Sunday, 03 May 2020
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As you will have seen from the Introduction to the Forum one possible way to treat the lung pathologies associated with COVID-19 would be by using hyaluronidase; this of course would need to be carefully assessed and tested.

Mike LaBarre (CTO Halozyme) has prepared a statement, indicating that Halozyme would be prepared to make their human recombinant hyaluronidase available for research and clinical trials:

Halozyme is happy to work with researchers investigating Covid-19. Any such agreement would have to go through the established process within Halozyme for review and potential approval to ensure compliance with all applicable laws and regulations. These would include specific documents such as confidentiality and material transfer agreements that describe the specific research activities and would need to be discussed and approved on a case by case basis.

Halozyme has 2 different versions of rHuPH20 that could be available for use in approved studies. It is important to note however that Halozyme has not evaluated rHuPH20 with respect to lung delivery in any model system or clinical trial.

HYLENEX recombinant (hyaluronidase human injection) – this is an FDA approved formulation of rHuPH20, provided as a sterile, clear, colorless, nonpreserved, ready-for-use solution. Each mL contains 150 USP units of recombinant human hyaluronidase (approximately 1.4 ug/mL) with sodium chloride, dibasic sodium phosphate, albumin human (1 mg/mL), L-methionine, polysorbate 80, and hydrochloric acid and sodium hydroxide added for pH adjustment. HYLENEX recombinant has an approximate pH of 7.0. HYLENEX recombinant is not approved in any jurisdiction outside of the United States. As per the FDA package insert, HYLENEX recombinant is an endoglycosidase indicated as an adjuvant; in subcutaneous fluid administration for achieving hydration (1.1), to increase the dispersion and absorption of other injected drugs (1.2), in subcutaneous urography for improving resorption of radiopaque agents (1.3)

ENHANZE Drug Product (EDP) – this is an investigational use drug product formulation that has been used in several Phase 1 clinical trials in both the US and EU. The EDP is approximately 110,000 U/mL (1 mg/mL) and contains additional excipients including histidine, sodium chloride, methionine and polysorbate-80. There is no human serum albumin or other carrier protein included in this formulation

Depending on the study, Halozyme may also be able to provide some analytical support for enzyme activity analyses if defined and agreed to in the research agreement.

If anyone is interested in pursuing this then please contact Dr. LaBarre, or contact me and I will pass your message on.

Tony Day
President, ISHAS
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