CURRICULUM VITAE
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`Devalingam Mahalingam, MD, PhD
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`2342 Fountain Way
`San Antonio, TX 78248
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`Cancer Therapy and Research Center
`7979 Wurzbach Road
`Mail Code 8232
`San Antonio, TX 78229
`(210) 450-5970
`(210) 450-1686
`mahalingam@uthscsa.edu
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`11/4/1975
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`2009 - PhD- Cancer Research. Dept. of Medicine
`National University of Ireland,
`Galway, Ireland
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`2000 - MB BCh BAO Medicine
`National University of Ireland,
`Galway, Ireland
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`2001-2003 –Medicine Residency
`Royal College of Medicine Ireland,
`Dublin, Ireland
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`2004-2009 -Medical -Higher Specialty in Medical Oncology,
`Royal College of Physicians Ireland,
`Dublin, Ireland
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`2008-2009 -Medicine- Oncology Fellowship
`Institute of Drug Development, UTHSCSA,
`San Antonio, TX, USA
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`Texas Medical Board -2009 to date.
` Permanent License 2012 – to date P1668
`Temporary Medical License 2011 -43610
`Temporary Medical License 2010 - 43148
`Temporary Medical License 2009- 42669
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`American Board of Internal Medicine (ABIM)-08/2013-354753
`ABIM Medical Oncology-11/2014-354753
`Specialty Registration Medical Oncology - Royal College of Physicians of
`Ireland-06/2011 to date
`Royal College of Physicians United Kingdom (Internal Medicine)-03/2003
`Royal College of Physicians of Ireland (Internal Medicine)-02/2003
`ACLS - ACLS -Certified -09/2015- to date
`United States Medical Licensing Exams - USMLE Step 3-03/2008
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`ARGENTUM EX1074
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`Awards:
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`United States Medical Licensing Exams - USMLE Step 2 CS-12/2007
`United States Medical Licensing Exams - USMLE Part 1-10/2007
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`09/2013-Texas Society of Clinical Oncology (TxSCO) Fellows Award:
`Mentored Sukeshi Patel (recipient)
`11/2012-Student Research Competition and the Dean James J Young
`Award: Medical student Jamie Pinckard (recipient)
`10/2012-Key to the Cure Award
`12/2011-CTRC Clinical Investigator of the year
`10/2009- Southwest Oncology Group Meeting, New Investigator Award
`06/2009-FECS/AACR/ASCO Methods in Cancer Biology Award
`06/2008-FECS/AACR/ASCO joint "Methods inClinical Cancer Research"
`03/2007-Oncology Scholar Travel Award
`01/2005-4th Masterclass in Oncology: European School of Oncology.
`12/2001-Annual Case Presentation Competition JCMH, Dublin.
`06/1997-Health Research Board (HRB) Ireland, Medical student award.
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`Professional Experience:
`09/2014 to date: Associate Professor
` Division of Hematolgy/Oncology
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`Department of Medicine,
`University of Texas Health Science Center, San Antonio.
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`2011-Leader Gastrointestinal Malignancies Program &
`Co-Leader GU malignancies program, UT Health Science Center
`Cancer Therapy and Research Center, San Antonio, TX
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`09/2009 - 08/2014 -Assistant Professor of Medicine --UT Health Science
` Center at Cancer Therapy and Research Center, San Antonio, TX
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`Staff physician
`2009 to date: University Health Care system
`2014 to date: St. Luke’s Baptist Health System
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` Professional Organizations: Southwest Oncology Group (SWOG)- GI & GU committee
`American Association of Cancer Research
`American Society of Clinical Oncology
`Royal College of Physicians of United Kingdom
`Royal College of Physicians of Ireland
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`Activities:
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`2011-to date -Leader Gastrointestinal Malignancies, UTHSCSA
`2010-2015 Co-leader GU malignancies, UTHSCSA
`2010- IIMS/CTSA Pilot Project Scientific Review Panel
`2010-CTRC clinical trial pilot grant-Internal Reviewer
`2015- British Journal of Cancer- Journal Reviewer
`2009--Molecular Cancer Therapeutics --Journal Reviewer
`2009--Targeted Oncology --Journal Reviewer
`2009--Expert Opinion Journal series --Journal Reviewer
`2009--Cancer Chemotherapy and Pharmacology --Journal Reviewer
`2009-2013 Protocol Review Committee, UT Health Science Center
`2009-Present--Data Safety and Review Committee, UT Health Science
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` Presentations:
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`07/2015-Oncolytic Virus Therapy in Pancreatic Cancer: Clinical Efficacy and Pharmacodynamic
`Analysis of REOLYSIN, ESMO 17th World GI Cancer 2015 Conference, European Society for
`Medical Oncology World 2015, Barcelona, Spain.
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`07/2015-Treatment Innovations for Advanced Prostate Cancer, CTRC Community Cancer
`Seminar, San Antonio, TX
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`06/2015-PREVENTION OF NEUROPATHY USING CALMANGAFODIPIR, MASCC/ISOO 2015,
`Bone and neurological complications and nausea and vomiting, PledPharma AB, Copenhagen,
`Denmark (Oral Presenter)
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`06/2015-First-in-human, phase I study assessing imalumab (Bax69), a first-in-class anti-oxidized
`macrophage migration inhibitory factor (oxMIF) antibody in advanced solid tumors, ASCO 2015-
`51st Annual Meeting, Developmental Therapeutics—Clinical Pharmacology and Experimental
`Therapeutics, American Society of Clinical Oncology, Chicago, IL (Poster Discussion session)
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`05/2015-A mass spectrometry based serum test for the detection of HCC, AACR 2015 Annual
`Meeting, Cancer Researchers, American Association of Cancer Research, Philadelphia, PA
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`03/2015-Hepatocellular carcinoma research/clinical care, UT System Hepatocellular Carcinoma
`Cancer Symposium, University of TX, Ausitn, TX (Panel)
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`01/2015- Clinical activity and correlative DCE-MRI imaging of G-202, a thapsigargin-based
`prostate-specific membrane antigen-activated prodrug, 2015 GI Cancers Symposium,
`Gastrointestinal Cancers, ASCO, San Francisco, CA
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`09/2014-Metformin in combo w/ castration therapy in Prostate Canc, AACR Metformin in clinical
`trials special workshop, Clinical Investigators, American Association of Cancer Research, New
`Orleans, LA.
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`02/2014-Therapeutic Advances in the Management of Advanced HCC, Practical Applications of
`New Agents in Oncology, Oncology, UTHSCSA, San Antonio, TX (Oral presentation)
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`10/2013-A First-in-Human, Phase I Clinical Study of G-202, a Thapsigargin-Based Prostate-
`Specific Membrane Antigen (PSMA)-Activated Prodrug, in Patients with Advanced Solid Tumors,
`EORTC-NCI-AACR Symposium, Medical Oncologists, UTHSCSA, Boston, MA
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`06/2013-Beyond VEGF inhibition: Comparative efficacy analysis of novel VEGF and non-VEGF
`therapeutic agents in phase I trials for patients with metastatic colorectal cancer (mCRC).,
`American Society of Clinical Oncology (ASCO), Colorectal cancer, Chicago, IL
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`06/2013-A first-in-human phase I study of CZ48, a lactone ring protected oral camptothecin, in
`patients with advanced solid tumors, American Society of Clinical Oncology (ASCO),
`Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics, Chicago.
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`11/2012-Inhibition of Autophagy: A Phase 1 Safety, Tolerability, Pharmacokinetic and
`Pharmacodynamic analysis of Hydroxychloroquine in combination with the HDAC inhibitor,
`Vorinostat, in patients with advanced solid tumors, EORTC-NCI-AACR, Clinical therapeutics,
`Dublin, Ireland
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`11/2012-A First-in-human, Phase 1 Clinical Study of the Safety, Tolerability and
`Pharmacokinetics (PK) of G-202, a Thapsigargin-based PSMA-activated Prodrug, in Patients with
`Advanced Solid Tumors, EORTC-NCI-AACR, Clinical Therapeutics, Dublin, Ireland
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`11/2012-A Study of REOLYSIN in Combination with Gemcitabine in Patients with Advanced
`Pancreatic Adenocarcinoma, EORTC-AACR-NCI, Clinical Therapeutics, Dublin, Ireland
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`11/2012-Pharmacokinetic Study of Enzastaurin in Cancer Patients with Varying Degrees of
`Hepatic Dysfunction, EORTC-NCI-AACR, Clinical Therapeutics, Dublin, Ireland
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`06/2012-Modulation of autophagy: Phase 1 Safety, Tolerability, and Pharmacokinetics (PK) of
`Hydroxychloroquine (H) in Combination with the HDAC inhibitor Vorinostat (V) in Patients with
`Advanced Solid Tumors., American Society of Clinical Oncology (ASCO), Early Therapeutics,
`Chicago
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`06/2012-Phase I pharmacokinetic study of dasatinib (BMS-354825) in patients with advanced
`malignancies and varying levels of liver dysfunction: S0711, a SWOG early therapeutics
`committee study., American Society of Clinical Oncology (ASCO), Developmental Therapeutics -
`Experimental Therapeutics, Chicago, IL
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`05/2012-GE junction cancers- Treatment update, 15th Annual Cancer Updates: Doctors Hospital
`Laredo., Laredo, TX (Invited Speaker)
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`11/2011-Phase 1 Pharmacokinetics (PK) Assessments of ATI-1123, a Novel Human Serum
`Albumin-Stabilized Nanoparticle Docetaxel Liposomal Formulation, in Patients with Advanced
`Solid Malignancies, EORTC-NCI-AACR, San Francisco, CA
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`09/2011-Current treatment advances in Gastric cancers, Fellows Conference, UTHSCSA, San
`Antonio, TX (Invited Speaker)
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`06/2011-MLN4924, an investigational NEDD8-activating enzyme (NAE) inhibitor, in patients (pts)
`with advanced solid tumors: Phase I study of multiple treatment schedules, American Society of
`Clinical Oncology, Developmental Therapeutics - Experimental Therapeutics, Chicago, IL
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`06/2011-Phase I study evaluating the pharmacokinetics (PK) of components of S-1 in patients
`with impaired hepatic function, American Society of Clinical Oncology, Developmental
`Therapeutics - Clinical Pharmacology and Immunotherapy, Chicago, IL
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`04/2011-Inhibition of the Hedgehog Signaling Pathway has significant pre-clinical activity and
`prevents development of Androgen-Independent Prostate Cancer, American Association of
`Cancer Research (AACR), Orlando, FL
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`01/2011-Phase 1 Pharmacokinetic (PK) Assessments of ATI-1123, a Novel Human Serum
`Albumin-Stabilized Nanoparticle Docetaxel Liposomal Formulation, in Patients with Advanced
`Solid Malignancies, American Society of Clinical Oncology (ASCO), Chicago, IL
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`11/2010-Phase II study evaluating the efficacy, safety, and pharmacodynamic correlative study of
`dual antiangiogenic inhibition using bevacizumab (B) in combination with sorafenib (S) in patients
`(pts) with advanced malignant melanoma., EORTC-NCI-AACR, Melanoma, Berlin, Germany
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`06/2010-Safety and pharmacokinetics (PK) of AMG 479 in combination with erlotinib (E) or
`sorafenib (S) in patients (pts) with advanced solid tumors., American Society of Clinical Oncology
`(ASCO), Chicago, IL
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`06/2010-Mammalian target of rapamycin (mTOR)-induced pneumonitis: Single-institution
`experience and treatment., American Society of Clinical Oncology (ASCO), Chicago, IL
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`06/2010-A New Rotary Powered Device for Bone Marrow Aspiration and Biopsy Yields Superior
`Specimens with Less Pain: Results of a Randomized Clinical Study, American Society of
`Hematology 2010, Atlanta, GA
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`02/2010-A Novel First in Class Inhibitor of the NEDD8 Activating Enzyme (NAE), has Potent
`Activity in Pre-ClinicalModels of Acute Myeloid Leukemia (AML), Fifth Internation Conference
`SUMO, MD Anderson Cancer Center, Houston, TX
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`01/2010-The First-In-Class Molecule Inhibitor of NEDD8-Activating Enzyme (NAE), MLN4924,
`Induces Stable Disease Regression in Pre-Clinical Models of Acute Myeloid Leukemia (AML),
`European Hematology Association
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`11/2009-SGI-1776: A novel PIM kinase inhibitor with potent preclinical activity against acute
`myeloid leukemia, AACR-EORTC-NCI
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`06/2009-A Novel First in Class Inhibitor of the NEDD8 Activating Enzyme (NAE), has Potent
`Activity in Pre-Clinical Models of Acute Myeloid Leukemia (AML)., European Hematology
`Association (EHA) 2009, Berlin, Germany
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`01/2009-The novel PIM kinase inhibitor SGI-1776 significantly enhances pre-clinical activity of
`sunitinib in renal cell carcinoma, AACR-EORTC-NCI Molecular Targets and Cancer Therapeutics
`Conference, AACR-EORTC-NCI, Boston, MA
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`01/2009-Vorinostat significantly improves the anticancer activity of temsirolimus in renal cancer
`through suppression of survivin levels, Annual Conference, American Assoc. of Cancer
`Research, Denver, CO
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`01/2009-A novel first in class inhibitor of the NEDD8 activating enzyme (NAE), has potent activity
`in pre-clinical models of acute myeloid leukemia (AML), European Hematology Association
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`01/2009-The Aurora A kinase inhibitor MLN8237 targets Aurora A kinase and BCR-ABL kinase in
`CML, is effective inImatinib resistant T315I mutations, and significantly increases the efficacy of
`Nilotinib, American Association of Cancer Research (AACR), AACR
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`01/2009-The Aurora A kinase inhibitor MLN8237 targets Aurora A kinase and BCR-ABL kinase in
`CML, is effective in Imatinib resistant T315I mutations, and significantly increases the efficacy of
`Nilotinib, European Hematology Association, EHA
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`01/2009-The Aurora A kinase inhibitor MLN8237 targets Aurora A kinase in AML, and
`significantly increases the efficacy of the standard of care agent Cytarabine, European
`Hematology Association, EHA
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`01/2009-SGI-1776: A novel PIM kinase inhibitor with potent preclinical activity against acute
`myeloid leukemia, European Hematology Association, EHA
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`12/2008-DR5 selective TRAIL variants induce efficient cell death in tumor cells, Irish Society of
`Medical Oncology, Irish Society of Medical Oncology
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`01/2008-A kinase inhibitor MLN8237 has potent anticancer activity in CML and Ph+ ALL models
`and significantly increases the efficacy of Nilotinib, American Society of Hematology
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`01/2008-The Aurora A kinase inhibitor MLN8237 targets Aurora A kinase and BCR-ABL kinase in
`CML, is effective inImatinib resistant T315I mutations, and significantly increases the efficacy of
`Nilotinib, American Society of Hematology
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`10/2007-The role of decoy receptors in TRAIL resistance of transformed cells, Capri Science
`Conferences: Cancer Therapeutics: The Road Ahead, Capri Science Conferences, Capri, Italy
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`01/2007-Receptor selective TRAIL variants kill tumour cells more efficiently without damaging
`non-transformed cells, Irish Association of Cancer, Irish Association of Cancer01/2007-Post San
`Antonio Breast Conference Novel Scientific approaches to treat breast cancer, San Antonio
`Breast Conference, Dublin, Ireland
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`01/2007-Decoy-insensitive TRAIL variants kill tumour cells more efficiently without damaging
`non-transformed cells, American Association of Cancer Research (AACR), American Association
`of Cancer Research, Los Angeles, CA
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`01/2007-Novel Scientific approaches to treat breast cancer, Post San Antonio Breast
`Conference, Irish society of medical oncology, Dublin, Ireland (Invited Speaker)
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`01/2006-TRAIL induces tumor cell apoptosis exclusively through DR4 or DR5, European Cell
`Death Organization (ECDO), European Cell Death Organisation, Sardinia, Italy
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`05/2005-Delays in discharging palliative care patient at UCHG, UCHG grand rounds, Galway,
`Ireland.
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`01/2005-4th Masterclass in Clinical Oncology An interesting case of Non HIV Primary CNS
`lymphoma, European School of Oncology, European School of Oncology
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`01/2005-Identification of genes regulated by TRAIL in Colo205 colorectal, Irish Association of
`Clinical Research, Irish Association of Cancer Research, Galway, Ireland (Invited Speaker)
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`01/2005-Clinical Audit: Delays in discharging palliative care patients to Hospice care - Impact on
`the Oncology ward and patient treatment, Grand Rounds, University College Hospital, Galway,
`Galway, Ireland
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`12/2004-ESMO UPDATE PRESENTATION Current perspective in treatment of metastatic
`colorectal cancer, Irish society of Medical Oncology, European Society of Medical Oncology,
`Dublin, Ireland (Oral presenter)
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`Mentoring/Advising:
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`Fellows/Junior faculty
`2014-2016- Christos Fountzillas
`1)2015-Awarded Cancer Prevention Research Institute of Texas (CPRIT) Postdoctoral
`Fellowship.
`2) 2015-ASCO/AACR Workshop on Methods in Clinical Cancer Research July 25-31, 2015 in
`Vail.
`3) 2015 -Protocol development and initiation of A Phase Ib study of pembrolizumab
`(KEYTRUDA®) in combination with REOLYSIN® and chemotherapy in patients with advanced
`melanoma and pancreatic cancer.
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`2012 -2014 Raed Al-Rajabi
`1) Published in J Gastrointest Oncol. 2015 Jun;6(3):259-267. Al-Rajabi R, Patel S, Ketchum NS,
`Jaime NA, Lu TW, Pollock BH, Mahalingam D. Comparative dosing and efficacy of sorafenib in
`hepatocellular cancer patients with varying liver dysfunction
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`2012 – 2016 Sukeshi Patel
`1) Published in J Gastrointest Oncol 2014 Apr;5(2):99-103. Patel SR, Karnad AB, Ketchum NS,
`Pollock BH, Sarantopoulos J, Weitman S, Mahalingam D. Should we move beyond VEGF
`inhibition in metastatic colorectal cancer? Lessons from early phase clinical trials.
`2) Role of autophagy inhibition in colon cancer. Selected to participate in the 2014 ASCO/AACR
`Workshop on Methods in Clinical Cancer Research in Vail, CO. Selected based on study merit.
`Protocol titled,“A randomized phase II study of Hydroxychloroquine/Vorinostat vs Regorafenib G-
`in advanced colorectal carcinoma. – Grants K award and CPRIT award
`3) Recruited to GI Oncology faculty in 2015
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`Medical Students
`2012 -2013 -Jamie Pinckard
`Published in Clinical Investigations Journal "Advanced Cancer patients‘ understanding and
`perceptions of Phase I Clinical trials" Jamie Pinckard, Laeeq Malik, Devalingam Mahalingam.
`Winner medical student research Dean James J Young Award: 2012
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`Teaching Activities
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`04/2013 - ANAT4007 Cancer Cell Biology-Graduate -Lecturer
`09/2009 - Present-Fellow and Student Lectures -University of Texas Health Science Center
` 07/2003 - 06/2008 -Medical Students in Ireland -National Univ. of Ireland, Galway
`07/2003 - 06/2008 -Instructor for Oncology Masters of Nursing Degree Course in Ireland
`07/2004 - 06/2008 -Instructor for Post-graduates for MRCP examinations in Ireland
`07/2004 - 06/2008 -Instructor for Post-graduates for MRCP examinations in the UK
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` Extramural Research Support
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`Title: Inhibition of Autophagy in Solid Tumors: A Phase I Pharmacokinetic and Pharmacodynamic Study
`of Hydroxychloroquine in Combination with HDAC inhibitor SAHA for the Treatment of Patients with
`Advances Solid Tumors. NIH R21. CA139476-02. 07/2009 - 06/2013
`Role: Principal Investigator. Effort: 13%. Total Costs: $654,821.00
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`Title: Expansion Study: Inhibition of Autophagy in Solid Tumors: A Phase I Pharmacokinetic and
`Pharmacodynamic Study of Hydroxychloroquine in Combination with the HDAC Inhibitor SAHA for the
`Treatment of Patients with Advanced Solid Tumors. CTRC Clinical Trial Funds 01/2013 - 01/2015.
`Role: Principal Investigator. Total Costs: $90,397.00 (awarded from NCI P30 funds)
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`Title: Modulation of autophagy: A Phase II study of vorinostat plus hydroxychloroquine versus
`regorafenib in refractory metastatic colorectal cancer (mCRC) patients. The Cancer Prevention and
`Research Institute of Texas, RP140685-IIRA. 09/2014 - 09/2017
`Role: Principal Investigator. Effort: 20% Total Costs: $825,285.00
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`Title: Metformin: Identifying a therapeutic role in castrated men with prostate cancer. 06/2011 - 12/2014.
`CTRC Clinical Trial Pilot Fund (awarded via NCI P30 grant)
`Role: Principal Investigator. Total Costs: $72,690.00
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`Title: The role of metformin in preventing hyperinsulinemia and improving anti-tumor activity of castration
`therapy in patients with advanced prostate cancer. Bill and Ella Owens Foundation. 01/2011 - 12/2016
`Role: Principal Investigator. Effort: 3%. Total Costs: $97,904.00
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`Title: Phase II, Randomized, Placebo Controlled, Double Blind, Prospective Study of Castration
`Compared to Castration Plus Metformin as First Line Treatment for Patients with Advanced Prostate
`Cancer. Ireland Prostate Cancer Institute. 01/2011 - 01/2016
`Role: Principal Investigator. Effort: 3%. Total Costs: $50,000.00
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`Title: Targeting hedgehog pathway for prostate cancer treatment. Cancer Prevention & Research
`Institute of Texas (CPRIT). RP120290-IIRA.12/2011 - 05/2015
`Role: Co-Investigator. Effort: 5%. Total Costs: $884,089.00
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`Title: Identification of Selective Regulators of TRAIL induced apoptosis in Colon Carcinoma Cells. Cancer
`Research Ireland. 07/2005 - 06/2008
`Role: Co-Investigator. PhD researcher. Total Costs: $153,000.00
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`Title: Screening of celiac disease among first degree relatives using Anti-Endomysial Antibody Kit
`HRB Ireland Student research grant. 06/1997 - 08/1997
`Role: Co-Investigator. Total Costs: $1,500.00
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`Clinical Trial Support (Role as PI)
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`Phase 2 study of the oncolytic virus, REOVIRUS, when combined with low dose chemo and the anti-PD-1
`immune checkpoint inhibition, Keytruda in patients with advance pancreatic cancer. Role: Principal
`Investigator (Investigator initiated study)
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`Phase II study of vorinostat plus hydroxychloroquine versus regorafenib in refractory metastatic colorectal
`cancer (mCRC) patients. Role: Principal Investigator (Investigator initiated sponsored study)
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`Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients with Loc, A Phase II, Multicenter,
`Single-Arm Study of MPDL3280A in Patients with Locally Advanced or Metastatic Urothelial Bladder
`Cancer. Role: PI
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`Phase II, MC, Randomized, D-B: RO5520985 + Folfox vs Bevacizumab Plus Folf, A Phase II, Multicenter,
`Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of RO5520985 Plus Folfox Versus
`Bevacizumab Plus Folfox in Patients with Previously Untreated Metastatic Colorectal Cancer. Role: PI
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` Two Part, Phase 1, Multi-Center, Open-Label Study of DKN-01 in Combination with Weekly Paclitaxel;
`Arm A: A Dose-Escalation Study in Patients with Relapsed or Refractory Esophageal Cancer or Gastro-
`Esophageal Junction Tumors; Arm B: An Expansion Cohort in Patients with Relapsed or Refractory
`Esophageal Cancer or Gastro-Esophageal Junction Tumors. Role: PI
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`Phase I trial of CBL0137 in patients with metastatic or unresectable advances solid neoplasms or
`refractory lymphomas. Role: PI
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` Phase II, multicenter, single-arm study of G-202 as second-line therapy following Sorafenib for adult
`patients with progressive advanced hepatocellular carcinoma, 3 patient accruals to date
`Role: Lead PI (Study chair)
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`Numeration and single-cell molecular profiling of circulating tumor cells as prognostic and predictive
`marker in patients with advanced metastatic tumors, 23 patients accruals to date. Role: Lead PI
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` randomized, Phase II, open-label study evaluating DN24-02 as adjuvant therapy in subjects with high
`risk her 2+ urothelial carcinoma. Role: Local PI
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`Clinical study evaluating the safety and efficacy of MSC1936369B(oral MEK inhibitor) in combination with
`SAR245409 (oral PI3K inhibitor).Role: Local PI
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`Phase 2 single arm study of iv administration of JX-594 weekly for sorafenib naive patients with HCC.
`Role PI.
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` double blinded randomized three armed phase I/II trial of PledOx® in two different doses in combination
`with FOLFOX6 compared to placebo + FOLFOX6 in patients with advanced metastatic colorectal (stage
`IV) cancer (PLIANT study). Role: International study, US lead PI
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` Phase 1 Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and
`Pharmacodynamics of BAX69 in Subjects with Malignant Solid Tumors. Role: Lead PI
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` Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination with
`Gemcitabine in Patients with Metastatic Pancreatic Cancer. Role: PI
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`Phase 2 study of Ruxolitinib Efficacy & Safety in Combination with CApecita, A randomized Phase 2
`study of Ruxolitinib Efficacy & Safety in Combination with Capecitabine for Subjects with Recurrent or
`Treatment Refractory Metastatic Pancreatic Cancer (The RECAP trial). Role: Local PI
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` A
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` Phase 1 A/B dose escalation study to evaluate the safety, tolerability, and Pharmacokinetics of AbGn-7
`therapy alone and in combination with the FOLFOX7 treatment regimen in patients with advanced solid
`tumors. Role: Local PI
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`o-Open Label Multicenter 2-Arm Phase I Study of RO5429083 with Dose-Escalation and Extension
`Cohorts, and Imaging Cohorts with RO5429083 and Zr-Labeled RO5429083, in Patients with Metastatic
`and/or Locally Advanced, CD-44-Expressing, Malignant Solid Tumors. 6 patient accruals/$41,270.00 per
`patient. Role: Local PI
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`Phase II, randomized, placebo controlled, double blind, prospective study of castration compared to
`castration plus Metaformin as first line treatment for patients with advanced prostate cancer, 21 patient
`accruals. Role: Lead PI, multicenter investigator initiated study
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`An Open-Label, Single-Arm, Dose-Escalation Phase 1 Study of G-202 in Patients with Advanced Solid
`Tumors. Prostate specific membrane antigen (PSMA) was initially discovered in prostate cancer epithelial
`cells. It has seen been shown to be overexpressed in tumor neo-vasculature. Based on this, a phase 1
`study to identify the maximum tolerated dose of G202, a pro-drug that consists of a cytotoxic agent
`Thapsigargin linked to a protein that binds to PSMA, there leading to direct cytoxicity to tumors or tumor
`vasculature expressing PSMA. Role: Lead PI
`
`Phase 1, Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic and Pharmacokinetic
`Study of GO-203-2c Given Intravenously Daily X 21 Repeated Every 28 Days in Patients with Advanced
`Solid Tumors. Role: Local PI
`
`Phase I and Pharmacology Study of Camptothecin.20-0-Propionate Hydrate (CZ48) in Patients with Solid
`Tumors or Lymphoma. Role: Lead PI
`
`Phase 3 study of Hyperacute Vaccine in combination with standard adjuvant therapy for resected
`pancreatic cancer. Role: Local PI
`
` A
`
` Randomized, Double-Blind, Multi-Center Phase III Study of Brivanib plus Best Supportive Care (BSC)
`versus Placebo plus BSC in Subjects with Advanced Hepatocellular Carcinoma (HCC) Who Have Failed
`or are Intolerant to Sorafenib: Role: Local PI
`
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`Phase 2, Open-Label, Single-Arm, Multi-Center Study to Evaluate the Safety and Efficacy of AMG 386
`and Sorafenib as First Line Therapy for Subjects with Advanced or Inoperable Hepatocellular Carcinoma
`Role: Local PI
`
` A
`
` Phase 1, Open-label, Dose-escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of ATI-
`1123, a Liposomal Docetaxel Formulation, on an every 3 week Schedule in Patients with Advanced Solid
`Tumors. Role: Lead PI
`
` A
`
` Phase 2 study of REOLYSIN® in combo with Gemcitabine for patients with Advanced Pancreatic
`Adenocarcinoma. Role: Lead PI (Investigator Initiated Study)
`
` A
`
` Phase I Pharmacokinetic and Pharmacodynamic Study of Hydroxychloroquine in Combination with the
`HDAC Inhibitor SAHA for the Treatment of Patients with Advanced Solid Tumors with an expansion study
`in advanced Renal and Colorectal Cancer. Role: Lead PI
`
`
` Publications
`
`
`
` Journal Article (Peer Reviewed)
`-
`1. Mahalingam D, Wilding G, Denmeade S, Sarantopoulas J, Cosgrove D, Cetnar J, Azad N, Bruce J,
`Kurman M, Allgood VE, Carducci M. Mipsagargin, A Novel Thapsigargin-Based PSMA-Activated
`Prodrug: Results of a First-in-Man Phase I Clinical Trial in Patients with Refractory, Advanced or
`Metastatic Solid Tumors. Br J Cancer. 2016 Apr 26;114(9):986-94.
`2. Wang CP, Lehman DM, Lam YW, Kuhn JG, Mahalingam D, Weitman S, Carlos L, Downs JR, Stuart
`E, Hernandez J, Thompson IM, Ramirez A. Metformin for Reducing Racial/Ethnic Difference in
`Prostate Cancer Incidence for Men with Type 2 Diabetes. Cancer Prev Res. 2016 Mar 29
`3. Sunkel B, Wu D, Chen Z, Wang CM, Liu X, Ye Z, Horning AM, Liu J, Mahalingam D, Lopez-Nicora
`H, Lin CL, Goodfellow PJ, Clinton SK, Jin VX, Chen CL, Huang TH, Wang Q. Integrative analysis
`identifies targetable CREB1/FoxA1 transcriptional co-regulation as a predictor of prostate cancer
`recurrence. Nucleic Acids Res. 2016 Jan
`4. Falchook GS, Zhou X, Venkatakrishnan K, Kurzrock R, Mahalingam D, Goldman JW, Jung J,
`Ullmann CD, Milch C, Rosen LS, Sarantopoulos J. Effect of Food on the Pharmacokinetics of the
`Investigational Aurora A Kinase Inhibitor Alisertib (MLN8237) in Patients with Advanced Solid
`Tumors. Drugs R D. 2016 Mar;16(1):45-52.
`5. Mishra S, Tai Q, Gu X, Schmitz J, Poullard A, Fajardo RJ, Mahalingam D, Chen X, Zhu X, Sun LZ.
`Estrogen and estrogen receptor alpha promotes malignancy and osteoblastic tumorigenesis in
`prostate cancer. Oncotarget. 2015 Oct 31.
`6. Pawlowski J, Malik L, Mahalingam D. Advanced Cancer Patients’ Understanding and Perceptions of
`Phase 1 Clinical Trials. Cancer Invest. 2015 Nov 26;33(10):490-5.
`7. Sarantopoulos J, Shapiro GI, Cohen RB, Clark JW, Kauh JS, Weiss GJ, Cleary JM, Mahalingam D,
`Pickard MD, Faessel HM, Berger AJ, Burke K, Mulligan G, Dezube BJ, Harvey RD. Phase I Study of
`the Investigational NEDD8-Activating Enzyme Inhibitor Pevonedistat (TAK-924/MLN4924) in Patients
`with Advanced Solid Tumors. Clin Cancer Res. 2016 Feb 15;22(4):847-57.
`8. Mahalingam D, Patel S, Nuovo G, Gill G, Selvaggi G, Coffey M, Nawrocki ST. The combination of
`intravenous Reolysin and gemcitabine induces reovirus replication and endoplasmic reticular stress in
`a patient with KRAS-activated pancreatic cancer BMC Cancer 2015 Jul
`9. Al-Rajabi R, Patel S, Ketchum NS, Jaime NA, Lu TW, Pollock BH, Mahalingam D. Comparative
`dosing and efficacy of sorafenib in hepatocellular cancer patients with varying liver dysfunction. J
`Gastrointest Oncol. 2015 Jun;6(3):259-267.
`10. Birzele F, Voss E, Nopora A, Honold K, Heil F, Lohmann S, Verheul H, Le Tourneau C, Delord JP,
`van Herpen C, Mahalingam D, Coveler AL, Meresse V, Weigand S, Runza V, Cannarile M . CD44
`Isoform Status Predicts Response to Treatment with Anti-CD44 Antibody in Cancer Patients. Clin
`Cancer Res 2015 Jun
`11. Mahalingam D, Nemunaitis JJ, Malik L, Sarantopoulos J, Weitman S, Sankhala K, Hart J, Kousba A,
`Gallegos NS, Anderson G, Charles J, Rogers JM, Senzer NN, Mita AC . Phase I study of
`
`Page 10
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`intravenously administered ATI-1123, a liposomal docetaxel formulation in patients with advanced
`solid tumors Cancer Chemother Pharmacol 2014 Dec.
`12. Malik L, Mejia A, Parsons HM, Ehler B, Mahalingam D, Sarantopoulos J, Brenner AJ, Weitman SD.
`Predicting success in regulatory approval from Phase I results. Cancer Chemother Pharmacol. 2014
`Nov;74(5):1099-1103.
`13. Mahalingam D, Osmulski P, Gaczynska ME, Liu J, Huang S, Horning AM, Wang CM, Thompson IM,
`Huang TH, Chen CL.. Nanomechanical biomarkers of single circulating tumor cells for detection of
`castration resistant prostate cancer. Prostate 2014 Sep;74(13):1297-1307.
`14. Mahalingam D, Mita M, Sarantopoulos J, Wood L, Amaravadi RK, Davis LE, Mita AC, Curiel TJ,
`Espitia CM, Nawrocki ST, Giles FJ, Carew JS. Combined autophagy and HDAC inhibition: A phase I
`safety, tolerability, pharmacokinetic, and pharmacodynamic analysis of hydroxychloroquine in
`combination with the HDAC inhibitor vorinostat in patients with advanced solid tumors. Autophagy
`2014 Aug;10(8):1403-1414.
`15. Mahalingam D, Malik L, Beeram M, Rodon J, Sankhala K, Mita A, Benjamin D, Ketchum N, Michalek
`J, Tolcher A, Wright J, Sarantopoulos J.. Phase II study evaluating the efficacy, safety, and
`pharmacodynamic correlative study of dual antiangiogenic inhibition using bevacizumab in
`combination with sorafenib in patients with advanced malignant melanoma. Cancer Chemother
`Pharmacol. 2014 Jul;74(1):77-84.
`16. Patel SR, Karnad AB, Ketchum NS, Pollock BH, Sarantopoulos J, Weitman S, Mahalingam D.
`Should we move beyond VEGF inhibition in metastatic colorectal cancer? Lessons from early phase
`clinical trials. J Gastrointest Oncol 2014 Apr;5(2):99-103.
`17. Mahalingam D, Rodon J, Tawbi HA, Thomas AL, Stoller RG, Turtschi CP, Baselga J, Sarantopoulos
`J, Shou Y, Moles MA, Yang L, Granvil C, Hurh E, Rose KL, Amakye DD, Dummer R, Mita AC.. A
`phase I, multicenter, open-label, first-in-human, dose-escalation study of the oral smoothened
`inhibitor Sonidegib (LDE225) in patients with advanced solid tumors. Clin Cancer Res. 2014
`Apr;20(7):1900-1909.
`18. Mahalingam D, Malik L, Parsons H, Ehler B, Goros M, Mejia A, Brenner A, Sarantopoulos J.. Clinical
`Outcomes and Survival of Advanced Renal Cancer Patients in Phase I Clinical Trials. Clin Genitourin
`Cancer. 2014 Feb
`19. Gowda PS, Deng JD, Mishra S, Bandyopadhyay A, Liang S, Lin S, Mahalingam D, Sun LZ..
`Inhibition of Hedgehog and Androgen receptor signaling pathways produced synergistic suppression
`of castration-resistant prostate cancer progression. Molecular Cancer Research 2013 Sep.
`20. Chen C-L, Mahali