Biopharmaceutical company Lorus Therapeutics has reported positive results from its first-in-human, dose-escalation trial of novel anticancer agent LOR-253.
LOR-253 is a small molecule optimised to induce tumour suppressor Krüppel-like factor 4, causing cancer cell cycle arrest and apoptosis and inhibiting metastasis.
In the study, LOR-253 demonstrated a considerable safety profile in addition to encouraging signs of antitumour activity.
Lorus president and CEO Dr Aiping Young said that the results demonstrate that LOR-253 is well tolerated without dose limiting toxicity even at the highest levels.
"More importantly, at higher doses we saw promising dose-related antitumor activity clearly attributable to the drug," she added.
"Safety and pharmacokinetic data suggest the additional opportunity for more frequent dosing of LOR-253 and by combining with other agents we expect to demonstrate even greater antitumor activity in a larger follow-up phase II clinical study."
A total of 27 patients with advanced solid tumours resistant to multiple standard therapies were enrolled in the study at seven dose levels ranging from 20 to 229mg/m2. The patients had previously failed a median of four prior chemotherapies.
Out of 17 patients evaluable for efficacy, around 41% achieved stable disease by response evaluation criteria in solid tumours (RECIST). The patients suffered from colorectal, lung, appendiceal, liver and uterine cancers.
At higher dose levels of 176mg/m2 and 229mg/m2, around 80% achieved sustained stable disease by RECIST ranging from 5.6 months to eight months, representative of disease control. A non-small cell lung cancer patient at the highest dose level additionally showed non-index tumour shrinkage.
With dose escalation not limited by toxicity, LOR-253 was well tolerated at all dose levels and the most common adverse event was Grade 1 or 2 fatigue seen in three patients.
A follow-up Phase II trial of the regimen in patients with non-small cell lung cancer as the first indication for further development is currently being designed by the company.