Commencement of phase 1 trial for AZD0466 utilising DEP®
Dec 30th, 2019
Starpharma today announced that AstraZeneca (LSE/STO/NYSE: AZN) has commenced a phase 1 clinical trial of AZD0466 (DEP® Bcl2/xL conjugate) and the first patient has been successfully dosed. The trial will recruit patients with a range of cancers and will be conducted at 4-5 US sites.
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Starpharma receives $4.9M R&D tax incentive refund
Dec 16th, 2019
Starpharma today announced that it has received a $4.9M R&D tax incentive refund which relates to the costs of research and development during the 2019 Financial Year. The refund is in respect of eligible R&D activities across Starpharma’s portfolio, including DEP® and VivaGel®.
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DEP® cabazitaxel progresses to phase 2 on positive results
Dec 10th, 2019
Starpharma today announced successful completion of the phase 1 component of its phase 1 / 2 trial for DEP® cabazitaxel. The trial met its objective of evaluating safety, tolerability and preliminary efficacy data, and identifying a recommended phase 2 dose of 20 mg/m2. The trial will now transition seamlessly into phase 2, with two new sites initiated and recruitment activities already underway.
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AGM Chairman’s address and CEO’s presentation
Nov 21st, 2019
Melbourne, Australia: Attached is the Chairman’s address together with the CEO’s presentation to the Annual General Meeting of Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY), to be held at 4.00pm today.
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VivaGel® condom receives regulatory approval in Europe
Nov 20th, 2019
Starpharma today announced that it has been granted marketing approval for the VivaGel® condom in Europe.
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2019 AGM details
Nov 19th, 2019
Starpharma today notifies that its 2019 AGM will be held at 4pm on 21 November 2019 at RACV City Club, Level 2, 501 Bourke Street, Melbourne, Victoria.
The AGM will be recorded and available via webcast later that day. To access the webcast, participants can register via the following link:
https://webcasting.boardroom.media/broadcast/5dccc1f06242591605116cb6
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UK launch of VivaGel® BV
Nov 13th, 2019
Starpharma today announced that VivaGel® BV has been launched in the UK under the brand Betafem® BV Gel. This launch follows the first European launches in June 2019, including in Germany and other countries.
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DEP® gemcitabine outperforms Gemzar® in human pancreatic cancer model
Oct 31st, 2019
Starpharma today announced results for its next internal development candidate, DEP® gemcitabine.
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Quarterly Cashflow Report
Oct 30th, 2019
Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2019.
Starpharma’s cash balance as at 30 September 2019 was $36.8 million, with net operating cash outflows for the quarter of $4.6 million. The cash balance does not include the anticipated $4.9 million R&D tax incentive which is expected to be received during the December quarter.
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Starpharma to present at US Drug Delivery Conference
Oct 8th, 2019
Starpharma today announced that it has been invited once more to present at the 9th Annual Partnership Opportunities in Drug Delivery (PODD) conference in Boston, USA, on 7-8 October.
The PODD conference showcases the latest advances in drug delivery and provides networking opportunities with senior scientific and commercial executives from many of the major international pharmaceutical companies. This year’s PODD conference will be chaired by AstraZeneca’s Head of Drug Delivery, Dr Shawn Davis.
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FDA Authorisation of First-in-Human Clinical Trial with AstraZeneca’s DEP® product AZD0466
Sep 26th, 2019
Starpharma today announced that that the U.S. Food and Drug Administration (FDA) has authorised the use of AstraZeneca’s DEP® Bcl2/xL conjugate AZD0466 in clinical trials under an investigational new drug (IND) application. This is the first DEP® candidate to reach this milestone from Starpharma’s multiproduct license with AstraZeneca.
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DEP® irinotecan synergistic with Lynparza® in refractory human colon cancer model
Sep 12th, 2019
Starpharma today announced that its patented clinical stage nanoparticle formulation, DEP® irinotecan, showed significantly enhanced efficacy benefits over standard irinotecan (Camptosar®) and olaparib (Lynparza®) alone and in combination, in an irinotecan-refractory HT-29 human colon cancer xenograft model.
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Starpharma’s VivaGel® BV regulatory approvals continue in Asia
Sep 3rd, 2019
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Finance News Network reported Starpharma received further regulatory approval in another Asian country for its breakthrough product for bacterial vaginosis, VivaGel® BV. The news follows the first approval in the region announced on 15 August. |
Read the full news coverage here.
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VivaGel® BV regulatory approvals continue in Asia
Sep 3rd, 2019
Starpharma today announced that it has received a further regulatory approval in an Asian country for VivaGel® BV. This approval follows multiple country approvals in the region as previously announced on 15 August 2019. Mundipharma will be rolling-out the product in Asia under the brand name BETADINETM BV Gel.
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Update on Starpharma’s latest positive interim DEP® trial results, VivaGel® and upcoming milestones
Aug 30th, 2019
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Online news outlet Boardroom Media interviewed Starpharma CEO Dr Jackie Fairley following the release of its annual report and full-year results. In the interview, Dr Fairley shared the company’s latest DEP® trial results, as well as VivaGel® and upcoming milestones. |
To listen to the full interview, click here.
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Starpharma sees positive results in ovarian cancer treatment
Aug 29th, 2019
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Online investor news outlet Finance News Network reported Starpharma’s positive results for its novel HER-2 targeted DEP® conjugate (ADC) which outperformed the leading HER-2 ADC, Kadcyla®, in a human ovarian cancer model. |
To watch the full news video, click here.
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Positive results with Targeted DEP® using antibody fragment in human ovarian cancer model
Aug 29th, 2019
Starpharma today announced that treatment with a novel HER-2 Targeted DEP® conjugate from its internal Targeted DEP® program resulted in tumour regression and 100% survival in a preclinical human ovarian cancer model.
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Promising efficacy signals for Starpharma’s DEP® trials
Aug 28th, 2019
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Biotech trade publication noted Starpharma announced promising efficacy signals in its ongoing clinical trials for both DEP® cabazitaxel and DEP® docetaxel. |
To read the full article, click here.
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Annual report and full year financial results
Aug 28th, 2019
Starpharma today released its annual report and financial results for the year ended 30 June 2019.
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Promising efficacy signals observed in ongoing DEP® trials, including DEP® cabazitaxel escalation phase
Aug 28th, 2019
Starpharma today announced that promising efficacy signals have been observed in its ongoing clinical trials for both DEP® cabazitaxel and DEP® docetaxel.
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First Asian Regulatory Approvals Received for VivaGel® BV
Aug 15th, 2019
Starpharma today announced that it has received the first regulatory approvals in South East Asia for VivaGel® BV. Mundipharma will be rolling-out the product in Asia under the brand name BETADINETM BV Gel.
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Starpharma commences phase 1/2 DEP® irinotecan trial
Aug 8th, 2019
Starpharma today announced that it has received the necessary regulatory and ethics approvals and will commence its phase 1/2 clinical trial for DEP® irinotecan. The objectives of the trial are to evaluate the safety, tolerability and pharmacokinetics of DEP® irinotecan to define a recommended phase 2 dose (RP2D), and to determine anti-tumour efficacy of the product in select tumour types. DEP® irinotecan is the third DEP® product to enter the clinic from Starpharma’s internal portfolio with a fourth, partnered DEP® candidate, AZD0466, also set to enter the clinic later this year.
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Starpharma CEO speaks with Alan Kohler on The Constant Investor
Jul 31st, 2019
Starpharma CEO Dr Jackie Fairley speaks with Alan Kohler for online investor publication The Constant Investor, where she discussed the launch of VivaGel BV in Australia and Europe as well as the company’s latest developments in its DEP® portfolio. To listen to the full interview, click here.
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Quarterly Cashflow Report
Jul 16th, 2019
Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 June 2019.
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Shareholder Update July 2019
Jul 1st, 2019
In this issue:
>> VivaGel® BV launched in Europe & Australia; US regulatory progress
>> VivaGel condom launched in Japan by Okamoto
>> DEP® docetaxel & DEP® cabazitaxel clinical trial update; DEP® irinotecan trial start & new data
>> Starpharma signs second commercial oncology agreement with AstraZeneca
>> AstraZeneca highlights AZD0466 at 2019 ASCO meeting & upcoming US FDA IND
>> Patent published for AstraZeneca Bcl2/xL DEP conjugates
>> DEP® radiotherapeutics
>> Outlook, recent news & events
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VivaGel® BV launched in Europe
Jun 27th, 2019
Starpharma today announced that VivaGel® BV has been launched in Europe under the brand name Betadine BVTM. The product has been launched in several countries in Europe, including Germany, with further roll-out in additional European countries during the year.
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Starpharma presents at Macquarie Emerging Leaders Forum
Jun 20th, 2019
Starpharma has been invited to present at the Macquarie Emerging Leaders Corporate Forum in Melbourne. The Macquarie Emerging Leaders Corporate Forum provides Starpharma with an opportunity to present to more than 100 investors from Melbourne and Sydney.
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US patent granted for DEP Bcl2/xL inhibitor conjugates
Jun 12th, 2019
Starpharma announced the first patent for DEP® Bcl2/xL inhibitor conjugates, developed in collaboration with AstraZeneca, has been granted by the US Patent and Trademark Office. These patented DEP® Bcl2/xL inhibitor conjugates combine Starpharma’s innovative DEP® delivery technology with AstraZeneca’s novel Bcl2/xL inhibitors, which are being investigated for treating various cancers, including leukemias.
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AstraZeneca inks new deal with Starpharma
Jun 4th, 2019
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Biotech trade publication noted Starpharma signed a new development and option agreement with AstraZeneca to progress the development of a DEP® version of one of AstraZeneca's existing oncology medicines. The news builds on a previous deal between the companies related to a multiproduct licence covering novel oncology drug candidates. |
Read the article here.
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Okamoto launches VivaGel® condom in Japan
Jun 4th, 2019
Starpharma today announced that the VivaGel® condom has been launched in Japan under Okamoto’s leading and highly successful Zero Zero Three (003) brand. This is the first condom with antiviral coating in Japan and will also carry Starpharma’s VivaGel® brand.
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Starpharma signs second oncology agreement with AstraZeneca
Jun 3rd, 2019
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Online investor news outlet Finance News Network reported on Starpharma’s second oncology agreement with global pharmaceutical giant AstraZeneca, noting that this is for the development of a DEP® version of an undisclosed and existing market oncology drug. |
Read the full article here (requires sign in).
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Starpharma signs second oncology agreement with AstraZeneca
Jun 3rd, 2019
Starpharma today announced a Development and Option Agreement with AstraZeneca (LON: AZN) to progress the development of a Dendrimer Enhanced Product (DEP®) version of an undisclosed AstraZeneca major marketed oncology medicine. This is the second DEP® commercial agreement Starpharma has signed with AstraZeneca, the first agreement being a multiproduct licence which covers novel oncology drug candidates such as AZD0466 (a Bcl2/xL inhibitor).
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Starpharma presents at UBS Healthcare Conference
May 29th, 2019
Starpharma has been invited to present today at the UBS Australian Emerging Companies Conference - Healthcare and Biotech – in Sydney. The UBS Healthcare Conference provides Starpharma with an opportunity to present to approximately 100 institutional investors.
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DEP® irinotecan combination outperforms in refractory human colon cancer model
May 24th, 2019
Starpharma today announced that its patented nanoparticle formulation, DEP® irinotecan, showed significant efficacy and safety benefits over leading colorectal cancer drugs irinotecan (Camptosar®) and cetuximab (Erbitux®), in the irinotecan-refractory HT-29 human colon cancer model.
These impressive results were despite the fact that these standard colorectal cancer (CRC) treatments, Camptosar® and/or Erbitux®, showed limited activity in this preclinical model.
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Regulatory progress for VivaGel BV in the US
May 23rd, 2019
Starpharma has received formal feedback from the recent meeting held with the US FDA in relation to the approval for two related bacterial vaginosis (BV) indications - BV treatment and the prevention of recurrent BV in the United States.
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Starpharma to present at US Drug Delivery Conference
May 7th, 2019
Starpharma today announced that it will be presenting its DEP® platform at the 2nd Annual Drug Delivery West conference in San Francisco on 6-7 May 2019 (US time).
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Starpharma presents at Macquarie Australia Conference
May 1st, 2019
Melbourne, Australia; 1 May 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) has been invited to present today at the Macquarie Australia Conference in Sydney. The Macquarie Australia Conference is a leading investment event in Australia and attracts more than 800 investors from around the world, including Asia, Europe and North America.
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Quarterly Cashflow Report
Apr 29th, 2019
Starpharma today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 March 2019.
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Starpharma on Channel Nine News (April 22, 2019)
Apr 22nd, 2019
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Channel Nine News reported on the launch of VivaGel® BV (Fleurstat BVgel) in Australia and noted it was a world first, novel and non-antibiotic treatment developed in Australia. The report noted BV affects 12 percent of Australian women and if left untreated could lead to infertility, early delivery or miscarriage. |
Read the TV news segment here.
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Markets Live: Starpharma shares rise 13 per cent following Australian launch of VivaGel BV
Apr 16th, 2019
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The Australian Financial Review reported Starpharma’s share price rose 13 per cent following the company’s announcement that VivaGel® BV was launched nationwide in Australia. The article noted this was the first of many launches for the breakthrough BV product. |
Read the full coverage here (paywall)
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First VivaGel BV launch globally in Australia by Aspen
Apr 16th, 2019
Starpharma today announced that VivaGel® BV has been officially launched in Australia by Aspen Pharmacare (Aspen) as Fleurstat BVgel. The product has undergone distribution across Australia and is already available in some pharmacies. It will be progressively rolled-out nationally over the coming weeks. This is the first launch of VivaGel® BV in the world and further launches by Mundipharma are expected in Europe in May/June this year.
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Starpharma meets with US FDA to discuss VivaGel® BV
Apr 11th, 2019
Starpharma today announced that a meeting was held with the US FDA overnight as part of the process to clarify and address FDA’s request for confirmatory data prior to the approval of VivaGel® BV in the US. This meeting was attended by senior representatives of Starpharma as well as internationally recognised Key Opinion Leaders in BV, statisticians and the Company’s expert FDA regulatory consultants, which include former senior FDA clinical personnel.
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Starpharma Investor Presentation to Goldman Sachs Conference
Apr 3rd, 2019
Starpharma will today present to institutional investors at the Goldman Sachs Tenth Annual Emerging Companies Conference in Sydney.
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Shareholder Update March 2019
Mar 18th, 2019
In this issue:
>> Fleurstat BVgel - Australian launch
>> Mundipharma's European launch of VivaGel® BV
>> Mundipharma's international roll-out of VivaGel® BV
>> FDA meeting to discuss VivaGel® BV approval in the US
Download: Shareholder Update March 2019 (pdf file, 453kb)
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Starpharma receives $4.0M R&D tax incentive refund
Mar 12th, 2019
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that it has received a $4.0M R&D tax incentive refund which relates to the costs of research and development during the 2018 Financial Year. The refund is in respect of eligible R&D activities across Starpharma’s portfolio, including VivaGel® and DEP® programs. This amount was not included in Starpharma’s cash balance reported in the Company’s Interim Report for the half-year ended 31 December 2018.
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Starpharma Interim Report and Half-Year Financial Results
Feb 27th, 2019
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its interim report and financial results for the half-year ended 31 December 2018.
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Quarterly Cashflow Report
Jan 30th, 2019
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 31 December 2018
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Shareholder Update January 2019
Jan 17th, 2019
In this issue:
>> FDA requests further data for VivaGel® BV approval in the US
>> Launch of VivaGel® BV in multiple territories
>> VivaGel® BV licensed to ITF Pharma in the US
>> VivaGel® condom approved in Japan
>> Clinical trials for internal DEP® products progressing well
>> Patent published for AstraZeneca-DEP® drugs: DEP® Bcl2/xL inhibitors show compelling efficacy & synergy in combination
>> DEP® docetaxel & DEP® cabazitaxel outperformed both gemcitabine & Abraxane®
>> SPL7013 eye drops for viral conjunctivitis
>> Partnering activities
>> Macquarie initiates coverage of Starpharma
>> Outlook
Download: Shareholder Update January 2019 (pdf file, 557kb)
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VivaGel® condom receives final regulatory approval in Japan
Jan 2nd, 2019
Melbourne, Australia; 2 January 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the VivaGel® condom has received final regulatory approval and is now able to be marketed in Japan, following the completion of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) review of the product’s medical device classification and associated data. This final approval follows on from the previously granted regulatory certification, which was attained for the VivaGel® condom.
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US FDA requests further data for VivaGel® BV approval
Dec 27th, 2018
Melbourne, Australia: Starpharma today received advice from the US FDA that it will require confirmatory clinical data prior to approving VivaGel® BV for treatment of bacterial vaginosis (BV) and the prevention of recurrent BV (rBV).
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