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FORT WASHINGTON, Pennsylvania, 1. März 2017 /PRNewswire/ -- Das National Comprehensive Cancer Network® (NCCN®) hat mithilfe von Finanzierung durch die NCCN Foundation® und die Kidney Cancer Association die deutsche Übersetzung der NCCN Guidelines for Patients®: Nierenkrebs veröffentlicht. Die NCCN Guidelines for Patients® [NCCN Leitlinien für Patienten] sind patientenfreundliche Anpassungen der NCCN Leitlinien für die klinische Praxis, die von Gesundheitsexperten in der ganzen Welt für die Bestimmung der besten Behandlungsmöglichkeiten von Krebspatienten verwendet werden. Sie enthalten unvoreingenommene fachkundige Anleitungen von Krebszentren in den USA, die Menschen dabei unterstützen sollen, mit ihren Ärzten über die besten Optionen für die Behandlung ihrer Krankheit zu sprechen. „Wir sind stolz, nun auch die deutsche Übersetzung der NCCN Guidelines for Patients®: Nierenkrebs vorstellen zu können. Der Zugriff auf leicht verständliche Behandlungsinformationen erlaubt es Patienten mit Nierenkrebs, informierte Entscheidungen über ihre Behandlung zu treffen", sagte Marcie R. Reeder, MPH, Executive Director der NCCN Foundation. Die NCCN Guidelines for Patients sind in leicht verständlicher Sprache verfasst und schließen patientenfreundliche Elemente ein, wie z. B. Fragen, die man seinem Arzt stellen sollte, ein Begriffsglossar und medizinische Illustrationen. Die deutsche Übersetzung der NCCN Guidelines for Patients®: Nierenkrebs kann von NCCN.org/patients und mit der mobilen App NCCN Patient Guides for Cancer heruntergeladen werden. Informationen über die Druckversion finden Sie unter NCCN.org/patients. Über NCCN Das National Comprehensive Cancer Network® (NCCN®) ist eine gemeinnützige Vereinigung von 27 weltweit führenden Krebszentren, die sich der Patientenbetreuung, Forschung und Bildung widmen. Es arbeitet an der Verbesserung der Qualität, Wirksamkeit und Effizienz der Krebsbetreuung, damit Patienten ein besseres Leben führen können. Unter der Leitung und mithilfe des Fachwissens von Klinikexperten der Mitgliederinstitutionen des NCCN entwickelt die NCCN Ressourcen, die den zahlreichen Stakeholdern in den Gesundheitsversorgungssystemen wertvolle Informationen bereitstellen. Als Vermittler bei hochqualitativer Krebsbetreuung unterstützt das NCCN die Bedeutung laufender Qualitätsverbesserung und ist sich der Bedeutung der Schaffung von Leitlinien für die klinische Praxis bewusst, die für die Verwendung durch Patienten, Kliniker und andere Entscheidungsträger im Gesundheitswesen angebracht sind. NCCN.org. Über die NCCN Foundation Die NCCN Foundation® wurde vom NCCN gegründet, um Menschen mit Krebs zu befähigen und fortschrittliche Innovation in der Onkologie zu fördern. Die NCCN Foundation unterstützt Menschen mit Krebs und ihre Betreuer während aller Phasen der Behandlung. NCCNFoundation.org Über die Kidney Cancer Association Die Kidney Cancer Association [Nierenkrebsvereinigung] ist eine wohltätige, nationale Organisation, die sich aus Patienten, Familienmitgliedern, Ärzten, Forschern und anderen Gesundheitsexperten zusammensetzt. Sie bietet ein breites Spektrum von Dienstleistungen an, darunter Patientenvertretung, Unterstützung sowohl öffentlicher als auch privater Forschung, Informationen und Bildung. KidneyCancer.org


News Article | February 15, 2017
Site: www.marketwired.com

London: Tuesday, February 14, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) and AstraZeneca PLC ("AstraZeneca") will present data from the ongoing Phase II clinical trial of savolitinib in patients with papillary renal cell carcinoma ("PRCC") at the 2017 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology ("ASCO-GU"), to be held in Orlando, Florida from February 16 to 18, 2017. Savolitinib, a highly selective inhibitor of c-Met receptor tyrosine kinase, has shown early clinical benefit in multiple Phase I and II studies in a number of cancers. It was developed as a potent and highly selective oral inhibitor specifically designed to address issues observed in the clinic with first-generation c-Met inhibitors, including renal toxicity. PRCC, the second most common histologic subtype of renal cell carcinoma ("RCC"), is associated with alterations in the c-Met gene (e.g. mutations, amplifications, and/or chromosomal changes). Therapies that are currently available for RCC patients have demonstrated only modest benefit in PRCC and there are no therapies specifically approved for the treatment of c-Met-driven PRCC. National Comprehensive Cancer Network guidelines recommend enrolling patients in clinical trials for first-line systemic therapy. "There is a clear unmet medical need in PRCC," said Toni Choueiri, Director of the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute. "The dataset from this Phase II study is compelling, with a very clear efficacy signal in MET-driven patients and an encouraging long duration of response, while remaining very well tolerated." He added, "These results support the initiation of the pivotal Phase III trial in a selected population of MET-driven PRCC. This innovative patient selection approach would be the first ever molecularly selected trial in renal cell carcinoma." "We are delighted to report this highly encouraging progression-free survival data in Met-driven papillary renal cell carcinoma, a disease with no approved treatment options," said Christian Hogg, Chief Executive Officer of Chi-Med. "With development of the companion diagnostic assay to screen Met-driven disease now also complete we are preparing for the initiation of our global Phase III study, the first global registration trial for savolitinib." The current Phase II trial is the largest prospective clinical study ever conducted in PRCC patients. It is a global single arm study of savolitinib in 109 patients with locally advanced or metastatic PRCC and was initiated in May 2014. It is being conducted in 22 clinical centers in the US, Canada, UK, and Spain, and completed enrollment in October 2015. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02127710. The most recent results of the study will be presented in detail as follows: Once presented, the presentation will be available at www.chi-med.com/news. Further information about ASCO-GU is available at gucasym.org. Chi-Med and AstraZeneca are currently initiating a global pivotal Phase III trial, the first pivotal study ever conducted in c-Met-driven PRCC and the first molecularly selected trial in RCC. Over the course of 2017, Chi-Med and AstraZeneca are also conducting a comprehensive molecular epidemiology study of approximately 300 PRCC patient samples to further understand the correlations between c-Met alterations and patient outcomes, including any predictive biomarkers. ABSTRACT A single-arm biomarker-based phase II trial of savolitinib in patients with advanced papillary renal cell cancer (PRCC) 1Dana-Farber Cancer Institute, Boston, US 2Fox Chase Cancer Center, Philadelphia, US 3Sarah Cannon Research Institute, London, UK 4MD Anderson Cancer Centre, Houston, US 5Tom Baker Cancer Center, Calgary, Canada 6Barts Cancer Institute, London, UK 7AstraZeneca, Waltham, US, 8AstraZeneca, Cambridge, UK 9Institute Gustave Roussy, Paris, France 10City of Hope, Duarte, US Background: Savolitinib (HMPL-504/Volitinib, AZD6094) is a potent, selective mesenchymal epithelial transition ("MET") inhibitor (IC of 4 nM). MET and its ligand, hepatocyte growth factor ("HGF"), are known to play an important role in the molecular events underlying oncogenesis in PRCC, a disease without a clear standard of care and marked by alterations of chromosome 7 (containing both MET and HGF genes) in a majority of patients as well as gene amplification or MET kinase domain mutations (Albiges et al 2014, Linehan et al, 2015). Methods: This study evaluates savolitinib in PRCC patients dosed at 600 mg daily until disease progression. Objective Response Rate ("ORR") is the primary endpoint. Progression-Free Survival ("PFS") & Duration of Response are secondary endpoints. Patient Reported Outcome ("PRO") and Health-Related Quality of Life ("HRQoL") questionnaires are exploratory endpoints. Eligibility includes naïve and previously treated metastatic PRCC, ECOG PS 0 or 1. Archival tumor was used to centrally confirm PRCC pathology post hoc and to determine MET status using Next Generation Sequencing (Foundation Medicine Inc, US). Results: As of 27 June 2016, 109 patients were dosed. Best response was PR n=8, SD n=43, PD n=48 & 10 patients were not evaluable for response. 44 patients are MET-driven (MET/HGF gene copy number gain or kinase domain mutations), 46 patients were MET-negative, 19 patients are status unknown. MET-driven pts included Papillary Type I & II histologies. All 8 responders were in the MET-driven group, 18% ORR in this subset. Median PFS in the MET-driven group was 6.2 months (95% CI: 4.1-7.0) vs. 1.4 months (95% CI: 1.4-2.7) in the MET-negative group (p=0.002). Overall 10/109 patients had adverse events ("AEs") leading to discontinuation. 23/109 patients had ≥ Grade 3 toxicity related to savolitinib. The most common AEs (all grades) includes: nausea (39%), fatigue (27%), edema (18%) and abnormal liver function tests (LFTs) (17%). One death from hepatic encephalopathy was considered related to savolitinib. PRO & HRQoL data was not statistically analyzed, descriptive data support main efficacy findings. Conclusions: In the largest biomarker-profiled trial dedicated to PRCC, savolitinib was generally well tolerated with anti-tumor activity in MET-driven patients. These findings warrant further clinical investigation of savolitinib in MET-driven PRCC. About the Unmet Medical Need in c-Met-Driven PRCC Patients Worldwide, about 366,000 new patients are diagnosed with kidney cancer annually, and the total market for kidney cancer treatments is expected to reach US$4.5 billion in 2020, according to Frost & Sullivan. RCC accounts for approximately 80-85% of kidney cancer and has several histological sub-types with different genetic and biochemical characteristics. Among these histologic variants of RCC, clear cell RCC ("ccRCC") is the most common, accounting for 75-80% of RCC. PRCC is the most common of the non-clear cell renal carcinomas accounting for 10-15% of RCC. The proportion of PRCC patients whose tumors are c-Met-driven has historically been estimated at 40-70%. In the largest study to date, presented at the annual meeting of the American Association for Cancer Research 2014, analysis of 220 frozen tumor samples catalogued in the French RCC Network indicated that 55-60% of PRCC patients showed gains in Chromosome 7 (i.e. c-Met amplification). The biology and molecular characteristics of PRCC are different from those of ccRCC. This results in significantly worse prognosis and treatment outcomes for patients with PRCC when compared to patients with ccRCC. Highlighting the unmet need is the fact that, although there are several drugs approved for use in RCC (the latest being approved in April 2016), these approvals were generally on the basis of studies conducted with a preponderance of ccRCC patients. The need for different agents and more specific data tailored to the PRCC disease setting has been identified as a critical gap in the care of these patients. About Chi-Med Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare-related consumer products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China. Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com. About AstraZeneca in Oncology AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With at least six new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca's six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology. By harnessing the power of four scientific platforms - Immuno-Oncology, the genetic drivers of cancer and resistance, DNA Damage Response and Antibody Drug Conjugates - and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of savolitinib, plans to initiate clinical studies for savolitinib in PRCC, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate savolitinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of savolitinib for a targeted indication and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med's filings with the US Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.


LONDON--(BUSINESS WIRE)--Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) and AstraZeneca PLC (“AstraZeneca”) will present data from the ongoing Phase II clinical trial of savolitinib in patients with papillary renal cell carcinoma (“PRCC”) at the 2017 Genitourinary Cancers Symposium sponsored by the American Society of Clinical Oncology (“ASCO-GU”), to be held in Orlando, Florida from February 16 to 18, 2017. Savolitinib, a highly selective inhibitor of c-Met receptor tyrosine kinase, has shown early clinical benefit in multiple Phase I and II studies in a number of cancers. It was developed as a potent and highly selective oral inhibitor specifically designed to address issues observed in the clinic with first-generation c-Met inhibitors, including renal toxicity. PRCC, the second most common histologic subtype of renal cell carcinoma (“RCC”), is associated with alterations in the c-Met gene (e.g. mutations, amplifications, and/or chromosomal changes). Therapies that are currently available for RCC patients have demonstrated only modest benefit in PRCC and there are no therapies specifically approved for the treatment of c-Met-driven PRCC. National Comprehensive Cancer Network guidelines recommend enrolling patients in clinical trials for first-line systemic therapy. “There is a clear unmet medical need in PRCC,” said Toni Choueiri, Director of the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute. “The dataset from this Phase II study is compelling, with a very clear efficacy signal in MET-driven patients and an encouraging long duration of response, while remaining very well tolerated.” He added, “These results support the initiation of the pivotal Phase III trial in a selected population of MET-driven PRCC. This innovative patient selection approach would be the first ever molecularly selected trial in renal cell carcinoma.” “We are delighted to report this highly encouraging progression-free survival data in Met-driven papillary renal cell carcinoma, a disease with no approved treatment options,” said Christian Hogg, Chief Executive Officer of Chi-Med. “With development of the companion diagnostic assay to screen Met-driven disease now also complete we are preparing for the initiation of our global Phase III study, the first global registration trial for savolitinib.” The current Phase II trial is the largest prospective clinical study ever conducted in PRCC patients. It is a global single arm study of savolitinib in 109 patients with locally advanced or metastatic PRCC and was initiated in May 2014. It is being conducted in 22 clinical centers in the US, Canada, UK, and Spain, and completed enrollment in October 2015. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02127710. The most recent results of the study will be presented in detail as follows: Once presented, the presentation will be available at www.chi-med.com/news. Further information about ASCO-GU is available at gucasym.org. Chi-Med and AstraZeneca are currently initiating a global pivotal Phase III trial, the first pivotal study ever conducted in c-Met-driven PRCC and the first molecularly selected trial in RCC. Over the course of 2017, Chi-Med and AstraZeneca are also conducting a comprehensive molecular epidemiology study of approximately 300 PRCC patient samples to further understand the correlations between c-Met alterations and patient outcomes, including any predictive biomarkers. A single-arm biomarker-based phase II trial of savolitinib in patients with advanced papillary renal cell cancer (PRCC) 1Dana-Farber Cancer Institute, Boston, US 2Fox Chase Cancer Center, Philadelphia, US 3Sarah Cannon Research Institute, London, UK 4MD Anderson Cancer Centre, Houston, US 5Tom Baker Cancer Center, Calgary, Canada 6Barts Cancer Institute, London, UK 7AstraZeneca, Waltham, US, 8AstraZeneca, Cambridge, UK 9Institute Gustave Roussy, Paris, France 10City of Hope, Duarte, US Background: Savolitinib (HMPL-504/Volitinib, AZD6094) is a potent, selective mesenchymal epithelial transition (“MET”) inhibitor (IC of 4 nM). MET and its ligand, hepatocyte growth factor (“HGF”), are known to play an important role in the molecular events underlying oncogenesis in PRCC, a disease without a clear standard of care and marked by alterations of chromosome 7 (containing both MET and HGF genes) in a majority of patients as well as gene amplification or MET kinase domain mutations (Albiges et al 2014, Linehan et al, 2015). Methods: This study evaluates savolitinib in PRCC patients dosed at 600 mg daily until disease progression. Objective Response Rate (“ORR”) is the primary endpoint. Progression-Free Survival (“PFS”) & Duration of Response are secondary endpoints. Patient Reported Outcome (“PRO”) and Health-Related Quality of Life (“HRQoL”) questionnaires are exploratory endpoints. Eligibility includes naïve and previously treated metastatic PRCC, ECOG PS 0 or 1. Archival tumor was used to centrally confirm PRCC pathology post hoc and to determine MET status using Next Generation Sequencing (Foundation Medicine Inc, US). Results: As of 27 June 2016, 109 patients were dosed. Best response was PR n=8, SD n=43, PD n=48 & 10 patients were not evaluable for response. 44 patients are MET-driven (MET/HGF gene copy number gain or kinase domain mutations), 46 patients were MET-negative, 19 patients are status unknown. MET-driven pts included Papillary Type I & II histologies. All 8 responders were in the MET-driven group, 18% ORR in this subset. Median PFS in the MET-driven group was 6.2 months (95% CI: 4.1–7.0) vs. 1.4 months (95% CI: 1.4–2.7) in the MET-negative group (p=0.002). Overall 10/109 patients had adverse events (“AEs”) leading to discontinuation. 23/109 patients had ≥ Grade 3 toxicity related to savolitinib. The most common AEs (all grades) includes: nausea (39%), fatigue (27%), edema (18%) and abnormal liver function tests (LFTs) (17%). One death from hepatic encephalopathy was considered related to savolitinib. PRO & HRQoL data was not statistically analyzed, descriptive data support main efficacy findings. Conclusions: In the largest biomarker-profiled trial dedicated to PRCC, savolitinib was generally well tolerated with anti-tumor activity in MET-driven patients. These findings warrant further clinical investigation of savolitinib in MET-driven PRCC. About the Unmet Medical Need in c-Met-Driven PRCC Patients Worldwide, about 366,000 new patients are diagnosed with kidney cancer annually, and the total market for kidney cancer treatments is expected to reach US$4.5 billion in 2020, according to Frost & Sullivan. RCC accounts for approximately 80-85% of kidney cancer and has several histological sub-types with different genetic and biochemical characteristics. Among these histologic variants of RCC, clear cell RCC (“ccRCC”) is the most common, accounting for 75-80% of RCC. PRCC is the most common of the non-clear cell renal carcinomas accounting for 10-15% of RCC. The proportion of PRCC patients whose tumors are c-Met-driven has historically been estimated at 40-70%. In the largest study to date, presented at the annual meeting of the American Association for Cancer Research 2014, analysis of 220 frozen tumor samples catalogued in the French RCC Network indicated that 55-60% of PRCC patients showed gains in Chromosome 7 (i.e. c-Met amplification). The biology and molecular characteristics of PRCC are different from those of ccRCC. This results in significantly worse prognosis and treatment outcomes for patients with PRCC when compared to patients with ccRCC. Highlighting the unmet need is the fact that, although there are several drugs approved for use in RCC (the latest being approved in April 2016), these approvals were generally on the basis of studies conducted with a preponderance of ccRCC patients. The need for different agents and more specific data tailored to the PRCC disease setting has been identified as a critical gap in the care of these patients. Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare-related consumer products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China. Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com. AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology. By harnessing the power of four scientific platforms – Immuno-Oncology, the genetic drivers of cancer and resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death. AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca. This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med’s current expectations regarding future events, including its expectations for the clinical development of savolitinib, plans to initiate clinical studies for savolitinib in PRCC, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate savolitinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of savolitinib for a targeted indication and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the US Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.


SAINT-GENIS-POUILLY, France, March 01, 2017 (GLOBE NEWSWIRE) -- Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (“AAA” or the “Company”), an international specialist in Molecular Nuclear Medicine (MNM), today announced that its product NETSPOT® (gallium Ga 68 dotatate) has been included in the National Comprehensive Cancer Network® (“NCCN”) Clinical Practice Guidelines in Oncology version 1.2017 update for the evaluation of neuroendocrine tumors (“NETs”). NCCN® is a not-for-profit alliance of leading cancer centers in the U.S. that produces authoritative guidelines for oncology physicians for the treatment of all major malignancies, and for their detection, prevention, risk reduction and associated supportive care. Eric Liu, MD, FACS, neuroendocrine tumor surgeon and Co-Director, The Neuroendocrine Institute at Rocky Mountain Cancer Center and HealthOne, stated, “As a physician that sees more than 400 patients with NETs per year, I am very grateful to have NETSPOT® available and included in the NCCN Guidelines®. This advance in imaging capability provides treating physicians with enormous insights, enabling better directed surgeries and enhanced decision making regarding different therapeutic options. Ultimately, I believe the use of NETSPOT® will lead to improved outcomes for patients.” Lale Kostakoglu, MD, MPH, Chief, Nuclear Medicine and Molecular Imaging, at the Icahn School of Medicine at Mount Sinai, stated, “We, as molecular imagers, are very pleased to see this valuable imaging modality be finally integrated into a national management algorithm for neuroendocrine tumors. The ability to image these patients with this compound is crucial to the success of any molecular imaging program. I believe this technology will lead to significant changes in patient management and will guide decisions for targeted therapies.” Stefano Buono, Chief Executive Officer of AAA said, “We are pleased to see NETSPOT® acknowledged by NCCN® as a clinically relevant tool for the evaluation of patients with NETs. The inclusion of NETSPOT® in the NCCN Guidelines® for NETs should facilitate coverage from private payors and increase access for many patients. The NET community has been very supportive of the innovation NETSPOT® brings and it is our goal to make it available in as many markets as possible.” NETSPOT® was approved by the US Food and Drug Administration (“FDA”) on June 1, 2016, 23 months from the first pre-Investigational New Drug meeting with the Agency. AAA and its radiopharmacy partners around the U.S. are now delivering 400 doses of NETSPOT® per month. The company is seeking to grow its network of radiopharmacy partners from 20 sites to more than 40 sites over the first half of 2017. In December 2016, the Centers for Medicare & Medicaid Services (“CMS”) granted NETSPOT® Transitional Pass-Through status under an “A-code” (A9587) for drug reimbursement, effective January 1, 2017. Additionally, the same Healthcare Common Procedure Coding System (“HCPCS”) “A Code” will be used on claims to private payers. NETSPOT®, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. There are no Contraindications for use. Warnings and Precautions include Ga 68 dotatate contributing to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. The safety of Ga 68 dotatate was evaluated in three single center studies and in a survey of the scientific literature. No serious adverse reactions were identified. NETSPOT® is available in two forms: As a drug kit for reconstitution using a Ga 68 generator, and as a ready-to-use injection delivered from local radiopharmacies in select metropolitan areas. The kit has been designated as an orphan drug by the EMA and the FDA. For full prescribing information for NETSPOT® please refer to: http://go.usa.gov/cSywA. Advanced Accelerator Applications is an innovative radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicine products. AAA’s lead investigational therapeutic candidate, Lutetium Lu 177 Dotatate (Lutathera®), is a novel MNM compound that AAA is currently developing for the treatment of Neuroendocrine Tumors, a significant unmet medical need. Founded in 2002, AAA has its headquarters in Saint-Genis-Pouilly, France. AAA currently has 22 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has 500 employees in 13 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, U.S. and Canada). AAA reported sales of €88.6 million in 2015 (+27% vs. 2014) and sales of €81.3 million for the first 9 months of 2016 (+23% vs. 9 months 2015). AAA is listed on the Nasdaq Global Select Market under the ticker “AAAP”. For more information, please visit: www.adacap.com. This press release may contain forward-looking statements. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company's strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the timing of our submission of applications for regulatory approvals, EMA, FDA and other regulatory approvals for our product candidates, the occurrence of side effects or serious adverse events caused by or associated with our products and product candidates; our ability to procure adequate quantities of necessary supplies and raw materials for Lutetium Lu 177 Dotatate and other chemical compounds acceptable for use in our manufacturing processes from our suppliers; our ability to organize timely and safe delivery of our products or product candidates by third parties; any problems with the manufacture, quality or performance of our products or product candidates; the rate and degree of market acceptance and the clinical utility of Lutetium Lu 177 Dotatate and our other products or product candidates; our estimates regarding the market opportunity for Lutetium Lu 177 Dotatate, our other product candidates and our existing products; our anticipation that we will generate higher sales as we diversify our products; our ability to implement our growth strategy including expansion in the U.S.; our ability to sustain and create additional sales, marketing and distribution capabilities; our intellectual property and licensing position; legislation or regulation in countries where we sell our products that affect product pricing, taxation, reimbursement, access or distribution channels; regulatory actions or litigations; and general economic, political, demographic and business conditions in Europe, the U.S. and elsewhere. Except as required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


SAINT-GENIS-POUILLY, France, March 01, 2017 (GLOBE NEWSWIRE) -- Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (“AAA” or the “Company”), an international specialist in Molecular Nuclear Medicine (MNM), today announced that its product NETSPOT® (gallium Ga 68 dotatate) has been included in the National Comprehensive Cancer Network® (“NCCN”) Clinical Practice Guidelines in Oncology version 1.2017 update for the evaluation of neuroendocrine tumors (“NETs”). NCCN® is a not-for-profit alliance of leading cancer centers in the U.S. that produces authoritative guidelines for oncology physicians for the treatment of all major malignancies, and for their detection, prevention, risk reduction and associated supportive care. Eric Liu, MD, FACS, neuroendocrine tumor surgeon and Co-Director, The Neuroendocrine Institute at Rocky Mountain Cancer Center and HealthOne, stated, “As a physician that sees more than 400 patients with NETs per year, I am very grateful to have NETSPOT® available and included in the NCCN Guidelines®. This advance in imaging capability provides treating physicians with enormous insights, enabling better directed surgeries and enhanced decision making regarding different therapeutic options. Ultimately, I believe the use of NETSPOT® will lead to improved outcomes for patients.” Lale Kostakoglu, MD, MPH, Chief, Nuclear Medicine and Molecular Imaging, at the Icahn School of Medicine at Mount Sinai, stated, “We, as molecular imagers, are very pleased to see this valuable imaging modality be finally integrated into a national management algorithm for neuroendocrine tumors. The ability to image these patients with this compound is crucial to the success of any molecular imaging program. I believe this technology will lead to significant changes in patient management and will guide decisions for targeted therapies.” Stefano Buono, Chief Executive Officer of AAA said, “We are pleased to see NETSPOT® acknowledged by NCCN® as a clinically relevant tool for the evaluation of patients with NETs. The inclusion of NETSPOT® in the NCCN Guidelines® for NETs should facilitate coverage from private payors and increase access for many patients. The NET community has been very supportive of the innovation NETSPOT® brings and it is our goal to make it available in as many markets as possible.” NETSPOT® was approved by the US Food and Drug Administration (“FDA”) on June 1, 2016, 23 months from the first pre-Investigational New Drug meeting with the Agency. AAA and its radiopharmacy partners around the U.S. are now delivering 400 doses of NETSPOT® per month. The company is seeking to grow its network of radiopharmacy partners from 20 sites to more than 40 sites over the first half of 2017. In December 2016, the Centers for Medicare & Medicaid Services (“CMS”) granted NETSPOT® Transitional Pass-Through status under an “A-code” (A9587) for drug reimbursement, effective January 1, 2017. Additionally, the same Healthcare Common Procedure Coding System (“HCPCS”) “A Code” will be used on claims to private payers. NETSPOT®, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. There are no Contraindications for use. Warnings and Precautions include Ga 68 dotatate contributing to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. The safety of Ga 68 dotatate was evaluated in three single center studies and in a survey of the scientific literature. No serious adverse reactions were identified. NETSPOT® is available in two forms: As a drug kit for reconstitution using a Ga 68 generator, and as a ready-to-use injection delivered from local radiopharmacies in select metropolitan areas. The kit has been designated as an orphan drug by the EMA and the FDA. For full prescribing information for NETSPOT® please refer to: http://go.usa.gov/cSywA. Advanced Accelerator Applications is an innovative radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicine products. AAA’s lead investigational therapeutic candidate, Lutetium Lu 177 Dotatate (Lutathera®), is a novel MNM compound that AAA is currently developing for the treatment of Neuroendocrine Tumors, a significant unmet medical need. Founded in 2002, AAA has its headquarters in Saint-Genis-Pouilly, France. AAA currently has 22 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has 500 employees in 13 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, U.S. and Canada). AAA reported sales of €88.6 million in 2015 (+27% vs. 2014) and sales of €81.3 million for the first 9 months of 2016 (+23% vs. 9 months 2015). AAA is listed on the Nasdaq Global Select Market under the ticker “AAAP”. For more information, please visit: www.adacap.com. This press release may contain forward-looking statements. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company's strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the timing of our submission of applications for regulatory approvals, EMA, FDA and other regulatory approvals for our product candidates, the occurrence of side effects or serious adverse events caused by or associated with our products and product candidates; our ability to procure adequate quantities of necessary supplies and raw materials for Lutetium Lu 177 Dotatate and other chemical compounds acceptable for use in our manufacturing processes from our suppliers; our ability to organize timely and safe delivery of our products or product candidates by third parties; any problems with the manufacture, quality or performance of our products or product candidates; the rate and degree of market acceptance and the clinical utility of Lutetium Lu 177 Dotatate and our other products or product candidates; our estimates regarding the market opportunity for Lutetium Lu 177 Dotatate, our other product candidates and our existing products; our anticipation that we will generate higher sales as we diversify our products; our ability to implement our growth strategy including expansion in the U.S.; our ability to sustain and create additional sales, marketing and distribution capabilities; our intellectual property and licensing position; legislation or regulation in countries where we sell our products that affect product pricing, taxation, reimbursement, access or distribution channels; regulatory actions or litigations; and general economic, political, demographic and business conditions in Europe, the U.S. and elsewhere. Except as required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


News Article | February 28, 2017
Site: www.prweb.com

Specific dairy foods may influence breast cancer risk in women, although risk varies by the source of the dairy product, according to a study published online ahead of print in the journal Current Developments in Nutrition. Researchers at Roswell Park Cancer Institute report that while high overall consumption of dairy products, and in particular of yogurt, is linked to a lower risk for breast cancer, high intake of American, cheddar and cream cheeses was associated with a slightly increased risk for breast cancer. The case-control study examined the association between the types and quantity of dairy foods consumed among 1,941 women diagnosed with breast cancer and 1,237 control participants in the Roswell Park Data Bank and BioRepository between 2003 and 2014. Participants’ usual intake of dairy foods was identified using a self-administered food frequency questionnaire and grouped into monthly intakes of total dairy, milk, yogurt, low-fat cheese, other cheese and sweet dairy products. The study adjusted for age, race, body-mass index, menopausal status, energy intake, type of milk usually consumed, cigarette smoking status and family history of breast cancer. “Dairy foods are complex mixtures of nutrients and non-nutrient substances that could be negatively as well as positively associated with breast cancer risk. Future studies are needed to confirm the protective potential of yogurt in this type of cancer,” says the lead author of the study, Susan McCann, PhD, RD, Professor of Oncology in the Department of Cancer Prevention and Control at Roswell Park. “This study of the differences among women and their consumption of dairy products offers significant new understanding into the potential risk factors associated with breast cancer,” says senior author Christine Ambrosone, PhD, Senior Vice President for Population Sciences and Chair of the Department of Cancer Prevention and Control. “While diet is thought to be responsible for 30% of all cancers, we hope that further research will help us to more fully understand which food products are most valuable in terms of reducing risk for this disease.” This research was supported, in part, by a grant from the National Cancer Institute (award no. P30CA016056). The study, “Usual consumption of specific dairy foods is associated with breast cancer in the Roswell Park Cancer Institute Data Bank and BioRespository,” is available at cdn.nutrition.org. For an online version of this release, please visit: https://www.roswellpark.org/media/news/dairy-intake-may-impact-risk-breast-cancer-reports-roswell-park-team The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. Founded in 1898, RPCI is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit http://www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email askrpci(at)roswellpark(dot)org. Follow Roswell Park on Facebook and Twitter.


Not intended for UK- or US-based media Merck, a leading science and technology company, announced today that the UK National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Determination (FAD) recommending the routine National Health Service (NHS) use of Erbitux® (cetuximab) in combination with either FOLFIRI or FOLFOX as a first-line treatment for patients with RAS wild-type metastatic colorectal cancer (mCRC). Erbitux has long been established and reimbursed as a first-line standard-of-care treatment option in most European countries and many other countries worldwide. "The NICE decision is great news for patients and their families in England, as it now means they will have access to this effective first-line treatment," said Maya Martinez-Davis, Global Head of Oncology Franchise for Merck's biopharma business. "Our efforts in working with NICE to reach this important milestone are part of our relentless commitment to bringing tailored, effective therapies to patients worldwide." This decision expands the previous NICE recommendation,[1] which endorsed the use of Erbitux in combination with either FOLFOX or FOLFIRI solely for patients whose cancer had spread only to the liver (liver-limited disease). It is based on robust data from Phase III clinical studies having demonstrated that Erbitux in combination with either FOLFIRI[2],[3],[4] or FOLFOX,[2],[5],[6] as a first-line treatment for patients with RAS wild-type mCRC, confers significant benefit in patient outcomes. "Patients with metastatic colorectal cancer in the UK have very limited access to effective first-line treatments," said Jola Gore-Booth, Founder/CEO of the colorectal cancer patient advocacy group, EuropaColon. "We are therefore delighted with NICE's decision, as it means there is now more choice for patients in England regarding treatment options that they can benefit from." Both the European Society for Medical Oncology and the US National Comprehensive Cancer Network clinical guidelines also recommend first-line treatment with Erbitux, in combination with either FOLFOX or FOLFIRI, for patients with RAS wild-type mCRC.[7],[8] Erbitux has obtained marketing authorization in over 90 countries worldwide. To date, more than 480,000 patients with mCRC have been treated with Erbitux. For further information and press materials please visit http://www.merckgroup.com/media-center-oncology. All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service. By publishing a Final Appraisal Determination (FAD), the National Institute for Health and Care Excellence (NICE) has made final recommendations on how Erbitux with FOLFOX/FOLFIRI should be used in the NHS. If there are no successful appeals, the final recommendations will be issued as NICE guidance. Approximately half of patients with mCRC have RAS wild-type tumors and half have RAS mutant tumors.[9] Results from studies assessing RAS mutation status in patients with mCRC have shown that anti-epidermal growth factor receptor (EGFR) monoclonal antibody therapies, such as Erbitux® (cetuximab), can improve outcomes in patients with RAS wild-type mCRC.[2]-[6] Colorectal cancer (CRC) is the third most common cancer worldwide, with an estimated incidence of more than 1.36 million new cases annually.[10] An estimated 694,000 deaths from CRC occur worldwide every year, accounting for 8.5% of all cancer deaths and making it the fourth most common cause of death from cancer.[10] Almost 55% of CRC cases are diagnosed in developed regions of the world, and incidence and mortality rates are substantially higher in men than in women.[10] Erbitux® is a highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe. Erbitux has already obtained market authorization in over 90 countries world-wide for the treatment of colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (SCCHN). Merck licensed the right to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas. All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service. Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2015, Merck generated sales of Euro12.85 billion in 66 countries. Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.


HOUSTON--(BUSINESS WIRE)--Radiologists from Synergy Radiology Associates (SRA) are now treating Houston-area patients with colon cancer that has spread to the liver, using an advanced treatment for inoperable liver tumors. Originally indicated for inoperable liver cancer, new national cancer guidelines allow for the use of Selective Internal Radiation Therapy (SIRT) in patients with liver dominant, chemotherapy resistant colorectal disease. “This treatment offers new hope to patients suffering from this difficult disease,” said SRA interventional radiologist Michael Richter, M.D. “For radiologists, this updated guideline means we have another tool in our arsenal for treating a very challenging cancer diagnosis.” SIRT is an interventional radiology procedure that delivers millions of tiny, radioactive SIR-Spheres® microspheres through blood vessels directly to the tumor site. Developed by Sirtex Medical Limited (ASX: SRX), SIR-Spheres is now included as a Category 2A recommended treatment in the latest National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines for colon cancer and rectal cancer. “SIRT is an important part of a multidisciplinary approach to liver cancer that can help improve quality of life with fewer side effects, and we’re excited to make it available to area patients,” said SRA President Walid Adham, M.D. “We will continue to look at new treatments that provide advantages over current treatments that can benefit our referring physicians and their patients.” SIR-Spheres microspheres are the only fully FDA-approved microspheres for colorectal cancer that has metastasized to the liver. The NCCN Category 2A designation means there is uniform consensus among the NCCN panel that SIRT with yttrium-90 (Y-90) microspheres is an appropriate option in chemotherapy resistant patients whose colorectal disease has spread to the liver. The recommendation also places SIR-Spheres on par with recommended metastatic colon cancer chemotherapy treatments. SRA radiologists are now performing the procedure at Memorial Hermann The Woodlands Hospital, Memorial Hermann Southwest Hospital, and Memorial Hermann Southeast Hospital. Most patients are usually able to go home four to six hours after the procedure, and the reported side effects are few. Patients experience mild, flu-like symptoms for a period of one to two weeks after the procedure. SIRT can be used for primary liver cancers as well as metastatic disease in the liver, including colorectal and breast cancer. For more information on SIRT and other minimally invasive procedures, visit our Y-90 informational page. Physician practices interested in learning more about Y-90 radioembolization should contact the Synergy Radiology interventional team at 713-897-5853. Formed in 2011 through the convergence of Houston’s top three radiology groups, Synergy Radiology Associates is the largest private radiology practice in the Houston metropolitan area. The SRA team of more than 80 board certified radiologists, highly skilled clinical staff and support professionals serve eleven area hospitals and several outpatient imaging centers with a broad range of subspecialties, including neuroradiology, body imaging, musculoskeletal, breast imaging, thoracic, cardiovascular, pediatric and interventional. SRA is committed to providing our patients and the medical communities we serve with the highest caliber of radiology services available. For more information, visit www.synergyrad.org, call (713) 621-7436 or connect with us on Facebook, LinkedIn or Pinterest.


News Article | February 27, 2017
Site: www.businesswire.com

DUARTE, Calif.--(BUSINESS WIRE)--An international team of researchers led by City of Hope’s Bart Roep, Ph.D., the Chan Soon-Shiong Shapiro Distinguished Chair in Diabetes and professor/founding chair of the Department of Diabetes Immunology, has been able to justify an alternative theory about the cause of type 1 diabetes (T1D) through experimental work. The study results were published online today in the journal, Nature Medicine. T1D, previously known as juvenile diabetes, affects an estimated 1.5 million Americans and is the result of the loss of insulin-producing cells in the pancreas. The prevailing belief was that the root cause of T1D was the immune system mistakenly identifying those insulin-secreting beta cells as a potential danger and, in turn, destroying them. Now Roep, along with researchers from the Leiden University Medical Center in the Netherlands, have found a mechanism in which stressed beta cells are actually causing the immune response that leads to T1D. “Our findings show that type 1 diabetes results from a mistake of the beta cell, not a mistake of the immune system,” said Roep, who is director of the Wanek Family Project for Type 1 Diabetes, which was recently created with gifts from the Wanek family and anonymous donors to support the institution’s goal of curing T1D in six years. “The immune system does what it is supposed to do, which is respond to distressed or ‘unhappy’ tissue, as it would in infection or cancer.” In order to gain a better understanding of why the immune system attacks the body’s own source of insulin — the pancreatic beta cells in the islets of Langerhans — the team took some clues from cancer molecules that are targeted by the immune system after successful treatment of the cancer with immunotherapy. One of these cancer targets is a so-called nonsense protein, resulting from a misreading of a DNA sequence that makes a nonfunctional protein. It turns out that the same type of protein error is also produced by the beta cells in T1D. Therefore, Roep and the other researchers believe it is a ‘wrong read’ of the insulin gene itself that proves to be a major target of the immune system. This error product of the insulin gene is made when beta cells are stressed, Roep said. “Our study links anti-tumor immunity to islet autoimmunity, and may explain why some cancer patients develop type 1 diabetes after successful immunotherapy,” he added. “This is an incredible step forward in our commitment to cure this disease.” According to the paper titled, “Autoimmunity against a defective ribosomal insulin gene product in type 1 diabetes,” the findings “further support the emerging concept that beta cells are destroyed in T1D by a mechanism comparable to classical antitumor responses where the immune system has been trained to survey dysfunctional cells in which errors have accumulated.” The results of the study give Roep new insight, he said, for his work in developing new vaccines to desensitize the immune system so that it will tolerate islets again, as well as for research into combining immunotherapy with more traditional diabetes treatments to reinvigorate islets. “Our goal is to keep beta cells happy,” Roep said. “So we will work on new forms of therapy to correct the autoimmune response against islets and hopefully also prevent development of type 1 diabetes during anti-cancer therapy.” The work described in the Nature Medicine paper was supported by the Dutch Diabetes Research Foundation, the DON Foundation and the JDRF. City of Hope is an independent research and treatment center for cancer, diabetes and other life-threatening diseases. Designated as one of only 47 comprehensive cancer centers, the highest recognition bestowed by the National Cancer Institute, City of Hope is also a founding member of the National Comprehensive Cancer Network, with research and treatment protocols that advance care throughout the world. City of Hope is located in Duarte, California, just northeast of Los Angeles, with community clinics throughout Southern California. It is ranked as one of “America’s Best Hospitals” in cancer by U.S. News & World Report. Founded in 1913, City of Hope is a pioneer in the fields of bone marrow transplantation, diabetes and numerous breakthrough cancer drugs based on technology developed at the institution. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.


News Article | February 16, 2017
Site: www.businesswire.com

DUARTE, Calif.--(BUSINESS WIRE)--City of Hope researchers and scientists strive to find less invasive ways to help treat patients diagnosed with kidney cancer. Despite a wave of new targeted therapies being approved to treat the disease, many of those therapies have been challenging to use because of the difficulty in obtaining cancer tissue for genomic testing. Now, researchers may have found a way to combat this problem: the liquid biopsy. The liquid biopsy, using cell-free cancer DNA that is circulating in the patient’s blood, is an easy and less invasive method of accessing the important genomic information in solid tumors, but had not yet been tested in patients with kidney tumors. In a study led by City of Hope’s Sumanta K. Pal, M.D., assistant professor in the Department of Medical Oncology & Therapeutics Research and co-director of the Kidney Cancer Program at City of Hope, he and his team identified cancer-related DNA in about 80 percent of patients who had a liquid biopsy performed. A majority of the patients were found to have clinically relevant genomic alterations, including alterations in the TP53, VHL, EGFR, NF1 and ARID1A genes. The results, based on data from Guardant Health, will be presented on Saturday, Feb. 18, at the 2017 Genitourinary Cancers Symposium, which is sponsored by the American Society of Clinical Oncology and the American Society for Radiation Oncology. The analysis of 224 patients diagnosed with metastatic renal cell carcinoma (mRCC) and tested with Guardant360 is the largest assessment of circulating tumor DNA in patients to date. Analysis of this large cohort demonstrated significant changes in circulating tumor DNA (ctDNA) profiles across patients’ clinical courses, which may have therapeutic implications. “Until now, the only means of assessing kidney tumor DNA has been through biopsies of cancer tissue, a procedure which can be associated with risk of infection and bleeding,” said Pal. “The liquid biopsy circumvents this completely.” Guardant360 has been used by more than 3,000 oncologists to identify somatic genomic alterations associated with targeted therapies in the tumor DNA of more than 30,000 patients with advanced cancer. Many doctors rely on biopsies to create an individual treatment plan that is directed toward specific genomic changes in the patient’s tumor. Because tumors evolve and develop resistance in response to treatment, the changes in ctDNA might provide key insights into how resistance to treatments for kidney cancer occurs. Pal and colleagues now aim to replicate this work in a larger study of patients to confirm the results. This study also represents an example of City of Hope’s ongoing commitment to developing personalized medicine and targeted therapies. Personalized medicine, which offers physicians the ability to better diagnose, treat, cure and prevent diseases, depends on three factors: discovering the genetic causes of diseases, understanding why individuals respond to different therapies and translating this understanding into new diagnostic tests and therapies. City of Hope is an independent research and treatment center for cancer, diabetes and other life-threatening diseases. Designated as one of only 47 comprehensive cancer centers, the highest recognition bestowed by the National Cancer Institute, City of Hope is also a founding member of the National Comprehensive Cancer Network, with research and treatment protocols that advance care throughout the world. City of Hope is located in Duarte, California, just northeast of Los Angeles, with community clinics throughout Southern California. It is ranked as one of "America's Best Hospitals" in cancer by U.S. News & World Report. Founded in 1913, City of Hope is a pioneer in the fields of bone marrow transplantation, diabetes and numerous breakthrough cancer drugs based on technology developed at the institution. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.

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