Life sciences company, Avacta Group plc, makes targeted oncology drugs and diagnostics, made the announcement yesterday (April 5).
The drug on trial is called AVA6000 and currently under its US investigational new drug (IND) application. The company also announced the first patient has been dosed in the fifth cohort of its first-in-human phase 1 trial. This follows approval of an amended clinical trial protocol by the Medical and Healthcare Products Regulatory Agency (MRHA) to allow for higher levels of dosing.
The company’s safety data monitoring committee (SDMC) is made up clinicians currently recruiting patients and recommended the trial continues to the fifth cohort with a dose of 250mg/m2 after the favourable safety profile of the drug generated in study to date.
This escalation falls outside the original clinical trial protocol and required amendment and approval by the MRHA which has been completed. The continued dose escalation is aimed at identifying a maximum tolerated dose necessary to inform the dosing levels for the next phase (1b) and future studies.
Alastair Smith, chief executive officer of Avacta Group, said: “We are very much encouraged by the positive safety and tolerability data emerging from the dose escalation phase 1a study of AVA6000. Following the recommendation from the SDMC, and approval by the MHRA, we are pleased to commence dosing in the fifth patient cohort of this trial.
“The recent confirmation of release of active chemotherapy in the tumour tissue and the safety data being generated in the ALS-6000-101 study are providing detailed insights into the pre|CISION platform which add significant value to the technology and confirm its tumour targeting potential.”
The two sites that have been opened are called Memorial Sloan Kettering Cancer Center (MSK) in New York and Fred Hutch Cancer Center in Seattle. Both are open and ready of the trial which is being led by doctors William Tap, chief of the sarcoma medical oncology service at MSK and Lee Cranmer. Professor at the clinical research division of FCC.
Neil Bell, chief development officer for Avacta Therapeutics, said: “This timely opening of these two key US sites, under the expert direction of Dr Tap and Professor Cranmer, is a major milestone in Avacta’s entry strategy into the US with our promising AVA6000 pre|CISION lead programme. 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 platform.”
