Thallion Pharmaceuticals Inc announced that it will close its phase-II trial evaluating TLN-4601 as a treatment for glioblastoma multiforme (GBM) due to a lack of measurable efficacy after analysis of the interim data. The company’s decision to close the study follows a recommendation by the Study Committee, comprised of the medical investigators leading the clinical trial.
“Although we are disappointed by the results of the study, the decision to close the TLN-4601 trial will allow us to focus our resources on programs with more immediate commercial potential. On behalf of Thallion, I would like to thank our clinical investigators and the patients that participated in the GBM trial,” said Lloyd M Segal, chief executive officer of Thallion.
The planned interim analysis was conducted after enrolling 20 of the targeted 40 patients in the open label trial. Study results showed that only three out of seventeen evaluable patients demonstrated stable disease after two cycles (six weeks) of treatment. No stable disease was observed after four cycles of treatment. TLN-4601 was considered as generally safe and well tolerated. In the absence of any meaningful clinical response, the Study Committee recommended to the Company that the study be stopped.
Thallion intends to complete a full analysis of the data package prior to making a decision on the next steps for the TLN-4601 program, including its partnership potential.
In the Phase II trial, TLN-4601 was continuously administered intravenously at a dosage level of 480 mg/m2/day over 14 days, followed by 7 days off treatment (three-week cycles). The primary endpoint of the open label trial was six-month progression free survival, with secondary endpoints including tumour response, progression-free survival at 12 months, as well as overall survival.
TLN-4601 is a novel small molecule derived from a nonpathogenic microorganism. It was discovered using Decipher, Thallion’s proprietary genomics-based drug discovery platform. TLN-4601 has demonstrated broad in vitro cytotoxic activity across a diverse panel of tumour cell lines and in vivo efficacy in a number of xenograft tumor models. Phase-I clinical testing showed the compound to be safe and well tolerated, with early signs of anti-tumour activity. TLN-4601 was being evaluated in a phase-II glioblastoma multiforme (GBM) clinical study based on its proposed mechanism of action and preclinical animal data demonstrating that the compound crosses the blood brain barrier and appears to preferentially accumulate within brain tumours.
Thallion Pharma is a biotechnology company developing pharmaceutical products in the areas of oncology and infectious disease.