MediGene reports additional phase II results of EndoTAG(TM)-1 for the treatment of triple receptor-negative breast cancer
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MediGene AG / MediGene reports additional phase II results of EndoTAG(TM)-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.
Clinical trial objective achieved - data confirm positive efficacy trend of
EndoTAG(TM)-1 combination therapy
Martinsried/Munich, June 24, 2010. The biotechnology company, MediGene AG
(Frankfurt, Prime Standard, MDG, TecDAX) announces additional phase II clinical
trial results of the drug candidate EndoTAG(TM)-1 for the treatment of triple
receptor-negative breast cancer. The extensive data analysis of the three-arm
trial conducted in 140 patients confirms a positive efficacy trend of
EndoTAG(TM)-1 in combination with paclitaxel for the treatment of this difficult
to treat type of cancer. The objective of the trial was achieved, and the
initial conclusion of the preliminary data published on May 6, 2010 was
verified.
The primary endpoint was achieved with EndoTAG(TM)-1 combination therapy. In
addition, the analysis of the secondary endpoints (median progression-free
survival, non-progression rate, safety, and tolerability) shows further positive
results for EndoTAG(TM)-1 combination therapy.
Trial design
The trial recruited 140 patients diagnosed with triple receptor-negative breast
cancer. These patients were randomized into three treatment groups, receiving
either EndoTAG(TM)-1 in combination with the cytotoxic drug, paclitaxel (55
patients), or EndoTAG(TM)-1 monotherapy (57 patients). The third group (28
patients) was treated with paclitaxel alone. The patients treated with
combination therapy received 22 mg/m(2) EndoTAG(TM)-1 plus 70 mg/m(2) paclitaxel
once per week. EndoTAG(TM)-1 monotherapy was administered twice per week, in a
dosage of 44 mg/m(2) per treatment. The paclitaxel monotherapy consisted of a
once weekly 90 mg/m(2 )dose. The clinical trial was conducted in more than 30
centers across several European countries and India. According to the trial
protocol, the trial results are based on centralized data analysis. The patient
numbers whose data were eligible for the central analysis are shown in the
following results.
Trial results
The trial objective of evaluating efficacy of EndoTAG(TM)-1 was achieved by the
combination therapy with Paclitaxel.
Primary endpoint: The primary endpoint was a progression-free survival rate of
the patients treated with either EndoTAG(TM)-1 monotherapy or EndoTAG(TM)-1 plus
paclitaxel combination of at least 30% after 16 weeks of treatment. At the same
time, the 95% confidence interval, which provides information about the
potential error rate, also had to be above 30%. The group of patients treated
with EndoTAG(TM)-1 and paclitaxel combination therapy showed a progression-free
survival rate of 59% (26 of 44 patients). The group treated with EndoTAG(TM)-1
monotherapy achieved a rate of 34% (13/38). For the group treated with
paclitaxel monotherapy, this rate was 48% (12/25). Regarding the set confidence
interval, the primary trial endpoint was met by the EndoTAG(TM)-1 combination
therapy arm only.
Secondary endpoints: Median progression-free survival time during the trial was
4.2 months in the EndoTAG(TM)-1 combination therapy arm (52 patients), 3.4
months in the EndoTAG(TM)-1 monotherapy arm (48), and 3.7 months in the
paclitaxel monotherapy arm (25). The rate of patients whose tumors had not
progressed further (clinical benefit rate) in treatment week 16 was 59% in the
EndoTAG(TM)-1 combination therapy arm (26/44 patients), 34% in the EndoTAG(TM)-1
monotherapy arm (13/38), and 50% in the paclitaxel monotherapy arm (12/24). In
76% of the patients in the EndoTAG(TM)-1 combination therapy arm (38/50), the
tumor was either stable or regressive at a certain point in time during the
treatment period (best overall response). The corresponding rate was 58% for the
EndoTAG(TM)-1 monotherapy arm (26/45), and 58% for the paclitaxel monotherapy
arm (14/24). Safety and tolerability profile of EndoTAG(TM)-1 was confirmed
during the trial. The combination of EndoTAG(TM)-1 with paclitaxel did not lead
to additional toxicity.
Professor Dr. Ahmad Awada, Head of the Medical Oncology Clinic, Department of
Medicine, Institut Jules Bordet, Brussels, and principal investigator of the
trial, commented: "These are promising results for a disease that is as
difficult to treat as triple receptor-negative breast cancer. Since the trial
demonstrated a clinical benefit combining EndoTAG(TM)-1 with paclitaxel, I am
confident that this therapy may represent a novel treatment option in the
future."
Dr. Frank Mathias, Chief Executive Officer of MediGene AG, commented: "Following
the positive phase II clinical results obtained in pancreatic cancer indication,
this trial conducted in another very difficult to treat type of cancer also
shows clear indication of efficacy of EndoTAG(TM)-1. The data represent further
clinical evidence of the therapeutic principle (proof-of-concept) of
EndoTAG(TM)-1 combination therapies for indications with high medical need."
About triple receptor-negative breast cancer: According to recent estimates by
the American Cancer Society, approximately 193,000 newly diagnosed cases of
breast cancer and 41,000 deaths associated with it occurred in the USA in 2009.
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 receptors are called "triple receptor-negative" breast
cancer. About 15% of all breast cancers belong to this subgroup.[1] 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 also provides only a limited number of suitable
therapeutics for this type of cancer.
About EndoTAG(TM)-1: EndoTAG(TM)-1 represents an innovative therapeutic approach
that unfolds its effect by both a targeted antivascular (against newly formed
tumor blood vessels), and an anti-tumoral (directed against the tumor)
mechanism. 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, which is expected to suppress further tumor growth.
EndoTAG(TM)-1 is a combination of positively charged liposomes with the
therapeutic substance paclitaxel embedded therein.
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 provides both cost
and timeline benefits in the drug development process.
Analyst conference call and webcast: An analyst conference call in English will
take place today at 2.30 p.m. (CEST), and will be webcast live. The webcast and
synchronized presentation slides can be accessed at www.medigene.com. A
recording of the live presentation will also be available thereafter.
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. MediGene,
EndoTAG(TM), and EndoTAG(TM)-1 are trademarks of MediGene AG. These trademarks
may be owned or licensed in select locations only.
- ends -
MediGene AG is a publicly listed (Frankfurt, Prime Standard: MDG, TecDax)
biotechnology company located in Martinsried/Munich, Germany, with subsidiaries
in Oxford, UK and San Diego, USA. MediGene is the first German biotech company
to have drugs on the market which are distributed by partner companies. It has
several drug candidates in clinical development, and possesses innovative
platform technologies. MediGene focuses on clinical research and development of
novel drugs with emphasis on oncology.
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: Cleator S, Heller W, Coombes R Ch. Triple-negative breast cancer:
therapeutic options. Lancet Oncol 2007; 8:235-44
[HUG#1426832]
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MediGene AG
Lochhamer Strasse 11 Martinsried / München Germany
WKN: 502090;ISIN: DE0005020903;
Listed: Freiverkehr in Börse Stuttgart,
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Freiverkehr in Niedersächsische Börse zu Hannover,
Prime Standard in Frankfurter Wertpapierbörse,
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Source: MediGene AG via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 24.06.2010 - 08:30 Uhr
Sprache: Deutsch
News-ID 22950
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contact information:
Town:
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Kategorie:
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