Thallion Pharmaceuticals Inc. has announced positive safety and efficacy data from the completed phase I/II trial of ECO-4601 for the treatment of advanced cancer patients. These results support and confirm preliminary results from the dose escalation portion of the study disclosed earlier this year at the annual ASCO meeting. ECO-4601 was safe and well-tolerated up to the maximum dose tested of 480mg/m2/day.
Adverse events potentially related to ECO-4601 were nonspecific and common in this type of patient population. Furthermore, in seven refractory cancer patients who had completed six cycles of treatment, six patients achieved stable disease.
"These results confirm the excellent safety profile of ECO-4601, which is a critical step necessary to advance this product candidate to the next stage of development. With six of seven patients demonstrating stable disease after six cycles of therapy, we believe this represents a positive signal of efficacy that warrants continued product development," said Lloyd M. Segal, chief executive officer, Thallion. "At this stage, we believe ECO-4601 could potentially be used as either a monotherapy or as part of a combination therapy approach for the treatment of several cancer indications. The data from this trial, together with the non-clinical data we have collected to date, now allow us to select an appropriate indication for our next phase of clinical development".
The company intends to advance ECO-4601 into a phase II trial in an indication to be selected over the coming weeks. The company plans to initiate regulatory filings prior to the end of the fourth quarter in order to commence a phase II trial.
The six patients that had demonstrated stable disease included four colorectal, one duodenal and one ovarian cancer patient. The pharmacokinetic data demonstrated that estimated therapeutic plasma concentrations of ECO-4601 were reached at the higher doses and that ECO-4601 was rapidly eliminated from the bloodstream following infusion.
The most common adverse events related to the treatment of the study were all mild to moderate, including: fatigue, nausea, vomiting and anemia. Only two serious adverse events related to the treatment were observed in the study: one anaphylaxis (grade 4) that occurred in the first patient and was procedure-related (flushing of central line) and one rash (grade 2) that was handled by premedication with pednisone.
The phase I/II clinical trial was designed to examine the safety, pharmacologic profile and anti-tumour efficacy of ECO-4601 as a treatment in 26 advanced cancer patients. ECO-4601 was administered in 21 day cycles consisting of a two week continuous intravenous infusion followed by a one week rest period. The trial was conducted in two portions. The first portion was a dose escalation study in 14 patients with doses ranging from 30 to 480mg/m2/day to assess the safety, pharmacokinetics and maximum tolerated dose of ECO-4601.
The second portion of the phase I/II trial included 12 additional patients treated at the highest dose, 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. The clinical study was conducted at the Segal Cancer Centre, Jewish General Hospital, McGill University and Hôpital Charles LeMoyne, Centre affilié universitaire et régional de la Montérégie in Montreal in conjunction with Thallion Pharmaceuticals Inc.