Rainbow Rare Earths Phalaborwa project shaping up to be one of the lowest cost producers globally. Watch the video here.
Prophylactic as in preventing disease irrespective of severity.
Awhatsup - you may want to brush up on your knowledge. Your last post contains multiple incorrect statements.
I’d hope Synairgen would not get cheaper. You most probably wanted to refer to SNG001. Quite a difference.
SNG001 as a treatment can’t get rid of the virus in the manner you suggest i.e. ending the pandemic.
SNG001 is not being trialed as a prophylactic and so there is no evidence to suggest it will prevent you from getting covid.
SNG001 does not prevent you from spreading it. You can still spread the virus prior to and during treatment prior to the virus being killed.
There is no available evidence yet to suggest it prevents long covid. Results from the data still to be released.
Fighting the pandemic is not a binary choice between vaccines and treatments. You need both.
The original post on this thread referred to SG018 phase III and not ACTIV-2. SG018 recruitment is estimated to conclude between 27 Aug - 01 Sep.
Re ACTIV-2. I would not bank on getting an RNS for last patient dosed. It's not our trial and as such Synairgen is in no position to release information as and when we like to.
Recruitment into ACTIV-2 phase II may have been adversely affected by a change in the recruitment criteria whereby only low risk patients are targeted. Refer to my posts from yesterday on this titled 'Updated version: ACTIV-2 Master protocol'.
The 'seamless' graduation mechanism from phase II to III for ACTIV-2 seems to have been removed from the latest protocol, however it's not possible to tell whether it was extended to SNG001 despite it being a non infused agent and this change in protocol. Dr Castro's comments seems to suggest it was extended.
A number of changes were made so difficult to tell how that may have impacted SNG001. Just got to wait. If we progress to phase III then at least recruitment should be faster, hopefully, given the replacement of the placebo with an active comparator. Patients won't be put off by a placebo and therefore more likely to participate.
Other notable amendments include:
1) The design of the phase III evaluation for future agents will be developed in a subsequent version of the protocol and will include an active controlled comparator instead of a placebo control.
2) Refer to my original post.
3) New phase III protocol seem not to differentiate between infused and non infused agents.
Page 25 contains a useful illustration of how randomisation works. Worth having a look. Page 58 & 59 contain additional text on randomisation.
https://fnih.org/our-programs/activ/therapeutics
Although the potential slower recruitment into phase II would’ve been (partially) offset by the commencement of phase III recruitment based on Dr Castro’s comments provided he did not misspeak.
It may just mean a longer wait for the official announcement of progression to phase III should SNG001 progress.
Version 6 dated 30 Apr 2021.
https://fnih.org/our-programs/activ/therapeutics
Not gone through it in much detail yet, but this caught my eye. The pace of recruitment into SNG001 phase II could have been adversely affected by the below change in protocol, as per the bold font printed paragraph on p.22, that’s if recruitment was still ongoing at the time of change. Lower risk patients excl those above 59 yrs of age. See p.15 for the definition of high risk patients.
Quote: ‘However, under version 6 of the protocol, further enrollment to the phase II evaluation is restricted to participants at lower risk of progression to severe COVID-19, regardless of the mode of administration of an agent.’
I think SNG001 will not be part of the selected 10 therapeutics simply because we may not require the program’s assistance at this late stage of the race. Synairgen have progressed so far with SG018 being in the final stages of recruitment, production almost sorted out, if not already, and our trial format does not allow a rolling review (not saying that’s a requirement).
Of course we’ve received advice from the EMA and they may have assisted in other ways which could be what RM was referring to. Not being part of this program does not mean they won’t grant marketing authorisation and/or not buy SNG001.
If we do end up as part of this program then great, but do we really need it at this late stage?
What about it?
Assuming the Primary Completion date of 01 Oct 2021 is the date to work with we're looking at last patient dosing towards the end of Aug.
If we were to believe the Study completion date is correct then last patient dosing is today which definitely is not the case.
Some 'interesting' changes made to the wording of the ACTIV-2 protocol on 11 May 2021.
With reference to no 1: It seems the aim with this amendment was to increase the likelihood of an improved efficacy signal in phase III vs phase II by being more targeted. Additionally it suggests that the graduation criteria from phase II to III includes a low threshold from an efficacy point of view. Difficult to say whether this change may or may not have had any relevance to SNG001.
With reference to no 2 & 3: These amendments suggest that the current phase III protocol will not be applied to future agents irrespective of whether they’re infused or non-infused. This amended version of the phase III protocol have not been made public or referenced in the most up to date version of this abridged protocol. Finalisation could delay progression of agents from phase II to III.
Quotes:
1) PREVIOUS WORDING
The study includes both infused and non-infused agents. For infused agents, enrolment will be restricted to participants at higher risk of progression to severe COVID-19. Non-infused agents will be open to participants at both "higher" and "lower" risk of progression to severe COVID-19.
1) NEW WORDING
The study includes both infused and non-infused agents. Version 6.0 of the protocol restricts enrolment to agents in phase II to participants at lower risk of progression to severe COVID-19, regardless of the mode of administration of the agent.
2) PREVIOUS WORDING
For infused agents, the study begins with a phase II evaluation, followed by a transition into a larger Phase III evaluation for promising agents. Phase III evaluation is a continuation of the phase II trial for agents that meet study-defined criteria for further evaluation and for which sufficient investigational agent is available. An infused agent may also enter directly into phase III evaluation based on Trial Oversight Committee (TOC) assessments.
2) NEW WORDING
The current phase III evaluation will continue as a placebo-controlled evaluation of the one agent that has previously been approved for full phase III evaluation by the Trial Oversight Committee (TOC) and will continue to include only participants who are at higher risk of progression to severe COVID-19.
3) PREVIOUS WORDING
For non-infused agents, the same phase II study will be undertaken as for infused agents. Following design of the phase III evaluation for non-infused agents in a subsequent version or amendment of the protocol these may also enter directly into phase III based on TOC assessments.
3) NEW WORDING
The design of the phase III evaluation for future agents will be developed in a subsequent version of the protocol and will include an active-controlled comparator instead of a placebo control.
https://clinicaltrials.gov/ct2/history/NCT04518410?A=69&B=70&C=merged#StudyPageTop
Joey - apparently Reddit’s private investigators concluded that big news will drop this week. We were not privy to further details.
GETINTHERE - ACTIV-2 was designed with speed & efficiency in mind which makes it possible for infused agents to seamlessly continue with recruitment once the phase II target of 220 is reached provided the agent met the graduation (i.e. phase II to III) criteria, but prior to the availability of full day 28 data analysis. If the full data analysis is positive it’ll formally progress to phase III even though phase III recruitment has already begun.
Based on Dr Castro’s comments from one of the Kansas Uni Hosp briefings it seems that this is where SNG001 is finding itself which would mean they’ve extended the seamless recruitment mechanism to non-infused agents (i.e. SNG001). So we’re still in Phase II, but seem to have started with phase III recruitment.
* correction to bullet point no 7. It should read Portugal instead of Spain. One site was added for Portugal.
In total 65 sites are listed, all of them recruiting, of which 47 are non-UK. The final number should be much higher.
Countries not listed: Germany, Romania, Argentina, Mexico & Brazil
And just spotted this change made today to the Indian leg of the trial. Four additional sites added taking the total to 14 as per their records (i.e. protocol).
http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53300&EncHid=&userName=Sng001
If that link does not work use the below and enter ‘SNG001’ in the ‘Keyword’ field.
http://ctri.nic.in/Clinicaltrials/advancesearchmain.php
Changes relate to recruitment sites:
1) Additional site in Belgium
2) Colombia added. One site recruiting.
3) Three additional sites in France - recruiting.
4) Four additional sites in Israel - recruiting.
5) Six sites in Italy - recruiting.
6) The Netherlands have been added which was not on the original list of countries. Two sites recruiting.
7) One additional site in Spain - recruiting
8) Spain’s been added with seven sites - recruiting.
9) India changed to ‘recruiting’.
https://clinicaltrials.gov/ct2/show/NCT04732949
I do not see any issue with AJ316 posts. It’s only sensible to keep expectations in check.
These comments from RM, which would’ve been for this article, are in line with the RNS titled ‘Home Cohort data of SG016 Phase II trial’ from 30 Apr 2021.
Don’t look at it that way. We don’t need to recruit 22 from Germany. The total for the EEA is 234 patients. The sum of Spain (87), Italy (41), Belgium (35), Portugal (50) and Germany (22) is 235. On top of that you have France and Romania.
Plus, you have the Delta variant making inroads in the EU.
Jez2 - your find is indeed a current recruitment. Well done. My assumption was not accurate as Synairgen took a few days to update their website.
They’ve advertised for a Clinical Quality Manager in Jan 2021 so I guess that hire is now the Head of Clinical Quality Management they’re referring to in this advertisement.
https://www.synairgen.com/contact-us/employment-opportunities/
That was more of an off the cuff remark. There could be many reasons as to why we’re not in the top 5. Not looking for possible justification.