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Found this on their website:
Tiziana Life Sciences plc (the “Company”) will be relying on the SEC Order to delay the filing of its Annual Report on Form 20-F for the year ended December 31, 2019 (the “Report”) due to the circumstances related to COVID-19. In particular, COVID-19 has caused severe disruptions in travel and transportation and limited access to the Company’s facilities resulting in limited support from its staff. This has, in turn, delayed the Company’s ability to complete its quarterly review and prepare the Report. Notwithstanding the foregoing, the Company expects to file the Report no later than June 14, 2020 (which is 45 days from the Report’s original filing deadline of April 30, 2020).......
So no annual report but hopefully an update on the covid-19 status
Even though red tape has been reduced because of the crisis it may not be as easy, otherwise, to organise the first clinical trial for an (early stage?) drug that was put on the shelf some time ago, and in particular by a small to medium-sized biotech company.
Still, June is only a couple of months away so at least we have a "deadline" for the announcement of the start of the clinical trials. Let's not forget Tiziana has a portfolio of projects and therefore it is not a one-trick pony or a firework type of company - having said that, the RNS issued in early March had this impact (intended or not).
Even so, TZLS 501 would not only be relevant for coronovirus if it was to make it to more advanced stages.
One more thought: wouldn't Tiziana want to announce a very signficant milestone success with respect to one of its projects before the transfer to NASDAQ?
1 April 2020
News
FDA launches new programme to speed-up Covid-19 therapies
The US Food and Drug Administration (FDA) has launched a new programme aimed at accelerating the development of potential treatments for Covid-19 infection.
Under the Coronavirus Treatment Acceleration Program (CTAP), FDA is working to quickly bring therapies to patients.
Furthermore, the agency is supporting research to validate the safety and effectiveness of these Covid-19 treatments.
Commenting on the programme, US Department of Health & Human Services secretary Alex Azar said: “The FDA is announcing a new, comprehensive public-private approach to bring coronavirus treatments to market as fast as possible.
“As part of this new programme, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies.”
Currently, multiple companies and researchers are working on Covid-19 therapies.
FDA’s Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are providing guidance and assistance under the agency’s accelerator programme.
Furthermore, the agency is working with federal partners, developers and researchers to devise protocols for use across institutions and programmes.
FDA Commissioner Stephen Hahn said: “Quickly after the emergence of this virus, we began working directly with federal health partners, academia and industry to advance medical countermeasures against Covid-19.
“Our staff continues to work across all sectors to expedite the development of numerous, innovative potential prevention and treatment approaches. We are also looking at pragmatic and expedited ways to make these products available to patients, while still ensuring the FDA’s standards are met.”
To support the fight against the pandemic, the regulator reassigned medical and regulatory staff, as well as designed specific processes and operations, for developers and scientists.
Therapies, developed across different areas, include antiviral drugs such as remdesivir, interleukin-6 (IL-6) receptor inhibitors and existing drugs such as hydroxychloroquine.
FDA is also collaborating with various public and private partners to rapidly gather and analyse real-world data, including illness trends and treatment outcomes.
The aim is to expedite the collection of clinical trial data required to approve a therapy for marketing.
11/3/20
Tiziana, meanwhile, will start assessing the drug in patients as soon as is practicable and will administer TZLS-501 using its proprietary formulation technology.
It said the features of its drug candidate should provide it with distinct advantages other anti-IL-6R mAbs such as Actemra and Kevzara in treating severely affected COVID-19 patients.
The aforementioned advantages are TZLS-501s dual mechanism of action to inhibit signalling by the membrane-bound and soluble IL-6 receptors along with the rapid depletion of circulating IL-6 cytokine, a major cause of lung damage.
We are excited to move forward with our clinical development plan to expedite evaluation in patients as soon as possible", said Tiziana's chief executive Dr Kunwar Shailubhai.
Gabriele Cerrone, chairman, added that Tiziana only became aware of the potential of its anti-IL6R mAb after people in Naples with lung problems caused by coronavirus started to respond to treatment with Actemra.
We are sitting on one of best anti-IL6R monoclonal antibodies on the market but had no idea it could be used for Covid-19 complications on the respiratory system as no-one had ever tried it before.
Every chance that TILS will receive substantial backing and funding from US and or UK agencies to accelerate TZLS-501's patient trials when they get the green light...... the fact that IL-6 is responsible for a large part of the acute-phase response in and high levels of IL-6 are associated with a poor prognosis in COVID-19.........and TILS IL-6 Inhibitor is reported to have distinct advantages over Roche & Sanofi's, and so no doubt patient trials for TLZ-501 will be top priority for all concerned. Gla ;-)