|[January 23, 2014]
Starpharma Commences Dendrimer-Docetaxel Clinical Trial
MELBOURNE, Australia --(Business Wire)--
Starpharma (ASX:SPL)(OTCQX:SPHRY) today announced that it has received
the necessary approvals to commence a phase 1 human clinical trial for
its dendrimer-enhanced docetaxel (Taxotere®) chemotherapeutic product,
referred to as DEP™-Docetaxel.
The trial will be conducted exclusively in Australia, at Nucleus
Network's clinical facility at the AMREP/Alfred Hospital initially, with
the plan to add 1 to 2 additional sites in the near future. The study
will enrol approximately thirty patients with solid tumours. The primary
objective of the study is to establish the maximum tolerated dose (MTD)
and dose limiting toxicities (DLT) of DEP™-Docetaxel, a new formulation
of the major chemotherapeutic agent, docetaxel, which is marketed
worldwide under the tradename, Taxotere®. The study will also include a
preliminary assessment of the anti-cancer efficacy of DEP™-Docetaxel.
Earlier preclinical studies of Starpharma's DEP™-Docetaxel demonstrated
the significantly superior anti-cancer effectiveness of the product
compared to Taxotere® across a range of important cancer types including
breast, prostate, lung and ovarian cancer. In addition, DEP™-Docetaxel
exhibited a lack of the severe toxicity, neutropenia, which is the most
important dose-limiting side effect of Taxotere®. Use of Starpharma's
DEP™ technology also improved the water solubility and tissue targeting
of docetaxel. This improvement means that unlike other marketed
formulations of docetaxel, Starpharma's DEP™-Docetaxel is detergent
(Polysorbate 80) free, delivering a number of potential patient
tolerability and safety advantages compared to other formulations.
Starpharma Chief Executive Dr Jackie Fairley said: "The commencement of
this clinical trial of DEP™-Docetaxel represents a key development
milestone for this product and follows very strong preclinical results,
which have included both improved efficacy and the reduction in
important dose limiting side effects."
"The multiple, clinically significant benefits of Starpharma's
DEP™-Docetaxel will place the product in a very compelling competitive
position. In addition, findings from this trial have potential flow-on
benefit for Starpharma's dendrimer platform more broadly, particularly
in oncology," said Dr Fairley.
DEP™-Docetaxel is the first clinical candidate using Starpharma's
dendrimer based DEP™ technology. The features of these products allow
them to access a streamlined development pathway compared to a
completely novel product.
The primary objective of the clinical study is to establish the maximum
tolerated dose (MTD) and dose limiting toxicities (DLT) of
DEP™-Docetaxel given intravenously (IV), once every three weeks. The
secondary objective is to identify the safety, pharmacokinetic and
tolerability profile of DEP™-Docetaxel in patients with advanced cancer.
Key outcomes of the study will be to define a recommended dose for
future studies as well as to explore preliminary anti-tumour efficacy of
Importantly, the study will also allow investigation of the impact of
the improved dendrimer formulation on problematic side effects seen with
Taxotere®, such as neutropenia, which was markedly reduced with the
dendrimer formulation in preclinical studies, anaphylaxis and hair loss.
The study will also employ a variety of imaging techniques and specific
investigations aimed at exploring anti-tumour efficacy. These include CT
scans and bone scans, as well as tumour markers.
Consultant Oncologist, Dr Jason Lickliter, MBBS, PhD, FRACP, Director,
Phase 1 Cancer Trials Program, Southern Health and Monash Institute of
Medical Research, and Medical Director, Nucleus Network, has been
appointed as the study Principal Investigator.
Starpharma's dendrimer-based drug delivery DEP™ technology has been
utilised to reformulate and improve a number of marketed cancer drugs
including docetaxel (Taxotere®), oxaliplatin (Eloxatin®) and
doxorubicin. Preclinical studies of the dendrimer-enhanced versions have
shown these reformulated DEP™ versions of the drugs to be superior to
the commercially available formulation, often in multiple ways including
improved efficacy, reduced toxicity and lower side effects. Starpharma
also has several partnered programs with leading pharma companies,
including in oncology.
Expenditure on this trial will be eligible for the 45% refundable R&D
Docetaxel is a leading chemotherapy drug used to treat a wide range of
solid tumours including breast, lung and prostate. It is marketed by
Sanofi Aventis as Taxotere® and generated sales in excess of US$3
billion in 2010.
For further information, please refer to the Starpharma
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