Starpharma making progress with clinical trials

Starpharma (ASX:SPL) has enrolled and dosed the first group of patients for a phase I trial of chemotherapy formulation DEP docetaxel in solid tumours.

In a market update, the company said the trial is now at the dose escalation phase and a number of patients have now received multiple cycles of therapy. Dosing for the trial commenced in January.

Results so far suggest that DEP docetaxel is well tolerated, as there has been no evidence of neutropenia.

Starpharma aims to enrol 25-30 patients for the trial. Two more trial sites, Austin Health/Olivia Newton-John Cancer & Wellness Centre and Royal Brisbane & Women’s Hospital, have recently received ethics approval to commence enrolment.

The primary objective is establishing the maximum tolerated dose, and secondary goals are to characterise the safety, pharmacokinetic and tolerability profiles of DEP docetaxel in patients with advanced cancer.

DEP docetaxel is Starpharma’s formulation of popular chemotherapeutic Taxotere, produced using the company’s dendrimer technology.

Starpharma hopes to determine whether its formulation mitigates some of the problematic side-effects of Taxotere, including neutropenia, anaphylaxis and hair loss.

Starpharma also revealed it has commenced final preparations for two phase III trials of VivaGel for the prevention of recurrent bacterial vaginosis (BV).

The company has reached agreements with the US FDA and the European Medicines Agency on the design of the trials and obtained initial ethics committee approvals.

Around 600 women will be recruited to each trial. The primary efficacy endpoint will be recurrence of BV over a 16-week treatment period.

During an earlier phase II trial, more than 80% of 1% VivaGel users remained BV-free at 16 weeks. But a 2012 phase III trial involving using VivaGel to treat BV failed to meet the primary endpoint required for FDA approval. As a result, the company had to shift its focus to the prevention of BV recurrence.

Starpharma (ASX:SPL) shares were trading 0.84% higher at $0.60 as of around 1 pm on Friday.