PGR2019-00002
`Patent 9,855,302 B2
`
`Declaration of Sridhar Mani, M.D.
`
`Appendix A
`
`117
`
`

`

`CURRICULUM VITAE
`SRIDHAR MANI, M.D.
`
`Work
`Albert Einstein Cancer Center
`1300 Morris Park Ave
`Chanin 302D-1
`Bronx, NY 10461
`Tel: 718-430-2871
`Email: sridhar.mani@einstein.yu.edu
`
`Date of Birth: January 22, 1964
`
`Present Rank:
`
`Professor, Departments of Medicine, Molecular Pharmacology and Genetics, Div. of
`Oncology, Albert Einstein School of Medicine (AECOM), Bronx, NY
`
`Education:
`1983-1988
`
`1988-1990
`
`Post-graduate Training:
`1990-1992
`
`1992-1995
`
`Professional Positions:
`1995-1998
`
`1997- 1998
`
`1999
`1999- Present
`2000
`
`1999
`2003
`2006
`2011
`2018
`
`Sophie Davis School of Biomedical Education at the City College of New York
`Degree: Bachelor of Science (BS), Summa Cum Laude
`Major: Biomedical Science/Anthropology
`Mount Sinai School of Medicine, New York
`Degree: Doctor of Medicine (MD), Alpha Omega Alpha
`
`Resident, Department of Internal Medicine, Yale New Haven Hospital, Yale University
`School of Medicine, New Haven, CT (Clinical Investigator Pathway in Internal Medicine)
`Postdoctoral Fellow, Departments of Oncology and Hematology, Yale New Haven
`Hospital, Yale University School of Medicine, New Haven, CT
`
`Instructor, Department of Medicine, Section of Hematology/Oncology, University of
`Chicago, Chicago, IL
`Program Director, GI Oncology, Section of Hematology/Oncology, University of Chicago,
`Chicago, IL
`Assistant Professor, Medicine/Oncology, Montefiore Medical Center (MMC), Bronx NY
`Member, Albert Einstein Cancer Center, Bronx, NY
`Director, Phase I Program, AECCC/ Albert Einstein College of Medicine
`(AECOM/MMC), Bronx, NY (now emeritus)
`Assistant Professor, Medicine, AECOM, Bronx, NY
`Associate Professor, Dept. of Medicine, Div. of Oncology, AECOM
`Associate Professor, Dept. of Molecular Genetics, AECOM
`Professor, Medicine & Genetics, AECOM
`Professor, Molecular Pharmacology, AECOM
`
`Board Certification/Eligibility:
`1993
`ABIM (Internal Medicine) (#150280); Re-certified 2003, 2012
`1997
`ABIM (Oncology) (#150280); Re-certified 2006, 2017
`
`1
`
`118
`
`

`

`ABIM (Hematology)(#150280); Board Eligible 2013
`
`Professional Society Memberships (past and present):
`American College of Physicians (ACP)
`American Federation for Clinical Research (AFCR)
`American Association for Cancer Research (AACR)
`American Society of Clinical Oncology (ASCO)
`European Society for Medical Oncology (ESMO)
`Eastern Oncology Cooperative Group (ECOG)
`American College of Clinical Pharmacology (ACCP)
`American Association of Pharmaceutical Scientists (AAPS)
`American Society for Clinical Pharmacology and Therapeutics (ASCPT)
`American Society of Gene Therapy (ASGT)
`New York Academy of Science (NYAS)
`Royal Society of Medicine, UK (RSM)
`American Society for Biochemistry and Molecular Biology (ASBMB)
`American Association of Immunologists (AAI)
`
`Awards and Honors:
`1989
` Alpha Omega Alpha Medical Honor Society
`1992
` American Medical Association/Burroughs Wellcome Leadership Award
`2002
`Damon Runyon – Lilly Clinical Investigator Award, New York, NY
`2003
`Fellow, American College of Physicians, USA
`2011
`Scientific Award, Society of Asian American Scientists in Cancer Research (AASCR)
`
`PCT/US2002/030276
`
`Awarded and Pending Patents:
`Bregman DB, Mani S, Agrawal A, Lu Y. Sensitization of Cells to Cytotoxic Agents Using
`PCT/US2002/030276
`Oligonucleotides Directed to Nucleotide Excision Repair or Transcription Coupled Repair
`Genes. (USPTO# 20030232767)
`Khandimala E, Zagardo BS, Sai S, Mani S, Agrawal S. Sensitization of Cells to Cytotoxic
`Agents Using Oligonucleotides Directed to Survivin. (USPTO# 20030125287)
`Mani S, Das B. Ketoconazole-Derivative Antagonists of Human Pregnane X Receptor and
`Uses Thereof (USPTO# 20110105522)
`Mani S. Das B. Hypoxia targeted compounds for cancer diagnosis and therapy. (USPTO #
`20110251189)
`Mani S, Wallace B, Redinbo MR. Compounds Inhibiting microbial beta-glucuronidases.
`Patent filed with UNC & AECOM (USTPO# 2010059690).
`PCT/US2013/072709 Mani S, Mukherjee S. Gut barrier dysfunction treatment and prevention. (USTPO#
`20180185422)
`Mani S, Kelly L, Li H. Endogenous microbial hyperswarmers protect against intestinal
`inflammation.
`Mani S, Azole PXR antagonist for Treatment of Nonalcoholic Fatty Liver Disease
`(NAFLD)
`Mani S et al. PXR agonists and uses thereof for gut barrier dysfunction, treatment and
`prevention
`
`96700/1320 D-665
`
`96700/1423 D-666
`
`WO/2011/072127
`
`Filed
`
`Filed
`
`PCT/US2018/14129
`
`Other Professional Activities:
`1998-1999
`Member, Cancer and Leukemia Group B (CALGB)
`Pharmacology and Experimental Therapeutics (PET) Committee
`PET Liaison to GI Committee, CALGB
`Member, GI Solid Tumor Correlative Science Committee, CALGB
`Member, Eastern Cooperative Oncology Group (ECOG)
`Executive Committee, ECOG Experimental Therapeutics Committee
`Member, Institutional Biosafety Committee (IBC) of AECOM, Bronx, NY
`Member, Committee on Patents of AECOM, Bronx, NY
`Member, NCI Organ Dysfunction Drug Development Consortium
`
`1998-1999
`1998-1999
`2002
`2005
`2000- 2014
`2000- 2013
`2000-Present
`
`2
`
`119
`
`

`

`2007-2015
`2013-2015
`2012-
`
`Member, The Harvey Society, New York, NY
`Member, Committee on Appointments & Promotions (Professors)
`Member, Advisory Committee K12 Paul Calabresi Career Development Award for Clinical
`Oncology (PI: Perez-Soler, R)
`
`Principle Investigator, National Group Trials:
`1998-1999
`Interracial Study of CPT-11 (Irinotecan) Pharmacokinetics in 5-Fluorouracil Refractory
`Colon Cancer: A Population Pharmacokinetic/Pharmacodynamic Study: MMTC# 6475
`98253 CALGB# 9864
`
`Editorial Board Membership:
`2004-
` Current Cancer Drug Targets
`2004-
` Current Medicinal Chemistry - Anti-Cancer Agents
`2007-
` Genes & Cancer
`2009-
` Clinical Cancer Research
`2009-
`Molecular Cancer Therapeutics
`2009-2013
`Cancer Research
`2009-
`Molecular Pharmacology (Associate Editor, 2015 -)
`2014-
`Journal of Visual Experiments (JoVE)
`2015-
`Journal of Biological Chemistry (JBC)
`2015-
`Nuclear Receptors Research (Associate Editor)
`
`2007
`2009
`2009
`2009
`2010
`
`2008-2010
`
`08/17/10-08/18/10
`10/10/10-10/11/10
`
`3/2/11 – 3/3/11
`
`NIH Grants Review and Study Section Membership:
`10/19/00 - 10/20/00
`CA00-001/Molecular Biology NCI Special Emphasis Panel ZCA1 SRRB-D (J2)
`Interdisciplinary Teams for Molecular Target Assessment, Bethesda MD
` Adhoc Member, ZRG1 SSMI-Q 10: Biomedical Devices and Bioengineering Study Section
` Adhoc Member, National Cancer Institute, DT Scientific Review Group
` NIH Challenge Grants Reviewer
` Adhoc member, Oncology 2 - Translational Clinical Integrated Review Group
`Adhoc member, ZRG1 OTC-L(10) Cancer Drug Development and Therapeutics (CDDT)
`SBIR/STTR , NCI
`Grant Reviewer, James and Esther King Biomedical Research Program, Florida
`Department of Health, FL
` Reviewer, 2010/10 ZRG1 EMB (02) M Member Conflict: Endocrinology and Obesity
` Chair, Cancer Drug Development and Therapeutics (CDDT) SBIR/STTR review panel
` [2011/01 ZRG1 OTC-J (10)]
` Permanent Member, Cancer Diagnostics and Treatments SBIR/STTR panel (ZRG1-OTC-
`H13)
`Permanent Member, National Cancer Institute, Developmental Therapeutics (DT) Scientific
`Review Group
` Co-chair, ZRG1 OTC-H (13) B Cancer Diagnostics and Treatments (CDT) SBIR/STTR
` Adhoc Member, ZRG1 OTC-H (14) B Small Business: Cancer Diagnostics and Treatments
`(CDT)
` Adhoc Member, NCI P01 Special Emphasis Panel II
`Adhoc, Special Emphasis Panel/Scientific Review Group 2015/01 ZCA1 RPRB-O (J1) P
`meeting
`Adhoc, Drug Discovery and Molecular Pharmacology Study Section
`Adhoc, MIRA Grant Panel, NIGMS
`ZRG1-BDCN-W-03, ZCA1-RPRB-J-O1, ASG, NIH
`CDMRP Reviewer
` R13 Review Panel, NCATS
`Adhoc, ASG Review Panel, NIH
`Adhoc, ZTR1 CG-5 (01) NCATS (NIH), Bethesda, MD
` BCRP, DOD Reviewer
`XNDA CSR, Reviewer
`
`09/01/11
`
`06/23/11 – 06/30/11
`07/0711 – 07/09/12
`
`07/12/13 -07/13/13
`2014
`
`2015
`
`2016
`2016, 2017
`2017
`2017
`2018
`2019
`2019
`
`3
`
`120
`
`

`

`2019
`
`Permanent Member, Xenobiotic and Nutrient Disposition and Action Study Section
`(XNDA), DKUS
`
`
`International (Other) Study Section(s)
`2008-
`
`
`Grant Reviewer, Georgia National Science Foundation, Tbilisi, Georgia
`06/30/13 -
` Reviewer, Foundation for Polish Science, Warsaw, Poland
`2016
`
`
`Review, Italian Ministry of Health, Italy
`2017
`
`
`DBT, India
`Reviewer, Oncopole EMC2 (Multi-institutional teams against cancer), Fonds de Recherche
`2018
`du Québec –Santé (FRQS), Quebec
`Reviewer, Czech Science Foundation, CZ
`Florida Department of Health
`
`2018
`2019
`
`
`
`AECOM PhD Thesis and Qualifying Committees (see Teaching Portfolio): Upon Request
`Undergraduate, Graduate and Postdoctoral Fellows/Trainees (see Teaching Portfolio): Upon Request
`AECOM Teaching (see Teaching Portfolio): Upon Request
`
`National Meeting (Podium/Poster Discussion) Presentations:
`2005, 2008
`Annual Meeting - American Society of Clinical Oncology
`Annual Meeting - American Association of Cancer Research
` NYAS: Co-Chair, Schwachman-Diamond Syndrome International Conference
`
`
`
`2009
`
`
`Invited Lectures:
`2001
`2002
`2003
`2004
`2005
`2009
`2009
`2010
`2010
`2010
`2011
`2011
`2012
`2012
`2013
`
`2014
`2015
`
`2016
`
`2017
`2018
`2018
`2019
`2019
`2019
`2019
`
`Other AECOM Committees:
`
`Johns Hopkins Hospital, Baltimore MD/Drug Development
`Georgetown University Medical Center, Washington DC
`Dana Farber Cancer Center, Harvard University, Boston, MA
`Georgetown University Medical Center, Washington DC
`Thomas Jefferson University, Philadelphia, PA
`Mount Sinai School of Medicine, New York, NY
`University of Connecticut Health Science Center, Hartford, CT
`Shanghai University of Traditional Chinese Medicine, Shanghai, China
`City of Hope Medical Center, Duarte, CA
`Drexel University College of Medicine, Philadelphia, PA
`Medical University of South Carolina, Charleston, South Carolina
`OMICs Meeting, Las Vegas, NV
`Penn State “Symposium on Molecular Biology” (June 2012)
`St. Judes Children’s Medical Center, Memphis, TN
`University of Kansas Medical Center, Kansas City, KS
`University of Connecticut Medical Center, Hartford, CT
`Fox Chase Chemical Diversity Center, Philadelphia, PA
`Experimental Biology, Boston, MA
`Palacky University, Olomouc, Czech Republic
`Microbiome Update 2016, BioPharma Research Council, Kean University, NJ
`University of Houston, Houston, TX
`Taipei Medical University, Taipei, Taiwan
`Brown University, Providence, RI
`Personalized Medicine, Gordon Research Conference, Hong Kong
`University of Oklahoma
`University of California, Davis CA
`Fondazione IRCCS Istituto Nazionale dei Tumori, Milan
`University of Perugia, Italy
`
`
`
`4
`
`121
`
`

`

`
`
`Member, Salome Gluecksohn-Waelsch Prize Committee, Dept of Genetics
`
`
`
`
`
`
`
`
`
`01/01/2019 – 12/31/2023
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2.4 cal mos
`
`3 Cal mos
`
`3.6 cal
`
`1.2 cal
`
`0.0 cal mos
`
`0.0 cal mos
`
`0.6 cal mos
`
`2010-2012
`
`Grant Funding (Awarded):
`
`4/1/2017 - 3/31/2020
`DOD BC:161093 (Mani)
`
`$ 126,228
`DOD
`
`
`
`Inhibition of Microbial Beta-Glucuronidase as a Strategy Toward Breast Cancer
`Chemoprevention
`This proposed research directly addresses the challenge of preventing breast cancer (primary prevention) and
`identifying what drives breast cancer growth and to determine how to stop it.
`
`9/30/2017 - 9/29/20
`
`DOD PR160167 (Mani)
`
`$250,000
`
`DOD
`
`
`Mechanisms and Therapeutic Implications of the Pregnane X Receptor Targeting Indole Bacterial Metabolites in
`Inflammatory Bowel Disease.
`
`09/01/2017 - 08/31/2022
`
`
`R01CA222469 (Mani)
`
`$ 549,306
`
`
`NIH
`
`
`The adopted orphan nuclear receptor, Pregnane X Receptor (PXR), is now an established therapeutic target for the
`incurable colitis-associated colon cancer (CRC). In this application, based on our preliminary data that establish
`microbial indoles activates the pregnane x receptor (PXR) and regulates mucosal barrier integrity via a specific host-
`TLR4 signaling pathway, we will develop early lead small molecules that mimic the binding of indole/IPA to human
`PXR and validate the proof-of-concept that these lead(s) are PXR-specific, potent and above all non-toxic to
`cells/tissues. The proposed studies will provide the rationale for the development of these novel leads in mammalian
`models of colitis-associated CRC with the aim towards clinical development.
`
`R01ES030197 (Cui/Mani/Haiwei)
`NIH $ 520,244
`Developmental study in mice of the effect of PDBE exposure on PXR mediated effects via alterations in the gut
`microbiome on diabetes.
`
`Completed
`06/15/2016—09/01/16
`
`Student Research Fellowship Award
`$2,500
`
`Crohn’s & Colitis Foundation
`
`Unique Biofilms Enable Isolation of Novel Probiotics
`The goal is to have the student test whether humans with and without IBD harbor bacterial swarmers.
`
`06/01/2014-05/31/2016
`
`
`2P30DK041296-26 (Wolkoff)
`$25,000
`
`
`NIH/NIDDK
`
`
`Liver Pathobiology and Gene Therapy Research Core Center
`The Liver Center Core Grant has a awarded a pilot project to develop PXR specific agonists, leading to a better
`understanding of the role of the receptor in the pathogenesis of DILI.
`
`07/01/2015-06/30/2016
`
`R43DK105694 (Wrobel) subcontract
`$48,075
`
`NIH/NIDDK
`
`
`
`Pregnane X Receptor (PXR) Antagonists as Pharmacological Treatment for Non-Alcoholic Fatty Liver Disease
`The goal of this project is to obtain preclinical drug candidates for non-alcoholic fatty liver disease, a malady that
`ultimately leads to liver fibroses and failure.
`
`
`08/13/2009-05/31/2015
`
`R01CA127231-05 (Mani)
`
`$151,359 (NCE)
`
`NIH/NCI
`
`
`Chemical Modulation of Orphan Nuclear Receptor Function
`The goal of this project is to determine the residues and molecular mechanisms governing azole inhibition of PXR
`
`R01CA127231-05S2 (Mani)
`
`2.4 cal mos
`
`
`
`
`
`09/16/2011-05/31/2015
`
`
`
`0.0 cal mos
`
`
`
`5
`
`122
`
`

`

`0.6 cal mos
`
`0.6 cal mos
`
`$46,099
`
`
`
`
`NIH/NCI
`Chemical Modulation of Orphan Nuclear Receptor Function
`Subtitle: Research Supplements to Promote Diversity in Health-Research.
`The goal of this project is to determine the residues and molecular mechanisms governing azole inhibition of PXR.
`This supplement provides salary support for PhD student Danielle Pasquel.
`
`06/01/2015—09/30/2018
`
`Broad Foundation (Mani)
`$118,182
`
`Broad Medical Research Program
`The goal of this application is to further the understanding of the role PXR plays in mediating effects of gut
`commensals on intestinal innate immunity and crohn’s ileitis.
`
`R01CA161879-03(MPI) (Mani & Redinbo) 04/01/2012-03/31/2018 (NCE)
`NIH/NCI
`
`
`
`
`$233,758
`Development of Novel Drugs to Alleviate CPT-11 Toxicity
`The goal of this project is to improve CPT-11 efficacy by alleviating its dose-limiting side effect. Includes a
`subcontract with UNC, Dr. Matt Redinbo, PI.
`
`Original Communication in Peer-Reviewed Journals:
`
`Clinical/Translational:
`1. Mani S. Dilatation of the biliary ductal system: Choledochal cysts. Mt Sinai J Med 57:177-184 (1990)
`2. Torres RA, Mani S, Altholz J, Brickner PW. Human immune deficiency virus infection among homeless men in
`New York City shelter. Association with mycobacterium tuberculosis infection. Arch Intern Med 150:2030-2036
`(1990)
`3. Mani S, Edberg SC, Patterson JE. Community-acquired bacteremia due to multiresistant Enterobacter in a patient
`with urosepsis. Clin Infect Dis 15:565-566 (1992)
`4. Mani S. Pentamidine induced renal magnesium wasting. AIDS 6:594-5 (1992)
`5. Mani S, Kocheril AG, Andriole VT. Case report: pentamidine and polymorphic ventricular tachycardia revisited.
`Am J Med Sci 305:236-240 (1993)
`6. Buzaid AC, Sandler AB, Mani S, Curtis AM, Poo WJ, Bolognia JL, Ariyan S. Role of computed tomography in
`the staging of primary melanoma. J Clin Onc 11:638-643 (1993)
`7. Mani S, Duffy T. Sickle myonecrosis revisited. Am J Med 95:525-530 (1993)
`8. Mani S, Flynn SD, Duffy T, Morgan W. Isolated amyloidosis of the penile urethra and corpus spongiosum: a case
`report. J Urol 150:1915-1916 (1993)
`9. Mani S, Barry M, Concato J. G-CSF therapy in drug induced agranulocytosis. Arch Intern Med 153:2500-2501
`(1993)
`10. Mani S, Duffy T. Pericardial tamponade in chronic myelomonocytic leukemia. Chest 106:967-970 (1994)
`11. Warner RR, Mani S, Profeta J, Grunstein E. Octreotide treatment of carcinoid hypertensive crisis. Mt. Sinai J
`Med 61: 349-55 (1994)
`12. Mani S, Todd MB, Katz KH, Poo WJ. Prognostic factors for survival in patients with metastatic renal cell cancer
`treated with biological response modifiers. J Urol 154: 35-40 (1995)
`13. Mani S, Haffty B, Sinard J, Fisher D, Papac RJ, Flynn S. DNA ploidy as a significant predictor of recurrence-free
`survival in male patients with breast cancer: A single institution experience of 55 cases. Breast J 1: 356-361 (1995)
`14. Mani S, Sadigh M, Andriole VT. Aeromonas infection: St. Mary's Hospital perspective. Inf Dis Clin Prac 4: 79-
`86 (1995)
`15. Mani S, Poo WJ. Single institution experience with recombinant gamma-interferon in the treatment of patients
`with metastatic renal cell carcinoma. Am J Clin Onc 19:149-53 (1996)
`16. Mani S, Todd MB. Recombinant beta interferon in the treatment of patients with metastatic renal cell carcinoma.
`Am J Clin Onc 19:187-9 (1996)
`17. Mani S. Phase II study of Uracil/Ftorafur (UFT) plus leucovorin in advanced hepatobiliary tumors and pancreatic
`adenocarcinomas [protocol summary, UFT meeting]. Oncol 11(9)(suppl 10): 124-128 (1997)
`18. Mani S, Iyer L, Janisch L, Wang X, Fleming GF, Schilsky RL, Ratain MJ. Phase I clinical and pharmacokinetic
`study of oral 9-aminocamptothecin. (NSC-603071). Cancer Chemother Pharmacol 42: 84-87 (1998)
`19. Vogelzang NJ, Mani S, Schilsky RL, Ansari RH, Taber D, Rhinehart SN, Meyer SC, Mick R, Schumm LP,
`Brockstein BE, Stadler WM, Ratain MJ, Vokes EE. Phase II and pharmacodynamic studies of pyrazine
`diazohydroxide (NSC 361456) in advanced renal and colorectal cancer. Clin Cancer Res 4: 929 (1998)
`20. Mani S, Kugler JW, Sciortino DF, Garcia JC, Ansari RH, Tembe S, DeMario MD, Humerickhouse R, Michelassi
`F, Posner MC, Shulman KL, Schilsky RL, List M, Vokes EE, Benner S. Phase II trial of Uracil/Tegafur (UFT) plus
`
`
`
`
`
`
`
`6
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`leucovorin in patients with advanced pancreatic carcinoma: A University of Chicago Phase II consortium study. Ann
`Oncol. 9: 1035-7 (1998)
`21. Mani S, Kugler JW, Knost JA, Sciortino DF, Gibbons J, Garcia JC, Ansari RH, Schilsky RL, Vokes EE. Phase II
`trial of 150-minute weekly infusion of gemcitabine in advanced colorectal cancer: minimal activity in colorectal
`cancer. Invest New Drugs. 16: 275-8 (1998)
`22. Mani S, Gerstner J, Wade J III, Kugler J, Geoffroy F, Hooberman A, Hadley T, Arrieta R, Vokes E. Phase II Trial
`of Pyrazoloacridine (NSC 366140) in Patients with Advanced Hepatobiliary and Pancreatic Cancer. Cancer
`Therapeutics 1:313-317 (1998)
`23. Mani S, Schiano T, Baker A, Lissoos T, Garcia JC, Ansari RH, Samuels B, Sciortino DF, Tembe S,
`Humerickhouse R, Posner MC, Shulman KL, Schilsky RL, Vokes EE, Benner S. Phase II trial of UFT plus leucovorin
`in patients with advanced hepatocellular carcinoma: A University of Chicago Phase II consortium study of nine
`institutions. Invest New Drugs 1: 1-5 (1999)
`24. DeMario MD, Ratain MJ, Vogelzang NJ, Mani S, Vokes EE, Fleming GF, Melton K, Johnson S, Benner S,
`Lebwohl D. A phase I study of oral uracil/Ftorafur (UFT) plus leucovorin and Bis-acetato-amminedichloro-
`cyclohexylamine-Platinum IV (JM 216) each given over 14 days every 28 days A phase I study of oral uracil/ftorafur
`(UFT) plus leucovorin and JM-216. Cancer Chemother Pharmacol. 43: 385-8 (1999)
`25. Vokes EE, Goh BC, Berfucci D, Vogetzang N, Mani S, Ratain MJ. A phase I study of Raltitrexed and Paclitaxel
`given every 3 weeks to patients with solid tumors. Cancer 86: 528-32 (1999)
`26. Mani S, Sciortino D, Samuels B, Arrietta R, Schilsky RL, Vokes EE, Benner S. Phase II trial of uracil/tegafur
`(UFT) plus leucovorin in patients with advanced biliary carcinoma. Invest New Drugs 1: 5-8 (1999)
`27. Mani S, Beck T, Chevlen E, Hochster H, O'Rourke M, Weaver C, Bell W, Levin J, Hohnekar J, Lokich J. A phase
`II open-label study to evaluate a 28 day regimen of oral 5-fluorouracil plus 776C85 for the treatment of patients with
`previously untreated metastatic colorectal cancer. J Clin Oncol 18:2894-901 (2000)
`28. Schilsky RL, Bukowski R, Burris H, Hochster H, O'Rourke M, Crawford J, Mani S, Bonny T, Levin J, Hohneker
`J. A multicenter phase II study of 5-day regimen of oral 5-flurouracil plus eniluracil with or without leucovorin in
`patients with metastatic colorectal cancer. Ann Oncol 11: 415-20 (2000)
`29. Schilsky RL, Dolan ME, Bertucci D, Ewesuedo RB, Vogelzang NJ, Mani S, Wilson LR, Ratain MJ. Phase I
`clinical and pharmacological study of O6-Benzylguanine followed by carmustine in patients with advanced cancer.
`Clin Cancer Res. 6: 3025-31 (2000)
`30. Kaufman HL, Conkright W, Divito J, Horig H, Kaleya R, Lee D, Mani S, Pancali D, Rajdev L, Ravikumar TS,
`Wise-Campbell S, Surhland MJ. A Phase I trial of intralesional RV-B7.1 vaccine in the treatment of malignant
`melanoma. Human Gene Therapy 11: 1065-1082 (2000)
`31. Venook AP, Egorin MJ, Rosner GL, Hollis D, Mani S, Hawkins M, Byrd J, Hohl R, Budman D, Meropol NJ,
`Ratain MJ. Phase I and Pharmacokinetic Trial of Gemcitabine in Patients With Hepatic or Renal Dysfunction: Cancer
`and Leukemia Group B 9565. J Clin Oncol 18: 2780-2787 (2000)
`32. Goh BC, Ratain MJ, Bertucci D, Smith R, Mani S, Vogelzang NJ, Schilsky RL, Hutchison M, Smith M, Averbuch
`S, Douglas E. Phase I study of ZD 9331 on short daily intravenous bolus infusion x 5 days every 3 weeks with fixed
`dosing recommendations. J Clin Onc 19: 1476-1484 (2000)
`33. Ewesuedo RB, Iyer L, Das S, Koenig A, Mani S, Vogelzang NJ, Schilsky RL, Brenckman , Ratain MJ. Phase I
`Clinical and Pharmacogenetic Study of Weekly TAS-103 in Patients with Advanced Cancer. J Clin Oncol. 19: 2084-
`90 (2001)
`34. Mani S, Sharma A, Hanna N, Guha C, Vikram B, Malik U, Makower D, Gucalp R, Wadler S, Chaimberlain R,
`DelRowe J, Butler J, Sparano J, Rajdev L, Sood B, Lee D, Rozenblit A, Regine W, Muhodin M, Valentino J, Herman
`J, Desimone P, Arnold S, Carrico J, Rockich AK, Carpenter JW, Baxter MB. An Open-label phase I dose-escalation
`study of tumor necrosis factor-a (TNFerade Biologic) gene transfer with radiation therapy for locally advanced
`recurrent or metastatic solid tumors. Human Gene Therapy 12: 1109-1131 (2001)
`35. Rudin CM, Holmlund J, Fleming GF, Mani S, Stadler WM, Schumm P, Monia BP, Johnston JF, Geary R, Yu RZ,
`Kwoh TJ, Dorr FA, Ratain MJ. Phase I Trial of ISIS 5132, an antisense oligonucleotide inhibitor of c-raf-1,
`administered by 24-hour weekly infusion to patients with advanced cancer. Clin Cancer Res. 7:1214-20 (2001)
`36. Mani S, Gordon GS, Vogelzang NJ, Bertucci D, Schilsky RL, Stadler WM, Ratain MJ. Phase I study of weekly
`gemcitabine and prolonged infusion 5-fluorouracil in patients with advanced cancer. Cancer 92:1567-76 (2001)
`37. Mani S, Rudin CM, Kunkel K, Holmlund JT, Geary RS, Kindler HL, Dorr AF, Ratain MJ. Phase I clinical and
`pharmacokinetic study of PKC-a antisense oligonucleotide ISIS 3521 administered in combination with 5-fluorouracil
`and leucovorin in patients with advanced cancer. Clin. Cancer Res. 8: 1042-1048 (2002)
`38. Goel S, Jhawer M, Rajdev L, Hopkins U, Fehn K, Baker C, Chun HG, Makower D, Landau L, Basu S, Hoffman
`A, Sparano J, Wadler S, Mani S. Phase I clinical trial of irinotecan and oral capecitabine in patients with
`gastrointestinal and other solid malignancies. Am J Clin Oncol. 25: 528-34 (2002)
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`39. Shepard DR, Mani S, Kastrissios H, Coughlin SL, Smith D, Ertel P, Magnum S, Janisch L, Fleming GF, Schilsky
`RL, Ratain MJ. Estimation of the effect of food on the disposition of oral 5-fluorouracil in combination with eniluracil.
`Cancer Chemother Pharmacol. 49:398-402 (2002)
`40. Makower D, Sparano J, Wadler S, Fehn K, Landau L, Mani S. A pilot study of edrecolomab (panorex, 17-1A
`antibody) and capecitabine in patients with advanced or metastatic adenocarcinoma. Cancer Invest. 21: 177-84 (2003)
`41. Goel S, Hoffman A, Volterra F, Zimmerman T, Wadler S, Mani S. Phase II study of a Rebecccamycin analog in
`patients with metastatic colorectal cancer. Invest New Drugs. 21:103-7 (2003)
`42. Masters GA, Brockstein BE, Mani S, Ratain MJ. Phase 1 dose escalation study of docetaxel with filgrastim
`support in patients with advanced solid tumors. Med Oncol. 20:7-12, 2003
`43. Goel S, Bulgaru A, Desai K, Nazario E, Hoffman A, Volterra F, Goldberg G, Fields A, Martin R, McKinlay M,
`Agrawal S , Mani S. A Safety and Pharmacodynamic Study of a Mixed-Backbone Oligonucleotide (GEM231)
`Targeting PKA RIa using a Continuous Infusion Schedule in Patients with Refractory Solid Tumors. Clin Cancer
`Res. 9:4069-76 (2003)
`44. Mani S, Goel S, Martin RM, Grindel JM, Rothenberg ML, Zhang R, Tortora G, Cho-Chung YS. Clinical Studies
`in Patients with tumors using a second generation oligonucleotide (GEMÒ231) targeting the Type I Protein Kinase A
`mRNA. Ann N Y Acad Sci. 1002:252-62 (2003)
`45. Aklilu M, Kindler HL, Donehower RC, Mani S, Vokes EE. Phase II study of flavopiridol in patients with
`advanced colorectal cancer. Ann Oncol. 14:1270-3 (2003)
`46. Takimoto CH, Remick SC, Sharma S, Mani S, Ramanathan RK, Doroshow J, Hamilton A, Mulkerin D, Graham
`M, Lockwood GF, Ivy P, Egorin M, Schuler B, Greenslade D, Goetz A, Knight R, Thomas R, Monahan BP, Dahut W,
`Grem JL; National Cancer Institute Organ Dysfunction Working Group Study. Dose-escalating and pharmacological
`study of oxaliplatin in adult cancer patients with impaired renal function: a National Cancer Institute Organ
`Dysfunction Working Group Study. J Clin Oncol. 21:2664-72 (2003)
`47. Goel S, Bulgaru A, Hochster H, Wadler S, Zamboni W, Egorin M, Ivy P, Leibes L, Muggia F, Lockwood G,
`Harvey E, Renshaw G, Mani S. Phase I clinical study of infusional 5-fluorouracil with oxaliplatin and gemcitabine
`(FOG regimen) in patients with solid tumors. Ann Oncol. 14:1682-7 (2003)
`48. Doroshow JH, Synold TW, Gandara D, Mani S, Remick SC, Mulkerin D, Hamilton A, Sharma S, Ramanathan
`RK, Lenz HJ, Graham M, Longmate J, Takimoto CH, Ivy P. Pharmacology of oxaliplatin in solid tumor patients with
`hepatic dysfunction: a preliminary report of the national cancer institute organ dysfunction working group. Semin
`Oncol. 30(4 Suppl 15):14-9 (2003)
`49. Takimoto CH, Remick SC, Sharma S, Mani S, Ramanathan RK, Doroshow JH, Hamilton A, Mulkerin D, Graham
`M, Lockwood GF, Ivy P, Egorin M, Greenslade D, Goetz A, Grem JL. Administration of oxaliplatin to patients with
`renal dysfunction: a preliminary report of the national cancer institute organ dysfunction working group. Semin Oncol.
`30(4 Suppl 15): 20-5 (2003)
`50. Mani S, McDaid H, Hamilton A, Hochster H, Cohen MB , Liebes L, Khabelle D, Lebwohl DE, Muggia F,
`Horwitz SB. Phase I Clinical and Pharmacokinetic Study of BMS-247550, a novel derivative of Epothilone B, in
`Solid Tumors. Clin Cancer Res. 10:1289-98 (2004)
`51. Senzer N, Mani S, Rosemurgy A, Nemunaitis J, Cunningham C, Guha C, Bayol N, Gillen M, Chu K, Rasmussen
`C, Rasmussen H, Kufe D, Weichselbaum R, Hanna N. TNFerade Biologic, an Adenovector With a Radiation-
`Inducible Promoter, Carrying the Human Tumor Necrosis Factor Alpha Gene: A Phase I Study in Patients With Solid
`Tumors. J Clin Oncol. 22:592-601 (2004)
`52. Undevia S, Vogelzang N, Mauer A, Janisch L, Mani S, Ratain M. Phase I Clinical Trial of CEP-2563
`Dihydrochloride, a Receptor Tyrosine Kinase Inhibitor, in Patients with Refractory Solid Tumors. Clin Pharmacol
`Ther. 76: 490-502 (2004)
`53. Kindler HL, Avadhani A, Wade-Oliver K, Karrison T, Mani S, Vokes EE. 9-Aminocamptothecin (9-AC) given as
`a 120-hour continuous infusion in patients with advanced adenocarcinomas of the stomach and gastroesophageal
`junction: A phase II trial of the University of Chicago phase II consortium. Invest New Drugs. 22:323-7 (2004)
`54. Eng C, Ramathan RK, Wong MK, Remick SC, Dai L, Wade-Oliver KT, Mani S, Kindler HL. A Phase II trial of
`fixed dose rate gemcitabine in patients with advanced biliary tree carcinoma. Am J Clin Oncol. 27: 565-9 (2004)
`55. Innocenti F, Undevia SD, Ramirez J, Mani S, Schilsky RL, Vogelzang NJ, Prado M, Ratain MJ. A phase I trial of
`pharmacologic modulation of irinotecan with cyclosporine and phenobarbital. Clin Pharmacol Ther. 76: 490-502
`(2004)
`56. Desai AA, Kindler HL, Taber D, Agamah E, Mani S, Wade-Oliver K, Ratain MJ, Vokes EE. Modulation of
`irinotecan with cyclosporine: a phase II trial in advanced colorectal cancer. Cancer Chemother Pharmacol. 56:421-6
`(2005)
`57. Kindler HL, Tothy PK, Wolff R, McCormack RA, Abbruzzese JL, Mani S, Wade-Oliver KT, Vokes EE. Phase II
`trials of dolastatin-10 in advanced pancreaticobiliary cancers. Invest New Drugs. 23: 489-93 (2005)
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`58. Zamboni WC, Goel S, Iqbal T, Parise RA, Strychor S, Repinski TV, Mani S. Clinical and pharmacokinetic study
`evaluating the effect of food on the disposition of 9-nitrocamptothecin and its 9-aminocamptothecin metabolite in
`patients with solid tumors. Cancer Chemother Pharmacol. 57:631-9 (2006)
`59. Ramanathan RK, Fakih M, Mani S, Deutsch M, Perez RP, Ritter MA, Eiseman JL, Ivy SP, Trump DL, Belani CP,
`Parise RA, Potter DM, Egorin MJ. Phase I and pharmacokinetic study of the novel redox-active agent, motexafin
`gadolinium, with concurrent radiation therapy in patients with locally advanced pancreatic or biliary cancers. Cancer
`Chemother Pharmacol. 57:465-74 (2006)
`60. Goel S, Desai K, Macapinlac M, Wadler S, Goldberg G, Fields A, Einstein M, Volterra F, Wong B, Martin R,
`Mani S. A phase I safety and dose escalation trial of docetaxel combined with GEMÒ231, a second generation
`antisense oligonucleotide targeting protein kinase A R1alpha in patients with advanced solid cancers. Invest New
`Drugs. 24:125-34 (2006)
`61. Jhawer M, Mani S, Lefkopoulou M, Hahn RG, Harris J, Catalano PJ, Haller D. Phase II study of mitomycin-C,
`adriamycin, cisplatin (MAP) and Bleomycin-CCNU in patients with advanced cancer of the anal canal: An eastern
`cooperative oncology group study E7282. Invest New Drugs. 24:447-54 (2006)
`62. Wang Y, Holland JF, Bleiweiss IJ, Melana S, Liu X, Pelisson I, Cantarella A, Stellrecht K, Mani S, Pogo B G-T.
`Detection of Mammary Tumor Virus ENV Gene-like sequences in human breast cancer. Cancer Res 55: 5173-5179
`(1995)
`63. Shankar SL, Mani S, O'Guin N, Kandimalla E, Agrawal S, Zagardo BS. Down-regulation of survivin by antisense
`oligonucleotides induces human nervous system tumor cell death. J Neurochem. 79: 426-36 (2001)
`64. Lu Y, Mani S, Kandimalla ER, Yu D, Agarwal S, States JC, Bregman DB. Mixed backbone oligonucleotides
`targeting the nucleotide excision repair protein XPA potentiate cisplatin cytotoxicity. Int J Oncol. 19: 1089-97 (2001)
`65. Wu K, Wang C, D'Amico M, Lee RJ, Albanese C, Pestell RG, Mani S. Flavopiridol and Trastuzumab
`Synergistically Inhibit Proliferation of Breast Cancer Cells: Association with Selective Cooperative Inhibition of
`Cyclin D1 Dependent Kinase and Akt Signaling Pathways. Mol Cancer Ther. 1: 695-706 (2002)
`66. McDaid HM*, Mani S*, Shen H-J, Muggia F, Sonnichsen D, and Horwitz SB. Validation of the
`Pharmacodynamics of BMS-247550, an Analogue of Epothilone B, during a Phase I Clinical Study. Clin Cancer Res
`8: 2035-2043 (2002) (* equal contributors)
`67. Shankar SL, Krupski M, Parashar B, Okwuaka C, O'Guin K, Mani S, Shafit-Zagardo B. UCN-01 alters
`phosphorylation of Akt and GSK3beta and induces apoptosis in six independent neuroblastoma cell lines. J
`Neurochem. 90: 702-11 (2004)
`68. Mani S, Huang H, Sundarababu S, Liu W, Kalpana G, Smith AB, Horwitz SB. Activation of the steroid and
`xenobiotic receptor (human pregnane X receptor) by nontaxane microtubule-stabilizing agents. Clin Cancer Res.
`11:6359-69 (2004)
`69. Wu KM, Wang CG, D'Amico M, Albanese C, Pestell, R, Mani S. Flavopiridol synergizes with UCN-01: Role of
`surviving in reversal of resistance to UCN-01. Invest New Drugs 23: 299-309 (2005)
`70. Alarcon-Vargas D,Zhang Z, Agarwal B, Challagulla K, Mani S*, Ganjam K*. Targeting Cyclin D1, a
`downstream effector of INI1/hSNF5, in rhabdoid tumors. Oncogene. 25:722-34 (2006)
`71. Zamboni WC, Ramanathan RK, McLeod HM, Mani S, Potter DM, Strychor S, Maruca L, King CR, Jung LL,
`Parise RA, Egorin MJ, Davis TA, Marsh TM. Disposition o