ECO-4601
ECO-4601 is a proprietary first-in-class small molecule with the potential to treat multiple solid tumours. like the well known chemotherapeutics, doxorubicin and mitomycin C. ECO-4601 is a natural product derived from a non-pathogenic micro-organism. Discovered using Thallion’s DECIPHER® technology, ECO-4601 has completed preclinical studies conducted by the National Cancer Institute and Thallion to establish safety and efficacy in animal and in vitro models.
The preclinical data suggests that ECO-4601 has a novel mechanism of action with dual activity. ECO-4601 is a potent inhibitor of the RAS-mitogen-activated phosphokinase (MAPK) pathway, a validated target for a number of commercially available oncology treatments. ECO-4601 acts at the centre of the pathway inhibiting RAS activation, leading to the inhibition of downstream intracellular events. In addition, ECO-4601 also binds selectively to the peripheral benzodiazepine receptor (PBR) that appear to be over-expressed a variety of different tumour types. This selective binding may concentrate the drug in the tumour tissue where it is most needed.
ECO-4601 is currently the subject of a Phase I/II trial designed to examine its safety, pharmacologic profile and anti-tumour efficacy for the treatment of advanced solid tumours. In the dose escalation portion of the study, ECO-4601 was administered to 14 patients, who had completed and not responded to the respective standard of care therapy, in 21-day cycles consisting of a two week continuous intravenous infusion followed by a one week rest period. The trial included colorectal, ovarian, duodenal and glioma patients. The product was safe, well tolerated and there was no maximum tolerated dose attained. Of the seven patients that received at least three cycles of treatment, six demonstrated stable disease.
In the second portion of the trial, currently underway, 15 additional patients are being treated with the highest dose, 480 mg/m2/day, as determined in the first portion of the study, to obtain additional safety and pharmacokinetic data, as well as an early indication of the compound’s clinical efficacy.
Thallion intends to complete the Phase I/II trial in the second half of 2007 and based on its analysis of the data, will then determine an appropriate indication(s) for further clinical development. The company anticipates a Phase II trial for the selected indication in late 2007.