Positive trial results for Starpharma's DEP cabazitaxel

Company News

Melbourne-based Starpharma (ASX:SPL) has announced further efficacy results of its most recent DEP candidate, DEP cabazitaxel, in a human breast cancer model.

The data will be presented along with an overview of the company's DEP platform at the BioEurope Spring 2016 conference in Stockholm later this week.

DEP cabazitaxel is Starpharma’s dendrimer-enhanced, water soluble (detergent free) version of Sanofi's PBS-listed cancer drug, Jevtana (cabazitaxel), which global sales in 2015 of US$430 million.

Jevtana is currently registered for use in advanced prostate cancer but is also under development for a number of other cancers, including breast cancer.

Like docetaxel, Jevtana (cabazitaxel) is formulated with a detergent (polysorbate 80) due to its poor solubility and can be associated with anaphylaxis and neutropenia.

According to Starpharma, DEP cabazitaxel is  detergent free and was compared with Jevtana in a human breast cancer pre-clinical model (xenograft).

"DEP cabazitaxel significantly outperformed Jevtana with respect to both level and duration of tumour regression (anticancer activity). Within four weeks of dosing, 100% of mice treated with Starpharma’s DEP cabazitaxel were tumour free and remained so for the duration of the extended study (150 days).

"In contrast, the Jevtana treated group exhibited significant tumour regrowth from day 60 onwards (Figure 1). Tumour growth in both drug treated groups was significantly inhibited compared with the vehicle group (P<0.0001)," said the company.

Starpharma also said its DEP cabazitaxel significantly outperformed Jevtana in terms of survival in the model.

"DEP cabazitaxel treated animals showed 100% survival to the end of the experiment (150 days), and survival was significantly prolonged vs Jevtana," it said.

“We are very encouraged by these results for DEP cabazitaxel, our latest development candidate," said Starpharma Chief Executive, Dr Jackie Fairley.

"The growing body of evidence of both efficacy-enhancement and survival benefits with DEP formulations is very positive and illustrates the utility and platform nature of Starpharma’s DEP technology.

“Early indications for DEP cabazitaxel are that it also demonstrates similar safety benefits to what we have seen with DEPTM docetaxel and other DEP conjugates in terms of reduced bone marrow toxicity. Additional benefits may also be seen as the DEP formulation is polysorbate 80 (detergent) free.

"The results from this study clearly demonstrate sustained efficacy and survival benefits for DEP cabazitaxel compared to Jevtana, and follow recently-announced impressive sustained efficacy results with our HER2-targeted DEP conjugate,” added Dr Fairley.