million. Management will host a business update conference call on Monday November 14, 2016 at 5:30 pm eastern time to review Third Quarter ended September 30, 2016 financial results and provide a company update. Following management's formal remarks, there will be a question and answer session. To listen to the call by phone, interested parties within the U.S. should call 1-844-824-3830 and International callers should call 1-412-317-5140. All callers should ask for the Atossa Genetics conference call. The conference call will also be available through a live webcast at www.atossagenetics.com. Details for the webcast may be found on the Company's IR events page at http://ir.atossagenetics.com/ir-calendar. A replay of the call will be available approximately one hour after the end of the call through December 14, 2016. The replay can be accessed via Atossa's website or by dialing 877-344-7529 (domestic) or 412-317-0088 (international) or Canada Toll Free at 855-669-9658. The replay conference ID number is 10096671. Atossa Genetics Inc, is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. For more information, please visit www.atossagenetics.com. Forward-looking statements in this press release, which Atossa undertakes no obligation to update, are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with actions and inactions by the FDA, the outcome or timing of regulatory approvals needed by Atossa, lower than anticipated rate of patient enrollment, results of clinical studies, the safety and efficacy of Atossa's products and services, performance of clinical research organizations and investigators, obstacles resulting from proprietary rights held by others with respect to fulvestrant, such as patent rights, and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.


News Article | January 21, 2016
Site: www.labdesignnews.com

Projections released by the U.S. Department of Education paint a bright future for jobs in the science, technology, engineering and mathematics (STEM) fields. As populations grow, natural resources diminish, disease prevention and treatment become more complex and evolutionary and universal mysteries continue to be explored, science and technology will remain critical to expanding human knowledge and solving challenges of today and for the future. Opportunities abound for STEM graduates today, but preparing enough STEM graduates to drive the scientific breakthroughs and technological innovations of tomorrow will be a daunting task for colleges and universities across the country. The U.S. President’s Council of Advisors on Science and Technology predicts that in the next decade, we will need approximately 1 million more STEM professionals than we will produce at our current rate. Currently, about 300,000 graduates obtain Bachelor and Associate degrees in STEM fields every year. In order to create this new workforce of 1 million additional STEM experts, that number needs to increase by 100,000 annually. The challenge is clear: Universities must attract more students to STEM programs. However, once these students have enrolled, another challenge begins to unfold: Only about 40 percent of students who enroll in STEM programs graduate with STEM degrees. The remaining 60 percent switch to non-STEM fields or drop out of college entirely. To address the challenges of attraction and retention, educational institutions throughout the country are trading in traditional teaching methods for new pedagogical techniques. These new methods move beyond a model where students passively listen to lectures and cram for tests, to methods that engage students in activities, enable collaboration across STEM disciplines and encourage students to use their hands just as much as their heads. With these new approaches to learning and teaching come new approaches to designing learning environments. These new spaces are eliminating the stereotypes associated with traditional STEM classrooms and fostering the type of creative brilliance that can help us educate and prepare one million new STEM graduates. Here are three ideas every university should consider when rethinking their STEM learning spaces to better recruit and retain students for the future. Get out of the basement Traditionally, STEM teaching labs and research spaces were located in building cores or basements. These underground “lairs” were uncomfortable and uninviting to students and faculty using these facilities. They featured little to no windows, no natural light and the overall environment felt more institutional than educational. For students that didn’t have a class assigned to these spaces, the labs were relatively unknown, and were considered untouchable and intimidating. Countless studies show the design of classroom environments influence students’ motivation and learning, and universities are seeing the value in encouraging the student body to observe the scientific process to raise curiosity and interest. From a design perspective, we use the term “putting science on display” pretty regularly. The general idea is to place science classrooms and labs in public, high-traffic areas. Instead of solid walls, expansive floor-to-ceiling windows celebrate the sciences and allow passersby the opportunity to observe research and watch it unfold. This helps make science an approachable, open process, and as an added benefit, it gives universities the chance to show off their cool research equipment. The University of Buffalo has embraced this idea with its Clinical Translational Research Center (CTRC). Embedded in the same building as Kaleida Health’s Gates Vascular Institute, the CTRC uses interior glass throughout the building to show science in an open, transparent process. Embrace startup culture A key component of successful STEM programs is experimentation. For example, if you look at the most successful technology startups over the last 10 years, very few started in a formal academic settings. More often than not, they started in garages or coffee shops—places with more sofas than fixed bench space. There’s a lot STEM learning environments can learn from these spaces, specifically in how they encourage free thinking and experimentation. Taking inspiration from startups, our team at CannonDesign is seeing an increase in makerspace, hackerspace and innovation hubs within STEM buildings. These spaces serve a pretty basic purpose: nurturing creativity, encouraging experimentation and stimulating intellectual inquiry in an informal setting. They don’t act exclusively as labs, garages or workshops, but they do include many of the tools found in these space (3-D printers, welding machines, computers, building materials). The Univ. of Utah sees the value in such spaces with their new Lassonde Studios Entrepreneurial building that features a 20,000-sf making/planning/hacking space to foster interdisciplinary and cross-disciplinary “mash-ups” extending beyond STEM disciplines and including others, such as business majors. Infuse appropriate technology into S&T academic environments Millennials and Generation Z grew up in a digital world and expect to take full advantage of technology in every aspect of life, especially college. However, technology hasn’t revolutionized education the way it has other industries. STEM learning environments can be leading examples for how using technology can enhance learning by making it more engaging and accessible. The flipped classroom is a good example of an effective use of technology for enhanced learning. The flipped classroom is a pedagogical model that has students watch video lectures and complete homework prior to class. Doing this creates richer face-to-face interactions when students are actually in class; instead of listening to a lecture, they spend their time asking questions, participating in hands-on activities and even getting involved in real university research efforts. On the most dramatic end of the spectrum, some universities are using virtual reality, simulation and gaming to inspire and educate future STEM innovators. These tools allow students to quite literally take part in technology. For example, CAVE environments, which are rooms wrapped in screens that project 3D virtual environments, allow students to immerse themselves in a setting and actually interact with what they’re seeing. From an infrastructure design standpoint, these technology-rich spaces require a building that provides enhanced server space, room for complex computing platforms, and the power and cooling sources to keep everything up and running. One interesting trend our team is also seeing related to technology is a decrease in dedicated computer labs. Prior to the days of constant connectivity, computer labs acted as the hub of higher education buildings. But today, 90 percent of students own a laptop, 86 percent of students own a smartphone and 47 percent of students own a tablet. The need to access university-owned equipment is dwindling, and the need to plug in personal devices and work anywhere is the new norm. There’s no denying universities need to prove themselves up to the challenge of attracting and retaining the much needed next generation of STEM professionals. How they choose to design their STEM learning environments can play a big role in helping them meet this challenge and exceed current projections. Stephen Blair leads CannonDesign’s global science and technology practice, focused on helping academic and corporate institutions design solutions that turn challenges into opportunities for success. www.cannondesign.com


News Article | December 22, 2016
Site: www.marketwired.com

International Recognition and Consistent Deployment of Quality Ethernet Services Propel WireIE Into a Solid Industry Leadership Position TORONTO, ON--(Marketwired - Dec 22, 2016) -  WireIE, a wholesale network operator specialized in the deployment of MEF-Certified Carrier Ethernet networks to Canada's underserved markets, celebrates a year filled with big growth and marked successes. The WireIE Canadian national footprint now reaches from coast to coast, and the goal of increasing the scope of high availability, secure and reliable networks in underserved markets across Canada allowed WireIE to grow 20%, in partnership with its wholesale carriers, in 2016. Specifically, growth accelerated within the federal government, the oil and gas industry, ehealth, banking and several other industries. "The growth levels we've enjoyed in 2016 are almost unheard of in our industry," says Rob Barlow, WireIE CEO, "I've spoken with many industry executives, and they're consistently surprised when we mention our growth." WireIE grew internationally as well, with 25% of the company growth being driven through the Americas, and new projects in Argentina and the Caribbean increasing presence and global accolades. Others in the industry recognized WireIE's growth as well, as two awards were presented to the WireIE team. The first award came in May at the Global Telecom Business Innovation Awards. "We were thrilled to win this award. It recognized WireIE's innovative solutions for underserved and geographically disperse markets," says CEO, Rob Barlow. Europe was particularly good to WireIE this year, following up with another win in November. "In Paris, we were honoured with the Best North American Project award at Capacity Europe," says Barlow, adding, "It was our privilege to receive both of these awards." Both European events are well known in the industry, with Capacity Europe being one of the most established and well-regarded conferences in the telecom industry, attended by over 2000 executives from 80 countries. Both awards reaffirm WireIE's goal of creating a more connected world and enabling carrier partners to future-proof their networks. With increased presence on the global stage, last month Barlow was invited to speak on two CEO Roundtables in LA. The first entitled "IOT & The Data Center: Talking Cloud, Power and Performance," and then "IOT & Cybersecurity: Risks in the Supply Chain, Privacy and Defense." The Roundtables provided an opportunity for industry leaders to share their predictions for tech and telecom's future and to participate in casual Q&A discussion moderated by industry analysts and journalists. In light of the recent announcement from the CTRC, WireIE is pleased that the Government of Canada recognizes connection to the internet as a basic service. WireIE crossed a new threshold of total circuits that have been flipped on and connected in underserved markets in 2016, growth of which is set to continue expanding rapidly, in support of the Government's mandate in 2017. To learn more about WireIE, visit www.wireie.com. About WireIE WireIE is a Canadian telecommunications carrier, specialized in the deployment of MEF Certified Carrier Ethernet 2.0 networks to underserved markets. WireIE's proven network performance, backed by industry-leading SLAs, has established the carrier as the provider of choice for mission critical network requirements, across all industry verticals including Oil & Gas, Mining, Utilities, Healthcare, Financial, Retail and Public Sector. Unleash the potential with WireIE - visit www.wireie.com and follow us on Twitter @WireIE.


News Article | December 23, 2016
Site: www.marketwired.com

TORONTO, ON--(Marketwired - Dec 22, 2016) - A WireIE, uma operadora de rede por atacado especializada em implantação de redes Ethernet de Transportadoras certificadas MEF nos mercados sem atendimento do Canadá, comemora um ano com muito crescimento e sucesso. A empresa canadense WireIE presente de costa a costa e com a meta de aumentar ainda mais o escopo das suas redes de alta disponibilidade, seguras e confiáveis nos mercados sem atendimento no Canadá permitiu que a WireIE aumentasse 20%, em parceria com suas transportadores de atacado em 2016. Especificamente, o crescimento acelerado do governo federal, indústria de petróleo e de gás, ehealth, bancos e outras. "O nível de crescimento que tivemos em 2016 é quase imbatível na indústria", disse Rob Barlow, CEO da WireIE, "Eu falei com muitos executivos do setor e todos ficaram surpresos com o nosso crescimento". A WireIE também cresceu no exterior, sendo que 25% do crescimento da empresa sendo realizado nas Américas, e novos projetos na Argentina e no Caribe, aumentando a presença e os elogios globais. A indústria também reconheceu o crescimento da WireIE, com dois prêmios para a equipe da WireIE. O primeiro prêmio foi em maio na Global Telecom Business Innovation Awards. "Ficamos contentíssimos em receber este prêmio. Ele reconheceu as soluções inovadoras da WireIE nos mercados não atendidos e localizados em diferentes áreas", disse o CEO, Rob Barlow. A Europa foi muito boa para a WireIE este ano, após outro prêmio que recebemos em novembro. "Em Paris, recebemos o prêmio de Melhor Projeto da América do Norte", disse Barlow, acrescentando: "Foi um grande privilégio receber esses dois prêmios". Os eventos europeus são bem conhecidos da indústria, sendo que a conferência Capacity Europe é uma das mais estabelecidas e bem consideradas da indústria de telecomunicações, com mais de 2.000 executivos de 80 países. Os dois prêmios confirmam a meta da WireIE de criar um mundo mais conectado e de viabilizar parcerias futuras para que as redes sejam a prova do futuro. Com uma presença global cada vez maior, no mês passado Barlow foi convidado para fazer uma palestra em duas Mesas Redondas de CEOs em LA. "IOT & The Data Center: Talking Cloud, Power and Performance" e "IOT & Cybersecurity: Risks in the Supply Chain, Privacy and Defense." As Mesas Redondas foram uma oportunidade para os líderes do setor compartilharem suas previsões para o futuro da tecnologia e das telecomunicações e para participarem de sessões de Perguntas e Respostas moderadas por analistas e jornalistas do setor. Devido ao recente anúncio da CTRC, a WireIE está muito contente com o fato de o governo do Canadá ter reconhecido a conexão com a Internet como um serviço básico. A WireIE ultrapassou um limite novo do total de circuitos ligados e conectados nos mercados sem atendimento em 2016, com sua rápida expansão, em suporte à exigência do governo para 2017. WireIE A WireIE é a operadora de telecomunicações canadense especializada na implantação de redes Ethernet 2.0 Certificadas MEF para os mercados não atendidos. A performance comprovada da WireIE, apoiada pelos SLAs líderes do setor, estabeleceu a transportadora como a principal provedora para exigências de rede de missão crítica, em todos os verticais da indústria, inclusive Petróleo e Gás, Mineração, Utilidades Públicas, Saúde, Finanças, Varejo e Setor Público. Libere o potencial com a WireIE - visite www.wireie.com e siga-nos no Twitter @WireIE.

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