Melbourne, Australia: Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow report for the period ended 30 June 2014.

The cash balance at 30 June 2014 was $24.0 million, after a net cash burn of $9.8 million for the full year.

Expenditures for the quarter include costs related to the clinical activities of both the DEP^TM docetaxel Phase 1 trial and the Phase 3 clinical trials for VivaGel^® to prevent recurrent bacterial vaginosis (BV).  

The DEP^TM docetaxel Phase 1 trial is progressing well with recruitment underway at three sites in Australia. A number of patients having already received multiple cycles of DEP™ docetaxel treatment and results so far indicate very good tolerability and no evidence of neutropenia.

Earlier this month, the US Food and Drug Administration (FDA) granted Starpharma a Special Protocol Assessment (SPA) agreement on the design and planned analyses of the Phase 3 clinical studies of VivaGel^® for the prevention of recurrent BV. During the year ended June 30 extensive trial start-up activities were completed by Starpharma and its appointed research organisation, Quintiles, to expedite trial commencement. These include site selection, regulatory and ethics submissions and ethic approvals at multiple sites, investigators’ meetings and preparation of trial materials.

The major regulatory milestone of Conformity Assessment Certification for the VivaGel^® condom by the Australian Therapeutic Goods Administration (TGA) was achieved subsequent to the end of the quarter, with product launch in Australia expected in the coming months, following listing on the Australian Register of Therapeutic Goods (ARTG).  

Download ASX Announcement: Appendix 4C - Quarterly Cashflow Report (pdf file, 151kb)