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mathsproof if you read the 2017 RNS .......... its exactly the same position as of today
London, UK., 18 December 2017: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to announce that the Company has received approval from the MHRA and REC for the Company to expand its VAL201 trial for the Phase I/II Dose Escalation Study in Patients with Locally Advanced or Metastatic Prostate Cancer and other Advanced Solid Tumours.
VAL201 has demonstrated consistently high safety and tolerability, as well as preliminary effectiveness throughout the clinical study. Following the successful completion of this stage one of clinical development, with no serious drug related adverse events noted, the MHRA and REC have accepted the Company and clinical team's request for this escalation to the study. This approval allows for a substantial increase in the dose of VAL201 being administered to patients, thereby allowing treatment to more speedily reach its full therapeutic potential and potential anti-cancer impact. Further analysis will be provided in due course following a more comprehensive evaluation of the data.
This regulatory approval permits ValiRx to;
· To substantially raise the dosing level in patients in order to reach therapeutic levels and reduce disease progression;
· To assess at what stage in disease development the compound can be most effectively deployed in subsequent, larger, outcome-oriented clinical trials; and
· To determine which route and with whom to take the project to its next stage - by the Company or with a partner.
no perception of speed thou ..
maybe a trip in vomit comet ?
as
the real hero's of power have shut the doors
NO MORE THRILLING JET SORTIES FROM THUNDER CITY
Thunder City, which has the world's largest civilian-owned fleet of ex-combat jets including three English Electric Lightnings, three BAe Buccaneers, seven Hawker Hunters and a retrofitted Puma helicopter, is to cease flying operations with immediate effect.
Bunsie ...
Why would any one go on Hunger Strike .. ?
how can you prove you would live longer ?
while staving and dreaming of food ... do you think that will improve your Quality of Life ... ?
simple quick method ... inject insulin .. and monitor .. you will see stars .. but it will stripe your blood of sugars ...and takes 15 mins ..
result one starving puppy ...
Spiro ... you are in the wrong share if you want to Cure Cancer ........... this product might have efficacy but it is competing with already approved drugs in this field and they don't cure cancer either
the Over 65's do not get the standard Flu jab .. but the quadrivalent vaccine so will not be impacted by any shortage again they will receive on the NHS so planned for.
the reason why they get a more potent vaccine is because of the efficacy is insufficient in this group to illicit a response.
exactly the same reasons why Scancells Covidity if proven has a major market place in the older generation and it may even sterilize in the younger generation blocking viral shedding
it leaves Val looking for another target to acquire, they have no in house inventions, no labs, everything is out sourced.
they seem to pride themselves of picking winners ... and convincing shareholders that putting assets into other vehicles is some how a lucrative business all i can say the only experience i see is that of the CEO trying to repurpose old drugs and getting it completely wrong 401 data is dreadful ...
i have miss read that . ........... what has happened to the 16mg/kg data ???????????????
"""" This segment of the trial is in the concluding stages of its Phase l/ll (announced 17/10/18) and is progressing with patients to establish the maximum tolerated acute dose in Humans (MTD). """"
VAL201
The Phase 1/2 clinical trial of VAL201 in the treatment of men with prostate cancer was closed to further recruitment on 27 January 2020, with recruitment standing at a total of 12 patients dosed across 5 cohorts. The dose escalation was carried out from 0.5 mg/kg up to 8 mg/kg with dosing being carried out once a week.
so they went to the max dose of 8mg /kg in approx 2 patients ... so all the Data of interest is "2 patients" the rest is not relevant to efficacy data otherwise why would you increase dosage.
But why stop the trial ??????
because back in march of 2019 16 mg was given approval
Based on these results, the MHRA approved an extension to the trial (announced 18/12/17), allowing for an intra-patient dose escalation of up to 16mg/kg. This segment of the trial is in the concluding stages of its Phase l/ll (announced 17/10/18) and is progressing with patients to establish the maximum tolerated acute dose in Humans (MTD). This part of the study is also further establishing potential efficacy levels and pharmacokinetic / pharmacodynamic profiles as well, providing supporting information with respect to the optimal therapeutic regimes to be tested in the subsequent late stage clinical trials.
why describe it as "subsequent" as a "late stage" ........... when really its a phase 1 dose escalation study ........
and all the data to date is Phase 1 stuff .................... not phase 2 because that's the point you have established a dose and proceed to efficacy studies ...
Not sure what you guys are seeing in the Data ............. but i see no evidence that a Major pharma would take this on at this stage unless you give it away ..
so if they are not taking it to the next trial .......
what is the point of VAL ........ ?
they had this "Big RNS " back in Dec 2018 claiming all sorts ....
Mon, 10th Dec 2018 07:00
RNS Number : 8910J
ValiRx PLC
09 December 2018
VALIRX PLC
("ValiRx" or the "Company")
UPDATE ON VAL201 CLINICAL TRIAL
"Positive Effect on Cancer Patients"
"Evidence revealed of decrease in prostate cancer biomarker PSA, related to dosing with VAL201"
London, UK., 10 December 2018: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is proud to announce that independent analysis of VAL201 data shows a statistically significant dose dependant response in the reduction of PSA correlated to time on the Phase l/ll clinical trial, involving patients with hormone-sensitive and hormone-resistant prostate cancer.
This represents an initial formal statistical analysis of the VAL201 clinical data conducted by Dr Wilson Caparrós-Wanderley, an independent statistical consultant. This was undertaken using a non-parametric approach - both the well-established 'Friedman Test' (developed by M. Friedman in 1937) and the most up-to-date statistical method, 'Repeated Measures Multiple Correlation Analysis' (refined by Bakdash and Marusich in 2017).
This analysis reveals that volunteers treated with VAL201 display a statistically significant correlation for reductions over time in the amount of Testosterone and Prostate Specific Antigen ("PSA"), both of which are commonly-used markers for disease progression in prostate cancer.
The data further confirms that VAL201 has no statistically significant adverse trends across liver or kidney function. Furthermore, with no impact on cardiac rhythm in the patients either, this data further reinforces the continuation of the good safety and tolerability data emerging from the trial.
In addition to the independent analysis, the pharmacokinetics information collected from the clinical evaluation of ValiRx's more recent patients, shows that ValiRx is addressing the protocol's primary and secondary endpoints - as well as all the exploratory tertiary end points.
Further information about the endpoints is to be found posted on the NIH website, www.ClinicalTrials.gov, under: 'Dose Finding Safety Study of VAL201 in Cancer Patients (VAL201-001)'.
Dr Satu Vainikka, CEO of ValiRx, commented: "I am delighted to receive this analysis from an external expert, showing that VAL201 is having a positive and desired effect on prostate cancer patients' disease markers. Effectively, the more a patient takes VAL201, the more a patient's PSA will decrease".
"This is fantastic news and it heralds our entry into the pivotal stage of VAL201's clinical trial programme. I thank the team for their hard work in delivering these very encouraging and positive outcomes".
well they continued to ... that was after the 401 results which many of us described as abysmal
yet the rampers said it was fantastic data ...
anyway it would appear I called it correct ... years on ....401 pretty well dead