MediGene publishes first, preliminary results obtained in a phase II clinical trial of EndoTAGTM-1 for the treatment of triple receptor-negative breast cancer
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MediGene AG / MediGene publishes first, preliminary results obtained in a phase II clinical trial of EndoTAGTM-1 for the treatment of triple receptor-negative breast cancer processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
Martinsried/Munich, May 6, 2010. The biotech company MediGene AG (Frankfurt,
Prime Standard, TecDAX) announces first preliminary results from its Phase II
clinical trial of the drug candidate EndoTAG(TM)-1 for the treatment of triple
receptor-negative breast cancer. The trial in 140 patients was conducted to show
efficacy of EndoTAG(TM)-1 against this extremely difficult to treat cancer type,
and to further investigate the safety of the drug candidate. The primary
endpoint was a progression-free survival rate at 16 weeks of at least 30% of
EndoTAG(TM)-1 monotherapy treated patients, and at least 30% of EndoTAG(TM)-1
plus paclitaxel combination treated patients respectively. At the same time the
bottom line of the 95% confidence interval also had to be above 30%.
Data available at this time reveal a progression-free survival rate of 59.1%
after treatment with EndoTAG(TM)-1 combination therapy, and further data are
currently being evaluated and will be published within the next few weeks. Upon
conclusion of this analysis, an overall trial evaluation will therefore be
possible. The data published today are based on a centralised image evaluation
of the trial results regarding progression-free survival.
Trial design: The trial recruited 140 patients diagnosed with triple
receptor-negative breast cancer. These patients were randomized into three
groups, receiving either treatment with EndoTAG(TM)-1 in combination with the
cytostatic drug paclitaxel (55 patients) or EndoTAG(TM)-1 monotherapy (57
patients). The third group (28 patients) was treated with paclitaxel alone. The
number of patients that could be considered for this centralised image
evaluation was 44 (EndoTAG(TM)-1 combination therapy), 38 (EndoTAG(TM)-1
monotherapy), and 25 (paclitaxel monotherapy). The patients treated with
combination therapy received 22 mg/m(2) EndoTAG(TM)-1 once a week plus 70
mg/m(2) paclitaxel. EndoTAG(TM)-1 monotherapy was administered twice every week,
in a dosage of 44 mg/m(2) each. The paclitaxel monotherapy consisted of one
weekly 90 mg/m(2 )dose. The clinical trial was conducted in over 30 centers
across several European countries and in India.
Trial results: The group of patients treated with EndoTAG(TM)-1 and paclitaxel
combination therapy showed a progression-free survival rate after 16 weeks of
treatment of 59.1% (95% confidence interval: 43.2% - 73.7%). The
progression-free survival rate of the group with EndoTAG(TM)-1 monotherapy was
34.2% (18,6 % - 51,4 %). In the group that received paclitaxel monotherapy, the
progression-free survival rate was 48%. (27,8 % - 68,7%).
Dr. Frank Mathias, Chief Executive Officer of MediGene AG, commented: "We are
delighted to show that patients treated with EndoTAG(TM)-1 combination therapy
could benefit in this way from our drug candidate. Subject to further data
analysis which will permit a more thorough evaluation, the achievement of the
primary endpoint in this trial with EndoTAG(TM)-1 combination therapy represents
a positive result of our clinical trial."
Triple receptor-negative breast cancer: According to recent estimates[1], in
2009 about 193,000 newly diagnosed cases of breast cancer and 41,000 deaths
associated with it occurred in the USA alone. Breast cancer is by far the most
common type of cancer in women, accounting for 27% of cancer diagnoses.
Malignant breast tumors that do not possess estrogen, progesterone or HER2/NEU
receptors are called triple receptor-negative breast cancer. About 15% of all
breast cancers belong to this subgroup.[2] Patients suffering from this type of
breast cancer have a significantly poorer prognosis, and there are very few
treatments available since conventional anti-hormonal treatments or treatments
targeting HER2 are not appropriate. In case of recurrence following initial
surgery, the only remaining treatment option is chemotherapy, and this provides
only a limited number of suitable therapeutics for this type of cancer.
EndoTAG(TM)-1: EndoTAG(TM)-1 adds an innovative variant to the validated
therapeutic approach of anti-angiogenesis. The drug candidate attaches itself
selectively to newly developed negatively charged tumor blood vessels, thus
attacking only these blood vessels and not those in healthy tissue.
Concurrently, EndoTAG(TM)-1 prevents the formation of new vessels, thus
suppressing further tumor growth. EndoTAG(TM)-1 is a combination of positively
charged liposomes with the therapeutic substance paclitaxel embedded therein.
MediGene believes that such an approach on genetically stable endothelial cells
will not lead to resistance formation.
EndoTAG(TM)-1 is MediGene's first product candidate derived from the EndoTAG(TM)
platform technology. MediGene obtained positive results with EndoTAG(TM)-1 in a
controlled phase II clinical trial in pancreatic cancer. In Europe and the USA
EndoTAG(TM)-1 has been granted orphan drug designation which potentially
provides both cost and timeline benefits in the drug development process.
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 statements made herein. MediGene is
not bound to update any of these forward-looking statements.
- ends -
Contact MediGene AG
E-mail: investor(at)medigene.com
Fax:++49 - 89 - 85 65 - 2920
Julia Hofmann / Dr. Nadja Wolf, Public Relations, Tel.: ++49 - 89 - 85 65 - 3324
Dr. Georg Dönges, Investor Relations, Tel.: ++49 - 89 - 85 65 - 2946
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[1] Source: American Cancer Society, 2009
[2] Source: Cleator S, Heller W, Coombes R Ch. Triple-negative breast cancer:
therapeutic options. Lancet Oncol 2007; 8:235-44
[2]
[HUG#1412815]
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MediGene AG
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Datum: 06.05.2010 - 17:28 Uhr
Sprache: Deutsch
News-ID 20422
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contact information:
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