FDA Grants SPA Agreement for Phase 3 Recurrent BV Trial
Starpharma today announced that the US Food and Drug Administration (FDA) has granted Special Protocol Assessment (SPA) agreement on the design and planned analyses of the phase 3 clinical studies of the VivaGel® bacterial vaginosis (BV) product for the prevention of recurrent BV.
Rob Thomas succeeds retiring Chairman Peter Bartels
Starpharma today confirmed Mr Peter Bartels AO will retire as Chairman as part of a planned succession. As announced in November 2013, Mr Rob Thomas AM will succeed Mr Bartels as Chairman, effective today.
Shareholder Update: June 2014
In this issue:
› VivaGel® BV prevention of recurrence: start of phase 3 trials close
› R&D tax incentive cash received
› DEP™ docetaxel trial progressing well
› VivaGel®-coated condom: preparing for launch
› VivaGel® BV symptomatic relief product: commercial and regulatory progress
› Strong results for dendrimer enhanced agrochemicals
Download: Shareholder Update: June 2014 ( pdf file, 2MB)
Starpharma's clinical trial programs accelerating
Starpharma today provided an update on the progress of its clinical trial programs, which include the Phase 1 DEP™ docetaxel trial and the Phase 3 pivotal trials of VivaGel® for prevention of recurrent bacterial vaginosis (BV).
Highlights:
Phase 1 DEP™ docetaxel trial:
- Ethics approval at 3 sites in Australia
- Enrolling patients; a number having received multiple cycles of therapy
- No evidence of neutropenia
Phase 3 VivaGel® for prevention of recurrent BV:
- Agreement with EMA and FDA on study design
- First ethics approval obtained
- Quintiles CRO engaged
- Nearing commencement
Appendix 4C - Quarterly Cashflow Report
Starpharma today released its Appendix 4C – Quarterly Cashflow report for the period ended 31 March 2014.
The cash balance at 31 March 2014 was $27.8 million. This strong cash position was assisted by the receipt of $4.7 million of R&D tax incentive relating to FY13 expenditures.
The Business on ABC TV: Interview with Starpharma CEO Jackie Fairley
ABC News’ The Business Presenter Ticky Fullerton interviewed Starpharma CEO Dr Jackie Fairley on Thursday 10 April 2014. With the biotechnology sector predicted to offer some of the best growth, Ticky discussed the newly announced expansion of Starpharma’s drug delivery platform, the receipt of $4.7M of R&D tax incentives and its benefits for the Australian biotechnology industry and more Australian-based clinical trials.
Starpharma expands its Drug Delivery Program with AstraZeneca
Starpharma today announced the signing of a second, expanded agreement with AstraZeneca in the field of cancer medicine using Starpharma’s proprietary DEP™ dendrimer drug delivery technology.
The agreement follows on from an evaluation by AstraZeneca which began in September 2012 of Starpharma’s delivery technology. The new agreement will see the application of Starpharma’s technology to a cancer drug, from AstraZeneca’s pipeline.
VivaGel®-coated condom approved for marketing in Japan
Starpharma today announced that regulatory certification has been granted for marketing Starpharma’s VivaGel®-coated condom in Japan, the world’s second largest condom market. VivaGel® is licensed to Okamoto as a condom coating for the Japanese market. Okamoto is the market leader for condoms sold in Japan and has held this position for many years.
Starpharma receives $4.7M R&D tax incentives
Starpharma today announced it has received the anticipated $4.7M of R&D tax incentive relating to FY13 expenditures, following the lodgement of the Company’s annual income tax return.
Starpharma to present to US institutional investors
Starpharma will participate later today in the ASX Spotlight New York event. Starpharma is one of 15 ASX listed companies to be featured at the event, which is held annually to showcase emerging Australian companies before US institutional investors.