Meditech gears up for Phase II anti-cancer trials

Meditech Research has been granted ethics committee approval to begin a Phase II clinical trial testing two anti-cancer drugs, HyFIVE and HyCAMP, on colorectal cancer patients, the company said yesterday.

The trial will be carried out at the Centre for Development of Cancer Therapeutics in Melbourne.

The two drugs use Meditech's proprietary HyACT technology to formulate the existing chemotherapeutic drugs 5-Fluorouracil and Irinotecan. The aim of the trial is to demonstrate patient tolerability and efficacy of the formulations.

Meditech's director of operations, Tracey Brown, said that the trial would be performed in two stages. Initially a small number of patients who have not responded to previous therapies will be treated for the purpose of obtaining pharmacokinetic and dose escalation data on HyCAMP prior to treating patients with the combination. While HyFIVE has previously been tested in Phase I studies, HyCAMP has not.

The second stage of the trial, Brown said, would look at the two drugs in combination. Previously untreated patients with metastatic colorectal cancer will receive both drugs in up to four rounds of intravenous treatment over a six-month period, depending on their response to the drug.

A feasibility study would be performed after the first 36 patients and depending on the results, a further 20 patients would be enrolled in the study, she said. The trial is expected to be completed in 12 to 18 months, and the company plans to release interim results as appropriate.

The company hopes that the combination of drugs used in the trial will provide a good validation of the HyACT technology, which they claim makes drugs more efficacious and less toxic.

"One of the reasons we selected this drug combination is that it is the preferred choice around the world for colorectal cancer," said Brown. But Irinotecan is known to be very toxic in its existing formulation and often results in early termination of treatment, she said.

Meditech hopes that positive results from the trial will put them in a good position to secure commercial agreements with pharmaceutical companies that either currently produce and market 5-Fluorouracil and Irinotecan or seek to establish new and improved anticancer products.

Meditech's share price rose 20 per cent to $AUD 0.10 yesterday in response to the announcement.