Sarah Cannon Research Institute PLLC

West End, TN, United States

Sarah Cannon Research Institute PLLC

West End, TN, United States

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NASHVILLE, Tenn.--(BUSINESS WIRE)--Sarah Cannon announced today that it will present cancer research insights through more than 90 presentations selected by the American Society of Clinical Oncology (ASCO®) at the 2017 Annual Meeting. Hosted in Chicago, June 2-6, the meeting brings together more than 30,000 cancer experts from around the world to review the latest research to improve the diagnosis and treatment of cancer. “2017 marks the 20th anniversary of our community-based drug development program, which was the first of its kind,” said Howard A. “Skip” Burris III, MD, President of Clinical Operations and Chief Medical Officer at Sarah Cannon. “Since our program’s inception, we have conducted more than 260 first-in-human clinical trials and made countless contributions to the advancement of cancer therapies. As we look to the future, the team at Sarah Cannon remains excited about our clinical research into how novel agents can provide an even greater benefit to patients and looks forward to sharing insights with our colleagues participating in the Annual Meeting.” Highlights of Sarah Cannon’s research include a presentation in a Clinical Science Symposium by Dr. Burris, who will discuss a study of combined inhibition of IDO1 and PD-L1 in patients with locally-advanced or metastatic solid tumors. Dr. Burris’ presentation, in the symposium titled "Check" This Out: The Step Beyond PD-1 Blockade, will take place on Sunday, June 4 during the session from 9:45-11:15 a.m. in Hall D1. Dr. Burris will also participate as a discussant in a Clinical Science Symposium, Hitting the Target: Antibody-Drug Conjugates, on Monday, June 5 from 9:45-11:15 a.m. in Hall D1, at which David Spigel, MD, Chief Scientific Officer and Director, Lung Cancer Research Program, Sarah Cannon Research Institute, will moderate the discussion. Additionally, Ian Flinn, MD, PhD, Director, Blood Cancer Research Program, Sarah Cannon Research Institute, will present an Oral Abstract on results of the BRIGHT 5-year follow-up study, a first-line treatment of iNHL or MCL patients with BR or R-CHOP/R-CVP, on Saturday, June 3 in the session from 3-6 p.m. in room S100BC. This abstract has also been selected as part of the Best of ASCO® program, which will be held this summer following the meeting, and highlights significant data impacting oncology research and care. Several other Sarah Cannon investigators are presenting noteworthy studies and insights at ASCO®: For a full listing of all presentations authored by Sarah Cannon investigators, visit sarahcannon.com/asco. Additional authors presenting for Sarah Cannon at the conference include: Hendrik-Tobias Arkenau, MD, PhD, FRCP, Raid Aljumaily, MD, Todd Bauer, MD, Johanna Bendell, MD, William Donnellan, MD, Professor Paul Ellis, MD, FRACP, Gerald Falchook, MD, MS, Carol Greenlees, PhD, Camille Gunderson, MD, Erika Hamilton, MD, John Hainsworth, MD, Lowell Hart, MD, Maen Hussein, MD, Jeffrey Infante, MD, Suzanne Jones, PharmD, Kathleen Moore, MD, Manish Patel, MD, DK Strickland, MD, Professor Charles Swanton, FRCP, BSc, PhD, Judy Wang, MD and Denise Yardley, MD. The researchers represent Sarah Cannon’s global network of strategic sites: Sarah Cannon Research Institute at Tennessee Oncology, Sarah Cannon Research Institute at HealthONE, Sarah Cannon Research Institute - United Kingdom, Colorado Blood Cancer Institute, The Center for Cancer and Blood Disorders - Ft. Worth, Sarah Cannon Research Institute at Florida Cancer Specialists, Sarah Cannon Research Institute at HCA Midwest Health and The Stephenson Cancer Center at the University of Oklahoma. Sarah Cannon Research Institute is the research arm of HCA Healthcare’s global cancer institute, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. Sarah Cannon’s network of strategic sites includes more than 275 physicians who engage in research. The organization has led more than 260 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in the majority of approved cancer therapies over the last 10 years. Additionally, Sarah Cannon offers management, regulatory, and other research support services for drug development and industry sponsors as well as strategic investigator sites through its contract research organization (CRO), Sarah Cannon Development Innovations. For more information, visit sarahcannon.com.


News Article | May 4, 2017
Site: globenewswire.com

REDWOOD CITY, Calif., May 04, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, announced today that the first patient has been dosed in the company’s Phase 1a clinical trial of anti-TIGIT (OMP-313M32).  Anti-TIGIT is an investigational immuno-oncology therapeutic candidate intended to block suppression of the immune system in tumors and enable immune system anti-tumor activity, similar to marketed checkpoint inhibitors that target the PD-L1-PD-1 axis. “The first wave of immuno-oncology agents demonstrated that disabling immune suppression mechanisms in tumors can enable the body’s immune system to fight cancers with good efficacy. Still, available immunotherapies have limited results for many cancer patients, and there remains a pressing need for new agents and combinations to improve outcomes,” said Johanna Bendell, M.D., Associate Director of the Drug Development Program at Sarah Cannon Research Institute and a lead investigator for the Phase 1a anti-TIGIT study.  “The immuno-suppressive receptor TIGIT is expressed on many different tumor types, giving us reason to believe that an anti-TIGIT antibody, such as OncoMed’s OMP-313M32, has potential for broad activity in cancer patients. I look forward to seeing its performance in the clinic.” The Phase 1 open-label clinical trial is designed to assess the safety and tolerability of escalating doses of anti-TIGIT in patients with advanced or metastatic solid tumors.  Secondary objectives for the trial include characterization of the pharmacokinetics, immunogenicity and anti-tumor efficacy of single-agent anti-TIGIT.  Pharmacodynamic and potential predictive biomarkers focused on changes in immune system activation will also be explored.  Anti-TIGIT will be administered as a single agent every two weeks at escalating dose levels.  Once a maximum-tolerated dose has been achieved, an expansion cohort will enroll patients with certain tumor types.  The trial will be conducted at five centers in the U.S. and is expected to enroll approximately 30 patients. “In multiple preclinical studies of anti-TIGIT antibodies, we have observed immune activation and single-agent as well as combination anti-tumor activity, including indications that an anti-TIGIT antibody induced a long-term immune memory response.” said Robert Stagg, Pharm.D., OncoMed’s Senior Vice President of Clinical Research and Development. “The initiation of this Phase 1a anti-TIGIT study represents the first of our novel immuno-oncology therapeutics to enter clinical trials.  We believe that by blocking TIGIT signaling, our anti-TIGIT antibody may enable T-cell activation and facilitate anti-tumor immune responses with the potential to impact tumor growth.” About Anti-TIGIT TIGIT (T cell immunoreceptor with Ig and ITIM domains) blocks T cells from attacking tumor cells and is similar in structure and function to the inhibitory protein PD-1. OncoMed’s anti-TIGIT antibody (OMP-313M32) is intended to activate the immune system through multiple mechanisms and enable anti-tumor activity. At the 2017 AACR Annual Meeting, OncoMed presented data from several studies characterizing anti-TIGIT’s mechanism, identifying pharmacodynamics biomarkers and demonstrating potent anti-tumor responses in in-vivo models. In preclinical studies, anti-TIGIT antibodies increased cytotoxic T-cell activity against tumor cells and decreased T-cell suppression. A surrogate anti-TIGIT antibody used in syngeneic mouse models of different solid tumors demonstrated dose-dependent, potent single-agent anti-tumor efficacy. Anti-TIGIT antibodies also demonstrated combination activity with checkpoint inhibitors anti-PD1 and anti-PD-L1 in preclinical models.  When mice whose tumors achieved complete regression following treatment with anti-TIGIT, anti-TIGIT plus anti-PD1 or anti-TIGIT plus anti-PD-L1 were re-challenged with increasing number of tumor cells, they remained protected from tumor growth, suggesting the induction of immunologic memory against the tumor cells. This program is part of OncoMed’s Celgene collaboration. About OncoMed Pharmaceuticals OncoMed Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics.  OncoMed has internally discovered a broad pipeline of investigational drugs intended to address the fundamental biology driving cancer’s growth, resistance, recurrence and metastasis.  Demcizumab (anti-DLL4, OMP-21M18), navicixizumab (anti-DLL4/VEGF bispecific, OMP-305B83), rosmantuzumab (anti-RSPO3, OMP-131R10) and anti-TIGIT (OMP-313M32) are part of the company’s strategic alliances with Celgene Corporation.  OncoMed is independently developing vantictumab (anti-Fzd, OMP-18R5), ipafricept (Fzd8-Fc, OMP-54F28) and GITRL-Fc (OMP-336B11), as well as continuing to pursue new drug discovery research.  For further information about OncoMed Pharmaceuticals, please see www.oncomed.com. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding OncoMed Pharmaceuticals, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, OncoMed's intentions and expectations regarding the ability of OncoMed’s anti-TIGIT  antibody to enable T-cell activation, block suppression of the immune system in tumors, facilitate an anti-tumor immune response, and impact tumor growth by blocking TIGIT signaling and/or through other mechanisms; the similarity of anti-TIGIT to marketed checkpoint inhibitors; and the potential for  anti-TIGIT to be broadly active and benefit a significant number of patients.  Such forward-looking statements involve substantial risks and uncertainties that could cause OncoMed's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; OncoMed's dependence on its collaboration partners, including Celgene, for the funding of its partnered programs; OncoMed's ability to raise additional capital to support the development of its unpartnered programs; OncoMed's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; OncoMed's reliance on single source third-party contract manufacturing organizations to manufacture and supply its product candidates; OncoMed's ability to discover, develop and commercialize additional product candidates; and OncoMed's dependence on its key executives. OncoMed undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to OncoMed's business in general, see OncoMed's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 9, 2017 and OncoMed’s other current and periodic reports filed with the SEC.


News Article | May 4, 2017
Site: globenewswire.com

REDWOOD CITY, Calif., May 04, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, announced today that the first patient has been dosed in the company’s Phase 1a clinical trial of anti-TIGIT (OMP-313M32).  Anti-TIGIT is an investigational immuno-oncology therapeutic candidate intended to block suppression of the immune system in tumors and enable immune system anti-tumor activity, similar to marketed checkpoint inhibitors that target the PD-L1-PD-1 axis. “The first wave of immuno-oncology agents demonstrated that disabling immune suppression mechanisms in tumors can enable the body’s immune system to fight cancers with good efficacy. Still, available immunotherapies have limited results for many cancer patients, and there remains a pressing need for new agents and combinations to improve outcomes,” said Johanna Bendell, M.D., Associate Director of the Drug Development Program at Sarah Cannon Research Institute and a lead investigator for the Phase 1a anti-TIGIT study.  “The immuno-suppressive receptor TIGIT is expressed on many different tumor types, giving us reason to believe that an anti-TIGIT antibody, such as OncoMed’s OMP-313M32, has potential for broad activity in cancer patients. I look forward to seeing its performance in the clinic.” The Phase 1 open-label clinical trial is designed to assess the safety and tolerability of escalating doses of anti-TIGIT in patients with advanced or metastatic solid tumors.  Secondary objectives for the trial include characterization of the pharmacokinetics, immunogenicity and anti-tumor efficacy of single-agent anti-TIGIT.  Pharmacodynamic and potential predictive biomarkers focused on changes in immune system activation will also be explored.  Anti-TIGIT will be administered as a single agent every two weeks at escalating dose levels.  Once a maximum-tolerated dose has been achieved, an expansion cohort will enroll patients with certain tumor types.  The trial will be conducted at five centers in the U.S. and is expected to enroll approximately 30 patients. “In multiple preclinical studies of anti-TIGIT antibodies, we have observed immune activation and single-agent as well as combination anti-tumor activity, including indications that an anti-TIGIT antibody induced a long-term immune memory response.” said Robert Stagg, Pharm.D., OncoMed’s Senior Vice President of Clinical Research and Development. “The initiation of this Phase 1a anti-TIGIT study represents the first of our novel immuno-oncology therapeutics to enter clinical trials.  We believe that by blocking TIGIT signaling, our anti-TIGIT antibody may enable T-cell activation and facilitate anti-tumor immune responses with the potential to impact tumor growth.” About Anti-TIGIT TIGIT (T cell immunoreceptor with Ig and ITIM domains) blocks T cells from attacking tumor cells and is similar in structure and function to the inhibitory protein PD-1. OncoMed’s anti-TIGIT antibody (OMP-313M32) is intended to activate the immune system through multiple mechanisms and enable anti-tumor activity. At the 2017 AACR Annual Meeting, OncoMed presented data from several studies characterizing anti-TIGIT’s mechanism, identifying pharmacodynamics biomarkers and demonstrating potent anti-tumor responses in in-vivo models. In preclinical studies, anti-TIGIT antibodies increased cytotoxic T-cell activity against tumor cells and decreased T-cell suppression. A surrogate anti-TIGIT antibody used in syngeneic mouse models of different solid tumors demonstrated dose-dependent, potent single-agent anti-tumor efficacy. Anti-TIGIT antibodies also demonstrated combination activity with checkpoint inhibitors anti-PD1 and anti-PD-L1 in preclinical models.  When mice whose tumors achieved complete regression following treatment with anti-TIGIT, anti-TIGIT plus anti-PD1 or anti-TIGIT plus anti-PD-L1 were re-challenged with increasing number of tumor cells, they remained protected from tumor growth, suggesting the induction of immunologic memory against the tumor cells. This program is part of OncoMed’s Celgene collaboration. About OncoMed Pharmaceuticals OncoMed Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics.  OncoMed has internally discovered a broad pipeline of investigational drugs intended to address the fundamental biology driving cancer’s growth, resistance, recurrence and metastasis.  Demcizumab (anti-DLL4, OMP-21M18), navicixizumab (anti-DLL4/VEGF bispecific, OMP-305B83), rosmantuzumab (anti-RSPO3, OMP-131R10) and anti-TIGIT (OMP-313M32) are part of the company’s strategic alliances with Celgene Corporation.  OncoMed is independently developing vantictumab (anti-Fzd, OMP-18R5), ipafricept (Fzd8-Fc, OMP-54F28) and GITRL-Fc (OMP-336B11), as well as continuing to pursue new drug discovery research.  For further information about OncoMed Pharmaceuticals, please see www.oncomed.com. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding OncoMed Pharmaceuticals, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, OncoMed's intentions and expectations regarding the ability of OncoMed’s anti-TIGIT  antibody to enable T-cell activation, block suppression of the immune system in tumors, facilitate an anti-tumor immune response, and impact tumor growth by blocking TIGIT signaling and/or through other mechanisms; the similarity of anti-TIGIT to marketed checkpoint inhibitors; and the potential for  anti-TIGIT to be broadly active and benefit a significant number of patients.  Such forward-looking statements involve substantial risks and uncertainties that could cause OncoMed's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; OncoMed's dependence on its collaboration partners, including Celgene, for the funding of its partnered programs; OncoMed's ability to raise additional capital to support the development of its unpartnered programs; OncoMed's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; OncoMed's reliance on single source third-party contract manufacturing organizations to manufacture and supply its product candidates; OncoMed's ability to discover, develop and commercialize additional product candidates; and OncoMed's dependence on its key executives. OncoMed undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to OncoMed's business in general, see OncoMed's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 9, 2017 and OncoMed’s other current and periodic reports filed with the SEC.


News Article | May 4, 2017
Site: globenewswire.com

REDWOOD CITY, Calif., May 04, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, announced today that the first patient has been dosed in the company’s Phase 1a clinical trial of anti-TIGIT (OMP-313M32).  Anti-TIGIT is an investigational immuno-oncology therapeutic candidate intended to block suppression of the immune system in tumors and enable immune system anti-tumor activity, similar to marketed checkpoint inhibitors that target the PD-L1-PD-1 axis. “The first wave of immuno-oncology agents demonstrated that disabling immune suppression mechanisms in tumors can enable the body’s immune system to fight cancers with good efficacy. Still, available immunotherapies have limited results for many cancer patients, and there remains a pressing need for new agents and combinations to improve outcomes,” said Johanna Bendell, M.D., Associate Director of the Drug Development Program at Sarah Cannon Research Institute and a lead investigator for the Phase 1a anti-TIGIT study.  “The immuno-suppressive receptor TIGIT is expressed on many different tumor types, giving us reason to believe that an anti-TIGIT antibody, such as OncoMed’s OMP-313M32, has potential for broad activity in cancer patients. I look forward to seeing its performance in the clinic.” The Phase 1 open-label clinical trial is designed to assess the safety and tolerability of escalating doses of anti-TIGIT in patients with advanced or metastatic solid tumors.  Secondary objectives for the trial include characterization of the pharmacokinetics, immunogenicity and anti-tumor efficacy of single-agent anti-TIGIT.  Pharmacodynamic and potential predictive biomarkers focused on changes in immune system activation will also be explored.  Anti-TIGIT will be administered as a single agent every two weeks at escalating dose levels.  Once a maximum-tolerated dose has been achieved, an expansion cohort will enroll patients with certain tumor types.  The trial will be conducted at five centers in the U.S. and is expected to enroll approximately 30 patients. “In multiple preclinical studies of anti-TIGIT antibodies, we have observed immune activation and single-agent as well as combination anti-tumor activity, including indications that an anti-TIGIT antibody induced a long-term immune memory response.” said Robert Stagg, Pharm.D., OncoMed’s Senior Vice President of Clinical Research and Development. “The initiation of this Phase 1a anti-TIGIT study represents the first of our novel immuno-oncology therapeutics to enter clinical trials.  We believe that by blocking TIGIT signaling, our anti-TIGIT antibody may enable T-cell activation and facilitate anti-tumor immune responses with the potential to impact tumor growth.” About Anti-TIGIT TIGIT (T cell immunoreceptor with Ig and ITIM domains) blocks T cells from attacking tumor cells and is similar in structure and function to the inhibitory protein PD-1. OncoMed’s anti-TIGIT antibody (OMP-313M32) is intended to activate the immune system through multiple mechanisms and enable anti-tumor activity. At the 2017 AACR Annual Meeting, OncoMed presented data from several studies characterizing anti-TIGIT’s mechanism, identifying pharmacodynamics biomarkers and demonstrating potent anti-tumor responses in in-vivo models. In preclinical studies, anti-TIGIT antibodies increased cytotoxic T-cell activity against tumor cells and decreased T-cell suppression. A surrogate anti-TIGIT antibody used in syngeneic mouse models of different solid tumors demonstrated dose-dependent, potent single-agent anti-tumor efficacy. Anti-TIGIT antibodies also demonstrated combination activity with checkpoint inhibitors anti-PD1 and anti-PD-L1 in preclinical models.  When mice whose tumors achieved complete regression following treatment with anti-TIGIT, anti-TIGIT plus anti-PD1 or anti-TIGIT plus anti-PD-L1 were re-challenged with increasing number of tumor cells, they remained protected from tumor growth, suggesting the induction of immunologic memory against the tumor cells. This program is part of OncoMed’s Celgene collaboration. About OncoMed Pharmaceuticals OncoMed Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics.  OncoMed has internally discovered a broad pipeline of investigational drugs intended to address the fundamental biology driving cancer’s growth, resistance, recurrence and metastasis.  Demcizumab (anti-DLL4, OMP-21M18), navicixizumab (anti-DLL4/VEGF bispecific, OMP-305B83), rosmantuzumab (anti-RSPO3, OMP-131R10) and anti-TIGIT (OMP-313M32) are part of the company’s strategic alliances with Celgene Corporation.  OncoMed is independently developing vantictumab (anti-Fzd, OMP-18R5), ipafricept (Fzd8-Fc, OMP-54F28) and GITRL-Fc (OMP-336B11), as well as continuing to pursue new drug discovery research.  For further information about OncoMed Pharmaceuticals, please see www.oncomed.com. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding OncoMed Pharmaceuticals, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, OncoMed's intentions and expectations regarding the ability of OncoMed’s anti-TIGIT  antibody to enable T-cell activation, block suppression of the immune system in tumors, facilitate an anti-tumor immune response, and impact tumor growth by blocking TIGIT signaling and/or through other mechanisms; the similarity of anti-TIGIT to marketed checkpoint inhibitors; and the potential for  anti-TIGIT to be broadly active and benefit a significant number of patients.  Such forward-looking statements involve substantial risks and uncertainties that could cause OncoMed's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; OncoMed's dependence on its collaboration partners, including Celgene, for the funding of its partnered programs; OncoMed's ability to raise additional capital to support the development of its unpartnered programs; OncoMed's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; OncoMed's reliance on single source third-party contract manufacturing organizations to manufacture and supply its product candidates; OncoMed's ability to discover, develop and commercialize additional product candidates; and OncoMed's dependence on its key executives. OncoMed undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to OncoMed's business in general, see OncoMed's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 9, 2017 and OncoMed’s other current and periodic reports filed with the SEC.


News Article | May 4, 2017
Site: globenewswire.com

REDWOOD CITY, Calif., May 04, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, announced today that the first patient has been dosed in the company’s Phase 1a clinical trial of anti-TIGIT (OMP-313M32).  Anti-TIGIT is an investigational immuno-oncology therapeutic candidate intended to block suppression of the immune system in tumors and enable immune system anti-tumor activity, similar to marketed checkpoint inhibitors that target the PD-L1-PD-1 axis. “The first wave of immuno-oncology agents demonstrated that disabling immune suppression mechanisms in tumors can enable the body’s immune system to fight cancers with good efficacy. Still, available immunotherapies have limited results for many cancer patients, and there remains a pressing need for new agents and combinations to improve outcomes,” said Johanna Bendell, M.D., Associate Director of the Drug Development Program at Sarah Cannon Research Institute and a lead investigator for the Phase 1a anti-TIGIT study.  “The immuno-suppressive receptor TIGIT is expressed on many different tumor types, giving us reason to believe that an anti-TIGIT antibody, such as OncoMed’s OMP-313M32, has potential for broad activity in cancer patients. I look forward to seeing its performance in the clinic.” The Phase 1 open-label clinical trial is designed to assess the safety and tolerability of escalating doses of anti-TIGIT in patients with advanced or metastatic solid tumors.  Secondary objectives for the trial include characterization of the pharmacokinetics, immunogenicity and anti-tumor efficacy of single-agent anti-TIGIT.  Pharmacodynamic and potential predictive biomarkers focused on changes in immune system activation will also be explored.  Anti-TIGIT will be administered as a single agent every two weeks at escalating dose levels.  Once a maximum-tolerated dose has been achieved, an expansion cohort will enroll patients with certain tumor types.  The trial will be conducted at five centers in the U.S. and is expected to enroll approximately 30 patients. “In multiple preclinical studies of anti-TIGIT antibodies, we have observed immune activation and single-agent as well as combination anti-tumor activity, including indications that an anti-TIGIT antibody induced a long-term immune memory response.” said Robert Stagg, Pharm.D., OncoMed’s Senior Vice President of Clinical Research and Development. “The initiation of this Phase 1a anti-TIGIT study represents the first of our novel immuno-oncology therapeutics to enter clinical trials.  We believe that by blocking TIGIT signaling, our anti-TIGIT antibody may enable T-cell activation and facilitate anti-tumor immune responses with the potential to impact tumor growth.” About Anti-TIGIT TIGIT (T cell immunoreceptor with Ig and ITIM domains) blocks T cells from attacking tumor cells and is similar in structure and function to the inhibitory protein PD-1. OncoMed’s anti-TIGIT antibody (OMP-313M32) is intended to activate the immune system through multiple mechanisms and enable anti-tumor activity. At the 2017 AACR Annual Meeting, OncoMed presented data from several studies characterizing anti-TIGIT’s mechanism, identifying pharmacodynamics biomarkers and demonstrating potent anti-tumor responses in in-vivo models. In preclinical studies, anti-TIGIT antibodies increased cytotoxic T-cell activity against tumor cells and decreased T-cell suppression. A surrogate anti-TIGIT antibody used in syngeneic mouse models of different solid tumors demonstrated dose-dependent, potent single-agent anti-tumor efficacy. Anti-TIGIT antibodies also demonstrated combination activity with checkpoint inhibitors anti-PD1 and anti-PD-L1 in preclinical models.  When mice whose tumors achieved complete regression following treatment with anti-TIGIT, anti-TIGIT plus anti-PD1 or anti-TIGIT plus anti-PD-L1 were re-challenged with increasing number of tumor cells, they remained protected from tumor growth, suggesting the induction of immunologic memory against the tumor cells. This program is part of OncoMed’s Celgene collaboration. About OncoMed Pharmaceuticals OncoMed Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics.  OncoMed has internally discovered a broad pipeline of investigational drugs intended to address the fundamental biology driving cancer’s growth, resistance, recurrence and metastasis.  Demcizumab (anti-DLL4, OMP-21M18), navicixizumab (anti-DLL4/VEGF bispecific, OMP-305B83), rosmantuzumab (anti-RSPO3, OMP-131R10) and anti-TIGIT (OMP-313M32) are part of the company’s strategic alliances with Celgene Corporation.  OncoMed is independently developing vantictumab (anti-Fzd, OMP-18R5), ipafricept (Fzd8-Fc, OMP-54F28) and GITRL-Fc (OMP-336B11), as well as continuing to pursue new drug discovery research.  For further information about OncoMed Pharmaceuticals, please see www.oncomed.com. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding OncoMed Pharmaceuticals, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, without limitation, OncoMed's intentions and expectations regarding the ability of OncoMed’s anti-TIGIT  antibody to enable T-cell activation, block suppression of the immune system in tumors, facilitate an anti-tumor immune response, and impact tumor growth by blocking TIGIT signaling and/or through other mechanisms; the similarity of anti-TIGIT to marketed checkpoint inhibitors; and the potential for  anti-TIGIT to be broadly active and benefit a significant number of patients.  Such forward-looking statements involve substantial risks and uncertainties that could cause OncoMed's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; OncoMed's dependence on its collaboration partners, including Celgene, for the funding of its partnered programs; OncoMed's ability to raise additional capital to support the development of its unpartnered programs; OncoMed's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; OncoMed's reliance on single source third-party contract manufacturing organizations to manufacture and supply its product candidates; OncoMed's ability to discover, develop and commercialize additional product candidates; and OncoMed's dependence on its key executives. OncoMed undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to OncoMed's business in general, see OncoMed's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 9, 2017 and OncoMed’s other current and periodic reports filed with the SEC.


News Article | April 13, 2017
Site: www.chromatographytechniques.com

A new study published this week in the journal Proceedings of the National Academy of Sciences refines our understanding of a human skill — the ability to instantaneously assess a new environment and get oriented thanks to visual cues. Whereas humans can look at a complex landscape like a mountain vista and almost immediately orient themselves to navigate its multiple regions over long distances, other mammals such as rodents orient relative to physical cues — like approaching and sniffing a wall — that build up over time. The way humans navigate their surroundings and understand their relative position includes an environment-dependent scaling mechanism, an adaptive coordinate system with differences from other mammals, according to the study led by researchers at The University of Texas at Austin. “Our research, based on human data, redefines the fundamental properties of the internal coordinate system,” said Zoltan Nadasdy, lead author of the study and an adjunct assistant professor in the university’s Department of Psychology. Nadasdy is also a researcher at Eötvös Loránd University and the Sarah Cannon Research Institute at St. David’s Medical Center. “Dysfunction in this system causes memory problems and disorientation, such as we see in Alzheimer’s disease and age-related decline. So, it’s vital that we continue to further our understanding of this part of the brain,” he said. Through a partnership with Seton Healthcare Family, the researchers in the UT Austin Human Brain Stimulation and Electrophysiology Lab were able to measure relevant brain activity of epileptic patients whose diagnostic procedure requires that they have electrodes planted in the entorhinal cortex of the brain. Neurons there serve as the internal coordinate system for humans. (The brains of individuals with epilepsy function normally when not undergoing a seizure.) Patients performed a virtual navigation task on a tablet computer in four environments daily for seven to eight consecutive days. By measuring their brain activity, the researchers identified three previously unknown traits of the system: The findings illuminate the fabric of the human memory and spatial navigation, which are vulnerable to disease and deterioration. Deeper knowledge of these neuronal mechanisms can inform the development of techniques to prolong the health of this part of the brain and combat diseases such as Alzheimer’s. The study builds on earlier Nobel Prize-winning research exploring the entorhinal cortex of rodents. Due to the differences discovered between the human and rodent systems of navigation, the researchers emphasize that generalizing results from studies on animal subjects may provide inaccurate conjectures. This study is one of the few on human subjects that report on the activity of individual neuron behavior, said György Buzsáki, an expert from New York University Medical Center who was not involved in the research. “They not only confirm a previous report but extend the findings by showing that the size of the neuronal representation by entorhinal grid cells scales with the environment,” Buzsáki said. “Our hypothesis is challenging the definition of a universal spatial scale of environment predominant in lower mammals, which may open up important avenues of discovery,” said Robert Buchanan, another lead author on the study and an associate professor at Dell Medical School. He is also an adjunct associate professor in the university’s Department of Psychology and a chief of neurosurgery at Seton Brain and Spine Institute. “Now, we can continue to explore this key component of what it means to be human — how we think about our past and future, how we imagine and plan,” Buchanan said. By using virtual reality, the researchers also refined a new experimental technology for facilitating spatial experiences that can’t be reproduced in a laboratory. The data implies that humans can seamlessly switch between reality and virtual reality — a finding that can be applied in other studies of the brain.


News Article | April 17, 2017
Site: www.futurity.org

Whereas humans can look at a complex landscape like a mountain vista and almost immediately orient themselves to navigate its multiple regions over long distances, other mammals such as rodents orient relative to physical cues—like approaching and sniffing a wall—that build up over time. This ability to navigate our surroundings and understand our relative position includes an environment-dependent scaling mechanism, according to a new study. “Our research, based on human data, redefines the fundamental properties of the internal coordinate system,” says Zoltan Nadasdy, lead author of the study and an adjunct assistant professor in the University of Texas at Austin’s psychology department. Nadasdy is also a researcher at Eötvös Loránd University and the Sarah Cannon Research Institute at St. David’s Medical Center. “Dysfunction in this system causes memory problems and disorientation, such as we see in Alzheimer’s disease and age-related decline. So, it’s vital that we continue to further our understanding of this part of the brain,” he says. Through a partnership with Seton Healthcare Family, the researchers in the UT Austin Human Brain Stimulation and Electrophysiology Lab were able to measure relevant brain activity of epileptic patients whose diagnostic procedure requires that they have electrodes planted in the entorhinal cortex of the brain. Neurons there serve as the internal coordinate system for humans. (The brains of individuals with epilepsy function normally when not undergoing a seizure.) Patients performed a virtual navigation task on a tablet computer in four environments daily for seven to eight consecutive days. By measuring their brain activity, the researchers identified three previously unknown traits of the system: The findings illuminate the fabric of the human memory and spatial navigation, which are vulnerable to disease and deterioration. Deeper knowledge of these neuronal mechanisms can inform the development of techniques to prolong the health of this part of the brain and combat diseases such as Alzheimer’s. The study, published in the Proceedings of the National Academy of Sciences, builds on earlier Nobel Prize-winning research exploring the entorhinal cortex of rodents. Due to the differences discovered between the human and rodent systems of navigation, the researchers emphasize that generalizing results from studies on animal subjects may provide inaccurate conjectures. This study is one of the few on human subjects that report on the activity of individual neuron behavior, says György Buzsáki, an expert from New York University Medical Center who was not involved in the research. “They not only confirm a previous report but extend the findings by showing that the size of the neuronal representation by entorhinal grid cells scales with the environment,” Buzsáki says. “Our hypothesis is challenging the definition of a universal spatial scale of environment predominant in lower mammals, which may open up important avenues of discovery,” says Robert Buchanan, another lead author of the study and an associate professor at Dell Medical School. He is also an adjunct associate professor in the university’s psychology department and a chief of neurosurgery at Seton Brain and Spine Institute. “Now, we can continue to explore this key component of what it means to be human—how we think about our past and future, how we imagine and plan,” Buchanan says. By using virtual reality, the researchers also refined a new experimental technology for facilitating spatial experiences that can’t be reproduced in a laboratory. The data implies that humans can seamlessly switch between reality and virtual reality—a finding that can be applied in other studies of the brain. Additional coauthors are from Baylor College of Medicine; Eötvös Loránd University and Hungarian Academy of Sciences; and UT Austin’s Dell Medical School and Seton Brain and Spine Institute. The Brain and Behavior Research Foundation and the Seton Seed Grant for Research supported the work.


– Company to Host Investor Conference Call and Webcast on Monday, December 19, 2016 – STAMFORD, Conn., Dec. 12, 2016 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that the abstract titled "Clinical safety and activity from a phase 1 study of LOXO-101, a selective TRKA/B/C inhibitor, in solid-tumor patients with NTRK gene fusions" has been accepted for oral presentation at the European Society for Medical Oncology (ESMO) Asia Congress, taking place December 16-19, 2016 in Singapore. Data from this trial were last presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2016. The presentation will include an efficacy and durability update for enrolled patients with TRK fusions. The schedule for the presentation is as follows: Presentation Session Date & Time: December 18, 2016, 4:30 p.m. to 6:00 p.m. SGT Title: Clinical safety and activity from a phase 1 study of LOXO-101, a selective TRKA/B/C inhibitor, in solid-tumor patients with NTRK gene fusions Abstract Number: 150O Session: Developmental Therapeutics, Proffered Paper Session (oral presentation) Presenter: Todd Bauer, M.D., Associate Director, Drug Development; Principal Investigator, Sarah Cannon Research Institute Conference Call and Webcast In conjunction with ESMO Asia, Loxo Oncology will be hosting a conference call and live webcast with slides and Q&A on December 19, 2016 at 8:00 a.m. ET to discuss the LOXO-101 Phase 1 data and provide a comprehensive program and pipeline update. The company anticipates that the conference call and webcast will last 60-90 minutes. To participate in the conference call, please dial (877) 930-8065 (domestic) or (253) 336-8041 (international) and refer to conference ID 16640119. A live webcast of the presentation will be available at http://ir.loxooncology.com/. A replay of the webcast will be available shortly after the conclusion of the call and archived on the company's website for 30 days following the call. About Loxo Oncology Loxo Oncology is a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers. Our pipeline focuses on cancers that are uniquely dependent on single gene abnormalities, such that a single drug has the potential to treat the cancer with dramatic effect. We believe that the most selective, purpose-built medicines have the highest probability of maximally inhibiting the intended target, thereby delivering best-in-class disease control and safety. Our management team seeks out experienced industry partners, world-class scientific advisors and innovative clinical-regulatory approaches to deliver new cancer therapies to patients as quickly and efficiently as possible. For more information, please visit the company's website at www.loxooncology.com.


Updated Data from Phase 1b Triplet Combination Trial at SABCS; Increased Median PFS to 7.8 Months and ORR to 61 Percent; Median Duration of Response (MDR) at 10 Months in Third-line Setting for Patients With and Without Brain Metastases  HER2CLIMB Amended to Single Pivotal Randomized Trial to Assess Progression-Free Survival (PFS) as Primary Endpoint SAN ANTONIO, Texas, Dec. 07, 2016 (GLOBE NEWSWIRE) -- Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage biopharmaceutical company, today announced that following a recent meeting with the U.S. Food and Drug Administration (FDA) and discussions with the Company’s external Steering Committee, it has amended the HER2CLIMB Phase 2 clinical trial of tucatinib (also known as ONT-380) by increasing the sample size so that, if successful, the trial could serve as a single pivotal study to support registration. This decision is supported by the most recent data from the Company’s ongoing Phase 1b study evaluating the same “triplet combination” therapy being investigated in the amended Phase 2 trial, which is tucatinib in combination with capecitabine and trastuzumab for patients with metastatic or locally advanced HER2-positive breast cancer, including patients with and without brain metastases. Tucatinib is an oral, small molecule kinase inhibitor that is highly selective for HER2 without significant inhibition of EGFR. HER2CLIMB is an ongoing randomized, controlled pivotal trial evaluating tucatinib in combination with trastuzumab (Herceptin®) and capecitabine (Xeloda®) in heavily pre-treated patients with advanced HER2-positive breast cancer with or without brain metastases. “We are extremely pleased with the outcome of our recent interactions with the FDA, and we have decided to amend the current Phase 2 clinical trial of tucatinib so that, if successful, HER2CLIMB could serve as a single pivotal registration trial and potentially provide us with a more efficient path to market,” commented Scott Myers, President and CEO of Cascadian Therapeutics. “We look forward to continuing a collaborative relationship with the agency and our clinical investigators as we advance the development of tucatinib in combination in the third-line metastatic breast cancer setting where there is no single standard-of-care and a need for more tolerable therapeutic options. The improvement in the updated data from our Phase 1b “triplet combination” study reinforces our strategy with tucatinib in this patient population.” Updated Phase 1b trial results for the triplet combination show that the combination (tucatinib with capecitabine and trastuzumab) continues to be well tolerated, with the updated median progression-free survival (PFS) increasing to 7.8 months, an overall response rate (ORR) of 61 percent and a median duration of response (MDR) of 10 months. Patients in the Phase 1b triplet combination previously received a median of 3 HER2-targeted agents, such as trastuzumab, pertuzumab, lapatinib or T-DM1. Poster presentations on the amended HER2CLIMB pivotal trial and the updated Phase 1b “triplet combination” trial data will be presented at the 2016 San Antonio Breast Cancer Symposium (SABCS), December 6-10, 2016. “The more mature dataset from the Phase 1b trial continues to show tucatinib may be combined with other current targeted therapies to achieve durable responses in patients who have received multiple prior lines of therapy,” said Erika Hamilton, M.D., Director of Breast and Gynecology Cancer Research at Sarah Cannon Research Institute. “Tucatinib in combination appears to be well-tolerated, potentially making it a highly desirable HER2 therapy for a patient population that vitally needs new options. An active agent showing systemic activity, with a tolerable safety profile and early signs of activity in HER2-positive brain metastases, would represent a meaningful advancement in treating metastatic breast cancer.” HER2CLIMB is a randomized (2:1), double-blind, controlled pivotal clinical trial comparing tucatinib vs. placebo in combination with capecitabine and trastuzumab in patients with locally advanced or metastatic HER2-positive breast cancer who have had prior treatment with a taxane, trastuzumab, pertuzumab and T-DM1. Following a meeting with the FDA, the primary endpoint remains PFS based upon independent radiologic review, and the sample size will increase to approximately 480 patients, including patients already enrolled in the trial. Key objectives related to assessing activity in brain metastases include a key secondary endpoint of PFS in a subset of patients with brain metastases. All patients will be followed for overall survival. HER2CLIMB is currently enrolling in the United States and Canada and is expected to expand into Europe, Australia and Israel. Details of the amended HER2CLIMB clinical trial design will be presented in a poster session (OT1-02-09) at SABCS on Wednesday, December 7, 2016 beginning at 5:00 p.m. CST. Results reported in June 2016 showed a median PFS of 6.3 months and ORR of 58 percent. Updated data from the SABCS poster (P4-21-01) of the Phase 1b study show encouraging safety and anti-tumor activity in patients with and without brain metastases, with an updated median PFS of 7.8 months (a 24 percent improvement over prior median PFS), ORR of 61 percent and a median duration of response of 10 months. Patients with and without brain metastases had similar response rate. The combination of tucatinib with trastuzumab and capecitabine was well-tolerated. Most treatment-emergent adverse events were Grade 1, with few tucatinib dose reductions and no required prophylactic use of antidiarrheal agents. Updated results will be presented in a poster session at SABCS on Friday, December 9, 2016 beginning at 7:30 a.m. CST. Tucatinib is an orally bioavailable, potent tyrosine kinase inhibitor that is highly selective for HER2 without significant inhibition of EGFR. Inhibition of EGFR has been associated with significant toxicities, including skin rash and diarrhea. Tucatinib has shown activity as a single agent and in combination with both chemotherapy and other HER2 directed agents such as trastuzumab.1 Studies of tucatinib in these combinations have shown activity both systemically and in brain metastases. HER2 is a growth factor receptor that is overexpressed in multiple cancers, including breast, ovarian and gastric cancers. HER2 mediates cell growth, differentiation and survival. Tumors that overexpress HER2 are more aggressive and historically have been associated with poor overall survival, compared with HER2-negative cancers. Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the aggressive spread of cancer cells. The American Cancer Society estimates that 20-25 percent of the approximately 234,000 annual breast cancer diagnoses in the U.S. are HER2-positive. Historically, HER2 disease has been associated with shorter survival times as well as a higher risk of recurrence and CNS disease (brain metastases). Approximately 30 to 50 percent of HER2-positive breast cancer patients develop brain metastases over time.2,3 Over the past two decades, the approvals of four targeted treatments (trastuzumab, pertuzumab, lapatinib, and ado-trastuzumab emtansine) have led to improved time to progression and survival rates of HER2-positive patients. Despite these advances, there is still a significant need for new therapies that can impact metastatic disease, including brain metastases, and be tolerated for longer periods of time. Cascadian Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative product candidates for the treatment of cancer. The lead product candidate, tucatinib (also known as ONT-380) is an oral, selective small molecule HER2 inhibitor. Cascadian Therapeutics is conducting a randomized, double-blind, placebo-controlled pivotal clinical trial called HER2CLIMB, which is evaluating tucatinib versus placebo in combination with capecitabine and trastuzumab in late stage HER2-positive breast cancer patients, with and without brain metastases, who have previously been treated with a taxane, trastuzumab, pertuzumab and T-DM1. Additional details on HER2CLIMB can be found at www.clinicaltrials.gov (Identifier: NCT02614794) or www.HER2CLIMB.com. For more information, please visit www.cascadianrx.com. In order to provide Cascadian Therapeutics' investors with an understanding of its current results and future prospects, this release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include Cascadian Therapeutics' expectations regarding clinical development activities, and the potential benefits of tucatinib. Forward-looking statements involve risks and uncertainties related to Cascadian Therapeutics' business and the general economic environment, many of which are beyond its control. These risks, uncertainties and other factors could cause Cascadian Therapeutics' actual results to differ materially from those projected in forward-looking statements, including the risks associated with the costs and expenses of developing its product candidates, the adequacy of financing and cash, cash equivalents and investments, changes in general accounting policies, general economic factors, achievement of the results it anticipates from its preclinical development and clinical trials of its product candidates and its ability to adequately obtain and protect its intellectual property rights. Although Cascadian Therapeutics believes that the forward-looking statements contained herein are reasonable, it can give no assurance that its expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For a detailed description of Cascadian Therapeutics' risks and uncertainties, you are encouraged to review the documents filed with the securities regulators in the United States on EDGAR and in Canada on SEDAR. Except as required by law, Cascadian Therapeutics does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof. All trademarks are the property of their respective owners. References: 1. Koch et al. American Association of Clinical Research (AACR) 2011. 2. Metro et al. Clinical outcome of patients with brain metastases from HER2-positive breast cancer treated with lapatinib and capecitabine, Annals of Oncology, vol. 212, no. 3, pp. 625-630, 2011. 3. DOI: 10.1200/JCO.2013.54.0955 Journal of Clinical Oncology32, no. 19 (July 2014) 2100-2108.


WOBURN, Mass.--(BUSINESS WIRE)--Sirtex Medical Limited (ASX: SRX) today announced that SIR-Spheres® Y-90 resin microspheres has been included as a Category 2A recommended treatment in the latest National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for colon cancer and rectal cancer. This designation denotes that there is uniform consensus among the NCCN panel that Selective Internal Radiation Therapy (SIRT) with yttrium-90 microspheres is an appropriate option in patients with liver dominant, chemotherapy resistant colorectal disease (mCRC). This recommendation places SIR-Spheres Y-90 resin microspheres at the same designation as the recommended mCRC systemic chemotherapeutic regimens. The new NCCN Guidelines are available online at https://www.nccn.org/professionals/physician_gls/f_guidelines.asp Nearly 140,000 Americans are diagnosed with colorectal cancer every year1, more than 50 percent of whom will see the cancer spread to their liver.2 “The NCCN Guidelines aim to assist medical teams, patients and their families in making informed treatment-related decisions with the goal of optimal cancer care,” said Kevin Richardson, chief executive officer for Sirtex Americas. “The 2A designation represents a very important milestone for SIR-Spheres resin microspheres and provides further validation for the role of our medical device as an important treatment option for unresectable, liver dominant metastatic colorectal cancer. We also have positive signals in the first-line setting through the results to date of the pivotal SIRFLOX study3 and eagerly anticipate the overall survival results in more than 1,100 patients from the SIRFLOX, FOXFIRE and FOXFIRE Global studies which we expect to be available in the first half of 2017.” These findings are also supported by the landmark MORE study4, a large retrospective analysis conducted in the United States with SIR-Spheres Y-90 resin microspheres in more than 600 mCRC patients. The MORE study helped to increase the understanding of SIRT as a treatment option for patients who have failed multiple lines of chemotherapy while highlighting the positive aspects of the safety and efficacy of the protocol for patients of all ages. “Clinical research has shown that SIRT brings patients with colorectal liver metastases improved and prolonged quality of life,” said lead investigator of the MORE study, Andrew S. Kennedy, M.D., F.A.C.R.O., director, Radiation Oncology Research at Sarah Cannon Research Institute, Nashville, Tenn. “We look forward to expanding access to this outpatient procedure, which has demonstrated minimal side effects, to improve outcomes for this population of patients and advance the standard of care.” SIR-Spheres Y-90 resin microspheres are the first and only microspheres with FDA premarket approval (PMA) for colorectal cancer that has metastasized to the liver.5 SIR-Spheres® Y-90 resin microspheres are a medical device used in an interventional radiology procedure known as selective internal radiation therapy (SIRT), or radioembolization, which targets high doses of radiation directly to liver tumors. The treatment consists of tens of millions of radioactive Y-90 coated resin particles, each no bigger in diameter than a human hair. Interventional radiologists inject these resin particles, or microspheres, into the hepatic artery via a catheter inserted into the femoral artery through an incision in the groin. The Y-90 resin microspheres become lodged in the capillaries that surround liver tumors, where they deliver a high dose of short-range (mean 2.5 mm; maximum 11 mm) beta radiation to the liver tumors, while sparing healthy liver tissue. The low specific gravity of the Y-90 resin microspheres allows the blood flow to distribute the radioactivity within and around the liver tumors. Available at more than 550 treatment centers in the U.S., more than 67,000 doses of SIR-Spheres Y-90 resin microspheres have been supplied worldwide. SIR-Spheres Y-90 resin microspheres have a Premarket Approval (PMA) by the FDA and are indicated for the treatment of non-resectable metastatic liver tumors from primary colorectal cancer in combination with intra-hepatic artery chemotherapy using floxuridine. SIR-Spheres Y-90 resin microspheres are approved for the treatment of inoperable liver tumors in Australia, the European Union, Argentina, Brazil, Canada and several countries in Asia, such as India and Singapore. The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 27 of the world’s leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. Sirtex Medical Limited (ASX:SRX) is an Australian-based global healthcare business working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres Y-90 resin microspheres. More than 67,000 doses have been supplied to treat patients with liver cancer at more than 1,000 medical centers in over 40 countries. SIR-Spheres® is a registered trademark of Sirtex SIR-Spheres Pty Ltd. Sarah Cannon Research Institute is the research arm of Hospital Corporation of America’s global cancer institute, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. Sarah Cannon’s network of strategic sites includes more than 275 physicians who engage in research. The organization has led more than 250 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in more than two-thirds of approved cancer therapies over the last 10 years. Additionally, Sarah Cannon offers management, regulatory, and other research support services for drug development and industry sponsors as well as strategic investigator sites through its contract research organization (CRO), Sarah Cannon Development Innovations (formerly known as SCRI Development Innovations). For more information, visit sarahcannon.com.

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