Seite 3 von 42
zeltia ( Seite 3)
Diskussionsstatistik
Anzahl Beiträge: 412
Aufrufe gesamt: 31.613
Aufrufe heute: 0
Diskussionsnr.: 922.553
Aufrufe gesamt: 31.613
Aufrufe heute: 0
Diskussionsnr.: 922.553
WKN: 868849
ISIN: ES0184940817
Symbol: ZEL
ISIN: ES0184940817
Symbol: ZEL
| 1,22 |
|
-1,93 % -0,024 |
Berlin (EUR), 25.05.12 | 08:06
Beitrag schreiben
Beliebteste Beiträge
Ansicht
- Umgekehrte Sortierung (neuste zuerst)
- Die letzten 30 Beiträge
- 500 Beiträge pro Seite
bonDiacomova
schrieb am 25.03.05 08:26:07
Beitrag Nr.21
(16.227.058)
Antwort
Zitat
Aplidin, der aus dem Meer gewonnene Anti-Tumor-Wirkstoff
Das aus der Seescheide Aplidium albicans gewonnene Aplidin, befindet sich z.Z. in Phase II Studien für Melanome und Non-Hodgkin-Lymphome, sowie Enddarm-, Nieren-, Lungen- und Pankreaskarzinome.
Aplidin bewirkt bei Krebs- bzw. Tumorzellen eine schnelle und anhaltende Aktivierung der Apoptose (programmierter Zelltod), die mit einer Blockierung der Zellteilung in einer bestimmten Entwicklungsphase der Zelle einhergeht. Ebenso hemmt Aplidin die Freisetzung des so genannten „vaskulären endothelialen Wachstumfaktors" (VEGF), einem wichtigen Protein, das bei der Gefäßneubildung, Versorgung und so dem Wachstum einer Reihe von Tumoren eine Rolle spielt.
Das aus der Seescheide Aplidium albicans gewonnene Aplidin, befindet sich z.Z. in Phase II Studien für Melanome und Non-Hodgkin-Lymphome, sowie Enddarm-, Nieren-, Lungen- und Pankreaskarzinome.
Aplidin bewirkt bei Krebs- bzw. Tumorzellen eine schnelle und anhaltende Aktivierung der Apoptose (programmierter Zelltod), die mit einer Blockierung der Zellteilung in einer bestimmten Entwicklungsphase der Zelle einhergeht. Ebenso hemmt Aplidin die Freisetzung des so genannten „vaskulären endothelialen Wachstumfaktors" (VEGF), einem wichtigen Protein, das bei der Gefäßneubildung, Versorgung und so dem Wachstum einer Reihe von Tumoren eine Rolle spielt.
bonDiacomova
schrieb am 25.03.05 08:29:04
Beitrag Nr.22
(16.227.066)
Antwort
Zitat
KAHALALIDE F
Ein Poster, präsentiert von Dr. Jos H. Beijnen et al., Niederländisches Krebs-Institut, stellte die Ergebnisse von: "Eine Phase-I- und pharmakokinetische Studie von Kahalalide F, intravenös verabreicht über eine Stunde, alle drei Wochen an fünf aufeinanderfolgenden Tagen bei Patienten mit fortgeschrittenem, metastatischem, androgen-refraktärem Prostatakrebs" ausführlich dar.
Ziele der Studie waren die Bestimmung der Sicherheit und maximalen verträglichen Dosis, Erforschung der Pharmakokinetik und Dokumentation der Anti-Tumor-Aktivität von Kahalalide F. Die Untersuchung wurde durchgeführt bei Patienten, die an androgenunabhängigen Prostatatumoren litten. Zweiunddreissig Patienten befanden sich im mittleren Alter von 68 Jahren. Sie litten an Metastasen im Knochen, Lymphknoten, Leber und/oder Lunge und hatten zuvor eine Hormontherapie oder Radiotherapie erhalten und/oder sich einer Operation unterzogen.
Die gesamten hämatologischen Toxizitäten waren vernachlässigbar und nicht eindeutig dosisbedingt. Unter Verwendung der NCIC-CTC (National Cancer Institute of Canada Common Toxicity Criteria)-Klassifikation wurden G1-Anämie, Thrombozytopenie und Neutropenie bei 22 festgestellt. G2-Anämie und Neutropenie traten bei 8 Patienten auf. Es gab keine G3- oder G4- hämatologischen Toxizitäten. Andere beobachtete Nebenwirkungen waren Übelkeit & Erbrechen, Müdigkeit, Hämaturie und Hypersensitivitätsreaktionen, wobei keine als G4 auftraten. Die wichtigste arzneimittelbedingte Toxizität war eine schnell-reversible Transaminaseerhöhung G3/G4.
Die Schlussfolgerung der Studie war, dass Kahalalide F als einstündige intravenöse Infusion während fünf aufeinanderfolgenden Tagen bei einer Dosis von 560 mg/m zum Quadrat/Tag einmal alle drei Wochen sicher verabreicht werden kann. Zukünftige Studien bei hormonrefraktärem, fortgeschrittenen Prostatakrebs sind begründet.
Dr. Miguel Angel Izquierdo, Direktor der Klinischen Entwicklung bei PharmaMar, sagte:
"Diese Ergebnisse sind mit vorherigen Studien von Kahalalide F konsistent. Wir sind beeindruckt von dem Sicherheitsprofil des Produkts und dabei, die Entwicklung dieser Substanz fortzusetzen."
Anmerkungen an die Herausgeber
Kahalalide F
Kahalalide F ist ein Peptid aus der Familie der neuartigen Peptide, die aus der Hawaii-Molluske Elysia rufescens isoliert wurden. Es befindet sich gegenwärtig in Phase-II-Studien bei Leberkarzinomen.
PharmaMar
Ein Poster, präsentiert von Dr. Jos H. Beijnen et al., Niederländisches Krebs-Institut, stellte die Ergebnisse von: "Eine Phase-I- und pharmakokinetische Studie von Kahalalide F, intravenös verabreicht über eine Stunde, alle drei Wochen an fünf aufeinanderfolgenden Tagen bei Patienten mit fortgeschrittenem, metastatischem, androgen-refraktärem Prostatakrebs" ausführlich dar.
Ziele der Studie waren die Bestimmung der Sicherheit und maximalen verträglichen Dosis, Erforschung der Pharmakokinetik und Dokumentation der Anti-Tumor-Aktivität von Kahalalide F. Die Untersuchung wurde durchgeführt bei Patienten, die an androgenunabhängigen Prostatatumoren litten. Zweiunddreissig Patienten befanden sich im mittleren Alter von 68 Jahren. Sie litten an Metastasen im Knochen, Lymphknoten, Leber und/oder Lunge und hatten zuvor eine Hormontherapie oder Radiotherapie erhalten und/oder sich einer Operation unterzogen.
Die gesamten hämatologischen Toxizitäten waren vernachlässigbar und nicht eindeutig dosisbedingt. Unter Verwendung der NCIC-CTC (National Cancer Institute of Canada Common Toxicity Criteria)-Klassifikation wurden G1-Anämie, Thrombozytopenie und Neutropenie bei 22 festgestellt. G2-Anämie und Neutropenie traten bei 8 Patienten auf. Es gab keine G3- oder G4- hämatologischen Toxizitäten. Andere beobachtete Nebenwirkungen waren Übelkeit & Erbrechen, Müdigkeit, Hämaturie und Hypersensitivitätsreaktionen, wobei keine als G4 auftraten. Die wichtigste arzneimittelbedingte Toxizität war eine schnell-reversible Transaminaseerhöhung G3/G4.
Die Schlussfolgerung der Studie war, dass Kahalalide F als einstündige intravenöse Infusion während fünf aufeinanderfolgenden Tagen bei einer Dosis von 560 mg/m zum Quadrat/Tag einmal alle drei Wochen sicher verabreicht werden kann. Zukünftige Studien bei hormonrefraktärem, fortgeschrittenen Prostatakrebs sind begründet.
Dr. Miguel Angel Izquierdo, Direktor der Klinischen Entwicklung bei PharmaMar, sagte:
"Diese Ergebnisse sind mit vorherigen Studien von Kahalalide F konsistent. Wir sind beeindruckt von dem Sicherheitsprofil des Produkts und dabei, die Entwicklung dieser Substanz fortzusetzen."
Anmerkungen an die Herausgeber
Kahalalide F
Kahalalide F ist ein Peptid aus der Familie der neuartigen Peptide, die aus der Hawaii-Molluske Elysia rufescens isoliert wurden. Es befindet sich gegenwärtig in Phase-II-Studien bei Leberkarzinomen.
PharmaMar
bonDiacomova
schrieb am 25.03.05 08:34:42
Beitrag Nr.23
(16.227.076)
Antwort
Zitat
YondelisTM
Dr. Axel Le Cesne, Leiter der Abteilung "Sarkome" am Institut Gustave
Roussy, Frankreich, wird über den Langzeiteinfluss von Yondelis bei der Behandlung von Patienten mit progressivem oder vorbehandeltem, fortgeschrittenem STS berichten, wobei er die Ergebnisse von drei Pivotalstudien vorstellen wird. An den Studien nahmen 183 erwachsene Patienten mit zuvor behandeltem STS teil. 41% der Patienten hatten zuvor zwei oder mehr Chemotherapiebehandlungen erhalten. Tumorschrumpfung und progressionsfreie Überlebensdaten wurden „peer-reviewed". Trotz einer vorhergehenden Chemotherapie, litten alle Patienten bei Studieneintritt unter progressiver Krankheit, wobei ihnen Yondelis-Infusionen über 24 Stunden in einer Dosis von 1,5 mg/m2 alle drei Wochen verabreicht wurden.
Von den 183 untersuchten Patienten zeigten 51,4 % (n = 94) einen klinischen Nutzen bezüglich Tumorwachstumskontrolle durch die Behandlung mit Yondelis. Eine Evaluation mittels konventioneller Wirksamkeitsmessungen zeigte, dass bei 7,7%
(n = 14) eine objektive Antwort erzielt wurde(> 50% Tumorschrumpfung), bei weiteren
7,7% (n = 14) wurde eine geringerfügige Antwort erzielt (25% bis 50% Tumorschrumpfung), und bei 36,1% (n = 66) zeigte sich eine Krankheitsstabilisierung mit einer mittleren Dauer von neun Monaten.
Die Anwendung der progressionsfreien Überlebensrate [1] (PFS) als Endpunkt für die Wirksamkeitsanalyse von Yondelis zeigte eine 6-Monats-PFS-Rate von 19,8%. Dieses Ergebnis hält einen günstigen Vergleich mit den Ergebnissen einer Krebsstudie der Europäischen Organisation für Forschung und Behandlung von Krebs stand, die vorschlägt, dass eine 6-Monats-PFS-Rate über 14% die Wirksamkeit von Anti-Tumorsubstanzen bei STS aufzeigt[2].
Nach der Yondelis-Behandlung waren 47,5% und 29,3% der Patienten nach 1 bzw. 2 Jahren noch am Leben. Die mittlere Gesamtüberlebenszeit betrug 10,3 Monate mit 55/183 (29%) Patienten, die nach 2 Jahren oder länger noch am Leben waren.
Es zeigte sich, dass eine Subpopulation von 63 Patienten sowohl gegenüber Doxorubicin als auch Ifosfamid resistent war. Die Ergebnisse bei diesen Patienten, die keine weiteren Behandlungsoptionen hatten, zeigten eine objektive Antwortrate von 9,5%. 22% der Patienten zeigten keine Tumorprogression über mindestens 6 Monate. 26% der Patienten blieben für mindestens 2 Jahre am Leben, verglichen mit einer mittleren Lebenserwartung von STS-Patienten von weniger als 1 Jahr.
Die häufigste Nebenwirkung war reversible Neutropenie
(51%). Nebenwirkungen waren behandelbar und nicht-kumulativ.
Während einer Diskussion auf der CTOS sagte Dr. Le Cesne: "Die bis heute gezeigte Evidenz unterstützt eine Aufnahme von Yondelis als drittes aktives Arzneimittel in das therapeutische Armamentarium von STS".
Dr. Axel Le Cesne, Leiter der Abteilung "Sarkome" am Institut Gustave
Roussy, Frankreich, wird über den Langzeiteinfluss von Yondelis bei der Behandlung von Patienten mit progressivem oder vorbehandeltem, fortgeschrittenem STS berichten, wobei er die Ergebnisse von drei Pivotalstudien vorstellen wird. An den Studien nahmen 183 erwachsene Patienten mit zuvor behandeltem STS teil. 41% der Patienten hatten zuvor zwei oder mehr Chemotherapiebehandlungen erhalten. Tumorschrumpfung und progressionsfreie Überlebensdaten wurden „peer-reviewed". Trotz einer vorhergehenden Chemotherapie, litten alle Patienten bei Studieneintritt unter progressiver Krankheit, wobei ihnen Yondelis-Infusionen über 24 Stunden in einer Dosis von 1,5 mg/m2 alle drei Wochen verabreicht wurden.
Von den 183 untersuchten Patienten zeigten 51,4 % (n = 94) einen klinischen Nutzen bezüglich Tumorwachstumskontrolle durch die Behandlung mit Yondelis. Eine Evaluation mittels konventioneller Wirksamkeitsmessungen zeigte, dass bei 7,7%
(n = 14) eine objektive Antwort erzielt wurde(> 50% Tumorschrumpfung), bei weiteren
7,7% (n = 14) wurde eine geringerfügige Antwort erzielt (25% bis 50% Tumorschrumpfung), und bei 36,1% (n = 66) zeigte sich eine Krankheitsstabilisierung mit einer mittleren Dauer von neun Monaten.
Die Anwendung der progressionsfreien Überlebensrate [1] (PFS) als Endpunkt für die Wirksamkeitsanalyse von Yondelis zeigte eine 6-Monats-PFS-Rate von 19,8%. Dieses Ergebnis hält einen günstigen Vergleich mit den Ergebnissen einer Krebsstudie der Europäischen Organisation für Forschung und Behandlung von Krebs stand, die vorschlägt, dass eine 6-Monats-PFS-Rate über 14% die Wirksamkeit von Anti-Tumorsubstanzen bei STS aufzeigt[2].
Nach der Yondelis-Behandlung waren 47,5% und 29,3% der Patienten nach 1 bzw. 2 Jahren noch am Leben. Die mittlere Gesamtüberlebenszeit betrug 10,3 Monate mit 55/183 (29%) Patienten, die nach 2 Jahren oder länger noch am Leben waren.
Es zeigte sich, dass eine Subpopulation von 63 Patienten sowohl gegenüber Doxorubicin als auch Ifosfamid resistent war. Die Ergebnisse bei diesen Patienten, die keine weiteren Behandlungsoptionen hatten, zeigten eine objektive Antwortrate von 9,5%. 22% der Patienten zeigten keine Tumorprogression über mindestens 6 Monate. 26% der Patienten blieben für mindestens 2 Jahre am Leben, verglichen mit einer mittleren Lebenserwartung von STS-Patienten von weniger als 1 Jahr.
Die häufigste Nebenwirkung war reversible Neutropenie
(51%). Nebenwirkungen waren behandelbar und nicht-kumulativ.
Während einer Diskussion auf der CTOS sagte Dr. Le Cesne: "Die bis heute gezeigte Evidenz unterstützt eine Aufnahme von Yondelis als drittes aktives Arzneimittel in das therapeutische Armamentarium von STS".
bonDiacomova
schrieb am 07.04.05 07:23:58
Beitrag Nr.24
(16.314.747)
Antwort
Zitat
Zeltia espera comercializar Yondelis en Europa y licenciar Aplidin
en 2006
Zeltia SA anunció que tiene previsto comercializar en 2006 el fármaco Yondelis en Europa.
MADRID (AFX-España) - Zeltia SA (Madrid: ZEL.MC) anunció que tiene previsto comercializar en 2006 el fármaco Yondelis en Europa.
Este fármaco que desarrolla su filial Pharmamar ha entrado en fase III de los ensayos clínicos, la última del proceso, sobre pacientes con cáncer de ovario.
La compañía farmacéutica y química indica que presentará los resultados de la fase II de este compuesto en el próximo congreso de oncología en la ciudad estadounidense de Orlando (Florida), conocido por las siglas ASCO, del 13 al 17 de mayo de 2005.
En una presentación, Zeltia indica que quiere licenciar el próximo año el compuesto Aplidin, actualmente en fase II para el tratamiento de cáncer de próstata y vejiga.
Otro de los objetivos de la compañía es colocar cada dos años un nuevo fármaco para su ensayo en clínica.
Zeltia reitera en esta presentación que cuenta con los recursos suficientes para alcanzar estos objetivos.
Zeltia SA anunció que tiene previsto comercializar en 2006 el fármaco Yondelis en Europa.
MADRID (AFX-España) - Zeltia SA (Madrid: ZEL.MC) anunció que tiene previsto comercializar en 2006 el fármaco Yondelis en Europa.
Este fármaco que desarrolla su filial Pharmamar ha entrado en fase III de los ensayos clínicos, la última del proceso, sobre pacientes con cáncer de ovario.
La compañía farmacéutica y química indica que presentará los resultados de la fase II de este compuesto en el próximo congreso de oncología en la ciudad estadounidense de Orlando (Florida), conocido por las siglas ASCO, del 13 al 17 de mayo de 2005.
En una presentación, Zeltia indica que quiere licenciar el próximo año el compuesto Aplidin, actualmente en fase II para el tratamiento de cáncer de próstata y vejiga.
Otro de los objetivos de la compañía es colocar cada dos años un nuevo fármaco para su ensayo en clínica.
Zeltia reitera en esta presentación que cuenta con los recursos suficientes para alcanzar estos objetivos.
bonDiacomova
schrieb am 07.04.05 16:23:26
Beitrag Nr.25
(16.320.297)
Antwort
Zitat
kurs 7,08
Yondelis medicamento huérfano en EEUU para cáncer ovario-Zeltia
MADRID (Reuters) - El grupo químico y farmacéutico Zeltia (Madrid: ZEL.MC) dijo el jueves que las autoridades sanitarias estadounidenses (FDA) han concedido a su compuesto antitumoral Yondelis la designación de "medicamento huérfano" para el tratamiento del cáncer de ovario.
Yondelis ya recibió la misma Publicidad
designación por parte de la FDA para el tratamiento de sarcomas de tejido blando.
En un comunicado a la CNMV, Zeltia señaló que la designación de Yondelis como "medicamento huérfano" fue promovido por su socio estadounidense Johnson & Johnson (NYSE: JNJ).
Yondelis es el compuesto anticancerígeno más desarrollado de PharmaMar, la filial biotecnológica de Zeltia.
La designación de fármaco huérfano permitiría un período especial de siete años de exclusividad para la comercialización en EEUU de Yondelis en esta indicación si se autorizase finalmente su comercialización.
Yondelis medicamento huérfano en EEUU para cáncer ovario-Zeltia
MADRID (Reuters) - El grupo químico y farmacéutico Zeltia (Madrid: ZEL.MC) dijo el jueves que las autoridades sanitarias estadounidenses (FDA) han concedido a su compuesto antitumoral Yondelis la designación de "medicamento huérfano" para el tratamiento del cáncer de ovario.
Yondelis ya recibió la misma Publicidad
designación por parte de la FDA para el tratamiento de sarcomas de tejido blando.
En un comunicado a la CNMV, Zeltia señaló que la designación de Yondelis como "medicamento huérfano" fue promovido por su socio estadounidense Johnson & Johnson (NYSE: JNJ).
Yondelis es el compuesto anticancerígeno más desarrollado de PharmaMar, la filial biotecnológica de Zeltia.
La designación de fármaco huérfano permitiría un período especial de siete años de exclusividad para la comercialización en EEUU de Yondelis en esta indicación si se autorizase finalmente su comercialización.
bonDiacomova
schrieb am 07.04.05 16:34:25
Beitrag Nr.26
(16.320.409)
Antwort
Zitat
04.04.2005
Phase III Trial of YONDELIS(R) (Trabectedin) Initiated in Ovarian Cancer Patients
MADRID, April 4 /PRNewswire/ -- PharmaMar today announced that, in collaboration with its partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), a pivotal, international, multicentre Phase III clinical trial in ovarian cancer patients has been initiated with YONDELIS(R) (trabectedin).
This Phase III study compares monotherapy liposomal doxorubicin, a Johnson & Johnson product(x) known as CAELYX(R) in Europe, and DOXIL(R) (doxorubicin HCI liposome injection) in the US, to a combination of YONDELIS and CAELYX (DOXIL) in ovarian cancer patients who have relapsed after receiving standard first-line chemotherapy. This randomised study will enrol 650 patients in 110 hospitals across 16 countries (including the US, Europe, Asia and South America). The primary objective is to test the hypothesis that combination therapy with YONDELIS and DOXIL/CAELYX improves progression-free and overall survival in women with relapsed ovarian cancer . There also will be complementary pharmacogenomic studies to improve knowledge of ovarian cancer biology and help in the selection of patients who will benefit most from the drug combination.
The study protocol was reviewed by the American regulatory agency, the US Food and Drug Administration (US FDA), through the special protocol assessment (SPA) process. The SPA procedure allows sponsors to obtain official written guidance from the FDA on pivotal Phase III clinical trials . This study also was reviewed by the European regulatory agency, the European Medicines Evaluation Agency (EMEA), through a similar process called Protocol Assistance (PA).
`PharmaMar and J&JPRD are committed to developing YONDELIS expeditiously to enable it to be considered for the treatment of relapsed ovarian cancer patients who currently are considered to be incurable,` said Dr. Miguel Ã?ngel Izquierdo, Director of Clinical Development at PharmaMar. `There is a need to offer additional treatment options to help to control this disease, improve the quality of life and increase patient survival. Based on data from Phase II trials with YONDELIS as a monotherapy in relapsed ovarian cancer patients, and in Phase I trials with YONDELIS in combination with CAELYX (DOXIL), we believe we may be able to provide a new option to these patients.`
In previous Phase II studies, YONDELIS demonstrated activity in ovarian cancer patients who had relapsed after standard first-line treatment. YONDELIS indicated a response rate, a significant reduction in the tumour, in those patients of up to 43%(1). Liposomal doxorubicin (CAELYX(R)/DOXIL(R)) already has been approved for this therapeutic use in this patient population. As the combination of YONDELIS with CAELYX (DOXIL) also demonstrated activity and tolerability in a previous study(2), the study`s theoretical premise is that the combination of two active drugs may improve the survival rate of the target patient population.
Ovarian cancer
According to the American Cancer Society (ACS) in the United States and Western Europe, ovarian cancer represents 4% of all cancers among women and ranks fifth as a cause of female deaths from cancer. The death rate for this disease has not changed significantly in the last 50 years. The median age of women with ovarian cancer is 60, although it may occur in younger women with a family history of the disease. Nearly 70% of women with epithelial ovarian cancer, the most common type of ovarian cancer, are not diagnosed until the disease is advanced. The 5-year survival rate for these women is only 15%-20%, whereas the 5-year survival rate for Stage I disease patients is nearly 90% and for Stage II disease patients is 70%.
In 2004, there were an estimated 25,580 new cases of ovarian cancer in the US, and more than 16,000 women died from the disease. Incidence in the European Union was about 48,000 new cases in 2004 and approximately 31,000 deaths (Globocan 2002, IARC, WHO). According to the World Health Organisation, the highest incidence rates occur in the United States, Canada, Scandinavia and Eastern Europe.
YONDELIS(R)
YONDELIS (trabectedin), is PharmaMar`s most advanced compound in development, and originally was isolated from the marine tunicate Ecteinascidia turbinata, but now is manufactured by chemical synthesis. YONDELIS currently is being developed by PharmaMar in partnership with Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PharmaMar will market YONDELIS in Europe (including Eastern Europe) while Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., will market it in the US, Ortho Biotech, a division of Janssen-Cilag, will market it in the rest of the world.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C., Ortho Biotech Products, L.P. and Tibotec Therapeutics all are part of the Johnson & Johnson Family of Companies, the world`s most comprehensive and broadly based manufacturer of health care products.
YONDELIS(R) currently is also in Phase II studies in soft tissue sarcoma (comparative pivotal trial) and for prostate cancer.
In clinical studies to date, YONDELIS has shown a good safety and tolerability profile. The most frequent side effect is neutropenia, which is reversible and controllable. A transient increase in transaminases also has been observed.
YONDELIS is a new chemical entity with unique multicomponent mechanism of action. It is the only chemotherapy agent that binds to the DNA`s minor groove and bends towards the major groove, producing its therapeutic effect by interfering with various cell division processes.
(x) DOXIL is marketed in the United States by Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., and in Israel by Janssen-Cilag. Schering-Plough Corporation, under a licensing agreement, has exclusive rights to market this medication as CAELYX(R) throughout the rest of the world, excluding Japan.
PharmaMar
PharmaMar is the world`s leading biopharmaceutical companies in advancing cancer care through the discovery and development of innovative marine-derived medicines. PharmaMar`s clinical portfolio currently includes: YONDELIS(R) (co-developed with Johnson & Johnson Pharmaceutical Research & Development) in Phase III clinical trials; it is also designated Orphan Drug for Soft Tissue Sarcomas by the European Commission (E.C.) in 2001 and by the FDA in 2004, and Orphan Drug for ovarian cancer by the E.C. in 2003. It also features Aplidin(R), in Phase II, designated Orphan Drug for acute lymphoblastic leukaemia by the E.C. in 2003 and by the FDA in 2004, and for multiple myeloma by the FDA and the EC in 2004; as well as Kahalalide F in Phase II, and ES-285 and Zalypsis(R) in Phase I clinical trials.
PharmaMar, based in Madrid, Spain, is a subsidiary of the Zeltia Group (Spanish stock exchange, ZEL).
This press release is also available in the News section on PharmaMar`s web site: www.pharmamar.com.
Phase III Trial of YONDELIS(R) (Trabectedin) Initiated in Ovarian Cancer Patients
MADRID, April 4 /PRNewswire/ -- PharmaMar today announced that, in collaboration with its partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), a pivotal, international, multicentre Phase III clinical trial in ovarian cancer patients has been initiated with YONDELIS(R) (trabectedin).
This Phase III study compares monotherapy liposomal doxorubicin, a Johnson & Johnson product(x) known as CAELYX(R) in Europe, and DOXIL(R) (doxorubicin HCI liposome injection) in the US, to a combination of YONDELIS and CAELYX (DOXIL) in ovarian cancer patients who have relapsed after receiving standard first-line chemotherapy. This randomised study will enrol 650 patients in 110 hospitals across 16 countries (including the US, Europe, Asia and South America). The primary objective is to test the hypothesis that combination therapy with YONDELIS and DOXIL/CAELYX improves progression-free and overall survival in women with relapsed ovarian cancer . There also will be complementary pharmacogenomic studies to improve knowledge of ovarian cancer biology and help in the selection of patients who will benefit most from the drug combination.
The study protocol was reviewed by the American regulatory agency, the US Food and Drug Administration (US FDA), through the special protocol assessment (SPA) process. The SPA procedure allows sponsors to obtain official written guidance from the FDA on pivotal Phase III clinical trials . This study also was reviewed by the European regulatory agency, the European Medicines Evaluation Agency (EMEA), through a similar process called Protocol Assistance (PA).
`PharmaMar and J&JPRD are committed to developing YONDELIS expeditiously to enable it to be considered for the treatment of relapsed ovarian cancer patients who currently are considered to be incurable,` said Dr. Miguel Ã?ngel Izquierdo, Director of Clinical Development at PharmaMar. `There is a need to offer additional treatment options to help to control this disease, improve the quality of life and increase patient survival. Based on data from Phase II trials with YONDELIS as a monotherapy in relapsed ovarian cancer patients, and in Phase I trials with YONDELIS in combination with CAELYX (DOXIL), we believe we may be able to provide a new option to these patients.`
In previous Phase II studies, YONDELIS demonstrated activity in ovarian cancer patients who had relapsed after standard first-line treatment. YONDELIS indicated a response rate, a significant reduction in the tumour, in those patients of up to 43%(1). Liposomal doxorubicin (CAELYX(R)/DOXIL(R)) already has been approved for this therapeutic use in this patient population. As the combination of YONDELIS with CAELYX (DOXIL) also demonstrated activity and tolerability in a previous study(2), the study`s theoretical premise is that the combination of two active drugs may improve the survival rate of the target patient population.
Ovarian cancer
According to the American Cancer Society (ACS) in the United States and Western Europe, ovarian cancer represents 4% of all cancers among women and ranks fifth as a cause of female deaths from cancer. The death rate for this disease has not changed significantly in the last 50 years. The median age of women with ovarian cancer is 60, although it may occur in younger women with a family history of the disease. Nearly 70% of women with epithelial ovarian cancer, the most common type of ovarian cancer, are not diagnosed until the disease is advanced. The 5-year survival rate for these women is only 15%-20%, whereas the 5-year survival rate for Stage I disease patients is nearly 90% and for Stage II disease patients is 70%.
In 2004, there were an estimated 25,580 new cases of ovarian cancer in the US, and more than 16,000 women died from the disease. Incidence in the European Union was about 48,000 new cases in 2004 and approximately 31,000 deaths (Globocan 2002, IARC, WHO). According to the World Health Organisation, the highest incidence rates occur in the United States, Canada, Scandinavia and Eastern Europe.
YONDELIS(R)
YONDELIS (trabectedin), is PharmaMar`s most advanced compound in development, and originally was isolated from the marine tunicate Ecteinascidia turbinata, but now is manufactured by chemical synthesis. YONDELIS currently is being developed by PharmaMar in partnership with Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PharmaMar will market YONDELIS in Europe (including Eastern Europe) while Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., will market it in the US, Ortho Biotech, a division of Janssen-Cilag, will market it in the rest of the world.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C., Ortho Biotech Products, L.P. and Tibotec Therapeutics all are part of the Johnson & Johnson Family of Companies, the world`s most comprehensive and broadly based manufacturer of health care products.
YONDELIS(R) currently is also in Phase II studies in soft tissue sarcoma (comparative pivotal trial) and for prostate cancer.
In clinical studies to date, YONDELIS has shown a good safety and tolerability profile. The most frequent side effect is neutropenia, which is reversible and controllable. A transient increase in transaminases also has been observed.
YONDELIS is a new chemical entity with unique multicomponent mechanism of action. It is the only chemotherapy agent that binds to the DNA`s minor groove and bends towards the major groove, producing its therapeutic effect by interfering with various cell division processes.
(x) DOXIL is marketed in the United States by Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., and in Israel by Janssen-Cilag. Schering-Plough Corporation, under a licensing agreement, has exclusive rights to market this medication as CAELYX(R) throughout the rest of the world, excluding Japan.
PharmaMar
PharmaMar is the world`s leading biopharmaceutical companies in advancing cancer care through the discovery and development of innovative marine-derived medicines. PharmaMar`s clinical portfolio currently includes: YONDELIS(R) (co-developed with Johnson & Johnson Pharmaceutical Research & Development) in Phase III clinical trials; it is also designated Orphan Drug for Soft Tissue Sarcomas by the European Commission (E.C.) in 2001 and by the FDA in 2004, and Orphan Drug for ovarian cancer by the E.C. in 2003. It also features Aplidin(R), in Phase II, designated Orphan Drug for acute lymphoblastic leukaemia by the E.C. in 2003 and by the FDA in 2004, and for multiple myeloma by the FDA and the EC in 2004; as well as Kahalalide F in Phase II, and ES-285 and Zalypsis(R) in Phase I clinical trials.
PharmaMar, based in Madrid, Spain, is a subsidiary of the Zeltia Group (Spanish stock exchange, ZEL).
This press release is also available in the News section on PharmaMar`s web site: www.pharmamar.com.
bonDiacomova
schrieb am 07.04.05 16:36:16
Beitrag Nr.27
(16.320.446)
Antwort
Zitat
07.04.2005
YONDELIS(R) Granted Orphan Drug Designation by the U.S. FDA For The Treatment of Ovarian Cancer
Madrid, Spain (ots/PRNewswire) - PharmaMar announced today that
its marine-derived anti-cancer drug, YONDELIS(R) (trabectedin), has
been granted Orphan Drug Designation by the U.S. Food and Drug
Administration (FDA) for the treatment of ovarian cancer. The U.S.
application sponsor, is Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. (J&JPRD), co-developing the compound with
PharmaMar. The European Commission granted orphan drug status to
YONDELIS for this indication in Europe in 2003.
Ovarian cancer
In the western world, ovarian cancer represents 4% of all cancers
among women and ranks fifth as a cause of female deaths from cancer
(American Cancer Society (ACS), Cancer Reference Information, 2005).
The death rate for this disease has not changed significantly in the
last 50 years. The median age of women with ovarian cancer is 60,
although it may occur in younger women with a family history of the
disease. Nearly 70% of women with epithelial ovarian cancer, the most
common type of ovarian cancer, are not diagnosed until the disease is
advanced. The 5-year survival rate for these women with advanced
disease is only 15 to 20%, whereas the 5-year survival rate for Stage
I disease patients approaches 90% and for Stage II disease patients
70%.
In 2004, there were an estimated 25,580 new cases of ovarian
cancer in United States, and more than 16,000 women died from the
disease. Incidence in the European Union was about 48,000 new cases
in 2004 and caused approximately 31,000 deaths (Globocan 2002, IARC,
WHO). According to the World Health Organisation, the highest
incidence rates occur in the United States, Canada, Scandinavia and
Eastern Europe.
Orphan Drug designation in the United States is awarded to
compounds that offer potential therapeutic value in the treatment of
rare diseases, defined as those affecting fewer than 200,000
Americans. If the company complies with certain FDA specifications
and should the drug receive marketing approval, orphan drug
designation qualifies the sponsor for seven years of marketing
exclusivity, exemption of the New Drug Application user fee and tax
credits related to clinical research. The designation does not
shorten the duration of the regulatory review and approval process.
Orphan Drug designation in Europe offers similar incentives
including, upon marketing approval, 10 years marketing exclusivity
for the indication in question.
Isabel Lozano, CEO of PharmaMar, said: "We are pleased that
YONDELIS has received Orphan Drug Designation from the FDA and we
look forward to further development in ovarian cancer together with
our partner Johnson & Johnson."
This press release is also available in the News section on
PharmaMar`s web site: www.pharmamar.com.
YONDELIS(R) Granted Orphan Drug Designation by the U.S. FDA For The Treatment of Ovarian Cancer
Madrid, Spain (ots/PRNewswire) - PharmaMar announced today that
its marine-derived anti-cancer drug, YONDELIS(R) (trabectedin), has
been granted Orphan Drug Designation by the U.S. Food and Drug
Administration (FDA) for the treatment of ovarian cancer. The U.S.
application sponsor, is Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. (J&JPRD), co-developing the compound with
PharmaMar. The European Commission granted orphan drug status to
YONDELIS for this indication in Europe in 2003.
Ovarian cancer
In the western world, ovarian cancer represents 4% of all cancers
among women and ranks fifth as a cause of female deaths from cancer
(American Cancer Society (ACS), Cancer Reference Information, 2005).
The death rate for this disease has not changed significantly in the
last 50 years. The median age of women with ovarian cancer is 60,
although it may occur in younger women with a family history of the
disease. Nearly 70% of women with epithelial ovarian cancer, the most
common type of ovarian cancer, are not diagnosed until the disease is
advanced. The 5-year survival rate for these women with advanced
disease is only 15 to 20%, whereas the 5-year survival rate for Stage
I disease patients approaches 90% and for Stage II disease patients
70%.
In 2004, there were an estimated 25,580 new cases of ovarian
cancer in United States, and more than 16,000 women died from the
disease. Incidence in the European Union was about 48,000 new cases
in 2004 and caused approximately 31,000 deaths (Globocan 2002, IARC,
WHO). According to the World Health Organisation, the highest
incidence rates occur in the United States, Canada, Scandinavia and
Eastern Europe.
Orphan Drug designation in the United States is awarded to
compounds that offer potential therapeutic value in the treatment of
rare diseases, defined as those affecting fewer than 200,000
Americans. If the company complies with certain FDA specifications
and should the drug receive marketing approval, orphan drug
designation qualifies the sponsor for seven years of marketing
exclusivity, exemption of the New Drug Application user fee and tax
credits related to clinical research. The designation does not
shorten the duration of the regulatory review and approval process.
Orphan Drug designation in Europe offers similar incentives
including, upon marketing approval, 10 years marketing exclusivity
for the indication in question.
Isabel Lozano, CEO of PharmaMar, said: "We are pleased that
YONDELIS has received Orphan Drug Designation from the FDA and we
look forward to further development in ovarian cancer together with
our partner Johnson & Johnson."
This press release is also available in the News section on
PharmaMar`s web site: www.pharmamar.com.
bonDiacomova
schrieb am 16.05.05 13:29:17
Beitrag Nr.28
(16.623.914)
Antwort
Zitat
kurs 6,62
Zeltia presenta datos `alentadores` sobre Yondelis para cáncer de próstata
zeltia presentiert `weiterbringendes` ueber yondelis
gegen prostata krebs
MADRID, 16 (EUROPA PRESS)
En el Congreso anual de la American Societyof Clinical Oncology (ASCO ), celebrado en Orlando, Florida, del 13 al 17 de mayo de 2005, se presentaron los resultados de cinco estudios clínicos de Yondelis, desarrollado por PharmaMar en asociación con Johnson & Johnson Pharmaceutical Research & Development, que han sido calificados como "alentadores" en el tratamiento contra el cáncer de próstata.
auf der derzeit stattfinfenden ASCO
werden resultate von 5 klinischen studien
ueber yondelis von zeltia presentiert,
durch pharma mar und partner j & j
![]()
http://www.asco.org/ac/1,1003,_12-0...-0040084,00.asp
http://www.asco.org/ac/1,1003,_12-002462,00.asp
Zeltia presenta datos `alentadores` sobre Yondelis para cáncer de próstata
zeltia presentiert `weiterbringendes` ueber yondelis
gegen prostata krebs
MADRID, 16 (EUROPA PRESS)
En el Congreso anual de la American Societyof Clinical Oncology (ASCO ), celebrado en Orlando, Florida, del 13 al 17 de mayo de 2005, se presentaron los resultados de cinco estudios clínicos de Yondelis, desarrollado por PharmaMar en asociación con Johnson & Johnson Pharmaceutical Research & Development, que han sido calificados como "alentadores" en el tratamiento contra el cáncer de próstata.
auf der derzeit stattfinfenden ASCO
werden resultate von 5 klinischen studien
ueber yondelis von zeltia presentiert,
durch pharma mar und partner j & j
http://www.asco.org/ac/1,1003,_12-0...-0040084,00.asp
http://www.asco.org/ac/1,1003,_12-002462,00.asp
bonDiacomova
schrieb am 16.05.05 13:34:51
Beitrag Nr.29
(16.623.946)
Antwort
Zitat
Según el Dr. D. Michaelson, del Massachusetts General Hospital
Cancer Center de Boston, se trata de datos alentadores. Los
resultados de este estudio sugieren que Yondelis es eficaz en la
reducción del PSA (antígeno prostático específico), y en el alivio
del dolor en aproximadamente el 12% de los hombres con cáncer de
próstata avanzado.
`El dato más alentador es el hecho de que Yondelis parece tener el mismo nivel de actividad en los hombres que presentan resistencia a la quimioterapia estándar con docetaxel, para los cuales actualmente no existe un tratamiento eficaz establecido. Por consiguiente, deben realizarse más estudios con YONDELIS en este contexto. Es posible que Yondelis ofrezca nuevas esperanzas a los hombres que padecen cáncer de próstata avanzado.
`El dato más alentador es el hecho de que Yondelis parece tener el mismo nivel de actividad en los hombres que presentan resistencia a la quimioterapia estándar con docetaxel, para los cuales actualmente no existe un tratamiento eficaz establecido. Por consiguiente, deben realizarse más estudios con YONDELIS en este contexto. Es posible que Yondelis ofrezca nuevas esperanzas a los hombres que padecen cáncer de próstata avanzado.
bonDiacomova
schrieb am 18.05.05 13:51:14
Beitrag Nr.30
(16.644.780)
Antwort
Zitat
YONDELIS(TM) (trabectedin) Phase II Trials Demonstrate Activity in
Prostate, Ovarian and Breast Cancer
Orlando, Florida (ots/PRNewswire) -
- New Results Presented at ASCO
Results from five clinical studies of YONDELIS (TM) (trabectedin)
were presented at the Annual Meeting of the American Society of
Clinical Oncology (ASCO), in Orlando, Florida, from 13-17 May 2005.
YONDELIS is being developed by PharmaMar in partnership with Johnson
& Johnson Pharmaceutical Research & Development, L.C.C. (J&JPRD).
In addition, a poster was presented on a second PharmaMar
anti-cancer drug, Kahalalide F.
YONDELIS presentations
Results from a Phase II study of a three hour, weekly infusion of
YONDELIS (trabectedin) in patients with androgen-independent advanced
prostate carcinoma were presented during an oral session (Sunday, 15
May, 11:15 - 11:30 am) by Dr D. Michaelson of the Massachusetts
General Hospital Cancer Center in Boston, MA.
This Phase II trial was designed to test the activity of
weekly administration of YONDELIS in patients with hormone refractory
prostate cancer with high levels of PSA (prostate specific antigen, a
biological marker related to tumor activity).
The primary objective of the trial was to assess the PSA responses
to the treatment, confirmed by decrease of PSA blood levels.
In this study, 27 patients have been enrolled to date; 19 received
YONDELIS as second line chemotherapy (following the approval of
Taxotere(R) (docetaxel) in 2004 by the U.S. Food and Drug
Administration (FDA) as standard front-line chemotherapy for
androgen-independent prostate cancer); eight patients received
YONDELIS as a first line therapy. Fourteen of the patients enrolled
were refractory to docetaxel-based chemotherapy.
The preliminary results demonstrated an overall PSA response rate
in the docetaxel refractory population of about 14% (two out of 14
patients). Another PSA response was observed in a chemotherapy naïve
patient. An additional three men have demonstrated an initial PSA
decline that will be assessed in subsequent evaluations as they are
still receiving treatment. To date, the overall PSA response rate is
12% (3/26 evaluable patients including one chemotherapy naïve
patient). A symptomatic improvement, with an average sustained PSA
response of 23 weeks, was observed in all the PSA responders.
The preliminary safety results indicate good tolerance of weekly
administration: no patients presented grade 4 adverse events. The
most frequent adverse events were fatigue, nausea and anaemia; only
five patients experienced grade 3 fatigue.
The activity observed in this study, including activity in
patients refractory to taxotere (docetaxel), is encouraging for the
further evaluation of YONDELIS in patients with prostrate cancer.
"This is encouraging data," said Dr. Michaelson. "The results from
this study suggest that YONDELIS is effective in reducing PSA and
alleviating pain in approximately 12% of men with advanced prostate
cancer. Most encouraging is that YONDELIS appears to have the same
level of activity in men who are refractory to standard chemotherapy
with docetaxel, for whom there is currently no established effective
treatment. Thus, YONDELIS should be studied further in this setting,
and may bring new hope to men with advanced prostate cancer."
An additional cohort of patients will now be recruited to expand
the study of YONDELIS in prostate cancer.
Poster: "Final results of Phase II study of weekly trabectedin in
second-line and third-line ovarian carcinoma," presented in
Gynaecologic Cancer session (Saturday 14 May, 1:00-4:00pm) by Dr. S.
McMeekin, University of Oklahoma Health Science Center.
The final results of a Phase II study of weekly YONDELIS
(trabectedin) administration in second/third line ovarian carcinoma
were presented.
The study in pre-treated patients with advanced ovarian cancer
featured a weekly dosing schedule using a 0.58 mg/m2 infusion. In the
platinum sensitive group (treatment free interval of 6 months or
greater) 55 patients were treated; the response rate was 28.8% and
the median PFS was 5.1 months. In the platinum resistant group
(treatment free interval of less than 6 months) 64 patients were
treated; the response rate was 4.8% and the median PFS was 2.0
months. Grade 3-4 toxicities in pooled cycles were reversible liver
ALT (alanine aminotransferase) elevation (12%), neutropenia (8%),
fatigue (5%), and nausea/vomiting (4%).
The conclusions of this study are that YONDELIS is active and well
tolerated when administered as a 3-hour infusion for three weeks out
of a four-week cycle in platinum sensitive patients.
This is the second study where YONDELIS has shown activity in
second line ovarian cancer. The activity with this dose and schedule
of YONDELIS is comparable to that reported for alternative agents
used in second line therapy after platinum therapy.
Poster: "Final results of a combination study between trabectedin
and pegylated liposomal doxorubicin (PLD) in patients with advanced
malignancies," presented in Developmental Therapeutics: Molecular
Therapeutics session (Sunday 15 May, 8:00-12:00pm) by Dr R. Cohen
from Fox Chase Cancer Center.
The final results of a combination study on YONDELIS (trabectedin)
and Pegylated Liposomal Doxorubicin (PLD) in patients with advanced
malignancies (Phase I) were presented.
A Phase I trial of 30 heavily pre-treated patients was conducted
to study the combination of YONDELIS and PLD, known as CAELYX(R) in
Europe, and DOXIL(R) (doxorubicin HCI liposome injection) in the US.
The recommended dose of YONDELIS combined with 30 mg/m2 PLD every
three weeks is 1.1 mg/m2 every 21 days. The combination was well
tolerated, and of the 30 patients included, six had a partial
response (2 sarcomas, 1 head & neck tumor, 1 peritoneal
adenocarcinoma, 1 vaginal adenocarcinoma and 1 neuroectodermal tumor)
and 14 had stable disease for more than three months.
YONDELIS has demonstrated activity in second line in ovarian
cancer as previously published. This study demonstrates the
combination of YONDELIS with PLD is well tolerated when administered
at near full therapeutic doses for prolonged periods of time. A Phase
III pivotal study in ovarian cancer comparing the combination of
YONDELIS plus DOXIL to DOXIL alone is ongoing to demonstrate that
YONDELIS plus DOXIL is superior to DOXIL as a single agent, in second
line in the treatment of patients with ovarian cancer.
Poster: "Tumor control and objective responses: single-centre
experience with ecteinascidin-743 (ET-743, Yondelis), an active
compound for the treatment of patients with advanced soft tissue and
bone sarcomas." presented in Sarcoma session (Sunday 15 May,
1:00-5:00pm) by Dr P. Schöffski et al from University Hospital
Gasthuisberg, Leuven (Belgium).
This poster summarised data on YONDELIS (trabectedin), in the
treatment of patients with advanced soft tissue and bone sarcomas.
A retrospective analysis was performed of data from a
single-centre of patients who received YONDELIS in a named-patient
compassionate use program sponsored by PharmaMar. A total of 89
patients were treated with YONDELIS given as a 24h infusion every
three weeks.
This analysis concluded that YONDELIS induced long-lasting
responses and tumor control in a clinically relevant proportion of
heavily pre-treated sarcoma patients (RR: 6.7%; clinical benefit at
three and six months was 43% and 25% respectively; median duration of
response: 9.8 months), with acceptable toxicity.
Poster: "Trabectedin in third line breast cancer: A multicenter,
randomized, Phase II study comparing two administration regimens."
will be presented in the Breast Cancer poster session today from 2:00
to 6:00pm by Dr J. Gurtler et al from Fox Chase Cancer Center.
This poster will discuss data regarding YONDELIS (trabectedin) in
third line breast cancer treatment. Patients with advanced breast
cancer previously treated with both anthracyclines and taxanes were
randomized in a multicenter Phase II study to receive YONDELIS either
weekly or every 3 weeks.
Dr Miguel Angel Izquierdo, Director of Clinical Development at
PharmaMar, said: "PharmaMar and J&JPRD are committed to developing
YONDELIS based on encouraging available clinical data. The companies
believe that YONDELIS may have a place in the therapeutic
armamentarium to provide benefit to patients suffering from incurable
cancers, thus fulfilling an unmet medical need in many clinical
situations."
Kahalalide F presentation
Poster: "Clinical and pharmacokinetic Phase I dose-finding study
of Kahalalide F (KF) administered as a prolonged infusion in patients
with solid tumors." presented in Developmental Therapeutics:
Cytotoxic Chemotherapy session (Sunday, 15 May, 8:00 - 12:00pm ) by
Dr R. Salazar et al from the Catalan Institute of Oncology, Barcelona
(Spain).
This poster presented the data of a Phase I trial of Kahalalide F
in patients with solid tumors.
The primary endpoint of the study was to identify the recommended
dose and to determine safety, toxicity profile and Dose Limiting
Toxicities (DLT) for Kahalalide F when administered weekly as a 3 h
or a 24 h infusion. Secondary objectives were to study Kahalalide F
pharmacokinetics and to document anti-tumor activity.
The results of the three hour arm were presented in this poster.
Overall, most toxicities were mild to moderate (G1-2). Grade 3-4 was
only reached by hypersensitivity and laboratory abnormalities. The
asymptomatic and reversible increases in transaminases constituted
the DLT for the schedule.
The recommended dose for Phase II for the three hour schedule
was 1 mg/m2 per week.
A Complete Response (CR) was reported in a patient with melanoma
and Stable Disease (SD) lasting for >3 months was seen in lung
(NSCLC), colon and unknown origin adenocarcinoma patients. These
findings suggest potential targets for Phase II evaluation of
Kahalalide F given as weekly 3 h infusions.
The conclusion of the study was that Kahalalide F may be
administered safely as a weekly 3-hour intravenous infusion at a dose
of 1000 mg/m squared. Future Phase II studies in patients with solid
tumors are warranted.
About YONDELIS(TM)
YONDELIS (trabectedin), is PharmaMar`s most advanced compound in
development. It was originally isolated from the marine tunicate
Ecteinascidia turbinata, but now is manufactured by chemical
synthesis. YONDELIS is being developed by PharmaMar in partnership
with Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
If key studies are successful and support marketing approval,
PharmaMar will market YONDELIS in Europe (including Eastern Europe)
while Tibotec Therapeutics, a division of Ortho Biotech Products,
L.P., will market it in the U.S., Ortho Biotech, a division of
Janssen-Cilag, will market it in the rest of the world.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.,
Ortho Biotech Products, L.P. and Tibotec Therapeutics all are part of
the Johnson & Johnson Family of Companies, the world`s most
comprehensive and broadly based manufacturer of health care products.
YONDELIS is currently under study in a Phase III pivotal trial in
ovarian cancer, and is also being evaluated in Phase II in soft
tissue sarcoma (a comparative pivotal trial) and for prostate cancer.
In clinical studies to date, YONDELIS has shown a good safety and
tolerability profile. The most frequent side effect is neutropenia,
which is reversible and controllable. A transient increase in
transaminases also has been observed.
YONDELIS is a new chemical entity with unique multicomponent
mechanism of action. It is the only chemotherapy agent that binds to
the DNA`s minor groove and bends toward the major groove, producing
its therapeutic effect by interfering with various cell division
processes.
DOXIL(R) (doxorubicin HCl liposome injection) is marketed in the
United States by Tibotec Therapeutics, a Division of Ortho Biotech
Products, L.P., and in Israel by Janssen-Cilag. Schering-Plough
Corporation, under a licensing agreement, has exclusive rights to
market this medication as CAELYX(R) throughout the rest of the world,
excluding Japan.
About Kahalalide F
Kahalalide F is a depsipeptide, a novel marine-derived
anti-tumour agent isolated from the sea slug Elysia rufescens.
Kahalalide F alters the function of the lysosomal membrane, a
mechanism that distinguishes it from all other known anti-tumour
agents. Other mechanisms of action are inhibition of the TGF-alpha
expression, blockade of intracellular signalling pathways downstream
of EGF and ErbB2 receptor family and induction of non-p53 mediated
apoptosis. Studies demonstrate that Kahalalide F induces cell
necrosis in vivo (oncosis) and shows selectivity for tumor compared
with normal cells in vitro. Its activity is independent of multidrug
resistance (MDR) expression.
Kahalalide F is currently undergoing Phase II clinical trials in
various solid tumours: melanoma, non-small cell lung cancer and
hepatocellular carcinoma. A Phase II trial for the treatment of
patients with severe psoriasis is also ongoing.
Orlando, Florida (ots/PRNewswire) -
- New Results Presented at ASCO
Results from five clinical studies of YONDELIS (TM) (trabectedin)
were presented at the Annual Meeting of the American Society of
Clinical Oncology (ASCO), in Orlando, Florida, from 13-17 May 2005.
YONDELIS is being developed by PharmaMar in partnership with Johnson
& Johnson Pharmaceutical Research & Development, L.C.C. (J&JPRD).
In addition, a poster was presented on a second PharmaMar
anti-cancer drug, Kahalalide F.
YONDELIS presentations
Results from a Phase II study of a three hour, weekly infusion of
YONDELIS (trabectedin) in patients with androgen-independent advanced
prostate carcinoma were presented during an oral session (Sunday, 15
May, 11:15 - 11:30 am) by Dr D. Michaelson of the Massachusetts
General Hospital Cancer Center in Boston, MA.
This Phase II trial was designed to test the activity of
weekly administration of YONDELIS in patients with hormone refractory
prostate cancer with high levels of PSA (prostate specific antigen, a
biological marker related to tumor activity).
The primary objective of the trial was to assess the PSA responses
to the treatment, confirmed by decrease of PSA blood levels.
In this study, 27 patients have been enrolled to date; 19 received
YONDELIS as second line chemotherapy (following the approval of
Taxotere(R) (docetaxel) in 2004 by the U.S. Food and Drug
Administration (FDA) as standard front-line chemotherapy for
androgen-independent prostate cancer); eight patients received
YONDELIS as a first line therapy. Fourteen of the patients enrolled
were refractory to docetaxel-based chemotherapy.
The preliminary results demonstrated an overall PSA response rate
in the docetaxel refractory population of about 14% (two out of 14
patients). Another PSA response was observed in a chemotherapy naïve
patient. An additional three men have demonstrated an initial PSA
decline that will be assessed in subsequent evaluations as they are
still receiving treatment. To date, the overall PSA response rate is
12% (3/26 evaluable patients including one chemotherapy naïve
patient). A symptomatic improvement, with an average sustained PSA
response of 23 weeks, was observed in all the PSA responders.
The preliminary safety results indicate good tolerance of weekly
administration: no patients presented grade 4 adverse events. The
most frequent adverse events were fatigue, nausea and anaemia; only
five patients experienced grade 3 fatigue.
The activity observed in this study, including activity in
patients refractory to taxotere (docetaxel), is encouraging for the
further evaluation of YONDELIS in patients with prostrate cancer.
"This is encouraging data," said Dr. Michaelson. "The results from
this study suggest that YONDELIS is effective in reducing PSA and
alleviating pain in approximately 12% of men with advanced prostate
cancer. Most encouraging is that YONDELIS appears to have the same
level of activity in men who are refractory to standard chemotherapy
with docetaxel, for whom there is currently no established effective
treatment. Thus, YONDELIS should be studied further in this setting,
and may bring new hope to men with advanced prostate cancer."
An additional cohort of patients will now be recruited to expand
the study of YONDELIS in prostate cancer.
Poster: "Final results of Phase II study of weekly trabectedin in
second-line and third-line ovarian carcinoma," presented in
Gynaecologic Cancer session (Saturday 14 May, 1:00-4:00pm) by Dr. S.
McMeekin, University of Oklahoma Health Science Center.
The final results of a Phase II study of weekly YONDELIS
(trabectedin) administration in second/third line ovarian carcinoma
were presented.
The study in pre-treated patients with advanced ovarian cancer
featured a weekly dosing schedule using a 0.58 mg/m2 infusion. In the
platinum sensitive group (treatment free interval of 6 months or
greater) 55 patients were treated; the response rate was 28.8% and
the median PFS was 5.1 months. In the platinum resistant group
(treatment free interval of less than 6 months) 64 patients were
treated; the response rate was 4.8% and the median PFS was 2.0
months. Grade 3-4 toxicities in pooled cycles were reversible liver
ALT (alanine aminotransferase) elevation (12%), neutropenia (8%),
fatigue (5%), and nausea/vomiting (4%).
The conclusions of this study are that YONDELIS is active and well
tolerated when administered as a 3-hour infusion for three weeks out
of a four-week cycle in platinum sensitive patients.
This is the second study where YONDELIS has shown activity in
second line ovarian cancer. The activity with this dose and schedule
of YONDELIS is comparable to that reported for alternative agents
used in second line therapy after platinum therapy.
Poster: "Final results of a combination study between trabectedin
and pegylated liposomal doxorubicin (PLD) in patients with advanced
malignancies," presented in Developmental Therapeutics: Molecular
Therapeutics session (Sunday 15 May, 8:00-12:00pm) by Dr R. Cohen
from Fox Chase Cancer Center.
The final results of a combination study on YONDELIS (trabectedin)
and Pegylated Liposomal Doxorubicin (PLD) in patients with advanced
malignancies (Phase I) were presented.
A Phase I trial of 30 heavily pre-treated patients was conducted
to study the combination of YONDELIS and PLD, known as CAELYX(R) in
Europe, and DOXIL(R) (doxorubicin HCI liposome injection) in the US.
The recommended dose of YONDELIS combined with 30 mg/m2 PLD every
three weeks is 1.1 mg/m2 every 21 days. The combination was well
tolerated, and of the 30 patients included, six had a partial
response (2 sarcomas, 1 head & neck tumor, 1 peritoneal
adenocarcinoma, 1 vaginal adenocarcinoma and 1 neuroectodermal tumor)
and 14 had stable disease for more than three months.
YONDELIS has demonstrated activity in second line in ovarian
cancer as previously published. This study demonstrates the
combination of YONDELIS with PLD is well tolerated when administered
at near full therapeutic doses for prolonged periods of time. A Phase
III pivotal study in ovarian cancer comparing the combination of
YONDELIS plus DOXIL to DOXIL alone is ongoing to demonstrate that
YONDELIS plus DOXIL is superior to DOXIL as a single agent, in second
line in the treatment of patients with ovarian cancer.
Poster: "Tumor control and objective responses: single-centre
experience with ecteinascidin-743 (ET-743, Yondelis), an active
compound for the treatment of patients with advanced soft tissue and
bone sarcomas." presented in Sarcoma session (Sunday 15 May,
1:00-5:00pm) by Dr P. Schöffski et al from University Hospital
Gasthuisberg, Leuven (Belgium).
This poster summarised data on YONDELIS (trabectedin), in the
treatment of patients with advanced soft tissue and bone sarcomas.
A retrospective analysis was performed of data from a
single-centre of patients who received YONDELIS in a named-patient
compassionate use program sponsored by PharmaMar. A total of 89
patients were treated with YONDELIS given as a 24h infusion every
three weeks.
This analysis concluded that YONDELIS induced long-lasting
responses and tumor control in a clinically relevant proportion of
heavily pre-treated sarcoma patients (RR: 6.7%; clinical benefit at
three and six months was 43% and 25% respectively; median duration of
response: 9.8 months), with acceptable toxicity.
Poster: "Trabectedin in third line breast cancer: A multicenter,
randomized, Phase II study comparing two administration regimens."
will be presented in the Breast Cancer poster session today from 2:00
to 6:00pm by Dr J. Gurtler et al from Fox Chase Cancer Center.
This poster will discuss data regarding YONDELIS (trabectedin) in
third line breast cancer treatment. Patients with advanced breast
cancer previously treated with both anthracyclines and taxanes were
randomized in a multicenter Phase II study to receive YONDELIS either
weekly or every 3 weeks.
Dr Miguel Angel Izquierdo, Director of Clinical Development at
PharmaMar, said: "PharmaMar and J&JPRD are committed to developing
YONDELIS based on encouraging available clinical data. The companies
believe that YONDELIS may have a place in the therapeutic
armamentarium to provide benefit to patients suffering from incurable
cancers, thus fulfilling an unmet medical need in many clinical
situations."
Kahalalide F presentation
Poster: "Clinical and pharmacokinetic Phase I dose-finding study
of Kahalalide F (KF) administered as a prolonged infusion in patients
with solid tumors." presented in Developmental Therapeutics:
Cytotoxic Chemotherapy session (Sunday, 15 May, 8:00 - 12:00pm ) by
Dr R. Salazar et al from the Catalan Institute of Oncology, Barcelona
(Spain).
This poster presented the data of a Phase I trial of Kahalalide F
in patients with solid tumors.
The primary endpoint of the study was to identify the recommended
dose and to determine safety, toxicity profile and Dose Limiting
Toxicities (DLT) for Kahalalide F when administered weekly as a 3 h
or a 24 h infusion. Secondary objectives were to study Kahalalide F
pharmacokinetics and to document anti-tumor activity.
The results of the three hour arm were presented in this poster.
Overall, most toxicities were mild to moderate (G1-2). Grade 3-4 was
only reached by hypersensitivity and laboratory abnormalities. The
asymptomatic and reversible increases in transaminases constituted
the DLT for the schedule.
The recommended dose for Phase II for the three hour schedule
was 1 mg/m2 per week.
A Complete Response (CR) was reported in a patient with melanoma
and Stable Disease (SD) lasting for >3 months was seen in lung
(NSCLC), colon and unknown origin adenocarcinoma patients. These
findings suggest potential targets for Phase II evaluation of
Kahalalide F given as weekly 3 h infusions.
The conclusion of the study was that Kahalalide F may be
administered safely as a weekly 3-hour intravenous infusion at a dose
of 1000 mg/m squared. Future Phase II studies in patients with solid
tumors are warranted.
About YONDELIS(TM)
YONDELIS (trabectedin), is PharmaMar`s most advanced compound in
development. It was originally isolated from the marine tunicate
Ecteinascidia turbinata, but now is manufactured by chemical
synthesis. YONDELIS is being developed by PharmaMar in partnership
with Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
If key studies are successful and support marketing approval,
PharmaMar will market YONDELIS in Europe (including Eastern Europe)
while Tibotec Therapeutics, a division of Ortho Biotech Products,
L.P., will market it in the U.S., Ortho Biotech, a division of
Janssen-Cilag, will market it in the rest of the world.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.,
Ortho Biotech Products, L.P. and Tibotec Therapeutics all are part of
the Johnson & Johnson Family of Companies, the world`s most
comprehensive and broadly based manufacturer of health care products.
YONDELIS is currently under study in a Phase III pivotal trial in
ovarian cancer, and is also being evaluated in Phase II in soft
tissue sarcoma (a comparative pivotal trial) and for prostate cancer.
In clinical studies to date, YONDELIS has shown a good safety and
tolerability profile. The most frequent side effect is neutropenia,
which is reversible and controllable. A transient increase in
transaminases also has been observed.
YONDELIS is a new chemical entity with unique multicomponent
mechanism of action. It is the only chemotherapy agent that binds to
the DNA`s minor groove and bends toward the major groove, producing
its therapeutic effect by interfering with various cell division
processes.
DOXIL(R) (doxorubicin HCl liposome injection) is marketed in the
United States by Tibotec Therapeutics, a Division of Ortho Biotech
Products, L.P., and in Israel by Janssen-Cilag. Schering-Plough
Corporation, under a licensing agreement, has exclusive rights to
market this medication as CAELYX(R) throughout the rest of the world,
excluding Japan.
About Kahalalide F
Kahalalide F is a depsipeptide, a novel marine-derived
anti-tumour agent isolated from the sea slug Elysia rufescens.
Kahalalide F alters the function of the lysosomal membrane, a
mechanism that distinguishes it from all other known anti-tumour
agents. Other mechanisms of action are inhibition of the TGF-alpha
expression, blockade of intracellular signalling pathways downstream
of EGF and ErbB2 receptor family and induction of non-p53 mediated
apoptosis. Studies demonstrate that Kahalalide F induces cell
necrosis in vivo (oncosis) and shows selectivity for tumor compared
with normal cells in vitro. Its activity is independent of multidrug
resistance (MDR) expression.
Kahalalide F is currently undergoing Phase II clinical trials in
various solid tumours: melanoma, non-small cell lung cancer and
hepatocellular carcinoma. A Phase II trial for the treatment of
patients with severe psoriasis is also ongoing.
[ Seite: 1, 2, 3, 4 … 40, 41, 42, neuster Beitrag ]
Geben Sie Ihre Bewertung zu dieser Seite: sehr gut
1
2
3
4
5
6 schlecht
Problem melden?
Impressum | Werben | Jobs | Allgemeine Nutzungsbestimmungen | Disclaimer | Archiv | Sitemap | Hilfe | Kontakt | RSS |
wallstreet:online AG | Börsen- & Finanzwidgets für Ihre Homepage |
Kurse:
Zeitverzögerung der Kursdaten: Deutsche Börsen +15 Min. NASDAQ +15 Min. NYSE +20 Min. AMEX +20 Min. Dow Jones +15 Min.
Alle Angaben ohne Gewähr. Copyright © 1998-2012 wallstreet:online AG - Alle Rechte vorbehalten.