MediGene Announces Investigator Initiated Trial of EndoTAG®-1 and Presentation of Final Phase II Overall Survival Data at the San Antonio Breast Cancer Symposium
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MediGene AG /
MediGene Announces Investigator Initiated Trial of EndoTAG®-1 and Presentation
of Final Phase II Overall Survival Data at the San Antonio Breast Cancer
Symposium
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The issuer is solely responsible for the content of this announcement.
* Investigator initiated trial of EndoTAG(®)-1 in combination with paclitaxel
for hormone-receptor-positive, HER2-negative breast cancer.
* Final overall survival data from the phase II clinical trial of EndoTAG(®)-
1 in triple-negative breast cancer (TNBC) will be presented for the first
time at the San Antonio Breast Cancer Symposium on December 8, 2011.
Martinsried/Munich, November 8, 2011.MediGene AG (MDG, Frankfurt, Prime
Standard) announced today that Prof. Dr. Ahmad Awada, principal investigator in
the EndoTAG(®)-1 phase II trial in TNBC, will conduct an investigator initiated
trial (IIT) of EndoTAG(®)-1 in hormone-receptor-positive, HER2-negative breast
cancer, which is an additional potential indication for the drug. The trial is
entitled "An open-label phase II trial evaluating the efficacy and safety of
neoadjuvant EndoTAG(®)-1 in combination with paclitaxel in patients with HER2-
negative high-risk breast cancer." MediGene will provide EndoTAG(®)-1 for the
study.
Prof. Dr. Ahmad Awada, Head of the Medical Oncology Clinic at Jules Bordet
Institute in Brussels, Belgium, commented: "The experience gathered with
EndoTAG(®)-1 in TNBC has encouraged me to initiate a trial to investigate this
interesting drug candidate in a type of breast cancer that affects 70 - 85% of
all breast cancer patients. Previous findings indicate that EndoTAG(®)-1 in
combination with paclitaxel might represent a novel treatment option for those
patients suffering from hormone-receptor-positive breast cancer."
During the IIT, 20 patients diagnosed with HER2-negative breast cancer will be
treated with EndoTAG(®)-1 (22 mg/m(2)) in combination with paclitaxel (70
mg/m(2)) once-weekly over a period of twelve weeks as neoadjuvant therapy prior
to surgery. Treatment of the patients with EndoTAG(®)-1 is expected to be
completed in the second half of 2012. Following EndoTAG(®)-1 therapy, the
patients will be treated with standard chemotherapy and, subsequently, surgery.
Endpoints of the trial include reduction in linear tumour size as measured by
MRI as well as pathological complete response (pCR) at the time of surgery. The
trial results are expected in 2013.
Separately, and for the first time, Prof. Dr. Ahmad Awada will present median
overall survival data from the phase II clinical trial of EndoTAG(®)-1 in TNBC
at the San Antonio Breast Cancer Symposium in San Antonio, Texas, USA. The
presentation, entitled "Final Results of a Controlled, Randomized 3-Arm Phase II
Trial of EndoTAG(®)-1, a Cationic Liposomal Formulation of Paclitaxel Targeting
Tumor Endothelial Cells, in Advanced Triple-Negative Breast Cancer (TNBC)" will
take place on December 8, 2011, from 5:00 pm - 7:00 pm (CST). 140 patients
participated in this trial.
EndoTAG(®)-1: Clinical drug candidate EndoTAG(®)-1 is a novel composition of
paclitaxel combined with neutral and positive lipids. It attacks activated
endothelial cells that are needed for the formation of new tumor blood vessels.
The drug candidate selectively attaches itself to newly developed, negatively
charged tumor blood vessels, thus attacking only the blood supply of the tumor
and not the blood supply of healthy tissue. EndoTAG(®)-1 is expected to prevent
the formation of new vessels and suppress further tumor growth.
MediGene assumes that due to the genetic stability of endothelial cells compared
to tumor cells, EndoTAG(®)-1 can be used for the treatment of those tumors that
have already developed a resistance to conventional paclitaxel therapy.
MediGene successfully completed two phase II clinical trials with EndoTAG(®)-1
in pancreatic cancer and triple-negative breast cancer, and has developed a more
cost-effective manufacturing process. European and US authorities have granted
orphan drug designation for EndoTAG(®)-1. This status affords certain benefits
in the development, approval process, and, under certain circumstances, the
commercialization of the drug.
HER2-negative breast cancer: According to recent estimates, about 193,000 newly
diagnosed cases of breast cancer and 41,000 deaths associated with it occurred
in 2009 in the USA alone. Breast cancer is by far the most common type of
cancer in women, accounting for 27% of cancer diagnoses. In 70 - 85% of all
breast cancer cases, the tumor cells do not express any HER2 receptors, and are
therefore referred to as HER2-negative. This type of breast cancer cannot be
treated with therapies targeted at the HER2 receptor, such as monoclonal
antibodies.
Triple-negative breast cancer (TNBC): The triple-negative breast cancer
represents a subtype of HER2-negative breast cancers. Triple-negative breast
tumors are malignant and do not show any HER2 receptors or hormone receptors for
estrogen or progesterone. About 15% of all breast cancer cases rank among this
group. There are very few treatment options available, since conventional anti-
hormonal treatments or treatments targeting HER2 are not appropriate. In case of
relapse following initial surgery, the only remaining treatment option is
chemotherapy, which also provides only a limited number of suitable therapeutics
for this type of cancer.
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.
- ends -
MediGene AG is a publicly listed (Frankfurt: MDG, prime standard) biotechnology
company headquartered in Martinsried/Munich, Germany. MediGene is the first
German biotech company to have revenues from marketed products. It has various
drug candidates in clinical development and possesses innovative platform
technologies. MediGene focuses on clinical research and development of novel
drugs against cancer and autoimmune diseases.
Contact MediGene AG
Julia Hofmann, Kerstin Langlotz
Investor & Public Relations
Tel.: +49 - 89 - 85 65 - 33 01
Fax: +49 - 89 - 85 65 - 29 20
Email: investor(at)medigene.com
--- End of Message ---
MediGene AG
Lochhamer Strasse 11 Martinsried / München Germany
WKN: 502090;ISIN: DE0005020903;
Listed: Freiverkehr in Börse Stuttgart,
Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg,
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Freiverkehr in Niedersächsische Börse zu Hannover,
Prime Standard in Frankfurter Wertpapierbörse,
Regulierter Markt in Frankfurter Wertpapierbörse;
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