Medigene publishes final results from phase II Investigator Initiated Trial of EndoTAG®-1 at ASCO 2013

•    Efficacy study with 15 patients meets primary endpoint

•    EndoTAG®-1 and paclitaxel combination show promising preliminary activity as preoperative treatment

Martinsried/Munich, May 16, 2013. Medigene AG (Frankfurt, Prime Standard; MDG) announced today the publication of final results from the phase II investigator initiated trial (IIT) of neoadjuvant EndoTAG®-1 in HER2-negative high risk breast cancer. The primary endpoint of this efficacy study was met, and the EndoTAG®-1 and paclitaxel combination showed promising preliminary activity as preoperative treatment, especially in patients with triple-negative breast cancer (TNBC). The abstract of the IIT (#114428) was chosen for inclusion online in the ASCO 2013 Annual Meeting Proceedings, a Journal of Clinical Oncology supplement, and was published today at www.asco.org.

Study design: Fifteen patients diagnosed with non-metastatic HER2-negative breast cancer (ECOG status 0/1) were treated with EndoTAG®-1 (22 mg/m2) in combination with paclitaxel (70 mg/m2) once-weekly over a period of twelve weeks as neoadjuvant therapy. Following EndoTAG®-1 therapy, the patients received standard chemotherapy FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2) every 3 weeks and, subsequently, surgery. The primary endpoint of the IIT study was the percent reduction in magnetic resonance imaging (MRI) estimated tumour volume at the end of EndoTAG®-1 plus paclitaxel administration as compared to baseline. Safety, pathological complete response (pCR), defined as no residual invasive tumour in breast and axillary nodes at surgery, and correlation between percentage reduction in MRI estimated tumour volume and pCR were also evaluated.

Results: Eleven out of 15 patients showed a reduction in tumour volume of 80% or greater at the end of EndoTAG®-1 plus Paclitaxel treatment. The median percent reduction in MRI estimated tumour volume was 90% (95% Confidence Interval: 69-99%), (p<0.001, sign test) for the 14 patients that underwent surgery; 99% (CI: 87-100%) for patients with pCR and 84% (CI:50-95%) for patients with no pCR.

Best results were observed in the TNBC patients (6 out of 15 patients) all of whom showed a reduction of tumour volume by 87 - 100%. Treatment in this group resulted in a pathological complete response (pCR) in five out of the six patients. 

During the treatment, grade 3 hypersensitivity reactions to EndoTAG®-1 were observed in 4 patients, two patients had a grade 3 increase in transaminases and 1 patient grade 4 neutropenia.

Prof. Dr. Ahmad Awada, Initiator of the IIT and Head of the Medical Oncology Clinic at the Institut Jules Bordet in Brussels, Belgium, commented: "The study results support the promising anti-tumoural effect of EndoTAG®-1 in combination with weekly Paclitaxel which were observed in previous phase II conducted studies. The marked reduction in tumour volume observed in TNBC patients during this IIT suggests a further clinical development in this indication with high unmet medical need."

About EndoTAG®-1: EndoTAG®-1 is a novel composition of the established cytostatic drug paclitaxel combined with neutral and positive lipids. The positively charged lipids imply that EndoTAG®-1 interacts with newly developed, negatively charged endothelial cells, which are primarily required for the growth of tumour blood vessels. The EndoTAG®-1 paclitaxel component attacks the endothelial cells as they divide, thus targeting the blood supply to tumours without affecting the supply to healthy tissue. By doing this, EndoTAG®-1 is expected to prevent the formation of new tumour blood vessels and to inhibit tumour growth. Medigene has successfully completed two clinical phase II trials of EndoTAG®-1 in the indications pancreatic cancer and triple-negative breast cancer (TNBC).

Medigene AG (Frankfurt: MDG, prime standard) is a publicly listed biotechnology company headquartered in Martinsried/Munich, Germany. Medigene focuses on clinical research and development of novel drugs against cancer and autoimmune diseases. Medigene is the first German biotech company to have revenues from a marketed product (Veregen®), which is distributed by partner companies. Medigene has two drug candidates in clinical trials, EndoTAG®-1 and RhuDex®, and is developing an innovative vaccine technology. For more information, please visit www.medigene.com.

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® and EndoTAG® are registered trademarks of Medigene AG. These trademarks may be owned or licensed in select locations only.

Contact

Julia Hofmann, Claudia Burmester

Investor & Public Relations

Tel.: +49 - 89 - 20 00 33 - 33 01

Email: investor@medigene.com

Posted: May 2013

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