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Select Scientific Publications

This site is intended for a U.S. audience and includes information about investigational products, or investigational indications for FDA-approved products. Safety and efficacy have not been established, and there is no guarantee that pipeline products or investigational uses will receive FDA approval.

Biliary Tract Cancers (BTC)
Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZONBTC-01): a multicentre, single-arm, phase 2b study
Publication: The Lancet Oncology
Author: Harding, J., Fa, J., Oh, D-Y., et al
Zanidatamab in previously-treated HER2-positive (HER2+) biliary tract cancer (BTC): Overall survival (OS) and longer follow-up from the phase 2b HERIZON-BTC-01 study 
Publication: 2024 ASCO Annual Meeting
Author: Pant, S., et al
 
A plain language summary of the results from the phase 2b HERIZON-BTC-01 study of zanidatamab in participants with HER2-amplified biliary tract cancer
Publication: Future Oncology
Author: Harding, J., et al
 
Quality of life (QoL) outcomes in patients (pts) with zanidatamab (zani)-treated HER2-positive (HER2+) biliary tract cancer (BTC) in the phase IIb HERIZON-BTC-01 study
Publication: ESMO Annals of Oncology
Author: Wasan, H.S., et al
 
Gastroesophageal Adenocarcinoma (GEA)
Zanidatamab + chemotherapy as first-line treatment for HER2-expressing metastatic gastroesophageal adenocarcinoma (mGEA)
Publication: Journal of Clinical Oncology
Author: Elimova, E., et al
HERIZON-GEA-01: Zanidatamab + chemo ± tislelizumab for 1L treatment of HER2-positive gastroesophageal adenocarcinoma
Publication: Future Oncology
Author: Tabernero, J., et al
Zanidatamab (ZW25) in HER2-expressing gastroesophageal adenocarcinoma (GEA): Results from a phase I study
Publication: Journal of Clinical Oncology
Author: Meric-Bernstam, F., et al
Zanidatamab (zani) plus chemotherapy (chemo) and tislelizumab (tis) as first-line (1l) therapy for patients (pts) with advanced HER2-positive (+) gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated results from a phase Ib/II study
Publication: ESMO Annals of Oncology
Author: Lee, K-W., et al
Other
Zanidatamab, a novel bispecific antibody, for the treatment of locally advanced or metastatic HER2-expressing or HER2-amplified cancers: a phase 1, dose-escalation and expansion study
Publication: The Lancet Oncology
Author: Meric-Bernstam, F., et al
Zanidatamab (zani), a HER2-targeted bispecific antibody, in combination with docetaxel as first-line therapy (1L) for patients (pts) with advanced HER2-positive breast cancer (BC): Updated results from a phase 1b/2 study
Publication: Journal of Clinical Oncology
Author: Wang, X., et al
An anti-HER2 biparatopic antibody that induces unique HER2 clustering and complement-dependent cytotoxicity
Publication: Nature Communications
Author: Weisser, N., et al
Super-resolution imaging studies of zanidatamab: Providing insights into its bispecific mode of action
Publication: Cancer Research
Author: Dixit, S., Abraham, L., et al
Primary results from a phase 2a study of zanidatamab (zani) + palbociclib (palbo) + fulvestrant (fulv) in HER2+/HR+ metastatic breast cancer (mBC)
Publication: Cancer Research
Author: Escriva-de-Romani, S., et al
Neoadjuvant zanidatamab for stage I node negative HER2 positive breast cancer
Publication: Cancer Research
Author: Velaro, V., et al
Population pharmacokinetics of zanidatamab, an anti-HER2 biparatopic antibody, in patients with advanced or metastatic cancer
Publication: Cancer Chemotherapy and Pharmacology
Author: Proctor, J., et al
ERBB2 amplification detected in ctDNA as a surrogate for tumor tissue FISH analysis of HER2 status in a phase 1 study with zanidatamab for the treatment of locally advanced or metastatic HER2 expressing cancers
Publication: Cancer Research
Author: Shpektor, D., et all
Essential Tremor (ET)
A Phase 2 Proof-of-Concept, Randomized, Placebo-Controlled Trial of CX-8998 in Essential Tremor
Publication: Movement Disorders
Author: Papapetropoulos, S., et al
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of CX-8998, a Selective Modulator of the T-Type Calcium Channel in Inadequately Treated Moderate to Severe Essential Tremor: T-CALM Study Design and Methodology for Efficacy Endpoint and Digital Biomarker Selection
Publication: Frontiers in Neurology
Author: Papapetropoulos, S., Lee, M., et al
Efficacy Result from a Phase 2, Double-Blind, Placebo-Controlled Study of CX-8998 a State-Dependent T-Type Calcium (Cav3) Channel Modulator in Essential Tremor Patients (T-CALM)
Publication: American Academy of Neurology
Author: Papapetropoulos, S., Lee, M., et al
Efficacy and safety of CX-8998 in T-CALM, a randomized, double-blind, placebo-controlled, phase 2a trial in participants with essential tremor: subgroup analysis by baseline tremor severity
Publication: Movement Disorders
Author: Jinnah, H., Papapetropoulos, S., et al
T-type calcium channels as therapeutic targets in essential tremor and Parkinson's disease
Publication: Annals of Clinical and Translational Neurology
Author: Matthews, L., Puryear, C., et al
A phase 2b randomized, double-blind, placebo-controlled study of suvecaltamide in the treatment of adults with moderate to severe essential tremor: study design and methodology
Publication: Movement Disorders
Author: Sterkel, A., Ondo, W., et al
TETRAS applicability and study design in randomized, placebo controlled clinical trial of Cav3 modulation for essential tremor patients.
Publication: Movement Disorders
Author: Maricich, Y., Newbold, E., et al
Parkinson’s Disease Tremor (PDT)
A Phase 2 Efficacy Study of CX-8998, a Potent and Selective T-Type Calcium (Cav3) Modulator in Parkinson’s disease Tremor (PDT) Patients: Design and Dose-Selection Rationale
Publication: Movement Disorders
Author: Papapetropoulos, S., Lee, M., et al
720TiP Phase I, open-label, first-in-human (FIH) study of JZP815 in advanced or metastatic solid tumors harboring mitogen-activated protein kinase (MAPK) alterations
Publication: Annals of Oncology
Author: Naqash, A-R., et al
JZP815, a potent and selective pan-RAF inhibitor, demonstrates efficacy in RAF and RAS mutant tumor pre-clinical models
Publication: Cancer Research
Author: Hauptschein, R., et al
JZP-258 Dose Titration and Transition from Sodium Oxybate in a Placebo-Controlled, Double-Blind, Randomized Withdrawal Study in Adult Participants With Narcolepsy With Cataplexy
Publication: Sleep
Author: Foldvary-Schaefer, N., et al
Effectiveness and tolerability in people with narcolepsy transitioning from sodium oxybate to low-sodium oxybate: Data from the real-world TENOR study
Publication: Sleep Medicine
Author: Bae, C., J., et al
Changes in Cataplexy Frequency in a Clinical Trial of Lower-Sodium Oxybate with Taper and Discontinuation of Other Anticataplectic Medications
Publication: CNS Drugs
Author: Dauvilliers, Y., et al
Cardiovascular Burden of Narcolepsy Disease (CV-BOND): a real-world evidence study
Publication: Sleep
Author: Ben-Joseph, R. H., et al
Cardiovascular Risks in People With Narcolepsy: Expert Panel Consensus Recommendations
Publication: Journal of the American Heart Association
Author: Kwon, Y., et al
Cardiovascular burden of narcolepsy: what have we learned and what do we still need to know?
Publication: Sleep
Author: Barateau, L., Dauvilleiers, Y., et al
Individualized Treatment Patterns for Patients with Narcolepsy Treated with Oxybate: A Clinical Practice Perspective
Publication: Nature and Science of Sleep
Author: Roy, A., et al
Pharmacokinetics, bioavailability, and bioequivalence of lower-sodium oxybate in healthy participants in two open-label, randomized, crossover studies
Publication: Clinical and Translational Science
Author: Chen, C., Jenkins, J., et al
Effect of sodium oxybate on body mass index in pediatric patients with narcolepsy
Publication: Journal of Clinical Sleep Medicine
Author: Dauvilliers, Y., et al
Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study
Publication: The Lancet Neurology
Author: Dauvilliers, Y., et al
Efficacy and Safety of Lower-Sodium Oxybate in an Open-Label Titration Period of a Phase 3 Clinical Study in Adults with Idiopathic Hypersomnia
Publication: Nature and Science of Sleep
Author: Thorpy, M. J., et al
Long-term efficacy and safety of low-sodium oxybate in an open-label extension period of a placebo-controlled, double-blind, randomized withdrawal study in adults with idiopathic hypersomnia
Publication: Journal of Clinical Sleep Medicine
Author: Morse, A. M., et al
Efficacy of Lower-Sodium Oxybate in the Treatment of Idiopathic Hypersomnia: Evaluation of Response Based on the Epworth Sleepiness Scale Score
Publication: Sleep
Author: Rosenberg, R., et al
Long-Term Treatment of Narcolepsy and Idiopathic Hypersomnia with Low-Sodium Oxybate
Publication: Nature and Science of Sleep
Author: Schneider, L. D., et al
Impairment in Functioning and Quality of Life in Patients with Idiopathic Hypersomnia: The Real World Idiopathic Hypersomnia Outcomes Study (ARISE)
Publication: Nature and Science of Sleep
Author: Stevens, J., et al
Implications of Oxybate Dosing Regimen for Sleep, Sleep Architecture, and Disrupted Nighttime Sleep in Patients With Narcolepsy: A Commentary
Publication: Neurology and Therapy
Author: Rosenberg, R., et al
Low-Sodium Oxybate Improved Symptoms in Adults With Idiopathic Hypersomnia: A Plain Language Summary of Publication
Publication: Future Neurology
Author: Dauvilliers, Y., et al
Dosing Optimization of Low-Sodium Oxybate in Narcolepsy and Idiopathic Hypersomnia in Adults: Consensus Recommendations
Publication: Neurology and Therapy
Author: Morse, A., et al
Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome
Publication: The New England Journal of Medicine
Author: Devinsky, O., et al
Add-on Cannabidiol Treatment for Drug-Resistant Seizures in Tuberous Sclerosis Complex
Publication: JAMA Neurology
Author: Thiele, E., et al
Seizure-free days as a novel outcome in patients with Lennox–Gastaut syndrome: Post hoc analysis of patients receiving cannabidiol in two randomized controlled trials
Publication: Epilepsia
Author: Auvin, S., et al
Effect of Cannabidiol on Drop Seizures in the Lennox-Gastaut Syndrome
Publication: The New England Journal of Medicine
Author: Devinsky, O., et al
Long-term Safety and Efficacy of Add-on Cannabidiol in Patients with Lennox-Gastaut Syndrome: Results of a Long-Term Open Label Extension Trial
Publication: Epilepsia
Author: Patel, A., et al
Consensus panel recommendations for the optimization of EPIDIOLEX treatment for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex
Publication: Epilepsia Open
Author: Wechsler, R., et al
Pharmacodynamic synergism contributes to the antiseizure action of cannabidiol and clobazam
Publication: Experimental Neurology
Author: Rena, R., et al
Retrospective chart review study of use of cannabidiol (CBD) independent of concomitant clobazam use in patients with Lennox-Gastaut syndrome or Dravet syndrome
Publication: Seizure: European Journal of Epilepsy
Author: Nabbout, R., et al
Long-term efficacy and safety of cannabidiol in patients with treatment-resistant epilepsies: Four-year results from the expanded access program
Publication: Epilepsia
Author: Szaflarski, J., et al
Efficacy of cannabidiol in convulsive and nonconvulsive seizure types associated with treatment-resistant epilepsies in the Expanded Access Program
Publication: Epilepsia
Author: Flamini, R. J., et al
Berg A.T., et al
Caregiver-Reported Seizure Outcomes with Real-World Use of Cannabidiol (CBD) in Tuberous Sclerosis Complex (TSC): Interim Results from the BECOME-TSC Survey
Publication: AES
Author: Koenig, M.K., et al
Nonseizure- and seizure-related benefits of cannabidiol treatment in the real world: plain language summary of the results from a caregiver survey
Publication: Future Neurology
Author: Berg, A.T., et al
Caregiver-Reported Nonseizure Outcomes With Real-World Use of Cannabidiol in Tuberous Sclerosis Complex: Interim Results From the BECOME-TSC Survey
Publication: AES
Author: Wilson, S., et al
Cannabidiol modulates excitatory-inhibitory ratio to counter hippocampal hyperactivity
Publication: Neuron
Author: Rosenberg, E., et al
Long-term Effectiveness of Cannabidiol (CBD) Against Focal-Onset Seizures in Treatment-Resistant Epilepsies (TRE)
Publication: AES
Author: Park, Y. D., et al
Real-World Outcomes of Cannabidiol (CBD) in Treatment-Resistant Focal Epilepsies: Experience from the Expanded Access Program (EAP)
Publication: American Epilepsy Society
Author: Patel, A., et al
Open-label use of highly purified CBD (Epidiolex®) in patients with CDKL5 deficiency disorder and Aicardi, Dup15q, and Doose syndromes
Publication: Epilepsy & Behavior
Author: Devinsky, O., et al
Recombinant Erwinia asparaginase (JZP458) in acute lymphoblastic leukemia: results from the phase 2/3 AALL1931 study
Publication: Blood
Author: Maese, L., et al
A phase II/III study of JZP-458 in patients with acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LBL) who are hypersensitive to E. coli-derived asparaginases
Publication: Journal of Clinical Oncology
Author: Maese, L., et al
Population pharmacokinetics of intramuscular recombinant Erwinia chrysanthemi asparaginase (JZP458) in patients with acute lymphoblastic leukemia
Publication: Clinical and Translational Science
Author: Lin, T., et al
Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial
Publication: The Lancet Oncology
Author: Trigo, J., et al
Efficacy of lurbinectedin in a clinical trial versus other standard of care in a real-world comparator arm in relapsed/refractory small cell lung cancer patients
Publication: Journal of Clinical Oncology
Author: Ganti, A., et al
Lurbinectedin in small cell lung cancer
Publication: Frontiers in Oncology
Author: Manzo, A., et al
Combination lurbinectedin and doxorubicin versus physician's choice of chemotherapy in patients with relapsed small-cell lung cancer (ATLANTIS): a multicentre, randomised, open-label, phase 3 trial
Publication: The Lancet Respiratory Medicine
Author: Aix, S., et al
Antitumor activity of lurbinectedin (PM01183) and doxorubicin in relapsed small-cell lung cancer: results from a phase I study
Publication: Annals of Oncology
Author: Calvo, E., et al
Efficacy and safety of lurbinectedin and doxorubicin in relapsed small cell lung cancer. Results from an expansion cohort of a phase I study
Publication: Invetigational New Drugs
Author: Olmedo, M., et al