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Polyrizon Enters into GMP Manufacturing Agreement for CTM Supply of its PL-14 Allergy Blocker in Preparation for Planned 2025 Clinical Trial
The engagement with an EU-based GMP manufacturing facility enables timely production and preparation for clinical trial. The EU-based GMP manufacturer has
About this update from Polyrizon Ltd.
[{"type":"text","content":"The engagement with an EU-based GMP manufacturing facility enables timely production and preparation for clinical trial. The EU-based GMP manufacturer has large-scale commercial production capabilities, to support Polyrizon in future commercialization efforts Raanana, Israel, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (the \"Company\" or \"Polyrizon\"), a development stage biotech company specializing in the development of innovative intranasal hydrogels, announces today the signing of a manufacturing agreement with Eurofins CDMO Amatsiaquitaine S.A.S, a leading European-based Good Manufacturing Practice (GMP) manufacturer. This collaboration will supply Clinical Trial Material (CTM) for Polyrizon’s PL-14 allergy blocker, in preparation for a clinical trial that is expected to commence in 2025. With this agreement, Polyrizon secures a reliable and compliant manufacturing source for the PL-14 clinical trial. The trial aims to evaluate the safety and efficacy of PL-14 as an allergy blocker, advancing Polyrizon's mission to address allergy-related health issues through unique nasal sprays. “We are pleased to have established this partnership with Eurofins CDMO Amatsiaquitaine S.A.S, which strengthens our preparation efforts for the upcoming PL-14 clinical trial,\" said Tomer Izraeli, CEO of Polyrizon. \"We believe that this collaboration marks a significant milestone in our journey toward providing effective allergy protection solutions to patients.\" The manufacturing site is set to support the CTM needs for Polyrizon's planned 2025 trial, offering high-quality and compliant development programs in line with USA and European regulatory standards. About Polyrizon Polyrizon is a development stage biotech company specializing in the development of innovative medical device hydrogels delivered in the form of nasal sprays, which form a thin hydrogel-based shield containment barrier in the nasal cavity that can provide a barrier against viruses and allergens from contacting the nasal epithelial tissue. Polyrizon’s proprietary Capture and Contain TM, or C&C, hydrogel technology, comprised of a mixture of naturally occurring building blocks, is delivered in the form of nasal sprays, and potentially functions as a “biological mask” with a thin shield containment barrier in the nasal cavity. Polyrizon are further developing certain as...