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The bod do like to do their news in clusters don’t they. £1.20/£1.30 is long gone now.
whimax taken from the RNS 4 Aug, so who knows if we will get the results Q1 or it starts Q1
New York/London, August 4, 2020 - 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 specialized testing services for biotechnology and pharmaceutical industries in North America, Europe and beyond. ITR is a Canadian Council on Animal Care (CCAC) and American Association for Accreditation of Laboratory Animal Care (AAALAC) CRO and is a fully compliant Good Laboratory Practices (GLP) CRO. ITR will be conducting safety and toxicity studies with TZLS-501 delivered by a nebulizer directly into the lungs of cynomolgus monkeys.
Cloudy/BM3, I’m sure Gabe said in this mornings interview that “animal trials are happening now” for TLZS 501, so again, this phase looks fast tracked and well ahead of the previously stated Q2 2021.
I thought TLZS 501 will be human trials as soon as they get gmp product and nebuliser, early next year. Monkey trials are now apparently.
whimaz Q1 for TZLS-501 was said in that RNS, but who knows!!!!!
BM3 (or anyone)?
As per this mornings podcast, TZLS-501 is currently having to go through animal testing (as per FDA protocols) prior to human trials. Do we know how long this trial takes (how long did Foralumab take) and once “cleared” would/could this be added to The trial announced this morning for Foralumab? They are both COVID related and both nebuliser.
I’m thinking of time lines here as TZLS-501 could be added in to this mornings announced trial around the time Of the StemPintER cut off date?
Ducks are very much lining up here, with lots more news on the horizon imo.
Who knows Jair Messias Bolsonaro may fast track approve TZLS-501.
TZLS-501 is lab trials stage for covid
Foralumab is at human trial stage for covid
This company has lots to offer new investors if you take the time to do some research, the covid trials are just a small part of the companies pipeline, and if the BOD are correct this company is life saving, and life changing for its investors.