On April 30, 2015 Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) reported its Appendix 4C – Quarterly Cashflow report for the period ended 31 March 2015 (Press release, Starpharma, APR 30, 2015, View Source [SID:1234506577]).
Highlights
DEPTM docetaxel dosage levels exceeds the most commonly used Taxotere dose
Majority of sites in phase 3 clinical trials for VivaGel to prevent recurrent bacterial vaginosis (R-BV) recruiting participants
Regulatory submissions for VivaGel Symptomatic Relief of bacterial vaginosis
Continued Australian rollout of VivaGel condom
Increased activity in partnered drug delivery and agrochemical programs
Solid cash balance of A$34.7 million
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During the quarter, activities have progressed across all of Starpharma’s programs for VivaGel, drug delivery and agrochemicals. These include the two active clinical programs – the two phase 3 clinical trials for VivaGel to prevent recurrent bacterial vaginosis (R-BV) and the phase 1 clinical trial of DEP docetaxel. The reported cash balance at 31 March 2015 of A$34.7 million supports these activities.
In drug delivery, the phase 1 clinical trial of DEP docetaxel continues to show very encouraging clinical data, with the drug remaining very well-tolerated and no neutropenia or hair loss observed to date with a number of patients having received multiple (up to 6) cycles of DEP docetaxel. Approximately 50% of the anticipated number of patients have now been recruited across four Australian sites with dose levels now above the most commonly used dose for Taxotere, a dose at which a vast majority of patients typically experience neutropenia and hair loss. A number of patients being treated with DEP docetaxel have exhibited potential anti-cancer activity, across a range of tumor types. This has been achieved despite the absence of dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) for DEP docetaxel not yet being reached.
In the two phase 3 clinical trials for VivaGel to prevent recurrent bacterial vaginosis (R-BV), the majority of sites are now recruiting across the US, Canada, Europe, Asia and Mexico. Each trial is anticipated to enrol approximately 600 women. The phase 3 study design was agreed with the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA), which reduces Starpharma’s regulatory risk through achieving a binding agreement from FDA on the acceptability of the trial design and planned analyses. Starpharma has also received agreement on the trial design from the European regulatory authority.
The VivaGel condom, marketed by Ansell as LifeStyles Dual ProtectTM, represents the first marketed product for Starpharma’s VivaGel portfolio. The condom is currently available in Woolworths stores and online directly from Ansell, with new retail channels including pharmacies and other supermarket chains expected to be added in the near future. In addition, the VivaGel condom is expected to be launched in New Zealand following regulatory approval in late 2014, and regulatory activities continue in a number of other markets including Japan.
Another focus during the quarter was the preparation and filing of a marketing application with relevant regulatory authorities for VivaGel vaginal gel for the symptomatic relief of bacterial vaginosis (BV). This opportunity for certain non-US markets utilises existing data for VivaGel, including from previously completed clinical trials which showed excellent and rapid relief from BV symptoms.
The quarter has also seen momentum and escalation in the level of activity in Starpharma’s partnered programs for drug delivery and agrochemicals as candidates are advanced in development.
As these clinical and commercial opportunities in VivaGel and drug delivery advance towards important inflection points, the solid cash balance positions Starpharma well for creating significant additional value. The above activities are further supported by Starpharma’s strategy in agrochemicals, which provides broader application of Starpharma’s dendrimer technology.
Operating and investing cash outflows were A$4.9 million for the quarter. This expenditure relates to all Starpharma programs, including the two phase 3 clinical trials for VivaGel R-BV, the phase 1 clinical trial of DEP docetaxel, and regulatory activities.
"This quarter has been another period of substantial progress for Starpharma. With two exciting clinical programs underway, a high level of activity with our partnered drug delivery programs, the VivaGel condom in market and other applications underway, and a strong cash position the company is very well placed to capitalise on," said Starpharma Chief Executive Officer Dr Jackie Fairley.