Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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Greend
I have been told from the horses mouth that we won't be getting the blood results from P1 from Brazil. I did try arguing with KS but he was adamant that we will not be hearing about it.
Below quoted from a conversation I had with KS.
"Objectives of these assays are to examine if nasally administered foralumab is systemically absorbed and circulates in blood (pharmacokinetics). The other assays are for biomarkers of immunology to understand mechanism of action. Hence, these assays are good to have for further development and are not going to change conclusions on clinical benefits reported in the press release"
P2RE & Greend,
Many thanks for all your research, the pipeline and timescales are compelling reasons to state the risk v reward is heavily slanted to reward.
I am curious as to the 5 NDA's, what products/ markets?
In Pharma Industry timescales are in the " Imminent " bracket.
Thanks again,
vbw
Thought it would be worth just collating some of the news due over the coming weeks...
Covid Trial in Brazil with Foralumab – think position on this is well understood, data on pharmacokinetics of nasally administered Foralumab, immunological biomarkers, stimulation of Tregs and anti-drug antibody (“ADA”) is expected to be reported in a few weeks (based on reports 2nd Feb, so 4-5 weeks into that “few” so can’t be far off). Just hoping they announce plans for wider trial at the same time.
Phase 2 Clinical trial – Progressive Multiple Sclerosis - administered Foralumab, Phase 2a trials were initiated in Q4 2020 for the treatment of MS. Anticipated completion Q2 2021, so 1-3 months to top-line data if Q2.
Phase 1b/2 Clinical Trial - Crohn's Disease: Collaboration with Parexel Biotech to conduct phase 1b/2 clinical trial in patients with Crohn's Disease. Take-home capsules of Foralumab. To be conducted in the United States and several European countries. This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. and Europe. Phase 1 study showed that oral treatment with Foralumab was well-tolerated in healthy volunteers, with no drug-related safety issues even at the highest dose of 5 mg2. Anticipated completion – Q2 2021.
Phase 1 of TZLS-501. Due to start next quarter. Think this will be very compelling giving other Anti-IL6 have shown positive results but we have the benefit of non-IV and fully human, probably the least risky of the products going through clinical trials, but equally the least advanced, and also where alternative treatments coming to the fore.
Initiate Phase 2b in HCC patients with Milciclib in combination with a TKI (Tyrosine-Kinase Inhibitor (TKI), such as Sorafenib or Regorafenib in Q2 2021. Phase 2a completed with 28 evaluated patients, 64% showed clinical benefits.
I think the majority here see a really positive mid/long term picture, it’s the short term that’s proving the pain point, and could see it continue to slide until news lands (issue is that we never know when that will be…, could be news this week, could be news in 2-3 weeks’ time on Covid trial with news on MS likely to follow relatively quickly afterwards…)
I am hoping for news sooner rather than later of an emergency phase 2 Foralumab Covid trial in the US (+?). Logically that would absolutely deserve a re-rate up to ‘at least’ the same price range as SNG (175+). That would be the correct holding stage before a bigger launch later this year/early next year, in my opinion.
If they haven’t sold out, probably we’ll check on the progress with the ceo every few months/before particular inflection points and ignore the sp for however long it takes for pharma investments to play out and reach their true potential value or not
Wonder what the 57 million dollar investors are thinking just now?!!