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(Sharecast News) - Life sciences company Avacta Group announced the successful completion of its sixth dose escalation cohort in the ALS-6000-101 phase one clinical trial on Tuesday, assessing the safety and tolerability of the drug, AVA6000.
The AIM-traded firm said the results from the sixth cohort revealed an impressive safety profile for AVA6000.
Notably, a significant reduction in tumour volume was observed in a patient with soft tissue sarcoma.
Indications of the drug's clinical activity were also observed in other patients with various cancer diagnoses.
Designed using Avacta's preCISION platform, AVA6000 was described as a chemically modified version of the chemotherapy drug doxorubicin.
Avacta said its unique structure targeted only tumour tissues, reducing systemic side effects commonly associated with chemotherapy.
Throughout the UK and US trial, 35 patients with advanced or metastatic solid tumours were treated with AVA6000.
Even when administered at 2.79 times the standard doxorubicin dose, AVA6000 was still well-received by the cohort's patients.
The trial's data suggested potential benefits like higher doses, increased treatment cycles, or more frequent dosing compared to standard doxorubicin.
Following the positive safety data, the safety data monitoring committee (SDMC) gave the green light to progress to the seventh dose cohort at a dose equivalent to around 3.5 times that of standard doxorubicin.
The seventh cohort would also mark the final dose escalation cohort in the ALS-6000-101 phase 1a safety study, comprising three-weekly dosing.
Given the encouraging results, Avacta said it was refining its clinical development strategy, focusing on initiating a pivotal phase two study in soft tissue sarcoma, pending regulatory approvals.
At the same time, by the end of 2023, it aimed to kick off a short study examining more frequent AVA6000 dosing - fortnightly - for soft tissue sarcoma patients, subject to approval by the US Food and Drug Administration (FDA).
The board said the new approach aimed to establish the most effective dosing regimen for phase two, potentially speeding up the efficacy study's initiation to 2024.
Avacta said it expected to release comprehensive data from the ALS-6000-101 clinical study in the fourth quarter.
"I believe that we are on the verge of a paradigm shift in how chemotherapy is delivered to cancer patients," said chief executive officer Dr Alastair Smith.
"The safety and initial efficacy signals emerging from the data in the AVA6000 phase one study are very encouraging indeed.
"The preCISION platform is doing exactly what it was designed to do - target the release of active chemotherapy to the tumour tissue, sparing healthy tissues and improving the safety and tolerability of the drug whilst delivering potentially superior efficacy."
Dr Smith said he was "particularly pleased" that, even at such an early stage and in the patient group, there was a confirmed, significant response in a patient with soft tissue sarcoma and other positive signals across several other patients.
"We're now aiming to accelerate the clinical development of AVA6000 and begin the phase two efficacy study earlier than originally planned.
"The phase two trial will follow a short study to determine the safety and efficacy of fortnightly dosing to allow us to determine the recommended phase two dosing regimen.
"I look forward very much to sharing the detailed data from the Phase 1a study in due course."
At 1316 BST, shares in Avacta Group were up 16.13% at 123.1p.
Reporting by Josh White for Sharecast.com.
