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Tiziana Life Sciences Announces an Expedited Clinical Development Plan for Its Anti-Interleukin-6-Receptor, a Fully Human Monoclonal Antibody, for the Treatment of COVID-19 Patients
Recently signed agreements with four contract research organizations (“CROs”) to initiate GMP manufacturing, develop inhalation technology, conduct inhalation
About this update from Tiziana Life Sciences Ltd
[{"type":"text","content":"Recently signed agreements with four contract research organizations (“CROs”) to initiate GMP manufacturing, develop inhalation technology, conduct inhalation safety toxicity study in monkeys, and initiate a human clinical trial in COVID-19 patients This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. NEW YORK and LONDON, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Tiziana Life Sciences plc (Nasdaq: TLSA / AIM: TILS) (“Tiziana” or the “Company”), a biotechnology company focused on innovative therapeutics for oncology, inflammation and infectious diseases, today announced that it has signed agreements with four CROs to expedite clinical development of TZLS-501, a novel fully human anti-interleukin-6 receptor (anti-IL6R) monoclonal antibody (mAb) for the treatment of COVID-19 (SARS-CoV-2) patients. The Company intends to initiate the clinical study in Q1 2021 and will work with the following CROs: FHI Clinical: A subsidiary of FHI 360, FHI Clinical is a multinational CRO specializing in clinical development of drugs for infectious diseases (https://www.fhiclinical.com). This company has conducted several recent trials in COVID-19 patients and has a large network of clinical sites throughout the US and abroad to expedite clinical trials with COVID-19 patients. In this trial, TZLS-501 will be delivered as an aerosol directly to the lungs using a hand-held nebulizer.STC Biologics: STC Biologics, Inc. is a boutique Good Manufacturing Practice (GMP) CRO that provides full chemistry, manufacturing and control (CMC) services to enable its partners to advance their biologic products from discovery to commercial approval. GMP manufacturing of TZLS-501 is ongoing. Sciarra Labs: Sciarra Laboratories, Inc., is an FDA-approved, current GMP manufacturer of drug solutions used in nebulizers, inhalers, metered dose inhalers (“MDI”) and nasal sprays. Tiziana worked with Sciarra Labs to establish clinical supply of nasal sprays of Foralumab used in the recently completed Phase 1. Sciarra Labs will be developing and testing a hand-held nebulizer and GMP manufacturing the anti-IL6R mAb solution to be used as clinical trial material for the clinical study in COVID-19 patients.ITR Laboratories Canada: ITR has been in operation for the last 30 years and is known for its reputation in toxicology testing and other s...