The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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5 days safety data isn't worth anything to anyone.
It would have been set at 14 days for a reason. The safety data for the Provention Bio anti cd3 drug was 14 days on IV
Because you need to get data on the cumulative effect of Foralumab over time.
And any signals of clinical bene?t are unlikely to show in such a short time frame.
Did they really not take Covid into account when they designed the trial?
Crikey they really are ****ing with you.
So the original plan was to dose with 5mg pills in an inpatient setting for 14 days to get safety data.
Given that Foralumab had severe adverse effects when it was originally given on IV that makes sense.
Now its just 5 days worth of safety data they are looking for in an at home setting.
What is the point? They agreed 14 days with FDA to demonstrate safety. Now they want to get the same safety data with 5 days not 14 with the same dose.
Absolute BS. How do they expect investors to keep falling for this nonsense.
Always another excuse, always another failure.
What's going on with the Covid trial?
Many thanks,
Looks like it could be broker or custodian
Lloyd's, Halifax and iweb all done and tradable. Happend a few weeks back.
Tiziana Announces Submission of Amendment to Investigational New Drug Application to Advance Oral Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, in Patients with Crohn’s Disease
February 4, 2022 at 7:00 AM EST
- Tiziana is Developing the First Oral Form of Foralumab in a Convenient Capsule to be Evaluated in Phase 1b Clinical Study
NEW YORK, Feb. 04, 2022 (GLOBE NEWSWIRE) -- Tiziana Life Sciences Ltd (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company enabling breakthrough immunotherapies via novel routes of drug delivery, today announced submission of an amendment to an Investigational New Drug (IND) application for evaluation of orally administered capsules of foralumab, which it believes would be the first “take home” immunotherapy, in patients with mild-to-moderately active Crohn’s Disease. If accepted by the U.S. Food and Drug Administration (FDA), the amendment is expected to expedite patient enrollment and completion of the foralumab Phase 1b study by the fourth quarter of 2022.
The currently planned Phase 1b study with an amended protocol is designed as a placebo-controlled, randomized and dose-escalating trial, in mild-to-moderate patients with Crohn’s Disease. The patients will be dosed up to 5 mg once daily for five consecutive days and safety of patients will be monitored throughout the treatment period in the hospital or clinical research unit (CRU). The primary objective of this study is to determine safety and tolerability. The study will also evaluate the pharmacodynamic (PD) effects on modulation of immunobiomarkers, including calprotectin, a widely used biomarker for gut inflammation, in stools, as a secondary endpoint. Data from an earlier Phase 1a, single-ascending dose (SAD) study with orally administered foralumab in healthy volunteers determined that the treatment was well-tolerated up to 5 mg, which was the highest dose tested.
This amendment would allow for the investigation of a broader patient population as well as a shorter dosing period. Previously, Tiziana had submitted an IND to conduct a Phase 1b study in moderate-to-severe active Crohn’s Disease patients to evaluate safety of enteric-coated foralumab capsules administered orally once daily for 14 days as an inpatient study in the hospital or CRU with safety monitoring, for which the FDA issued a ‘Study May Proceed letter’. However, initial feasibility findings indicated that enrollment of patients in this initial safety study, requiring 14-day hospitalization, was highly challenging due to the COVID-19 pandemic. Thus, the clinical protocol has been amended to expedite patient enrollment and study completion.
The clinical findings from this Phase 1b study could support moving foralumab into a Phase 2 clinical trial in patients with mild-to-moderate Crohn’s Disease. Tiziana is awaiting FDA’s comments on the amended TILS-014 protocol and, with clearance of the amendment, anticipates completing the Phase 1b study by the fourth
Still old allocation showing on IG and still unable to trade - IG are claiming they have not been instructed.......
Haven’t posted before, been in Tils for a while. I made a complaint to HL about my shares to try find out if problem is with broker, custodian. or Tils. Is anybody able to trade with other brokers. If I can find out if it’s the company , I can complain to SEC
They don't want a price rise whilst buying back shares
I'm guessing they've friends buying up cheap accustem shares I'm the USA
Only once they completed will we see news or progress again
Exactly ROCKZ. Highly odd behavior.
There was also no SEC filing in regards of the decision to take the route of using Foralumab as a treatment for Type 1 diabetes, administered subcutaneously.
In the old days of TILS, this kind of information was RNS’d for fun.
I think they will notify via SEC filing on Successful application with no pick ups from the FDA.
'Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.'
https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application
The presentation also shows the market cap as of: 20/12/21. Was this the time it went to press?
Q1/Q2 will be interesting and hopefully the start of the next rise back to £1 in old money. Only a 330% increase from here! 8 weeks of Q1 left.
BB
On page 8, it says the IND for TZLS 501 il6 MAB for interstitial lung disease, was submitted 4th quarter 2021.
That news had certainly passed me by, and I am signed up for their corporate notifications since they delisted in the UK.
Not a good reflection on their comms people
Same with Shell pls, HQ now in London rather than the Hague, and no longer Royal Dutch Shell.
One new bit of news I noticed in the presentation was the fact that the IND for TZLS 501 il6 mab has already been submitted, it was stated twice.
So things have been going on in the background.
S97 thanks for posting the link. The presentation is a very good reference document and I will save it. TILS is looking like a three year hold and hope.
Most have one HQ but not all. Unilever had HQs in Netherlands and London until recently
more luaghter here:-
"Headquartered Offices: London, UK and
New York , NYHeadquartered Offices: London, UK and
New York , NY"
Call me old fashioned but a Corporation has one Headquarter, not multiple.
I've no idea what you are talking about. What are apportionment factors? What do you mean "the UK listed line"? The share isn't yet properly on any market so there would be no "first day dealing prices".
It is being traded on the PTC pink market but AFAIK very few/none of the UK holders have been able to trade it. I believe a few people (me included) can see the shares (not ADRs) on their accounts.
https://ir.tizianalifesciences.com/static-files/82ce0d51-2d25-4e40-b3ef-b87fa110c40f
Not sure if this has been posted before. Looks good.
Has anyone been able to obtain apportionment factors for the initial demerger of Accustem shares from TILS? due to having the UK listed line there were no first day dealing prices provided. Now at the stage of waiting for the new Accustem shares to be received from the recent consolidation. I've contacted link and Computershare but they cannot provide me any details. Has anyone with UK shares received the adrs?
This is good news for anti cd3 mabs. Any news on Tizianas outreach efforts are various fora recently. Faint signs of life at Tiziana?
SEC Form F-3 Filing at
https://ir.tizianalifesciences.com/node/10166/html
[In bold in the first section]
"Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this registration statement."
"The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Commission, acting pursuant to such Section 8(a), may determine."
So the effective date of this registration statement is delayed until a further amendment is filed?
So a nothing burger?
Don't blame you for laughing daveycaferacer
Wonder if Nazia Khan Esq is related to our former resident rampmeister Shiraz Khan? Wonder if he can fire up the old Khan network to find out what's going on with Tiziana......we would all surely love to know.
struggling to contain my laughter at this filing today
"We may offer, issue and sell from time to time up to $250,000,000, or its equivalent in any other currency, currency units, or composite currency or currencies, of our common shares, "
Interesting to see that the FDA have given ProventionBio another chance. Stock rose 30% on news.
TLSA are also following the diabetes route now.
https://www.nasdaq.com/articles/why-provention-bio-stock-skyrocketed-today?amp