US-based biotechnology firm Advaxis has started dosing in the first stage of its Phase II trial of fighting anal-cancer with a CTL-enhancing tumour therapy (FAWCETT) study, to evaluate axalimogene filolisbac (AXAL) for the treatment of persistent or recurrent metastatic anal cancer.
The first stage of this multi-centre, open-label, two-stage trial will enrol 31 anal cancer patients who have received a prior treatment regimen, after which they have experienced the recurrence of the disease.
The patients will be administered with AXAL 1×109 colony forming unit (CFU) doses every three weeks up to a duration of two years.
Advaxis president and CEO Daniel O’Connor said: "The FAWCETT study is an important step in the development programme for AXAL.
"People living with anal cancer desperately need new treatment options, which is why Advaxis is pursuing two areas of evaluation, including monotherapy with AXAL and a second study with an immune checkpoint inhibitor in combination with AXAL."
Anal cancer is a rarely occurring cancer from whereby approximately 7,270 new cases were diagnosed and around 1,010 people died in 2014, according to the American Cancer Society.
AXAL is based on Advaxis’ Lm Technology that uses live, attenuated bioengineered Listeria monocytogenes (Lm) bacteria to signal the immune system for differentiating tumour cells as bacterial infected cells and destroy them.
AXAL currently has orphan drug designations from the US FDA for the treatment of invasive cervical cancer, head and neck cancer, and anal cancer.
Administration of AXAL in another randomised, Phase II study for recurrent or refractory cervical cancer has exhibited apparent prolonged survival, objective tumour responses, and a manageable safety profile alone or in combination with chemotherapy.