OPKO Health, Inc.

Publications

Enhancing the longevity and in vivo potency of therapeutic proteins: The power of CTP

Doron Calo, et al. Precis Med 2015; 2: e989. doi: 10.14800/pm.989

Pharmacokinetic and Pharmacodynamic Modeling of MOD-4023, a Long-Acting Human Growth Hormone, in Growth Hormone Deficiency Children

Horm Res Paediatr, DOI: 10.1159/000470842

Pharmacokinetics, Pharmacodynamics, and Safety of a Long-Acting Human Growth Hormone (MOD-4023) in Healthy Japanese and Caucasian Adults

Clinical Pharmacology in Drug Development 2017, 00(0) 1–10, Copyright 2017 The Authors. Clinical Pharmacology in Drug Development, published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology, DOI: 10.1002/cpdd.414

In Vitro and in Vivo Characterization of MOD-4023, a Long-Acting Carboxy-Terminal Peptide (CTP)-Modified Human Growth Hormone

DOI: 10.1021/acs.molpharmaceut.5b00868, Mol. Pharmaceutics 2016, 13, 631−639

MOD-4023, a long-acting carboxy-terminal peptide-modified human growth hormone: results of a Phase 2 study in growth hormone-deficient adults

European Journal of Endocrinology, C J Strasburger and others, Phase 2 study of MOD-4023 in GHD adults, 176:3, 283–294, DOI: 10.1530/EJE-16-0748

Long-Acting CTP-Modified hGH (MOD-4023): Results of a Safety and Dose-Finding Study in GHD Children

The Journal of Clinical Endocrinology & Metabolism; DOI: 10.1210/jc.2016-3547

Long-Term Safety of a Once-Weekly Somatrogon (hGH-CTP): 4-Year Results of a Phase 2 Extension Study in Children with Growth Hormone Deficiency

Zelinska et. al., 2019. Poster presented at: the 58th Annual Meeting of the European Society for Paediatric Endocrinology; 2019 Sep 21; Vienna Austria

Clinical Validation Studies of the 4Kscore

A multi-institutional prospective trial in the USA confirms that the 4Kscore accurately identifies men with high-grade prostate cancer

Parekh DJ et al. Eur Urol 2014; 68:462-70.

A Multi-Institutional Prospective Trial in the Veterans Affairs Health System Confirms Noninvasive Blood Test Maintains Predictive Value in African American Men

Punnen S et al. J Urology (2018), doi: 10.1016/j.juro.2017.11.113.

Predicting high-grade cancer at ten-core prostate biopsy using four kallikrein markers measured in blood in the ProtecT study

Bryant RJ et al. J Natl Cancer Inst. 2015 Apr 11;107(7)

Clinical Performance of the 4Kscore Test to Predict High-grade Prostate Cancer at Biopsy: A Meta-analysis of US and European Clinical Validation Study Results

Zappala SM et al. Rev Urol. 2017;19(3):149-155

4Kscore as a Predictor of Prostate Cancer Metastases and Prostate Cancer Mortality

Improving the Specificity of Screening for Lethal Prostate Cancer Using Prostate-specific Antigen and a Panel of Kallikrein Markers: A Nested Case–Control Study

Stattin P et al. Eur Urol. 2015 Aug; 68(2):207-13

Twenty-year Risk of Prostate Cancer Death by Midlife Prostate-specific Antigen and a Panel of Four Kallikrein Markers in a Large Population-based Cohort of Healthy Men

Sjoberg DD et al. Eur Urol (2018), https://doi. org/10.1016/j.eururo.2018.02.016

4Kscore: Its Clinical Use to Reduce Prostate Biopsies and Reduce Healthcare Costs

The 4Kscore® Test Reduces Prostate Biopsy Rates in Community and Academic Urology Practices

Konety B et al. Rev Urol. 2015;17(4):231-40

Use of the 4Kscore test to predict the risk of aggressive prostate cancer prior to prostate biopsy: Overall cost savings and improved quality of care to the us healthcare system

Voigt JD et al. Rev Urol. 2017;19(1):1-10

NCCN® Prostate Cancer Early Detection Guidelines

National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)

Prostate Cancer Early Detection, Version 1.2018. Accessed March 20, 2018.

NCCN Prostate Cancer Early Detection Guidelines

Prostate Cancer Early Detection, Version 2.2019. Accessed Oct 21, 2019.

Iron-magnesium hydroxycarbonate (fermagate): a novel non-calcium-containing phosphate binder for the treatment of hyperphosphatemia in chronic hemodialysis patients.

McIntyre CW, Pai P, Warwick G, Wilkie M, Toft AJ, Hutchison AJ. Clin J Am Soc Nephrol. 2009 Feb;4(2):401-9. doi: 10.2215/CJN.02630608. Epub 2009 Jan 21.