RE: It's obvious the science works now3 Dec 2025 13:40
@nps4, you can't KNOW that there is "a patient alive nearly 12months later at the point, another nearly at 9months". All you can KNOW is what the company has put into the public domain, or rather your INTERPRETATION of what the company has put into the public domain.
15 Aug 2025 - https://www.lse.co.uk/rns/HEMO/third-patient-treated-with-hg-ct-1-car-t-therapy-e94pv0bsis7krx9.html "The Company is pleased to report that the first two patients treated with HG-CT-1 remain alive at six months and three months post-treatment, respectively."
17 Sep 2025 - https://www.lse.co.uk/rns/HEMO/third-patient-safety-0wzf8og3t8ibihn.html "... the third patient has been successfully treated ... early indications of clinical efficacy have been observed. Preliminary assessment shows that original AML cells were not detectable in the patient using standard testing methods. ... Safety data from the first three patients treated at the lowest dose of HG-CT-1 will be submitted to an independent Data Safety Monitoring Board (DSMB) for review."
29 Oct 2025 - https://www.lse.co.uk/rns/HEMO/clinical-trial-update-and-grant-of-share-awards-r1xlgv3aa8n6fwf.html "The DSMB's positive recommendation follows the successful completion of initial safety assessments for all three patients treated at the lowest dose, with no dose-limiting toxicities observed. ... The Phase I study of HG-CT-1 is a dose-escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy... The DSMB's clearance to proceed represents a key de-risking milestone in the clinical development of HG-CT-1. It reinforces the favorable safety profile observed to date and signals continued regulatory and operational momentum. For investors, this milestone marks a potential value-inflection point as the Company advances into higher dose cohorts where enhanced efficacy signals are anticipated, paving the way toward broader clinical validation and future pivotal studies."
Apologies if I've missed any other mentions of treated patients and the purpose of this Phase 1 dose escalation trial. Full details of the trial, including incusion/exclusion criteria, and primary and secondary endpoints are given on the ClinicalTrials site: https://clinicaltrials.gov/study/NCT06786533
This is primarily a safety and tolerability study - to prove that the treatment at each dose level won't kill the patients or give them bad side effects (especially grades 3 and 4) or further illnesses. The efficacy part of the the study is 'preliminary efficacy', meaning does it even work? It may be that at the lowest dose the treatment doesn't show any efficacy, but might at higher doses. That obviously isn't the case here. Showing efficacy at this stage doesn't mean cure, prolonged improvement or still alive. The last time the company said in an RNS that patients 1 and 2 were still alive was on 15 August. Patients can die during the trial from disease progression and the dose still be regarded as 'safe' to g