(Alliance News) - Avacta Group PLC on Thursday said it opened its first two clinical investigator sites for the phase 1 clinical trial of AVA6000 on Wednesday, under it US investigational new drug application.
The life sciences company, developing targeted oncology drugs and diagnostics, said the two sites are the Memorial Sloan Kettering Cancer Center in New York and the Fred Hutch Cancer Center in Seattle, both of which are now open for patient enrolment to ALS-6000-101.
This is the first-in-human trial of AVA6000, its lead 'preCISION' drug candidate for the treatment of soft tissue sarcoma, Avacta said.
The news follows Avacta on Wednesday saying the first patient had been dosed in the fifth cohort of the first-in-human phase 1 trial of AVA6000, after approval of an amended clinical trial protocol by the UK Medical & Healthcare Products Regulatory Agency to allow higher levels of dosing.
Avacta said the opening of the US phase 1 trial sites for recruitment "marks a significant milestone" for its plan to expand AVA6000 clinical studies.
The US trial sites will initially contribute patients to the dose escalation phase, while being uniquely positioned to lead the enrolment of soft tissue sarcoma patients in the phase 1b dose expansion stage of the AVA6000 study when this begins, Avacta said.
It added patients will receive the same doses at each stage of the trial as in the UK.
"This timely opening of these two key US sites, under the expert direction of Dr [William] Tap and Professor [Lee] Cranmer, is a major milestone in Avacta's entry strategy into the US with our promising AVA6000 preCISION lead programme," said Avacta Chief Development Officer Neil Bell.
"We share with our US colleagues a clear vision to transform treatment outcomes for patients, and we look forward to working together as we continue to build the clinical evidence base for the safety and tolerability of AVA6000, in addition to the significant tumour-targeting potential of the preCISION platform."
Shares in Avacta were up 4.5% at 127.44 pence each in London on Thursday shortly after midday.
Avacta said it will provide further updates in respect of the progress of the US phase 1 trial as appropriate.
By Greg Rosenvinge, Alliance News reporter
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