VivaGel® BV phase 3 trials for prevention of BV completed

Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced completion of its international, multicentre, phase 3 clinical studies evaluating VivaGel® BV for the prevention of recurrent bacterial vaginosis (rBV). Starpharma expects topline results of the trials to be available in the second quarter of 2017.

Interim Report and Half-Yearly Financial Results

Starpharma released its interim report and financial results for the half-year ended 31 December 2016.

 

Financial Summary

  • Reported loss of $9.0M (Dec 2015: $10.0M)
  • R&D tax incentives of $1.7M reported in the half-year (Dec 2015: $1.8M)
  • Cash position at 31 December 2016 of $36.3M (June 2016: $46.0M)
  • Receipt of $3.5M R&D tax incentive refund from FY16

Appendix 4C - Quarterly Cashflow Report

Starpharma released its Appendix 4C – Quarterly Cashflow report for the period ended 31 December 2016.

Shareholder Update January 2017

In this issue:

›› Enrolment completed for phase 3 program: VivaGel® BV for prevention of recurrence

›› VivaGel® BV granted QIDP and Fast Track designation by US FDA

›› Favourable revision to FDA guidance for BV Treatment

›› VivaGel® condom approved in Canada; licensed in China and Iran

›› New DEP® partnered programs with AstraZeneca and world leading antibody-drug conjugate companies

›› DEP® docetaxel phase 1 program in final expansion phase; preparations underway for phase 2

›› DEP® cabazitaxel shows no neutropenia

›› DEP® irinotecan internal program shows superior performance

Download: Shareholder January 2017 (pdf file, 751kb)


Starpharma VivaGel® BV gets FDA fast track

The Australian reports that Bell Potter sees further upside for Starpharma, setting its share price target at $1.05, given the company had been granted Qualified Infectious Disease Product (QIDP) and fast track designation for VivaGel® BV by the US Food and Drug Administration.

 Go to the article (external link)

VivaGel® BV granted QIDP and Fast Track designation by US FDA

Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced it has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designation for VivaGel® BV by the US Food and Drug Administration (FDA).

Starpharma receives $3.5M R&D tax incentive refund

Starpharma Holdings Ltd today announced it has received the anticipated $3.5M of R&D tax incentive refund related to FY16 expenditures. 

AGM Chairman’s address and CEO presentation

Chairman’s address and the CEO’s presentation to the 2016 Annual General Meeting of Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY).

Starpharma signs license for VivaGel® Condom in Iran

Starpharma Holdings Ltd today announced the signing of a License and Supply Agreement with Koushan Pharmed for the sales and marketing rights to the VivaGel® condom in Iran.

Starpharma to present at Bio-Europe conference

Starpharma will be presenting at the Bio-Europe® conference held in Cologne, Germany this week. At the conference Starpharma will also be conducting licensing discussions for DEP™ and VivaGel® with pharmaceutical companies.

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