Clinical Trial Update
Released
Released
Announcement PDF
Clinical trial update
Melbourne, Australia; 27 June 2023: A voluntary partial clinical hold has been implemented
on a trial in which Starpharma (ASX: SPL, OTCQX: SPHRY) technology is used: AZD0466
Monotherapy or in Combination in Patients with Advanced Haematological Malignancies
(NCT04865419). This Phase 1/2 study is in the dose escalation phase.
The asymptomatic reported events leading to the voluntary partial hold were assessed as not
related to Starpharma’s DEP® dendrimer. The voluntary partial clinical hold does not impact
Starpharma’s platform technology, or other clinical DEP® programs or partnerships.
The other clinical study of AZD0466 in patients with non-Hodgkin’s lymphoma (NCT05205161)
is not impacted and continues to enroll patients.
Starpharma will provide further details to the market when additional relevant information
becomes available. AstraZeneca (LSE/STO/Nasdaq: AZN) is the study sponsor.
About Starpharma
Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY) is a biopharmaceutical company focussed on the development of
pharmaceutical and medical products for unmet patient needs, including in the areas of oncology and infectious diseases.
Starpharma’s innovative technology is based on proprietary polymers called dendrimers, which are precise, synthetically
manufactured, nanoscale molecules. The unique properties of dendrimers – including their size, structure, high degree of
branching, polyvalency, and water solubility – are advantageous in medical and pharmaceutical applications.
Starpharma uses its dendrimer technology to develop novel therapeutics and to improve the performance of existing
pharmaceuticals. Starpharma’s portfolio includes multiple clinical stage oncology products, which utilise its Dendrimer Enhanced
Product (‘DEP®’) drug delivery technology; and marketed products, including VIRALEZE™ and VivaGel® BV, which utilise
SPL7013, a proprietary dendrimer with antimicrobial properties.
Starpharma’s DEP® drug delivery platform is being used to enhance the effectiveness of existing and novel therapies and to
reduce drug-related toxicities through controlled and specified drug delivery.
In addition to Starpharma’s internal DEP® programs, Starpharma has multiple DEP® partnerships with international
biopharmaceutical companies including AstraZeneca (oncology); MSD (antibody drug conjugates); Chase Sun (anti-infectives);
and other world leading pharmaceutical companies. Due to the broad applicability and optionality of Starpharma’s DEP® platform,
partnered DEP® programs have the potential to generate significant future milestones and royalties.
Starpharma’s topical antiviral nasal spray, VIRALEZE™, is now registered in more than 35 countries*, including in Europe, in the
UK, and in Asia. Starpharma’s novel non-antibiotic vaginal gel, VivaGel® BV, for treatment of bacterial vaginosis (BV) and
prevention of recurrent BV, is registered in more than 50 countries, including in the UK, in Europe, in Southeast Asia, South
Africa, Australia and New Zealand.
* Note: VIRALEZE™ is not approved for use or supply in Australia.
Starpharma.com | Twitter | LinkedIn
Media: Sumit Media
Grant Titmus
Mob: +61 419 388 161
grant@sumitmedia.com.au
Starpharma Holdings Limited
Dr Jackie Fairley, Chief Executive Officer
Justin Cahill, CFO and Company Secretary
+61 3 8532 2704
investor.relations@starpharma.com
4-6 Southampton Crescent
Abbotsford Vic 3067
Disclosure
This ASX Announcement
was authorised for release
by the Chair, Mr Rob
Thomas.
Forward Looking Statements
This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the use of
forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”,
“targeting”, “aiming”, “set to”, “potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”, or
similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of
product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause
actual results to be materially different from any future results, performance or achievements expressed or implied by such statements.
There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other authorities’ requirements regarding
any one or more product candidates nor can there be any assurance that such product candidates will be approved by any authorities for
sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding the approval
and commercialization of the product candidates could be affected by, among other things, unexpected trial results, including additional
analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain
or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public
pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial
results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Starpharma is
providing this information as of the date of this document and does not assume any obligation to update any forward-looking statements
contained in this document as a result of new information, future events or developments or otherwise. Clinical case studies and other
clinical information given in this document are given for illustrative purposes only and are not necessarily a guide to product performance
and no representation or warranty is made by any person as to the likelihood of achievement or reasonableness of future results. Nothing
contained in this document nor any information made available to you is, or shall be relied upon as, a promise, representation, warranty
or guarantee as to the past, present or the future performance of any Starpharma product.
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