St. David's HealthCare

St. David's HealthCare is one of the largest health systems in Texas and Austin's
third-largest private employer, with more than 60 sites throughout Central Texas,
including seven hospitals, four urgent care centers, four ambulatory surgery centers,
and two freestanding emergency departments, with a third set to open in Bastrop this summer.

St. David's HealthCare has a long history of serving the residents of Central Texas
with exceptional medical care. Our 7,500 employees touch over 858,000 lives each
year with a spirit of warmth, friendliness and personal pride.

Visit our main website at www.StDavids.com

St. David's Medical Center (512) 476-7111
St. David's North Austin (512) 901-1000
St. David's South Austin (512) 447-2211
St. David's Round Rock (512) 341-1000
St. David's Georgetown (512) 943-3000
St. David's Rehabilitation (512) 544-5100
Heart Hospital of Austin (512) 407-7000
Edward J. Fox, MD

Edward J. Fox, MD, PhD, is a Diplomate of the American Academy of Psychiatry and Neurology, and is board certified in Neurology. He completed combined MD/PhD degrees through the Medical Scientist Training Program at Baylor College of Medicine in Houston, with a PhD focus on Immunology. Dr. Fox also completed his residency in Neurology at Baylor, where he was appointed Chief Administrative Resident and selected Outstanding Academic Resident in Neurology.

Dr. Fox is renowned in the area of multiple sclerosis, and in 2003 was named to the Volunteer Hall of Fame by the Lone Star Chapter of the National Multiple Sclerosis Society, an organization for which he serves on the Clinical Advisory Committee. In 2004, Dr. Fox was appointed Clinical Assistant Professor at the University of Texas Medical Branch. In addition to treating patients, Dr. Fox conducts extensive research in the field of multiple sclerosis. His works have been published in numerous medical journals such as the Journal of Immunology and Neurology. Dr. Fox’s research is directed at various facets of multiple sclerosis, including the study of pharmaceutical agents and their mechanism of action, as well as methods of managing the disease as it worsens. Dr. Fox holds a bachelor’s degree in Biology from Washington University in St. Louis, Missouri. While pursuing his undergraduate degree, he was involved with immunological research at Washington University and at M.D. Anderson Hospital and Tumor Institute.

Curriculum vitae of Edward J. Fox, MD (PDF)

Education:

Residency Neurology, 1992
Baylor College of Medicine Department
Houston, TX

Internship Internal Medicine, 1989
Baylor College of Medicine Department
Houston, TX

Doctor of Medicine, 1987
Baylor College of Medicine
Houston, TX

Doctorate Immunology, 1988
Baylor College of Medicine
Houston, TX

Bachelor of Arts in Biology, 1988 – 1990
Washington University
St. Louis, Missouri

Clinical Appointments:

Neurologist, 1992 - Present
Central Texas Neurology Consultants
Round Rock, TX

Licensure & Certification

License – Texas, 1989
Board Certified, American Academy of Psychiatry and Neurology,1995

Honors and Awards

Outstanding Research Presentation Award, 1st Place, 1985
Junior Member of the American Academy of Neurology, 1989 Chief Administrative Resident, Department of Neurology, Baylor College of Medicine, 1991
Selected Outstanding Academic Resident within the Department of Neurology, 1992
Chairman, Department of Medicine, Round Rock Hospital, 1995
Director, Multiple Sclerosis Clinic of Central Texas, 2000
Director, MS Comprehensive Rehabilitation Program in conjunction with St. Davids Medical Center and the National Multiple Sclerosis Society, 2002 Received Volunteer of the Year Award, Medical Division, and entry into the Volunteer Hall of Fame, Lone Star Chapter of the National Multiple Sclerosis Society, 2003 Clinical Assistant Professor, University of Texas Medical Branch, 2004
Invited Chair, Multiple Sclerosis Immunology II scientific session of 2009 AAN Meeting, 2008
Invited Chair, MS Therapy Educational Program, 2009 AAN Meeting, 2010

Professional Organizations

National Multiple Sclerosis Society Affiliated Clinic, 2007
Member, Consortium of Multiple Sclerosis Centers, 2003
Clinical Advisory Committee, Lone Star Chapter, NMSS, 2002
Member of the Texas Multiple Sclerosis Consortium, 2000
Active Member of the American Academy of Neurology, 1995
Member of the Medical Advisory Committee, Southeast Texas Chapter of the Multiple Sclerosis Society, 1994
Active Member of the Texas Medical Association, the Travis County Medical Association, and the Austin Neurologic Society, 1993
Associate Member of the American Academy of Neurology, 1993
Junior Member of the American Academy of Neurology, 1989

Research

Work-Study student at the Washington University School of Medicine, Department of Immunology, 1978 -1980
Summer Student Trainee at M.D. Anderson Hospital and Tumor Institute, Department of Molecular Carcinogenesis and Virology, 1979 -1980
Undergraduate Independent Research Project, Washington University School of Medicine, Department of Immunology, 1980-1981
Doctoral Research in the Department of Microbiology and Immunology at Baylor College of Medicine. Dissertation - "Proliferation Requirements of Human Suppressor T Lymphocytes." 1982-1987
Clinical Investigator for A.R.C. in post-marketing pharmaceutical trials, 1997-1999
Investigator in Phase II, III and IV studies as Director of the Multiple Sclerosis Clinic of Central Texas, 2000-present.

Current Speakers Bureaus and Consultant Agreements

Biogen-Idec
EMD Serono
Genzyme
Opexa Therapeutics
Pfizer
Teva Neuroscience

Journal Editing, Commentary, and Reviewer Status

MS Consults: Case Study and Commentary – Editor
Multiple Sclerosis Monitor and Commentary – Commentary Writer
Neura – Editor
American Academy of Neurology – Abstract reviewer for 2009 and 2010 meetings
International Journal of MS Care – Reviewer

Current MS Research Studies

Biogen Idec ADVANCE 105MS301 Phase III
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis
Biogen Idec CONFIRM NCT00451451 Phase III
A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
Biogen Idec DELIVER 101MS102 Phase 1b
A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics and initial Safety of Subcutaneous and intramuscular Natalizumab in Subjects with Multiple Sclerosis
Biogen Idec TYGRIS Registry NCT00477113 Phase IV
Safety Observational Program Designed to Obtain Long-Term Safety Data in Patients Treated with Tysabri in a Clinical Practice Setting
Eli Lilly H9B-MC-BCDJ (a) Phase II
Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis
EMD Serono ONWARD Protocol 26593 Trial Phase II
A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy with Rebif New Formulation in Multiple Sclerosis Subjects with Active Disease
Genzyme CARE-MS-I CAMMS323 Phase III
A Phase III Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Treatment-Naïve Patients with Relapsing-Remitting Multiple Sclerosis
Genzyme CARE-MS-II CAMMS32400507 Phase III
A Phase 3, Randomized, Rater-and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed on Therapy
Genzyme CARE-MS CAMMS03409 Phase III
An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab
IMPAX Pharmaceuticals IPX056-B09-01 Phase II
A Study With IPX056-01 in Subjects with Spasticity Associated With Multiple Sclerosis
ONO Pharmaceuticals ONO-4641 Phase I
An Open-Label, Flexible-dose Titration, Fixed-Dose, Or Fixed-Dose Titration Study of the Safety and Tolerability Of ONO-4641 In Patients With A Relapsing Form Of Multiple Sclerosis
Sanofi-Aventis TOPIC EFC6260 Phase III
An International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis
Washington Neuropsychology Research Group, LLC
Comparison of alemtuzumab (CamPath) and high dose interferon beta-1a (Rebif) treatment on cognition in subjects with relapsing forms of MS

Completed Enrollment MS Research Studies

Biogen Idec ENER-G 001-06-NAT Phase IV
Multi-center, Open-Label Study to Evaluate the Effects of Natalizumab Treatment on Fatigue and Cognition in Subjects with Relapsing Forms of MS
Biogen Idec Avonex Combination Trial (ACT) NCT00112034 Phase IV
A Multi-Center, Randomized, Blinded, Parallel-Group Study of AVONEX Compared With AVONEX in Combination With Oral Methotrexate, Intravenous
Methylprednisolone, or Both in Subjects With Relapsing Remitting MS Who Have
Breakthrough Disease on AVONEX Monotherapy
Biogen Idec C-1802 SENTINEL NCT00030966 Phase III
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to AVONEX® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple Sclerosis
Biogen Idec C-1808 NCT00276172 Phase III
An Open-Label, Multicenter Extension Study to Evaluate the Safety an Tolerability of Natalizumab in Subjects With Multiple Sclerosis Who Have Completed Studies C-1801, C-1802, or C-1803
Biogen Idec Protocol 101-MS-201
A Multicenter, Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material (BG00002-E) in Subjects with Relapsing Forms of Multiple Sclerosis
Biogen Idec STRATA Study
A Multicenter Study to Determine the safety and efficacy of
Natalizumab in Subjects with relapsing-Remitting Multiple
Sclerosis Previously in the 1801,1802, and 1803 Studies.
BioMS Technology Corp. MAESTRO MBP8298-SP-03 Phase III
A Double-blind, Placebo Controlled Multi-center Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects with Secondary Progressive Multiple Sclerosis
Cognition Pharmaceuticals Cognition:22029 Phase II
A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study to Assess the Safety, Tolerability and Efficacy of C105 in Persons With Multiple Sclerosis with Cognitive impairment
EMD Serono Rebiject – Rebif Tolerability Phase IV Tolerability of Rebif® Injection With and Without the Use of Rebiject™ Mini in
Relapsing Remitting Multiple Sclerosis Patients
EMD Serono RebiQoL NCT00472797 Phase III
A Randomized, Multicenter, Two-Arm, 12 Week Phase IIIb Study to Evaluate Quality of Life (QoL) Measures in Subjects With Relapsing Forms of Multiple Sclerosis Who Are Transitioning From Rebif® (Interferon-Beta1a) to Rebif New Formulation (RNF)
EMD Serono RENEW NCT00262314 Study Phase IV
Phase IV, Prospective, Open-Label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis patients.
EMD Serono REGARD IMP24735 Study Phase IV
Comparison Study of Rebif and Copaxone: Phase IV, multicenter, open label, randomized study of Rebif 44 mcg administered three times per week by subcutaneous injection compared with Copaxone 20 mg administered daily by subcutaneous injection in the treatment of relapsing remitting multiple sclerosis.
Genzyme CAMMS223 Study Phase II
A Phase II, Randomized, Open-Label, Three-Arm Study Comparing
Low-Dose and High-Dose CAMPATH (MABCAMPATH) and High-Dose Rebif
in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis
Genzyme iCAM091 Study Phase II
An Investigator Sponsored, Open-Label, Single-Arm Study of High-
Dose Campath in Patients with Active Relapsing-Remitting Multiple
Sclerosis Who Have Failed Licensed Beta-Interferon Therapies.
Genzyme CARE-MS-I CAMMS323 Phase III
A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Treatment-Naïve Patients with Relapsing-Remitting Multiple Sclerosis
Neurocrine Biosciences NBI-5788-020 Phase II
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of NBI-5788 in Patients with Relapsing Multiple Sclerosis
Opexa Therapeutics, Inc. TERMS NCT00245622 Phase II
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin in Subjects With CIS or RR-MS
Protein Design Labs, Inc. Daclizumab Phase II A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis
Teva Neuroscience SONG PMO33 Phase IIIb
An Open-Label, Multicenter Randomized Study Evaluating the Tolerability and Safety of Two Formulations of Glatiramer Acetate (GA) for Subcutaneous Injection
Teva Neuroscience FORTE NCT00337779 Phase III
A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind Study to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to That of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects With Relapsing Remitting (R-R) Multiple Sclerosis (MS)
Teva Neuroscience NAbsCount NCT00336557 Phase IV
A Randomized, Controlled, Open-Label Parallel Group Study to Evaluate the Effect of Regularly Scheduled Neutralizing Antibody Testing on Treatment Patterns Versus Usual Care in High-Dose Interferon Treated Patients
Teva Neuroscience READY NCT00238654 Phase IV
A Multicenter, Open-Label, Two-Arm Prospective Study to Evaluate the Impact of Patient Readiness to Self-Inject on Outcomes When Using the Copaxone® Prefilled Syringes [The “READY” Trial]
Teva Neuroscience ASSERT NCT00203047 Phase IV
A Multi-Centered, Randomized, Double-Blind, Placebo Controlled Study Assessing the Add-on Effect of Oral Steroids in Relapsing Remitting Multiple Sclerosis Subjects Treated With Glatiramer Acetate (GA)

Journal Publications

Brown MF, Van M, Abramson SL, Fox EJ, Rich RR.
Cellular requirements for induction of human primary proliferative responses to trinitrophenyl-modified cells. J Immunol. 1984 Jan;132(1):19-24.
Fox EJ, elMasry MN, Lewis DE, Rich RR.
Dissociation of proliferative and differentiative signals for human suppressor T cells. Trans Assoc Am Physicians. 1985;98:150-7.
Fox EJ, Cook RG, Lewis DE, Rich RR.
Proliferative signals for suppressor T cells. Helper cells stimulated with pokeweed mitogen in vitro produce a suppressor cell growth factor. J Clin Invest. 1986 Jul;78(1):214-20.
ElMasry MN, Fox EJ, Rich RR.
Opposing immunoregulatory functions of CD8+ lymphocytes: a requirement for monocytes in suppressor cell induction. J Immunol. 1986 Oct 15;137(8):2468-77.
Rich RR, elMasry MN, Fox EJ.
Human suppressor T cells: induction, differentiation, and regulatory functions. Hum Immunol. 1986 Dec;17(4):369-87.
Fox EJ, Lewis DE, Deemer KP, ElMasry MN, Rich RR.
T suppressor cell growth factor and anti-CD3 antibodies stimulate reciprocal subsets of T lymphocytes. J Exp Med. 1987 Aug 1;166(2):404-18.
ElMasry MN, Fox EJ, Rich RR.
Sequential effects of prostaglandins and interferon-gamma on differentiation of CD8+ suppressor cells. J Immunol. 1987 Aug 1;139(3):688-94.
Rich RR, Elmasry MN, Fox EJ.
Human suppressor T lymphocyte growth and differentiation. Trans Am Clin Climatol Assoc. 1987;99:32-40.
Rich RR, elMasry MN, Fox EJ.
Induction of suppressor T cells by cytokines. Transplant Proc. 1988 Dec;20(6):1156-7.
Vartanian TK, Zamvil SS, Fox E, Sorensen PS.
Neutralizing antibodies to disease-modifying agents in the treatment of multiple sclerosis. Neurology. 2004 Dec 14;63(11 Suppl 5):S42-9.
Fox EJ. Immunopathology of multiple sclerosis. Neurology. 2004 Dec 28;63(12 Suppl 6):S3-7.
Fox EJ. Mechanism of action of mitoxantrone. Neurology. 2004 Dec 28;63(12 Suppl 6):S15-8.
Rizvi SA, Zwibel H, Fox EJ. Mitoxantrone for multiple sclerosis in clinical practice. Neurology. 2004 Dec 28;63(12 Suppl 6):S25-7.
Cohen BA, Khan O, Jeffery DR, Bashir K, Rizvi SA, Fox EJ, Agius M, Bashir R, Collins TE, Herndon R, Kinkel P, Mikol DD, Picone MA, Rivera V, Tornatore C, Zwibel H. Identifying and treating patients with suboptimal responses. Neurology. 2004 Dec 28;63(12 Suppl 6):S33-40.
Fox EJ. Management of worsening multiple sclerosis with mitoxantrone: a review. Clin Ther. 2006 Apr;28(4):461-74.
Fox EJ, Vartanian TK, Zamvil, SS. The immunogenecity of disease-modifying therapies for multiple sclerosis: Clinical implications for neurologists.
Neurologist. 13(6):355-362, November 2007
Fox EJ, Lisak RP Clinicians Primer on Multiple Sclerosis: Immunology and the Basic Mechanisms of Action of Pharmacological and Therapeutic Agents – September 2009
Fox EJ Alemtuzumab in the treatment of relapsing-remitting multiple sclerosis
Expert Reviews – Drug Profiles, 2009 In Press
Coyle PK, Foley JF, Fox EJ, Jeffery DR, Munschauer FE, Tornatore C.
Best practive recommendations for the selection and management of patients with multiple sclerois receiving natalizumab therapy.Multiple Sclerosis, Suppliment 2009, In Press
Ford CC, Fox EF, De Greinel ES, Agrella S. The Art & Science of Managing MS: A Case-Based Approach Multiple Sclerosis, Suppliment 2009, In Press
Fox E, Sullivan H, Gazda S, Mayer L, O’Donnell L. A Single-Arm, Open-Label Study of Alemtuzumab in Treatment-Refractory Patients with Multiple Sclerosis.
Multiple Sclerosis, submitted

Abstract Publications

Numerous abstracts published in meetings of the American Association of Neurology, American Committee for the Treatment and Research in Multiple Sclerosis, Consortium of Multiple Sclerosis Centers, European Neurologic Society, and the European Committee for the Treatment and Research in Multiple Sclerosis. Most recent abstracts:
Fox E, Mayer L. Alemtuzumab treatment in relapsing-remitting multiple sclerosis patients who have failed licensed beta-interferon treatment – One-year data. ENS, 2006 P.231

E. Fox, A. Al-Sabbagh, R. Bennett, P. Coyle, D. Mikol, H. Panitch, V. Rivera, L. Rolak, W. Sheremata, S.B. Elias on behalf of the RENEW Study Group

Ongoing evaluation of the safety and tolerability of Novantrone (mitoxantrone) in worsening multiple sclerosis: The RENEW study.ECTRIMS, 2006 P.759

Fox E, Coles A, Margolin D, Haas J, Goldberg M, Norris K, Sullivan H, Bass A, Beardsley D, Compston A. ITP following treatment of multiple sclerosis patients with alemtuzumab in CAMMS223: Case reports and risk management plan implementation. ECTRIMS, 2006 P.800

Fox E, Sullivan H, Gazda S, Mayer L, O’Donnell L. Open-label single-arm, Phase 2 study of alemtuzumab in patients with active relapsing-remitting multiple sclerosis who have failed licensed beta-interferon therapies. AAN, 2007. P06.079
Rivera V, Al-Sabbagh A, Bennett R, Coyle P, Mikol D, Panitch H, Fox E, Rolak L,Sheremata W, Elias S. Ongoing evaluation of the safety and tolerability of mitoxantrone in worsening multiple sclerosis: The RENEW trial. AAN, 2007. P06.080
Markowitz C, Fox E, Goodman A, Green B, Murray R. The impact of regularly scheduled neutralizing antibody testing on treatment patterns versus usual care in MS patients taking high-dose interferon. ECTRIMS. 2007. P.453
Fox E, Mayer L, Sullivan H, O’Donnell L, Gazda S, Melia K, Lake S. Two-year results with alemtuzumab in patients with active relapsing-remitting multiple sclerosis who have failed licensed beta interferon therapies. ECTRIMS, 2007. P558
Fox, E for the CARE-MS steering committee and CARE_MS design team.

The CARE-MS II trial (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis): Design of a Phase 3, open-label, rater and dose-blinded study of alemtuzumab in patients with MS who have relapsed on therapy. AAN, 2008. P02.150
Fox EJ, Markowitz CE, Wynn D, Cohan C, Inman SM, Riser ME, Rill DR, Newsom BS, Garces PC, Williams JC. TERMS (Tovaxin for Early Relapsing MS) pahse 2b placebo-controlled trial of autologous T-cell caccination in patients with clinically isolated syndrome or relapsing-remitting multiple sclerosis. ECTRIMS, 2008. S56
Rivera V, Al-Sabbagh A, Bennett R, Coyle P, Elias S, Mikol D, Panich H, Rolak LA, Sheremata W, Weinstock-Guttman B, Fox E. RENEW study update XVIII: ongoing evaluation of the safety and tolerability of mitoxantrone in worsening multiple sclerosis. ECTRIMS. 2008. P500

Fox, EJ, Markowitz C, Cohan S, Wynn D, Rill D, Riser M, Williams J. TERMS trial T-cell vaccination secondary analysis of clinical and immunologic outcomes in relapsing-remitting multiple sclerosis patients. AAN, 2009. P06.132
Fox E on behalf of the CAMMS223 Study Team Alemtuzumab Improves EDSS Functional System Scores Better than Interferon Beta-1ain Patients with Relapsing Remitting Multiple Sclerosis ACTRIMS, 2009 P.03
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