drugset / Press release

DEP Docetaxel Trial Dose Exceeds Common Taxotere Dose Level

2015-04-29 · Starpharma Pty Ltd · original starpharma.com ↗

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/m2 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 anti- cancer 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.” Page 2 of 3 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®). Page 3 of 3 Media: Buchan Consulting Rebecca Wilson Mob: +61 417 382 391 [email protected] Gabriella Hold +61 3 9866 4722 [email protected] Starpharma: Dr Jackie Fairley, Chief Executive Officer Nigel Baade, CFO and Company Secretary +61 3 8532 2704 [email protected] www.starpharma.com 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”, “estim ated”, “targeting”, “aiming”, “set to”, “potentia l”, “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 fu ture 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 s tatements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other authorities’ require ments 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, unexpect ed trial results, including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; our abi lity to obtain or maintain patent or other proprietary intellectual property protection; com petition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candid ates, 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. St arpharma 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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