Time to update this thread following an update by Avacta on the in-person Cancer trials going on both here in the UK and in America on end-of-life patients and it seems very pertinent given the recent loss of several members due to this awful disease.
A recap: Chemo drugs have been in use for nearly 50 years in limited doses due to the chemo drug toxicity and harm caused to other organs especially the heart. In some cases, people with underlying health issues are excluded from chemo due to the inherent risks. A patient has a maximum tolerated lifetime dose due to the toxicity of the ‘red devil’
Avacta have taken existing and very effective chemo drugs and installed a delivery method that renders the chemo drug inert while it circulates the body seeking out the tumour which expresses itself with an enzyme – FAP. The chemo drug locates then enters the tumour and activates in the tumour limiting the amount of free-flowing chemo in the rest of the body reducing its toxic damage elsewhere. The current trials are to check the safety profile only with the next phase of the trial looking into effectiveness. In today’s update it would seem that some terminally ill patients have been on this latest trial (5th Cohort or group) for 10 months and are showing signs that their cancer is not progressing further and ALL side effects have been much reduced or even eliminated which will be truly ground breaking. The same goes for patients in earlier cohorts so it could be that already their lives have been extended for a year or more!
News | Avacta Life Sciences Limited
Today 07:00
RNS Number : 3595D
Avacta Group PLC
21 June 2023
This announcement contains inside information for the purposes of Article 7 of the UK version of Regulation (EU) No 596/2014 which is part of UK law by virtue of the European Union (Withdrawal) Act 2018, as amended ("MAR"). Upon the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.
21 June 2023
Avacta Group plc
("Avacta" or the "Company" and, together with its subsidiary undertakings, the "Group")
Successful Completion of Fifth Dose Escalation in AVA6000 Phase 1 Clinical Study
Very positive safety profile of AVA6000 continues to be observed in the fifth cohort
Several patients remain on trial in different dose cohorts and continue to receive AVA6000 as their disease has not progressed
Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics, today announces that the fifth dose escalation cohort in the ALS-6000-101 dose escalation Phase 1 clinical trial to evaluate the safety and tolerability of AVA6000 has been completed successfully. The data continue to show a very favourable safety profile for the tumour targeted chemotherapy and several patients in cohort 5 and earlier cohorts remain on treatment as their disease has not progressed.
AVA6000 is a form of doxorubicin that has been chemically modified with Avacta's pre|CISIONTM platform designed to reduce systemic side effects by targeting the release of active chemotherapy in tumour tissue. Despite the high dose level in the fifth cohort which is approximately 2.25 times a typical dose of doxorubicin, AVA6000 has continued to be well tolerated by patients with a marked reduction in the incidence and severity of the typical toxicities associated with the standard doxorubicin chemotherapy administration.
The emerging positive safety and pharmacokinetic data from the study support the potential clinical differentiation of AVA6000 over doxorubicin. This includes: (i) higher dosing of AVA6000 compared to standard doxorubicin, (ii) more frequent dosing of AVA6000 compared to doxorubicin - doxorubicin is typically dosed every three weeks in order for patients to recover from the side effects of treatment, (iii) the ability to administer many more cycles of AVA6000 compared to doxorubicin.
A total of 29 patients with a range of advanced and/or metastatic solid tumours have now been dosed at the clinical trial in sites in the UK and United States. On the basis of the very favourable safety profile of AVA6000 in the study to date, the Safety Data Monitoring Committee (SDMC) has recommended continuation to the sixth dose cohort at 310 mg/m2, which is equivalent to 2.7 times the standard dose of doxorubicin. This continued dose escalation is aimed at identifying a maximum tolerated dose (MTD) necessary to inform the dosing levels for the Phase 1b and future studies.
Dr Alastair Smith, Chief Executive of Avacta Group plc commented:
"The continued positive safety profile of AVA6000 at these dose levels compared with standard doxorubicin is remarkable. We are seeing a significant reduction in the incidence and severity of all doxorubicin side effects. Analysis of the tumour biopsies to date also confirms that enough doxorubicin is being released in the tumour to have a therapeutic effect. If even higher doses of AVA6000 are tolerated then this may make a significant difference to the outcomes for patients in the upcoming efficacy study.
"We are keen to progress onto the Phase 1b efficacy study as soon as possible following completion of the dose finding Phase 1a study. The dose expansion Phase 1b study will provide an initial evaluation of efficacy and of the relative improvement in patient outcomes and quality of life of different dosing regimens of AVA6000 compared with the standard doxorubicin regimen."
