DEP Docetaxel Trial Dose Exceeds Common Taxotere Dose Level
Released
Released
Announcement PDF
DEP™ Docetaxel Trial Dose Exceeds Common Taxotere®
Dose Level
Melbourne, Australia; 30 April 2015: Starpharma Holdings Ltd (ASX: SPL, OTCQX:
SPHRY) today released an update to the progress of its phase 1 clinical trial of DEP™
docetaxel for advanced solid cancers. The DEP™ docetaxel dose level now exceeds the
most commonly used dose for Taxotere® of 75mg/m2, with no dose limiting toxicities
(DLT), including neutropenia, having been observed to date.
Approximately 50% of the anticipated number of patients have been recruited into the
study and dosed with DEP™ docetaxel. Several patients have received multiple (up to 6)
cycles of DEP™ docetaxel.
Available data show that DEP™ docetaxel has been very well-tolerated, with no
observations of neutropenia to date. According to the available product information for
Taxotere® (currently marketed docetaxel formulation), neutropenia occurs in virtually all
patients given 60mg/m2 to 100mg/m2 of Taxotere®, and the most severe (grade 4)
neutropenia occurs in 75% of patients given 60mg/m 2 of the product. The clinical data
for DEP™ docetaxel are in line with preclinical studies in animals that showed that
DEP™ docetaxel eliminated the neutropenia seen with equivalent doses of docetaxel
alone whilst enhancing anticancer efficacy.
There have also been no reports in the trial of vomiting or hair loss related to the DEP™
docetaxel treatment. By comparison these events occur in a significant proportion of
patients receiving Taxotere® as monotherapy.
In contrast to therapy with Taxotere®, which is formulated in polysorbate-80, a detergent
that can cause significant hypersensitivity reactions, patients receiving DEP™ docetaxel
therapy do not need to receive pre-treatment with corticosteroids (cortisone) because
DEP™ docetaxel is detergent free. Additionally, patients receiving DEP™ docetaxel
therapy have not required prophylactic treatment with anti-emetics (to stop
nausea/vomiting).
Available pharmacokinetic data show, as previously reported, that DEP™ docetaxel also
has the benefits of longer half-life and reduced peak concentrations of docetaxel
compared to when the drug is given in its native form.
Starpharma CEO, Dr Jackie Fairley, commented: “We are very pleased that the study is
progressing so well. The fact that a number of patients have exhibited potential anticancer activity, across a range of tumor types, despite the absence of dose limiting
toxicities (DLTs) and the maximum tolerated dose (MTD) for DEP™ docetaxel not yet
being reached, is very encouraging.”
Taxotere® is approved for treatment of breast cancer, non-small cell lung cancer,
prostate cancer, gastric cancer and head and neck cancer. Patients with a range of
advanced solid tumour types are enrolled in the current study. The study is being
conducted across four Australian sites – Nucleus Network/Alfred Hospital, Austin
Health/Olivia Newton John Cancer Centre, Liverpool Hospital and Royal Brisbane &
Women’s Hospital.
In recent weeks there has been significant recent media focus on Starpharma and its
DEP™ platform technology, including a report on Starpharma’s DEP™ docetaxel clinical
trial on National Nine News, which is available here.
Starpharma uses its DEP™ technology to improve the performance of pharmaceuticals.
Both pre-clinical and early clinical data have shown DEP™ versions of drugs to be
superior in a variety of ways to the unmodified drugs. DEP™ docetaxel is wholly owned
by Starpharma. The company also has a number of important partnered DEP™
programs underway where Starpharma’s DEP™ technology is being applied to partners’
drugs to improve their performance and formulation characteristics.
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY), located in Melbourne Australia, is an ASX 300 company and is a
world leader in the development of dendrimer products for pharmaceutical, life science and other applications.
Starpharma’s underlying technology is built around dendrimers – a type of synthetic nanoscale polymer that is highly regular
in size and structure and well suited to pharmaceutical and medical uses. Starpharma has three core development
programs: VivaGel® portfolio, DEP™ drug delivery, and agrochemicals with the Company developing a number of products
internally and others via commercial partnerships.
Starpharma’s lead products are based on VivaGel® (SPL7013, astodrimer sodium), a proprietary dendrimer which is a
potent microbicidal agent. VivaGel® formulated as a water based gel and delivered vaginally is under clinical development
for the management and prevention of bacterial vaginosis (BV). Starpharma has also signed separate licence agreements
with Ansell Limited (ASX:ANN) and Okamoto Industries. Inc., (TSE: JP3192800005) to market a value-added, VivaGel®
condom. The VivaGel® condom is available for purchase in Australia under Ansell’s Lifestyles® Dual ProtectTM brand. Ansell
manufactures and sells leading condom brands worldwide, including LifeStyles®, ZERO® and SKYN®. Okamoto is the
market leader for condoms sold in Japan, which is the world’s second largest condom market.
In the wider pharmaceutical and life science fields, Starpharma has both partnered and internal programs in Drug Delivery.
Drug Delivery partners include GSK, Lilly and AstraZeneca. A number of dendrimer-enhanced, or DEP™ versions of
existing drugs are under development. The most advanced of these is DEP™docetaxel, a dendrimer-enhanced version of
docetaxel (Taxotere®), which is in clinical development. In preclinical studies DEP™ docetaxel has shown significant
tumour-targeting and superior anti-cancer effects across a range of important cancer types including breast, prostate, lung
and ovarian tumour, when compared to Taxotere® (docetaxel).
In agrochemicals Starpharma has a series of partnerships with leading industry players including global leader Adama
(formerly Makhteshim Agan) as well as internal programs including an enhanced version of glyphosate (the active ingredient
in Roundup®).
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Media:
Buchan Consulting
Rebecca Wilson
Mob: +61 417 382 391
rwilson@buchanwe.com.au
Starpharma:
Dr Jackie Fairley, Chief Executive Officer
Nigel Baade, CFO and Company Secretary
+61 3 8532 2704
investor.relations@starpharma.com
www.starpharma.com
Gabriella Hold
+61 3 9866 4722
ghold@buchanwe.com.au
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”,
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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.
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