US-based clinical stage biopharmaceutical firm Rexahn Pharmaceuticals has started a Phase Ib clinical trial to evaluate the safety and efficacy of its next-generation cancer cell specific drug candidate RX-3117 in cancer patients with solid tumours.
The multi-centre dose-escalation Phase Ib trial will assess the safety, tolerability, dose-limiting toxicities and maximal tolerated dose (MTD) of RX-3117 in patients with solid tumours.
Secondary endpoints in the trial will include characterising the pharmacokinetic profile of RX-3117 and assessing the preliminary anti-tumour effects of RX-3117.
About 30 patients from several sites in the US will be enrolled in the trial and they will be given RX-3117 orally three times a week for three weeks followed by one week off, and will have the ability to continue on the drug for up to eight cycles of treatment.
A decision to enrol the next group of patients and escalate the dose will be made after one cycle of treatment, based on safety and tolerability.
In the trial, patients will be evaluated for tumour progression by CT or MRI before the start of therapy and after every two cycles of therapy.
The company intends to complete enrolment of patients by the end of 2014, while the results are expected to be release in the first half of 2015.
Rexahn chief executive officer Peter Suzdak said RX-3117 is exciting to work with, as it has a unique profile with demonstrated activity against gemcitabine-resistant human cancer cells.
"We were pleased to see reduced side-effect liability and oral bioavailability in cancer patients in our initial exploratory Phase I clinical trial conducted in Europe, and we believe that RX-3117 may represent a significant advancement in the treatment of cancer patients with solid tumours," Suzdak said.
The company said that RX-3117 possesses a broad spectrum of anticancer activity with reduced side-effects.
In an investigative Phase I trial carried out in Europe, RX-3117 showed oral bioavailability, and safety and tolerability in cancer patients with solid tumours.
The drug candidate has also demonstrated efficacy in human cancer cell lines resistant to gemcitabine, which is one of the widely used chemotherapy drugs on the market.
According to the company, resistance to the anti-cancer effects of gemcitabine represents a major clinical issue in the treatment of cancer patients.
It has been estimated that about 25% of cancer patients receiving one or more cycles of gemcitabine become resistant to its anti-cancer activity.
Image: RX-3117 has broad spectrum anti-tumour activity against 80 different human cancer cell lines. Photo: courtesy of freedigitalphotos.net.