Professional Address:
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`UCLA:
`Institute of Urologic Oncology at UCLA
`300 Stein Plaza
`Suite 347
`Los Angeles, CA 90095
`Phone: (310) 794-3565
`Fax: (310) 794-3512
`e-mail: mrettig@mednet.ucla.edu
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`CURRICULUM VITAE
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`Matthew Rettig, M.D.
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`VA Greater Los Angeles Healthcare System
`11301 Wilshire Blvd.
`Building 304, Room E1-113
`Los Angeles, CA 90073
`Phone: (310) 478-3711 x44761
`Fax: (310) 268-4508
`e-mail: matthew.rettig@va.gov
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`VA:
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`EDUCATION:
`⇒ Wesleyan University, Middeltown, CT. B.A Chemistry, 1986.
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`⇒ Duke University School of Medicine, Durham, NC. M.D. 1990.
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`⇒ Internship, Internal Medicine, University of Southern California, Los Angeles,
`CA., 1991.
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`⇒ Residency, Internal Medicine, University of Washington, Seattle, WA., 1993.
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`⇒ Fellowship, Hematology/Oncology, David Geffen School of Medicine at UCLA,
`Los Angeles, CA., 1996.
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`⇒ DEA: BR5210911
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`LICENSURE
`⇒ Medical License: California (A52586).
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`JANSSEN EXHIBIT 2039
`Mylan v. Janssen IPR2016-01332
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`BOARD CERTIFICATION
`⇒ Internal Medicine
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`⇒ Medical Oncology 1998 (recertified 2008)
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`PROFESSIONAL EXPERIENCE
`⇒ Clinical Instructor, UCLA School of Medicine, 1996-97.
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`⇒ Assistant Professor-in-Residence, Dept. of Medicine, UCLA School of Medicine,
`1997-2004.
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` Associate Professor-in-Residence, Dept. of Medicine, UCLA School of Medicine,
`2004-2012.
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` Associate Professor-in-Residence, Dept. of Urology, UCLA School of Medicine,
`05/2007-2012.
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` Professor-in–Residence, Dept. of Medicine, UCLA School of Medicine, 7/2012-
`present.
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` Professor-in–Residence, Dept. of Urology, UCLA School of Medicine, 7/2012-
`present.
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` Staff physician, VA Greater Los Angeles Healthcare System – West Los
`Angeles, 1996 – present.
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` Chief, Division of Hematology-Oncology, VA Greater Los Angeles Healthcare
`System – West Los Angeles, 10/1/2007 – present.
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` Medical Director, Prostate Cancer Program, Institute of Urologic Oncology, David
`Geffen School of Medicine at UCLA. 10/2008 – present.
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`⇒ Director, Operation Mend Project to Enhance Cancer Care for Veterans. 2014 –
`present.
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`PROFESSIONAL ACTIVITIES:
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`Committee Service:
`⇒ Full-time member, VA Merit Review Oncology A Study Section, 2015-present.
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`⇒ Full-time member, VA Merit Review Oncology Study Section, 2006-2009.
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`⇒ Chair, Oncology Study Section, Merit Review Program, Department of Veterans
`Affairs, 2007-2009.
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`⇒ Scientific Advisory Board, Tower Cancer Research Foundation, 2008-present.
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`⇒ Full-time member, Data Safety Monitoring Board (VA), 2001-2009.
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`⇒ Full-time member, Internal Review Board (VA), 1998-2001.
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`⇒ Ad-Hoc Reviewer for Internal Review Board (VA), various dates.
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`⇒ Search Committee, Chief, Department of Pathology and Laboratory Medicine,
`2005.
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`⇒ Chair, VA West Los Angeles Anti-coagulation Task Force, 2008. Developed
`comprehensive guidelines on use and monitoring of anti-coagulants.
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`Institute (non-profit
`⇒ Board of Directors, Brentwood Biomedical Research
`organization at VA that administers non-VA grants), 2009-present.
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`⇒ Member, Prostate Cancer Inter-SPORE Androgen Receptor Working Group,
`2009-present.
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`⇒ Director, Multidisciplinary Tumor Board, VA-West LA, 2006-present.
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`⇒ Associate Director, Hematology-Oncology Fellowship Program, David Geffen
`School of Medicine at UCLA, 2007-present.
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`⇒ Jonsson Comprehensive Cancer Center at UCLA, Genitourinary Oncology
`Section Member, 1997-present.
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`⇒ VA Cooperative Studies Program: Chemotherapy after Prostatectomy for High
`Risk Prostate Carcinoma: A Phase III Randomized Study: Member, Endpoint
`Adjudication Committee.
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`⇒ Various dates, up to and including 2011: Jonsson Comprehensive Cancer Center
`at UCLA, Grant Reviewer.
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`⇒ Planning Committee: NCI meeting: Androgen Receptor Signaling in Prostate
`Cancer: Translating Biology in to Clinical Practice, 2010.
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`⇒ American Urologic Association, 5/2010: Moderator for Kidney Cancer: Basic
`Science Session.
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`⇒ Full-time Member, VA National Research Career Scientist Program Promotions
`Evaluation Committee, 2010-present.
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`⇒ Tower Cancer Research Foundation, Grant Reviewer, 2009-present.
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`⇒ Prostate Cancer Foundation, Grant Reviewer, Challenge Awards, 2011-present.
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`⇒ Tokai Pharmaceuticals, Internal Monitoring Committee, 2010-present.
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`⇒ Chairman, Board of Directors, Brentwood Biomedical Research Institute (non-
`profit organization at VA that administers non-VA grants), 2011-present.
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`⇒ Prostate Cancer Foundation, Challenge Award in-person programmatic review
`panel. July, 2013.
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`⇒ Prostate Cancer Foundation, Grant Reviewer, Young Investigator Awards, 2013-
`present.
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`⇒ American Society of Clinical Oncology (ASCO) Prostate Cancer Quality
`Measures Development Panel, 2014-present
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`⇒ Tower Cancer Research Foundation’s Medical Advisory Board, 2014-present.
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`⇒ Ad hoc reviewer, VA Merit Review Panel ONC A. December 2015.
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`Society Memberships:
`⇒ American Society of Hematology.
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`⇒ American Association for the Advancement of Science.
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`⇒ American Association for Cancer Research.
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`⇒ American Society of Clinical Oncology.
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`Journal Reviewer:
`⇒ Nature Biotechnology.
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`⇒ Lancet.
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`⇒ Leukemia.
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`⇒ Infectious Diseases.
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`⇒ Blood.
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`⇒ Molecular Cancer Therapeutics.
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`⇒ Clinical Cancer Research.
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`⇒ Cancer Research.
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`⇒ Molecular and Cellular Biology.
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`⇒ Science Translational Medicine.
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`⇒ Cancer Discovery.
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`⇒ Prostate Cancer and Prostatic Diseases.
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`TEACHING RESPONSIBILITIES:
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`Clinical:
`⇒ Attending, outpatient clinic, VA West LA: One half-day per week.
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`Didactic:
`⇒ Leukemia and Lymphomas: Bimonthly lecture to UCLA MS3s on general
`medicine wards at VA West Los Angeles.
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`⇒ Attending, outpatient clinic, Clark Urology Center, one day per week.
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`⇒ Hematology-Oncology
`months/year.
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`Inpatient Consultative Service, VA West LA: 2-3
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`⇒ Molecular Basis Oncology Graduate Course, UCLA, 5/08: “Targeted Therapies
`for Castration Resistant Prostate Cancer.”
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`⇒ Molecular Basis Oncology Graduate Course, UCLA, 5/09: “Targeted Therapies
`for Castration Resistant Prostate Cancer.”
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`⇒ Molecular Basis Oncology Graduate Course, UCLA, 5/10: “Targeted Therapies
`for Castration Resistant Prostate Cancer.”
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`⇒ Molecular Basis Oncology Graduate Course, UCLA, 5/11: “Targeted Therapies
`for Castration Resistant Prostate Cancer.”
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`⇒ Molecular Basis Oncology Graduate Course, UCLA, 5/12: “Targeted Therapies
`for Castration Resistant Prostate Cancer.”
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`⇒ Molecular Basis Oncology Graduate Course, UCLA, 5/13: “Targeted Therapies
`for Castration Resistant Prostate Cancer.”
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`⇒ Prostate Cancer Journal Club: one month (4 dates) per year for UCLA
`hematology-oncology fellows.
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`⇒ Department of Urology Annual Lecture Series, UCLA 07/14. Three topics: 1)
`Clinical State of the Rising PSA Value after Definitive Local Therapy, 2) Hormone
`Therapy for Prostate Cancer, and 3) Treatment of Castration-Resistant Prostate
`Cancer.
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`COMMUNITY SERVICE/TALKS:
`⇒ Lectures at the Wellness Community to prostate cancer patients. Once/year.
`Variable dates.
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`HONORS AND AWARDS:
`⇒ American Society of Clinical Oncology Young Investigator’s Award, 1995.
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`⇒ Santa Monica YMCA, March, 2008. Update on prostate cancer to support group.
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`⇒ Santa Monica Synagogue, January, 2009. Update on prostate cancer to support
`group.
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`⇒ American Cancer Society Walk for Cancer, June, 2009, Silverlake, CA. Invited
`speaker on state of cancer research.
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`⇒ UCLA Simms-Mann Center for Integrative Oncology, November, 2010. “Update
`and State-of-the-Art Approaches to the Treatment of Advanced Prostate Cancer”
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`⇒ Richard and Elaine Dwyer Award for Research Excellence from Jonsson
`Comprehensive Cancer Center at the UCLA School of Medicine, 1996.
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`⇒ American Society of Hematology Scholar Award for Junior Faculty, 1997
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`⇒ Invited Participant: Lymphoma Think Tank. Atlanta, GA., 2000.
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`⇒ Creativity Award, Prostate Cancer Foundation, March, 2010, for the development
`of a nano-structured platform for the enumeration of circulating tumor cells of
`advanced prostate cancer patients.
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`⇒ Creativity Award, Prostate Cancer Foundation, March, 2011, for the identification
`and characterization of novel small molecule inhibitors of the N-terminus of the
`androgen receptor.
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`⇒ Challenge Award, Prostate Cancer Foundation, October, 2012, for “Preventing
`Treatment Resistance by co-targeting of Androgen Receptor and SRC/MEK1-
`Dependent Epithelial to Mesenchymal Transition.”
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`⇒ Los Angeles Magazine “Best Doctors” issue: 2013.
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`⇒ Los Angeles Magazine “Best Doctors” issue: 2014.
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`⇒ Los Angeles Magazine “Best Doctors” issue: 2015.
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`⇒ STOP Cancer Award. Jerry Janger Memorial Seed Grant, 2015.
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`⇒ Los Angeles Magazine “Best Doctors” issue: 2016.
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`RESEARCH GRANTS AND FELLOWSHIPS: (DOLLAR FIGURES ARE DIRECT COSTS ONLY).
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`Active:
`1. NIH/NCI UCLA Prostate Cancer SPORE, 1P50CA128611. “Project 3: Evaluating a
`Novel Strategy to Target Trop2 in Prostate Cancer.” ~12/1/13 – 11/30/18. Dual PIs:
`Matthew Rettig, MD/Owen Witte, MD. The goal of this project is to credential Trop2
`as a marker for prostate cancer self-renewal, proliferation and castration resistance.
`$189,000/year.
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`2. Prostate Cancer Foundation Challenge Award. “MEK Inhibition as a Treatment for
`Metastatic Castration Resistant Prostate Cancer.” 01/01/16 – 12/31/17. PI =
`Matthew Rettig, MD. This project represents a phase 2 study of the MEK inhibitor
`known as trametinib in patients with metastatic CRPC who have progressed on
`enzalutamide and/or abiraterone acetate. $250,000/year.
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`3. Department of Defense Prostate Cancer Clinical Trials Consortium Award,
`PC131977 – “UCLA Clinical Consortium Award: Clinical Research Site.” Awarded,
`start date pending (three year award). PI = Matthew Rettig, MD. The purpose of this
`award is to support clinical trials infrastructure for the execution of prostate cancer
`clinical trials performed in collaboration with other member institutions of the DoD
`prostate cancer clinical trials consortium. $200,000/year.
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`4. Department of Defense Idea Development Award (established investigators).
`PC140960. “ Determine the Dynamic Response to Androgen-Blockade Therapy in
`Circulating Tumor Cells of CRPC Patients by Transcription-Based Reporter
`Vectors.” 07/01/2015-6/30/2018. Role = co-PI (PI = Lily Wu, MD, PhD). The goal of
`this project is to determine the functional activity of the androgen receptor in freshly
`isolated CTCs.
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`“HIF-alpha-
`5. Department of Veterans Affairs Merit Review. 1I01BX002778.
`independent Druggable Targets in Renal Cell Carcinoma.” 04/01/2015-03/31/2019.
`PI = Matthew Rettig, MD. The goal of this project is to validate TAK1 as a
`therapeutic target in clear cell renal cell carcinoma. $150,000/year.
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`6. NIH/NCI UCLA Prostate Cancer SPORE, 1P50CA128611. Project 2: “PI3K/AKT and
`MAPK Pathway Inhibition Therapies in Metastatic and Castration Resistant Prostate
`Cancer (CRPC).” ~12/1/13 – 11/30/18 Dual PIs: Matthew Rettig, MD/Hong Wu,
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`PhD. The goal of this project is to establish the role of the MAPK and PI3K/AKT
`pathways in the development of metastases and castration resistance in prostate
`cancer and to determine if reciprocal activation of AR transcriptional output and AKT
`signaling output occurs when either pathway is inhibited in isolation. $189,000/year.
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`7. Prostate Cancer Foundation Young Investigator Award. “Utilizing Vortex Chip for
`Enumeration and Determination of Single-Cell Heterogeneity of Circulating Tumor
`Cells in Prostate Cancer.” 02/2014-01/2017. PI = Rajan Kulkarni, MD, PhD. Role =
`Mentor. The goal of this project is to develop a rapid and inexpensive technology to
`capture and isolate pure populations of CTCs in prostate cancer patients for
`downstream real-time analysis. Dr. Rettig serves as the primary mentor for Dr.
`Kulkarni. $75,000/year.
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`8. Department of Veterans Affairs Career Development Award-Level 2. “Programmable
`DNA Binders as Radio-Modulators and Therapeutics for Prostate Cancer.” 07/14-
`06/2019. PI = Nicholas Nickols. Role = Mentor. The goal of this project is to further
`investigate pyrrole-imidazole compounds that inhibit androgen receptor binding to its
`cognate response elements as a potential therapy for advance prostate cancer. This
`is a five year award that provides full salary and research support for Dr. Nickols with
`75% time protected for research. Dr. Rettig is the primary mentor. Salary plus direct
`costs for research = $290,000/year.
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`9. NIH/NCI UCLA Prostate Cancer SPORE, 1P50CA128611 Developmental Award.
`“Androgen Receptor Degraders for the Treatment of Prostate Cancer.” 02/14-01/15.
`PI = Michael Jung, Ph.D. Role = co-PI. The goal of this one year award is to
`develop analogues of the potent AR antagonists that also have the property of
`enhancing degradation of the AR. $50,000/year.
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`10. NIH/NCI UCLA Prostate Cancer SPORE, 1P50CA128611 Developmental Award.
`“Blocking Tumor-Infiltrating Myeloid Cells to Improve Treatment Outcome of ADT
`and RT in High Risk Prostate Cancer.” PI = Lily Wu, MD, PhD. Role = co-PI. The
`goal of this one year award is to determine the feasibility of inhibiting the infiltration
`of myeloid cells into primary prostate tumors that are undergoing radiation therapy.
`Rettig component = $17,000/year.
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`Inhibition as a
`“Correlative Molecular Analysis of MEK
`11. GlaxoSmithKline.
`Neoadjuvant Therapy for High Risk Prostate Cancer amongst Patients Undergoing a
`Radical Prostatectomy.” 10/01/2011-09/30/2017. Role = PI. The goal of this project
`is to perform “omics” analyses of prostate cancer tissue obtained prior to and at the
`conclusion of neoadjuvant therapy with the MEK inhibitor, trametinib. Total Direct
`Costs = $200,000 that is disbursed based on reaching pre-specified milestones.
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`12. NIH/NCI 1R01CA164331. “Identification of Inhibitors of the N-Terminal Region of the
`Androgen Receptor.” 10/01/12-09/30/17. PI = Matthew Rettig, M.D. The goal of this
`project it to screen small molecule libraries to identify, characterize, validate and
`optimize inhibitors of the N-terminus of the androgen receptor. $205,000/year.
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`13. VA Merit Review 1I01BX002015. “Development of Pharmacologic Inhibitors of the
`Androgen Receptor N-terminus.” 10/01/12-09/30/16. PI = Matthew Rettig, M.D. The
`goal of this project is to perform structure activity relationship analysis on potential
`AR N-terminus inhibitors identified in a pilot screen. $150,000/year (refused because
`of overlap).
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`14. Prostate Cancer Foundation Creativity Award. “Identification, Characterization, and
`Validation of Novel Inhibitors of the AR N-terminus.” 09/01/2011-08/31/2014. PI =
`Matthew Rettig, M.D. The purpose of this award is to lead optimize compounds
`novel inhibitors of the AR N-terminus through structure activity relationship studies.
`Total direct costs = $300,000.
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`a. Extension/Amplification for additional year funded at $200,953.
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`15. Prostate Cancer Foundation Challenge Award. Preventing Treatment Resistance by
`co-targeting of Androgen Receptor and SRC/MEK1-Dependent Epithelial
`to
`Mesenchymal Transition. 10/01/2012-09/30/2014. Role = PI (multi-PI project with
`Reiter and Witte). The goal of this project is to determine if inhibition of the SRC or
`MEK pathways can prevent the EMT response to castration. Total amount =
`$1,000,000.
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`16. Stand Up To Cancer. “Targeting Adaptive Pathways of Resistance in Metastatic
`CRPC”. 01/01/2013-10/31/2015. Role = Clinical lead at UCLA. The goal of this
`multi-center project is to comprehensively identify the molecular and biochemical
`pathways that drive therapeutic resistance in castration resistant prostate cancer.
`Total award = $10,000,000.
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`17. VA Merit Review. “Targeting HPV E6-Dependent Hypoxia-Induced NF-kappa B in
`Cervical Cancer.” 10/1/2011-9/30-2015. Role = PI. Purpose: To elucidate the role of
`NF-kappa B activation induced by hypoxia in the progression of HPV-related cervical
`cancer. $150,000/year.
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`18. STOP Cancer Award. “Development of Vortex Technology for Rapid Isolation of
`Circulating Tumor Cells in Patient with Advanced Prostate Cancer.” Role = PI.
`Purpose = To enhance the performance characteristics of a novel technology to
`isolate CTCs from patients with metastatic castration resistant prostate cancer.
`$25,000 one time gift.
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`19. Department of Defense Idea Development Award. PC111719. "Disrupting the
`Protumorigenic Influences of Tumor-Infiltrating Myeloid Cells by CSF1R Blockade to
`Augment Androgen Deprivation Therapy in Prostate Cancer." 10/01/12 – 09/30/15.
`Role = Co-PI. The goal of this project is to establish the role of protumorigenic
`inflammatory cells in prostate cancer and whether inhibition of the CSF1 receptor
`can mitigate these protumorigenic effects. Total direct costs = $375,000. Rettig
`component = $17,000/year.
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`Completed:
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`20. NIH. Grant # 1P50CA128611-01. UCLA SPORE in Prostate Cancer. Project III.
`“Lymphangiogenesis and Lymphatic Metastasis in Prostate Cancer.” 01/02/08-
`12/31/13. Role = Clinical Science PI. Purpose: To gain a better understanding of
`the biochemical signaling events that lead to lymphangiogenesis and lymphatic
`metastases in prostate cancer and to translate these findings into early phase
`clinical trials. Total direct costs = $100,000 (Rettig component).
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`21. NIH/NCI R33 CA157396. “Advance Development of an Integrated CTC Enrichment
`Technology.” 09/01/2011-08/31-2013. Role = Co-PI. Purpose: To optimize the
`technical performance characteristics of a nanotechnology-based platform to capture
`circulating tumor cells using advanced prostate cancer as the model system. (Total
`direct costs = $600,000; Rettig component = $200,000.
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`22. Prostate Cancer Foundation Creativity Award. "A Nano-Structured Platform for
`Enhanced Detection of CTCs in Prostate Cancer Patients.” 04/01/2010-03/31/2012.
`PI = Matthew Rettig, M.D. Purpose: To validate the performance of a nano-
`structured platform to detect circulating prostate cancer cells (CTCs); to establish
`enumeration of CTCs as a biomarker across a range of stages/states of prostate
`cancer; to molecularly characterize CTCs with the specific goal of determining if the
`presence androgen receptor splice mutants predicts for resistance to 17α-
`hydroxylase inhibitors. Total direct costs = $300,000.
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`23. Department of Defense Synergy Award. PC081249. N-cadherin in Prostate Cancer:
`Downstream Pathways and Their Translational Application for Castrate Resistant
`Prostate Cancer. 10/01/09-09/31/12. Dual PIs = Matthew Rettig, M.D. and Robert
`Reiter, M.D. The goals of this project is to identify downstream molecular pathways
`with a focus on NF-κB that regulate the effects of N-cadherin on the development of
`castration resistant prostate cancer and to validate the efficacy of a therapeutic
`neutralizing N-cadherin antibody. Total direct costs = $750,000.
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`24. VA Cooperative Studies Program 553. “Chemotherapy after Prostatectomy (CAP)
`for High Risk Prostate Cancer: A Phase III Randomized Study.” 2007-2012. Site PI =
`William Aronson, M.D. Role = Site co-PI. Purpose: To determine whether
`chemotherapy (docetaxel) reduces the risk of biochemical (PSA) recurrence in men
`who are at high risk for recurrence after prostatectomy for prostate cancer.
`Anticipated to enroll 5-6 patients/yr. Direct costs = $40,000 start up + ~$14,000 per
`patient enrolled.
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`25. Medivation, Inc. A Multinational Phase 3, Randomized, Double-Blind, Placebo-
`Controlled Efficacy and Safety Study of Oral MDV3100 in Patients with Progressive
`Castration-Resistant Prostate Cancer Previously Treated with Docetaxel-Based
`Chemotherapy. Role = UCLA PI. (Ongoing). Purpose: To determine whether
`MDV3100, an androgen receptor “superantagonist”, improves the overall survival
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`and is safe in patients with metastatic, castration resistant prostate cancer who have
`progressed after docetaxel-based chemotherapy.
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`26. Astra-Zeneca. A Phase III, Randomized, Placebo-Controlled, Double-blind Study to
`Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 10 mg in
`Non-metastatic Hormone Resistant Prostate Cancer. Role = UCLA PI. (Ongoing).
`Purpose: To determine whether ZD4054, an endothelin receptor antagonist, delays
`the development of metastasis, in patients with non-metastatic, castration resistant
`prostate cancer.
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`the Maximum Tolerated Dose,
`to Determine
`27. Supergen. Safety Study
`Pharmacokinetics and Pharmacodynamics of SGI-1776, a PIM Kinase Inhibitor, in
`Subjects with Hormone and docetaxel Refractory Prostate Cancer and
`Relapsed/Refractory Non-Hodgkin’s Lymphoma. Role = UCLA co-PI. (Ongoing).
`Purpose: To establish the safety and maximum tolerated dose of an inhibitor of PIM
`kinase, a protein that is overexpressed and hyperactivated in prostate cancer and
`non-Hodgkin’s lymphoma.
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`28. A Pilot Study of Circulating Tumor Cells in Patients with Advanced Prostate Cancer.
`Role = Clinical PI. (Ongoing). Purpose: To establish the sensitivity and specificity of
`a novel nano-structured platform to detect circulating tumor cells in prostate cancer
`patients.
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`29. Cougar Biotechnology. A Phase 3, Randomized, Double-blind, Placebo-Controlled
`Study of Abiraterone Acetate (CB7630) in Patients with Metastatic Castration-
`Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy. Role
`= Site PI. 10/01/08 = start date. Now closed to accrual and patients in follow-up
`(Ongoing). Purpose: To determine if treatment with a 17α-hydroxylase, 17,20 lyase
`inhibitor prolongs overall survival of patients with metastatic castration resistant
`prostate cancer who have progressed after docetaxel-based chemotherapy.
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`30. Tokai Pharmaceuticals. Phase1-2 Open Label, Dose Escalation, Selected Dose
`Comparison Trial of TOK-001 for the Treatment of Chemotherapy Naïve Castration
`Resistant Prostate Cancer. Role = UCLA PI. (Ongoing). Purpose: To establish the
`safety, maximum tolerated dose and efficacy of TOK-001, an inhibitor of 17α-
`hydroxylase, an enzyme regulating the rate limiting step in androgen synthesis, in
`patients with metastatic castration resistant prostate cancer who have not received
`chemotherapy.
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`31. A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Abiraterone
`Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients
`with Metastatic Castration-Resistant Prostate Cancer. Role = Site Co-PI. (Ongoing).
`Purpose: To determine if abiraterone, a 17α-hydroxylase inhibitor, improves
`progression-free and overall survival in patients with metastatic castration resistant
`prostate cancer who are asymptomatic or mildly symptomatic.
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`32. VA Merit Review. “Targeting Hypoxia/VHL-Mediated Signaling In Renal Cell
`Carcinoma.” 10/01/2006 – 09/30/2010. PI = Matthew Rettig, M.D. Purpose: To
`identify molecular substrates for therapeutic targeting in renal cell carcinoma. Total
`direct costs = $500,000.
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`33. UCLA Prostate Cancer SPORE Developmental Project. “Identification of Androgen
`Receptor Transcriptional Inhibitors.” 01/02/08 -12/31/09. Role = PI. Purpose: To
`perform a high throughput drug screen in yeast to identify small molecule inhibitors
`of androgen receptor transcriptional activity. Total direct costs = $75,000.
`
`34. NIH. Grant # 1R21CA113351. “Targeting Androgen Receptor Activity in Prostate
`Cancer.” 01/06-12/08. Role = PI. Total direct costs = $150,000.
`
`35. NIH R01. Grant # 1R01CA80004. “Increased IL-6 Transcription by HHV8.” 03/01/03-
`03/31/08. Role = PI. Total direct costs = $831,250.
`
`
`36. Tower Research Foundation. Regulation of p120-catenin in Lung Cancer. Role =
`Mentor. (PI = Fred Mortazavi, M.D.). 09/30/08-08/31/09. Purpose: To elucidate the
`transcriptional regulation of p120-catenin in non-small cell lung cancer. Total direct
`costs = $50,000.
`
`37. DOD. Grant # PC030686. Health Disparity Award. “Examination of Racial
`Differences in the IGF Axis in African-American and Caucasian Men with Prostate
`Cancer.” 04/01/04-03/31/08. Role = PI. Total direct costs = $383,000.
`
`38. DOD. Grant # PC040014. “Inhibition of Androgen Receptor Binding to the Androgen
`Response Element as a Therapeutic Strategy for Androgen-Independent Prostate
`Cancer.” 12/04-05/06. Role = PI. Total direct costs = $75,000.
`
`39. Millennium Pharmaceuticals. “Targeting NF-kappa B in Prostate Cancer.” No dates.
`Role = PI. Total direct costs = $10,000.
`
`
`(Velcade)
`II Study of Bortezomib
`“A Phase
`40. Millennium Pharmaceuticals.
`Administered as a Single Agent in Metastatic Non-Clear Renal Cell Carcinoma.”
`09/05-08/07. Role = PI. Total direct costs = $28,000.
`
`41. Jonsson Comprehensive Cancer Center Interdisciplinary Grant. “The Role of IL-6 in
`HHV8-Associated Malignancies.” 09/00-08/02. Overall PI = Ren Sun, Ph.D. Role =
`PI for Project 3 (“vFLIP Mediated IL-6 Upregulation). Overall funding =$150,000.
`Project 3 funding = $35,000/yr.
`
`42. American Cancer Society. Grant# RPG-00-305-01-MBC. “HHV8 Latent Nuclear
`Antigen Mediated IL-6 Upregulation.” 07/01/00-06/30/03. Role = PI. Total direct
`costs = $312,000.
`
`
`
`
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`

`

`43. Advanced Career Development Award, Veterans Affairs. “HHV8 Regulation of IL-6
`Expression.” 01/01/99-12/31/01. Role = PI. Total direct costs = 8/8 FTEE +
`$150,000.
`
`44. Veterans Affairs, Cancer Gene Therapy Research Enhancement Award Program
`(REAP). 10/98-9/03. Overall PI = Steven Dubinett, M.D. Role = PI for sub-project
`5. Funding for sub-project 5 = $40,000.
`
`45. Jonsson Comprehensive Cancer Center Seed Grant. “The Role of Kaposi’s
`Sarcoma-Associated Herpesvirus
`in
`the Pathogenesis of KSHV-Associated
`Diseases.” 07/00-06/01. Role = PI. Total direct costs - $30,000.
`
`46. Veterans Administration, Type II Merit Review. “The Role of Human Herpesvirus-8 in
`the pathogenesis of Multiple Myeloma.” This was a three year award, which was
`replaced by the VA Advanced Career Development Award. Role = PI. Total direct
`costs = $150,000.
`
`47. American Society of Hematology Junior Faculty Scholar Award. “The Role of KSHV
`in the Pathogenesis of Multiple Myeloma.” 07/98-06/00. Role = PI. Total direct costs
`= $120,000.
`
`48. International Myeloma Foundation. “Kaposi’s Sarcoma-Associated Herpesvirus
`Cytokines in the Oncogenesis of Multiple Myeloma.” 01/01/98-12/31/98. Role = PI.
`Total direct costs = $40,000.
`
`49. Lymphoma Research Foundation of America. “Proto-Oncogene Translocations to
`the Immunoglobulin Heavy Chain Locus in Multiple Myeloma.” 07/97-06/98. Role =
`PI. Total direct costs = $35,000.
`
`“The Role of CD38
`50. Jonsson Comprehensive Cancer Center Fellowship.
`Immunoadsorption in the Depletion of Malignant Plasma Cells from Leukapheresis
`Autografts.” 07/96-06/97. Role = PI. Total direct costs = $30,000.
`
`
`
`ONGOING AND RECENTLY COMPLETED CLINICAL TRIALS:
`
` ⇒
`
` Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition with and without
`SRC or MEK Inhibition on the Development of EMT in Prostate Cancer. Role = PI.
`
` ⇒
`
` STRIVE: A Multicenter Phase 2, Randomized, Double-Blind, Efficacy and Safety
`Study of Enzalutamide vs. Bicalutamide in Men with Prostate Cancer Who Have
`Failed Primary Androgen Deprivation Therapy. Role = PI.
`
`⇒ Exelixis: A Phase 3, randomized, double-blind, controlled trial of cabozantinib
`(XL184) vs. mitoxantrone plus prednisone
`in men with previously
`treated
`symptomatic castration resistant prostate cancer. Role = PI.
`
`
`
`13
`
`

`

` ⇒
`
` Cougar Biotechnology, Inc. - A Multicenter, Open-label, Single-arm, Phase 2 study
`of Abiraterone Acetate plus Prednisone in Patients with Advanced Prostate Cancer
`without Radiographic Evidence of Metastatic Disease (IRB#11-001526). Role = Co-
`PI.
`
` ⇒
`
` GTX: Phase II, open label study of the effect of GTx-758 as secondary hormonal
`therapy on serum PSA and serum free testosterone levels in men with metastatic
`castration resistant prostate cancer maintained on androgen deprivation therapy.
`Role = PI.
`
` ⇒
`
` Tokai Pharmaceuticals. Androgen Receptor Modulation Optimized for Response
`(ARMOR 2). Role = PI.
`
` ⇒
`
` PROSPER: A multinational, phase 3, randomized, double-blind, placebo-controlled,
`efficacy and safety study of enzalutamide in patients with nonmetastatic castration-
`resistant prostate cancer. Role = PI.
`
` ⇒
`
` UCLA/ImaginAb, Inc. “A Phase I Open Label Study to Evaluate the Tumor-Targeting
`Properties and Safety of 124I-A11 PSCA Minibody in Patients with Metastatic
`Prostate, Bladder and Pancreatic Cancer.” Role = co-PI. The safety and tumor-
`targeting of a PSCA minibody will be determined in this phase I study.
`
` ⇒
`
` Medivation/Astellas. STRIVE: A Multicenter Phase 2, Randomized, Double-Blind,
`Efficacy and Safety Study of Enzalutamide vs. Bicalutamide in Men with Prostate
`Cancer Who Have Failed Primary Androgen Deprivation Therapy. Role = PI.
`Purpose: To determine the benefit of enzalutamide compared to bicalutamide as
`assessed by progression-free survival.
`
` ⇒
`
` Medivation. PREVAIL: A Multinational Phase 3, Randomized, Double-Blind,
`Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-
`Naïve Patients with Progressive Metastatic Prostate Cancer Who Have Failed
`Androgen Deprivation Therapy. Role = PI. Purpose: To determine the effect of
`enzalutamide versus placebo on overall survival and progression-free survival in
`metastatic castration resistant prostate cancer patients who are chemotherapy-
`naïve.
`
` ⇒
`
` Medivation. AFFIRM: A Multinational Phase 3, Randomized, Double-Blind, Placebo-
`Controlled Efficacy and Safety Study of Oral MDV3100 in Patients with Progressive
`Castration-Resistant Prostate Cancer Previously Treated with Docetaxel-Based
`Chemotherapy. Role = PI. Purpose: To assess the efficacy of enzalutamide on
`overall survival in patients with metastatic castration resistant prostate cancer who
`have previously been treated with docetaxel.
`
` ⇒
`
` Tokai. ARMOR2: A Phase 2 Study of Galeterone (TOK-001) in Patients with
`Metastatic Castration Resistant Prostate Cancer. Role = PI. Purpose: To assess the
`
`
`
`14
`
`

`

`efficacy of galeterone on biochemical and radiographic response in metastatic
`castration resistant prostate cancer patients.
`
` ⇒
`
` GTx. Phase II, open label study of the effect of GTx-758 as secondary hormonal
`therapy on serum PSA and serum free testosterone levels in men with metastatic
`castration resistant prostate cancer maintained on androgen deprivation therapy.
`Role = PI. Purpose: To study the effect of a novel ER agonist on biochemical
`responses and testosterone levels in men with metastatic castration resistant
`prostate cancer who continue androgen deprivation therapy.
`
` ⇒
`
` A Multicenter, Randomized, double-blind, Placebo-Controlled, Phase III Study of
`ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer.
`Role = PI. Purpose: To test the effects of the androgen receptor antagonist, ARN-
`509, versus placebo on metastasis-free survival in men with non-metastatic CRPC.
`
` ⇒
`
` Identifying Mechanisms of Resistance to Enzalutamide (MDV3100) Treatment in
`Men with Castration-Resistant Prostate Cancer. Role = co-PI. Purpose: To identify
`the predictors of response/resistance in mCRPC patients treated with enzalumatide
`by comparing “omics” level analysis on pre- and post-treatment biopsies of
`metastatic lesions.
`
` ⇒
`
` A Single-arm, Phase 2 Study to Evaluate the Safety and Efficacy of VT-464 in
`Patients with Castration-Resistant Prostate Cancer Progressing on Enzalutamide or
`Abiraterone. Role = co-PI. Purpose: To determine whether VT-464, a selective
`inhibitor of lyase activity of CYP17 elicits responses in mCRPC patients previously
`treated with enzalutamide or abiraterone.
`
` ARMOR3-SV: A Phase 3, Randomized, Open, Label, Multicenter, Controlled Study
`of Galeterone Compared to Enzalutamide in Men Expressing Androgen Receptor
`Splice Variant-7 mRNA (AR-V7) Metastatic (M1) Castrate Resistant Prostate Cancer
`(CRPC). Role = co-PI. Purpose: To determine if galeterone, a multifunctional AR
`inhibitor, improves clinical outcomes compare to enzalutamide in mCRPC patients
`who have detectable AR-V7 in CTCs.
`
` ⇒
`
`
`
`
`
`
`
`LECTURES, SYMPOSIA, AND PRESENTATIONS:
`⇒ Invited Lecturer: VI International Workshop on Multiple Myeloma. Boston, MA. 06/97.
`“Identification of