Starpharma (ASX: SPL, OTCQX: SPHRY) today announces that it has completed the formal dispute resolution process with the US Food and Drug Administration (FDA) in relation to VivaGel^® BV. The FDA has maintained its position that they require additional clinical efficacy data to be generated for the regulatory approval of VivaGel^® BV for bacterial vaginosis (BV) in the US. The formal dispute resolution process involved multiple submissions, meetings, detailed analyses, and the preparation of regulatory precedents relating to recent product approvals. Starpharma was supported through this process by highly experienced regulatory advisers, key opinion leaders, and biostatistical and legal advisers, including several who were ex-FDA.

Starpharma (ASX: SPL, OTCQX: SPHRY) today releases its Quarterly Activities Report and Appendix 4C for the period ended 31 December 2023 (Q2 FY24). Starpharma’s closing cash balance as at 31 December 2023 was $32.1 million.

Starpharma (ASX: SPL, OTCQX: SPHRY) today announces the results of the post-market clinical study of Viraleze™ nasal spray in participants with COVID-19, demonstrating that Viraleze™ reduced SARS-CoV-2 viral load in the nose, increased the rate of virus clearance from the nose, improved key symptoms of COVID-19, including loss of smell (anosmia), and was well-tolerated.

 

Starpharma (ASX: SPL, OTCQX: SPHRY) today announces it has signed a sales and distribution agreement for its VivaGel® BV product with ITROM Pharmaceutical Group, covering 13 countries across the Middle East and North Africa (MENA) region. In this region, the prevalence of bacterial vaginosis among a female population of 238 million is 25%, indicating a high need for new effective therapeutic approaches and a significant opportunity for VivaGel® BV

Starpharma (ASX: SPL, OTCQX: SPHRY) today announces the presentation of the positive results from its Phase 2 clinical trial of DEP® cabazitaxel at the American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium[1], which is being held from 18 to 20 January 2024 in San Francisco, US. ASCO is the world's leading professional organisation for physicians and oncology professionals. The ASCO GI Cancers Symposium is the only global meeting of its kind focusing on the latest innovative science and clinical developments in GI cancer treatment, research, and care. It brings together oncology thought leaders, practising clinicians, novel drug developers, and GI specialists from around the world.

Starpharma today announces positive final results from the completed Phase 2 clinical program of DEP^® docetaxel. The clinical program included a monotherapy arm and two combination arms. The Phase 2 trial objectives were met, with endpoints demonstrating encouraging anti-tumour activity of DEP^® docetaxel when administered as a monotherapy or in combination with other anti-cancer agents, nintedanib or gemcitabine, in multiple advanced, metastatic cancers, including pancreatic, gastro-oesophageal, non-small cell lung cancer (NSCLC) and cholangiocarcinoma. 

Starpharma (ASX: SPL, OTCQX: SPHRY) today announces it is presenting at the Targeted Radiopharmaceuticals Summit Europe, having been invited to present at the specialist radiotheranostics conference being held in Berlin, Germany, from 5 to 7 December 2023.

Starpharma refers to its Notice of Annual General Meeting dated 27 October 2023 (Notice).

Starpharma is today pleased to announce the appointment of Ms Cheryl Maley as Chief Executive Officer (CEO) and Managing Director of Starpharma effective 8 January 2024.