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The first clinical trial of VAL201, safety and tolerability data are of paramount importance.
The headline safety and tolerability results demonstrated only one dose-limiting toxicity event occurred. This was at a maximum dose of 8 mg/kg, with the patient having raised blood pressure (severe hypertension). Following treatment for the raised blood pressure, the patient completed the remainder of the trial.
A Maximum Tolerated Dose has not been determined for VAL201, and all doses remain available for further testing.
No deaths were reported in patients during the clinical trial.
Further minor events listed as likely to be related to the administration of VAL201 are: Injection site disorders in 11 out of 12 patients; fatigue (5/12); dyspepsia (1/12); muscle spasm (1/12); hypertension (2/12); bradycardia (1/12).
It should also be remembered that these results will be essential for the progression of a BC201 combo treatment
Joey
ffs - I know you have an agenda here, but that's just idiotic.
tell me what the maximum tolerated dose of water is?
Further trials will be taken up by a much bigger player, the results today are very good imo and now will be taken further by a bigger company with the necessary resources. Val will be on so many radars now so a big deal will be announced very soon imo. Dr. Dilly with reveal further details quickly imo. We also have news from other products. Val301 and the Japanese collaboration news must be due very soon as well. So many positives to come here. The sp has been manipulated in a big way by the MMs today but will move back up strongly over the coming days as bigger players take an interest here
The drug has demonstrated safety at lower doses no one disputes that but the primary outcome failed as they haven't determined/estimated what the maximum dose is. Ive linked the direct evidence.
Suzy says
With this data in hand, future studies will investigate optimal dosing strategies for VAL201 and help confirm these early indications of a positive response rate."
So we have confirmation that more trials are required. The current trial of 12 took 6 years so logic dictates a similar trial will take just as long.
While considering these results it is important to remember that this is only the first clinical trial using VAL201, so there is another one to come ??
The previous trial took so long due to two individuals who shall not be named, dragging their heels and using VAL as a lifestyle company, they are now no longer in control and in the short time that Suzy has been at the helm, we've seen some great progress.
well done ... You are correct, VAL201 has to be able to compete against current standard of care , the reason why they keep upping the dose is because it didn't . You have no idea how long the efficacy lasts ... because of resistance, and the patients numbers are so small that its difficult to generate statistical significance have you not seen this before in other trials By the CEO ? history repeats
Dr Suzy Dilly, Chief Executive Officer commented: "I am delighted to be able to share these exciting results today, which are an accumulation of a lot of work by the wider team, both within and external to ValiRx. While considering these results it is important to remember that this is only the first clinical trial using VAL201, so this data has been generated using the utmost caution in sequentially dosing patients. Nevertheless, the headline results clearly demonstrate that VAL201 has the potential to be a safe and well-tolerated drug. With this data in hand, future studies will investigate optimal dosing strategies for VAL201 and help confirm these early indications of a positive response rate."
Seems to be happy with results to me.. oh but what does she know LOL
I'd stop posting if I were you, starting to look silly.
Dr Suzy Dilly, Chief Executive Officer commented: " While considering these results it is important to remember that this is only the first clinical trial using VAL201, so this data has been generated using the utmost caution in sequentially dosing patients. Nevertheless, the headline results clearly demonstrate that VAL201 has the potential to be a safe and well-tolerated drug. With this data in hand, future studies will investigate optimal dosing strategies for VAL201 and help confirm these early indications of a positive response rate."
Yes confirmed by Suzy more trials required timeline likely 6-7 years again
now I know why it's dropping,
people can't read and understand basic English.
"A Maximum Tolerated Dose has not been determined for VAL201" means that at the highest does it was STILL safe.
to find a maximum tolerated dose you need to find the dose at which it ISN'T tolerated.
this is GOOD news.
ffs!
It will have taken 6-7 years to complete the trial of 12 patients
Dose Finding Safety Study of VAL201 in Cancer Patients (VAL201-001)
https://clinicaltrials.gov/ct2/show/NCT02280317?cond=VAL201&draw=2&rank=1
Primary Outcome Measures :
To estimate the MTD/MAD of VAL201. [ Time Frame: The average timeframe is 18-26 weeks per subject ]
Assessment of the MTD/MAD of VAL201.
From RNS
A Maximum Tolerated Dose has not been determined for VAL201, and all doses remain available for further testing.
May be I misunderstand but that means the trial failed its primary outcome? Which would suggest further P1/2 trials are required which will likely take another 6 years.