Solbec trial patients ask for more drug

By Melissa Trudinger
Thursday, 09 September, 2004

Early results from Solbec Pharmaceutical's (ASX: SBP) Phase I clinical trial to test the safety and tolerability of its glycoalkaloid-based anti-cancer drug SBP002 in patients with advanced mesothelioma and melanoma have been unexpectedly good, with a number of the patients requesting to continue on the drug after the trial ended.

"We were expecting about one in 30 of the patients to have some sort of response, but two of the first five patients had a reduction in tumour size and opted to continue treatment," said CEO Steven Carter. He noted that without the treatment, most of those patients would probably be dead due to the advanced state of their cancers.

"The doctors and trial investigators are very excited by the results. As it's a straight out safety and tolerability study with no efficacy component, we didn't expect to see efficacy, particularly at the lower doses."

The Phase I trial, which as of today has 15 patients enrolled, is expected to wind up in December, with results due early next year. Carter said plans for a Phase II trial are already underway based on the results to date, and the next trial is likely to commence in March or April next year.

"The Phase I trial has essentially reached its endpoints," he said.

The company plans to license the compound out to a pharmaceutical company once Phase II data is in hand, and has been engaged in preliminary discussions with a number of companies.

"Once we have the Phase II data we'll ramp up those discussions," Carter said.

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