Clinical trials update: Psivida; Solbec

Psivida (ASX: PSD) has reported that the second patient cohort from its Phase IIa trial of BrachySil in inoperable primary liver cancer patients shows the product is safe and effective in prompting tumour regression.

The four patients showed an average of 80 per cent tumour regression by volume 12 weeks after treatment with BrachySil, and no product-related adverse events were reported. The first cohort of patients showed average regression of 60 per cent. Both cohorts received the same dose of radioactive 32P-BioSilicon.

The patients will be followed for a total of six months post treatment, and the company expects that the full Phase IIa results will be released in approximately three months. A Phase IIb dose profiling study is expected to take place later this year, and the company hopes to also commence a multi-centre pivotal trial for the product this year, which will support registration of BrachySil as an approved treatment for primary liver cancer. The company plans to follow a device-based regulatory pathway for the product.

Solbec Pharmaceuticals (ASX: SBP) has completed the second stage of its Phase I trial of its anti-cancer drug Coramsine for treatment of advanced solid tumours.

The trial is intended to assess safety, tolerability and pharmacokinetics of the drug as well as to provide information on the maximum tolerated dose and efficacy. In the second stage of the trial the drug was administered by infusion over a four hour period rather than the two hour period used initially. Dose-limiting toxicity was identified by a transient rise in liver enzymes.

Preliminary results show that the drug is safe and tolerated at a level 50 per cent greater when delivered over a four hour period instead of a two hour period. Three out of the 19 patients in the study to date have shown reductions in tumour size.

Evaluation of the patients in the trial is continuing.