ENHANZE^® drug delivery technology: a novel approach to subcutaneous administration using recombinant human hyaluronidase PH20

References

• Alexion Pharmaceuticals I. (2017). Alexion and Halozyme Enter License Agreement for ENHANZE Technology. Available at: http://files.shareholder.com/downloads/ALXN/6264479688x0x966094/4E5A51B2-4A6E-4C45-83C1-1F8B8373B8C0/ALXN_News_2017_12_7_General.pdf [last accessed 7 Sep 2018].
   Google Scholar
• Alexion Pharmaceuticals I. (2018). Alexion development programs. Available at: http://alexion.com/research-development/development-programs [last accessed 19 Nov 2018].
   Google Scholar
• Assouline S, Buccheri V, Delmer A, et al. (2016). Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial. Lancet Haematol 3:e128–38.
   PubMed Web of Science ®Google Scholar
• Atkinson WS. (1949). Use of hyaluronidase with local anesthesia in ophthalmology; preliminary report. Arch Ophthal 42:628–33.
   PubMed Web of Science ®Google Scholar
• Baumgartner G, Gomar-Hoss C, Sakr L, et al. (1998). The impact of extracellular matrix on the chemoresistance of solid tumors-experimental and clinical results of hyaluronidase as additive to cytostatic chemotherapy. Cancer Lett 131:85–99.
   PubMed Web of Science ®Google Scholar
• Baxter BioScience. (2014). HyQvia Blood Products Advisory Committee Meeting. Available at: https://wayback.archive-it.org/7993/20170406182957/https:/www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM407013.pdf [last accessed September 2018].
   Google Scholar
• Bookbinder LH, Hofer A, Haller MF, et al. (2006). A recombinant human enzyme for enhanced interstitial transport of therapeutics. J Control Release 114:230–41.
   PubMed Web of Science ®Google Scholar
• Burcombe R, Chan S, Simcock R, et al. (2013). Subcutaneous trastuzumab (Herceptin®): a UK time and motion study in comparison with intravenous formulation for the treatment of patients with HER2-positive early breast cancer. Adv Breast Cancer Res 02:133–40.
   Google Scholar
• Chaik E, Duthie ES. (1939). A mucolytic enzyme in testis extracts. Nature 144:977.
   Google Scholar
• Chao KL, Muthukumar L, Herzberg O. (2007). Structure of human hyaluronidase-1, a hyaluronan hydrolyzing enzyme involved in tumor growth and angiogenesis. Biochemistry 46:6911–20.
   PubMed Web of Science ®Google Scholar
• Chari A, Nahi H, Mateos M-V, et al. (2017). Subcutaneous delivery of daratumumab in patients (pts) with relapsed or refractory multiple myeloma (RRMM): pavo, an open-label, multicenter, dose escalation phase 1b study. Blood 130:838.
   Web of Science ®Google Scholar
• Cherr GN, Yudin AI, Overstreet JW. (2001). The dual functions of GPI-anchored PH-20: hyaluronidase and intracellular signaling. Matrix Biol 20:515–25.
   PubMed Web of Science ®Google Scholar
• Connolly S, Korzemba H, Harb G, et al. (2011). Techniques for hyaluronidase-facilitated subcutaneous fluid administration with recombinant human hyaluronidase: the increased flow utilizing subcutaneously enabled administration technique (INFUSE AT) study. J Infus Nurs 34:300–7.
   PubMedGoogle Scholar
• Csoka AB, Frost GI, Stern R. (2001). The six hyaluronidase-like genes in the human and mouse genomes. Matrix Biol 20:499–508.
   PubMed Web of Science ®Google Scholar
• Davies A, Merli F, Mihaljevic B, et al. (2017). Efficacy and safety of subcutaneous rituximab versus intravenous rituximab for first-line treatment of follicular lymphoma (SABRINA): a randomised, open-label, phase 3 trial. Lancet Haematol 4:e272–82.
   PubMed Web of Science ®Google Scholar
• Davies A, Merli F, Mihaljevic B, et al. (2014). Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study. Lancet Oncol 15:343–52.
   PubMed Web of Science ®Google Scholar
• De Cock E, Pivot X, Hauser N, et al. (2016). A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Med 5:389–97.
   PubMed Web of Science ®Google Scholar
• Dillman RO. (1999). Perceptions of herceptin: a monoclonal antibody for the treatment of breast cancer. Cancer Biother Radiopharm 14:5–10.
   PubMed Web of Science ®Google Scholar
• Dunn AL, Heavner JE, Racz G, Day M. (2010). Hyaluronidase: a review of approved formulations, indications and off-label use in chronic pain management. Expert Opin Biol Ther 10:127–31.
   PubMed Web of Science ®Google Scholar
• Duran-Reynals F. (1928). Exaltation de l’activité du virus vaccinal par les extraits de certainesorgans. Comptes Rendu Hebdomadaire de Séances et Mémoires de la Société deBiologie 99:6–7.
   Google Scholar
• Duran-Reynals F. (1933). Further studies on the influence of testicle extract upon the effect of toxins, bacteria, and viruses, and on the Shwartzman and Arthrus phenomena. J Exp Med 58:451–63.
   PubMedGoogle Scholar
• Dychter SS, Harrigan R, Bahn JD, et al. (2014). Tolerability and pharmacokinetic properties of ondansetron administered subcutaneously with recombinant human hyaluronidase in minipigs and healthy volunteers. Clin Ther 36:211–24.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. (2013a). HyQvia EPAR Public Assessment Report. Available at: https://www.ema.europa.eu/documents/assessment-report/hyqvia-epar-public-assessment-report_en.pdf [last accessed 19 Nov 2018].
   Google Scholar
• European Medicines Agency. (2013b). HyQvia EPAR summary of product characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002491/WC500143851.pdf [last accessed 31 May 2018].
   Google Scholar
• European Medicines Agency. (2018a). DARZALEX summary of product characteristics. Available at: https://www.ema.europa.eu/documents/product-information/darzalex-epar-product-information_en.pdf [last accessed 19 Nov 2018].
   Google Scholar
• European Medicines Agency. (2018b). Herceptin summary of product characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.pdf [last accessed 25 May 2018].
   Google Scholar
• European Medicines Agency. (2018c). MabThera summary of product characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000165/WC500025821.pdf [last accessed 31 May 2018].
   Google Scholar
• Frost GI. (2007). Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv 4:427–40.
   PubMed Web of Science ®Google Scholar
• Garrun D. (2013). Breaking barriers – the potential of subcutaneous drug delivery. Available at: https://www.drugdevelopment-technology.com/features/featurehalozyme-roche-subcutaneous-drug-delivery-platform/ [last accessed Nov 13].
   Google Scholar
• Great Ormond Street Hospital. (2017). Immunoglobulin infusions: intravenous and subcutaneous. Available at: https://www.gosh.nhs.uk/health-professionals/clinical-guidelines/immunoglobulin-infusions-intravenous-and-subcutaneous#Rationale [last accessed Nov 15].
   Google Scholar
• Halozyme Therapeutics Inc. (2018). FDA accepts biologics license application for subcutaneous formulation of herceptin. Available at: https://www.halozyme.com/investors/news-releases/news-release-details/2018/FDA-Accepts-Biologics-License-Application-For-Subcutaneous-Formulation-Of-Herceptin/default.aspx [last accessed 13 Aug 2018].
   Google Scholar
• Jackisch C, Kim SB, Semiglazov V, et al. (2015). Subcutaneous versus intravenous formulation of trastuzumab for HER2-positive early breast cancer: updated results from the phase III HannaH study. Ann Oncol 26:320–5.
   PubMed Web of Science ®Google Scholar
• Kang DW, Nekoroski TA, Printz MA, et al. (2013). Recombinant human hyaluronidase PH20 (rHuPH20) facilitated subcutaneous delivery of proteins in nonclinical models. Controll Release Newsl 30:9–11.
   Google Scholar
• Lin Y, Mahan K, Lathrop WF, et al. (1994). A hyaluronidase activity of the sperm plasma membrane protein PH-20 enables sperm to penetrate the cumulus cell layer surrounding the egg. J Cell Biol 125:1157–63.
   PubMed Web of Science ®Google Scholar
• Lugtenburg P, Avivi I, Berenschot H, et al. (2017). Efficacy and safety of subcutaneous and intravenous rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in first-line diffuse large B-cell lymphoma: the randomized MabEase study. Haematologica 102:1913–22.
   PubMed Web of Science ®Google Scholar
• Morrow L, Muchmore DB, Hompesch M, et al. (2013). Comparative pharmacokinetics and insulin action for three rapid-acting insulin analogs injected subcutaneously with and without hyaluronidase. Diabetes Care 36:273–5.
   PubMed Web of Science ®Google Scholar
• Morrow L, Muchmore DB, Ludington EA, et al. (2011). Reduction in intrasubject variability in the pharmacokinetic response to insulin after subcutaneous co-administration with recombinant human hyaluronidase in healthy volunteers. Diabetes Technol Ther 13:1039–45.
   PubMed Web of Science ®Google Scholar
• Perez EE, Orange JS, Bonilla F, et al. (2017). Update on the use of immunoglobulin in human disease: a review of evidence. J Allergy Clin Immunol 139:S1–S46.
   PubMed Web of Science ®Google Scholar
• Pierpont TM, Limper CB, Richards KL. (2018). Past, present, and future of rituximab-the world's first oncology monoclonal antibody therapy. Front Oncol 8, Article 163.
   PubMed Web of Science ®Google Scholar
• Pivot X, Gligorov J, Muller V, et al. (2014). Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study. Ann Oncol 25:1979–87.
   PubMed Web of Science ®Google Scholar
• Roche Canada. (2018a). Pr HERCEPTIN® SC product monograph. Available at: http://www.rochecanada.com/content/dam/roche_canada/en_CA/documents/Research/ClinicalTrialsForms/Products/ConsumerInformation/MonographsandPublicAdvisories/Herceptin/HerceptinSC_PM_E.pdf [last accessed Sep 2018].
   Google Scholar
• Roche Canada. (2018b). Pr RITUXAN® SC product monograph. Available at: http://www.rochecanada.com/content/dam/roche_canada/en_CA/documents/Research/ClinicalTrialsForms/Products/ConsumerInformation/MonographsandPublicAdvisories/RituxanSC/RituxanSC_PM_E.pdf [last accessed 10 August 2018].
   Google Scholar
• Rosengren S, Dychter SS, Printz MA, et al. (2015). Clinical immunogenicity of rHuPH20, a hyaluronidase enabling subcutaneous drug administration. AAPS J 17:1144–56.
   PubMed Web of Science ®Google Scholar
• Rule S, Collins GP, Samanta K. (2014). Subcutaneous vs intravenous rituximab in patients with non-Hodgkin lymphoma: a time and motion study in the United Kingdom. J Med Econ 17:459–68.
   PubMedGoogle Scholar
• Rummel M, Kim TM, Aversa F, et al. (2017). Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol 28:836–42.
   PubMed Web of Science ®Google Scholar
• Salar A, Avivi I, Bittner B, et al. (2014). Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study. J Clin Oncol 32:1782–91.
   PubMed Web of Science ®Google Scholar
• Shepard HM. (2015). Breaching the castle walls: hyaluronan depletion as a therapeutic approach to cancer therapy. Front Oncol 5, Article 192.
   Web of Science ®Google Scholar
• Silverstein SM, Greenbaum S, Stern R. (2012). Hyaluronidase in ophthalmology. J Appl Res 12:1–13.
   Google Scholar
• Spandorfer PR, Mace SE, Okada PJ, et al. (2012). A randomized clinical trial of recombinant human hyaluronidase-facilitated subcutaneous versus intravenous rehydration in mild to moderately dehydrated children in the emergency department. Clin Ther 34:2232–45.
   PubMed Web of Science ®Google Scholar
• Stern R, Jedrzejas MJ. (2006). The hyaluronidases: their genomics, structures, and mechanisms of action. Chem Rev 106:818–39.
   PubMed Web of Science ®Google Scholar
• Sutera SP, Skalak R. (1993). The history of Poiseuille’s law. Annu Rev Fluid Mech 25:1–19.
   Web of Science ®Google Scholar
• Thomas JR, Wallace MS, Yocum RC, et al. (2009). The INFUSE-Morphine study: use of recombinant human hyaluronidase (rHuPH20) to enhance the absorption of subcutaneously administered morphine in patients with advanced illness. J Pain Symptom Manage 38:663–72.
   PubMed Web of Science ®Google Scholar
• Thomas JR, Yocum RC, Haller MF, Flament J. (2009). The INFUSE-Morphine IIB study: use of recombinant human hyaluronidase (rHuPH20) to enhance the absorption of subcutaneous morphine in healthy volunteers. J Pain Symptom Manage 38:673–82.
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration. (2003). United States Food and Drug Administration clinical review of NDA 21-640 (Vitrase®). Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-640_Vitrase_Medr.pdf [last accessed 31 May 2018].
   Google Scholar
• U.S. Food and Drug Administration. (2005). HYLENEX prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021859s009lbl.pdf [last accessed 15 May 2018].
   Google Scholar
• U.S. Food and Drug Administration. (2012). September 12, 2014 Approval Letter - HYQVIA. Available at: http://wayback.archive-it.org/7993/20170723025727/https:/www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm414148.htm [last accessed 19 Nov 2018].
   Google Scholar
• U.S. Food and Drug Administration. (2014). HYQVIA prescribing information. 2014. Available at: https://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM414440.pdf [last accessed 15 Nov 2018].
   Google Scholar
• U.S. Food and Drug Administration. (2017a). ODAC briefing document rituximab and hyaluronidase. Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM548659.pdf [last accessed 15 May 2018].
   Google Scholar
• U.S. Food and Drug Administration. (2017b). RITUXAN HYCELA FDA approval. Available at: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm564235.htm [last accessed 7 May 2018].
   Google Scholar
• U.S. Food and Drug Administration. (2017c). RITUXAN HYCELA prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf [last accessed 31 May 2018].
   Google Scholar
• U.S. Food and Drug Administration. (2017b). Rituximab and hyaluronidase injection, for subcutaneous use (rituximab SC). Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM551240.pdf [last accessed 11/07/18].
   Google Scholar
• Vaughn DE, Muchmore DB. (2011). Use of recombinant human hyaluronidase to accelerate rapid insulin analogue absorption: experience with subcutaneous injection and continuous infusion. Endocr Pract 17:914–21.
   PubMed Web of Science ®Google Scholar
• Vaughn DE, Yocum RC, Muchmore DB, et al. (2009). Accelerated pharmacokinetics and glucodynamics of prandial insulins injected with recombinant human hyaluronidase. Diabetes Technol Ther 11:345–52.
   PubMed Web of Science ®Google Scholar
• Veneziale RW, Printz MA, Jorge M, et al. (2014). Nonclinical studies to assess possible effects of antibodies to rHuPH20 on the endogenous counterpart. Prague, Czech Republic: ESID.
   Google Scholar
• Wasserman RL. (2012). Progress in gammaglobulin therapy for immunodeficiency: from subcutaneous to intravenous infusions and back again. J Clin Immunol 32:1153–64.
   PubMed Web of Science ®Google Scholar
• Wasserman RL. (2014). Overview of recombinant human hyaluronidase-facilitated subcutaneous infusion of IgG in primary immunodeficiencies. Immunotherapy 6:553–67.
   PubMed Web of Science ®Google Scholar
• Wasserman RL. (2014). Subcutaneous immunoglobulin: facilitated infusion and advances in administration. Clin Exp Immunol 178:75–7.
   PubMed Web of Science ®Google Scholar
• Wasserman RL, Melamed I, Kobrynski L, et al. (2016). Recombinant human hyaluronidase facilitated subcutaneous immunoglobulin treatment in pediatric patients with primary immunodeficiencies: long-term efficacy, safety and tolerability. Immunotherapy 8:1175–86.
   PubMed Web of Science ®Google Scholar
• Wasserman RL, Melamed I, Stein MR, et al. (2016). Long-term tolerability, safety, and efficacy of recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulin for primary immunodeficiency. J Clin Immunol 36:571–82.
   PubMed Web of Science ®Google Scholar
• Wasserman RL, Melamed I, Stein MR, et al. (2012). Recombinant human hyaluronidase-facilitated subcutaneous infusion of human immunoglobulins for primary immunodeficiency. J Allergy Clin Immunol 130:e951–7, e911.
   PubMed Web of Science ®Google Scholar
• World Health Organization. (2003). WHO Guidelines on transmissible spongiform encephalopathies in relation to biological and pharmaceutical products. Available at: http://www.who.int/biologicals/publications/en/whotse2003.pdf?ua=1&ua=1 [last accessed 31 May 2018].
   Google Scholar
• Wynne C, Harvey V, Schwabe C, et al. (2013). Comparison of subcutaneous and intravenous administration of trastuzumab: a phase I/Ib trial in healthy male volunteers and patients with HER2-positive breast cancer. J Clin Pharmacol 53:192–201.
   PubMed Web of Science ®Google Scholar
• Yocum RC, Kennard D, Heiner LS. (2007). Assessment and implication of the allergic sensitivity to a single dose of recombinant human hyaluronidase injection: a double-blind, placebo-controlled clinical trial. J Infus Nurs 30:293–9.
   PubMedGoogle Scholar