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(Alliance News) - Avacta Group PLC on Tuesday said it successfully completed the sixth dose escalation of the ALS-6000-101 phase 1 clinical trial, in which its AVA6000 soft tissue sarcoma treatment demonstrated an "excellent" safety profile.
Shares in Avacta were up 17% at 124.00 pence each in London on Tuesday afternoon.
AVA6000 is a tumour targeted form of doxorubicin that has been chemically modified with Avacta's preCISION platform, designed to reduce systemic side effects by targeting the release of the active chemotherapy to tumour tissue.
The Wetherby, England-based life sciences company, which develops targeted oncology drugs and diagnostics, said a "significant" reduction in tumour volume was confirmed in a patient with soft tissue sarcoma.
Avacta said a total of 35 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 US, with AVA6000 continuing to be "well tolerated" by patients in cohort 6, despite receiving 2.79 times the typical dose of doxorubicin.
A clinically significant reduction in the toxicities usually associated with standard doxorubicin chemotherapy continues to be observed, Avacta said, with these data continuing to demonstrate the potential to administer higher doses, more cycles of AVA6000, or more frequent dosing compared to doxorubicin.
Cohort 7 is set to be the final dose escalation cohort in the Phase 1a study, Avacta said, with detailed phase 1a data expected to be released in the fourth quarter of 2023.
Avacta also noted that its revised regulatory strategy aims to achieve earlier commencement of pivotal Phase 2 study in soft tissue sarcoma in 2024.
"I believe that we are on the verge of a paradigm shift in how chemotherapy is delivered to cancer patients. The safety and initial efficacy signals emerging from the data in the AVA6000 phase 1 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," said Chief Executive Alastair Smith.
"I'm particularly pleased that, even at this early stage and in this patient group, we have a confirmed, significant response in a patient with soft tissue sarcoma, as well as other positive signals across a number of other patients. We're now aiming to accelerate the clinical development of AVA6000 and begin the phase 2 efficacy study earlier than originally planned. The phase 2 trial will follow a short study to determine the safety and efficacy of fortnightly dosing to allow us to determine the recommended phase 2 dosing regimen."
By Greg Rosenvinge, Alliance News reporter
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