Archive for Publications

FUTURE DIRECTIONS FOR IMMUNOTHERAPY IN OVARIAN CANCER

Manning L, Nemunaitis J. Future Directions for Immunotherapy in Ovarian Cancer. Journal of Gynecology and Women’s Health. 2017; 2(3): 555587.

EFFECTS OF RIFAMPIN, ITRACONAZOLE AND ESOMEPRAZOLE ON THE PHARMACOKINETICS OF ALISERTIB, AN INVESTIGATIONAL AURORA A KINASE INHIBITOR IN PATIENTS WITH ADVANCED MALIGNANCIES

Zhou X, Pant S, Nemunaitis J, Lockhart AC, Falchook G, Bauer TM, Patel M, Sarantopoulos J, Bargefrede M, Muehler A, Rangachari L, Zhang B, Venkatakrishnan K. Effects of rifampin, itraconazole and esomeprazole on the pharmacokinetics of alisertib, an investigational Aurora A kinase inhibitor in patients with advanced malignancies. Investigational New Drugs. 2017 Aug 30; [Epub ahead of print].

IMMUNOTHERAPY, CHECKPOINT INHIBITOR ADVANCE TO FRONTLINE NSCLC

Nemunaitis J, Senzer N. Editorial: Immunotherapy, checkpoint inhibitor advance to frontline NSCLC. Translational Cancer Research. 2017;6(Suppl 1):S141-144.

ASSESSMENT OF LOW DOSE VIGIL® ENGINEERED AUTOLOGOUS TUMOR CELL (EATC) IMMUNOTHERAPY IN PATIENTS WITH ADVANCED SOLID TUMORS

Manning L, Barve M, Wallraven G, Kumar P, Taquet N, Bognar E, Mendeloff E, Oh J, Rao D, Pappen BO, Senzer N, Nemunaitis J. Assessment of Low Dose Vigil® Engineered Autologous Tumor Cell (EATC) Immunotherapy in Patients with Advanced Solid Tumors. Clinics in Oncology. 2017 April 3; 2:1254.

EFFECTS OF STRONG CYP3A INHIBITION AND INDUCTION ON THE PHARMACOKINETICS OF IXAZOMIB, AN ORAL PROTEASOME INHIBITOR

Gupta N, Hanley MJ, Venkatakrishnan K, Bessudo A, Rasco DW, Sharma S, O’Neil BH, Wang B, Liu G, Ke A, Patel C, Yeo KR, Xia C, Zhang X, Esseltine DL, Nemunaitis J. Effects of strong CYP3A inhibition and induction on the pharmacokinetics of ixazomib, an oral proteasome inhibitor: results of drug-drug interaction studies in patients with advanced solid tumors or lymphoma and a physiologically-based pharmacokinetic analysis. Journal of Clinical Pharmacology. 2018 Feb;58(2):180-192.

IMMUNE MEDIATED COMPLETE RESPONSE IN A PATIENT WITH RECURRENT ADVANCED EWING’S SARCOMA (EWS) FOLLOWING VIGIL® IMMUNOTHERAPY

Ghisoli M, Rutledge M, Stephens P, Mennel R, Barve M, Manley M, Oliai B, Murphy K, Manning L, Gutierrez B, Rangadass P, Walker A, Wang Z, Rao D, Adams N, Wallraven G, Senzer N, Nemunaitis J. Case Report: Immune Mediated Complete Response in a Patient with Recurrent Advanced Ewing’s Sarcoma (EWS) Following Vigil® Immunotherapy. Journal of Pediatric Hematology/Oncology. 2017 May;39(4):e183-186.

VIGIL THERAPY IN PATHOLOGY DEFINED HIGH-RISK DIFFERENTIATED THYROID CANCER COMPOUNDED BY POST ABLATION HIGH-RISK FACTORS

Barve M, Barve R, Rao D, Rao J, Manning L, Adams N, Senzer N, Nemunaitis J. Case Report: Vigil Therapy in Pathology Defined High-Risk Differentiated Thyroid Cancer Compounded by Post Ablation High-Risk Factors. Journal of Surgical Oncology and Clinical Research. 2017; 1(1):1005.

A PHASE 1 STUDY TO ASSESS THE RELATIVE BIOAVAILABILITY OF TWO CAPSULE FORMULATIONS OF IXAZOMIB, AN ORAL PROTEASOME INHIBITOR, IN PATIENTS WITH ADVANCED SOLID TUMORS OR LYMPHOMA

Hanley MJ, Gupta N, Venkatakrishnan K, Bessudo A, Sharma S, O’Neil BH, Wang B, Van De Velde H, Nemunaitis J. A Phase 1 Study to Assess the Relative Bioavailability of Two Capsule Formulations of Ixazomib, an Oral Proteasome Inhibitor, in Patients with Advanced Solid Tumors or Lymphoma. Journal of Clinical Pharmacology. 2018 Jan;58(1):114-121.

SAFETY AND ACTIVITY OF VARLILUMAB, A NOVEL AND FIRST-IN-CLASS AGONIST ANTI-CD27 ANTIBODY, IN PATIENTS WITH ADVANCED SOLID TUMORS

Burris H, Infante J, Ansell SM, Nemunaitis J, Weiss GR, Villalobos VM, Sikic BI, Taylor MH, Northfelt DW, Carson WE, Hawthorne TR, Davis TA, Yellin MJ, Keler T, Bullock T. Safety and Activity of Varlilumab, a Novel and First-in-Class Agonist Anti-CD27 Antibody, in Patients with Advanced Solid Tumors. Journal of Clinical Oncology. Jun 20;35(18):2028-2036.

PHARMACODYNAMIC AND PHARMACOKINETIC NEOADJUVANT STUDY OF HEDGEHOG PATHWAY INHIBITOR SONIDEGIB (LDE-225) IN MEN WITH HIGH-RISK LOCALIZED PROSTATE CANCER UNDERGOING PROSTATECTOMY

Ross AE, Hughes RM, Glavaris S, Ghabili K, He P, Anders NM, Harb R, Tosoian JJ, Marchionni L, Schaeffer EM, Partin AW, Allaf ME, Bivalacqua TJ, Chapman C, O’Neal T, DeMarzo AM, Hurley PJ, Rudek MA, Antonarakis ES. Pharmacodynamic and Pharmacokinetic Neoadjuvant Study of Hedgehog Pathway Inhibitor Sonidegib (LDE-225) in Men with High-risk Localized Prostate Cancer Undergoing Prostatectomy. Oncotarget. 2017 Oct 26;8(61):104182-104192. eCollection 2017 Nov 28.