Transkaryotic mit positiver frühklinischer Studie - 500 Beiträge pro Seite

[puhvogel]

08:46 ET Transkaryotic reports long-term Hunter syndrome study results (TKTX)
Co announces that its lead clinical investigator presented long-term data from TKT`s Phase I/II clinical trial evaluating iduronate-2-sulfatase enzyme replacement therapy for the treatment of Hunter syndrome, also referred to as MPS II, a debilitating disease for which there is currently no effective therapy. The one-year data showed improvements in a variety of clinical measures and continued to demonstrate a favorable safety profile. "The significant clinical improvements observed in these patients treated with I2S at both six and twelve months indicates that this product provides a clinical benefit and appears to represent a promising treatment for Hunter syndrome."
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TKT`s Long-Term Hunter Syndrome Phase I/II Data Show Continued Improvement in Patients
Thursday September 4, 8:43 am ET


BRISBANE, Australia, Sept. 4 /PRNewswire-FirstCall/-- Transkaryotic Therapies, Inc. (Nasdaq: TKTX - News) today announced that its lead clinical investigator, Joseph Muenzer, M.D., Ph.D., of the University of North Carolina at Chapel Hill, presented long-term data from TKT`s Phase I/II clinical trial evaluating iduronate-2-sulfatase (I2S) enzyme replacement therapy for the treatment of Hunter syndrome, also referred to as MPS II, a debilitating disease for which there is currently no effective therapy. The one-year data showed improvements in a variety of clinical measures and continued to demonstrate a favorable safety profile. These findings were presented at the IXth International Congress of Inborn Errors of Metabolism meeting being held this week in Australia. Additional data from this study will be presented in November 2003 at the American Society of Human Genetics 53rd Annual Meeting.
"The significant clinical improvements observed in these patients treated with I2S at both six and twelve months indicates that this product provides a clinical benefit and appears to represent a promising treatment for Hunter syndrome," said Dr. Joseph Muenzer, Associate Professor of Pediatrics, Division of Genetics and Metabolism, Department of Pediatrics at the University of North Carolina at Chapel Hill.

After successfully completing the six-month randomized, double-blind, placebo-controlled study evaluating three doses of I2S (0.15 mg/kg, 0.5 mg/kg, and 1.5 mg/kg) bi-weekly for 24 weeks, all 12 patients elected to enroll in the open-label extension study. The six-month data showed a significant reduction in urinary glycosaminglycan (GAG) excretion, significant reductions in liver and spleen volumes, as well as reductions in left ventricular mass and improvements in forced vital capacity. Patients receiving placebo that crossed over to I2S also showed a similar treatment response. Patients showed a greater improvement in their joint range of motion and with the six-minute walk test at one year. Any significant infusion-related reactions that occurred were successfully managed by slowing the infusion rate and using pre- medications. Data from the six-month Phase I/II study were previously presented at the American Society of Human Genetics Annual Meeting in October 2002.

TKT is preparing to commence a pivotal study of I2S in September 2003. The primary objective of the study is to determine safety and efficacy of I2S as a treatment for Hunter syndrome. Ninety patients will be randomized to three treatment groups to receive either weekly or every other week infusions of I2S at a dose of 0.5 mg/kg or weekly infusions of placebo. The primary endpoint will be a single composite variable designed to evaluate the efficacy of I2S therapy across multiple outcomes. The composite variable will combine two clinical measurements: forced vital capacity as a measure of respiratory function and the six-minute walk test as a measure of functional capacity.

"The final preparations for the pivotal trial in patients with Hunter syndrome are being made and we are on track to begin enrolling patients in the trial this month," said Michael J. Astrue, President and Chief Executive Officer of TKT.



P.S.: Was soll denn eigentlich der Unsinn mit den historischen Threads. Gerade bei den Biotechs ist es eigentlich wichtig , dass man die Kontinuität der Nachrichten liest

[Heinerle2]

Da kannst Du gut sehen, ob sich bisher überhaupt jemand großartig für TKTX interessiert hat. Ich bin dabei, schon seit längerem, und das war bisher auch gut so *g*

Greetinxx Heinerle2

[Heinerle2]

...und hat sich weiter deutlich gebessert......

Greetinxx Heinerle2

[faku]

was meint ihr wie weit transk noch hoch geht ??
bin schon seit ewigkeiten dabei

[Heinerle2]

Schwierig zu sagen. Mein Kursziel leitet sich prozentual von meinem Einstiegskurs ab und hat nichts mit Charttechnik o.ä. zu tun. Ab >17 USD denke ich nach. Auf der anderen Seite könnte man den Eindruck bekommen, als sammle jemand das Zeugs peu a peu ein (Genzyme??)....

Greetinxx Heinerle2

[faku]

ich kann mich erinnern , daß das schon mal so war .
da wurde richtig gezockt : mal 10 $ rauf dann wieder runter .
da hab ich immer schön mitgemacht
aber diesmal könnte es wirklich was werden

[aquismat]

Starker Kursanstieg in USA !

Weiss jemand Gründe?

Ich vermute Fortschritte in der Entwicklung eines Produktes von Transkariotic Th.

Kursziel in den nächsten 5 Tagen: min. 23 $

[aquismat]

Und hier die Antwort auf meine eigene Frage (letzter "aquismat"):




Transkaryotic erhält Vermarktungsrechte zurück, Aktie plus 43 Prozent

Die Aktien des Biotechnologieunternehmens Transkaryotic Therapies Inc. verzeichnen am Freitag einen Höhenflug, nachdem das Unternehmen bekannt gab, die europäischen Vermarktungsrechte an einem Medikament von Aventis zurück gewonnen zu haben.

Die beiden Parteien haben bisher über die Rechte am Medikament namens Dynepo im Streit gelegen. Transcaryotic hat das Präparat entwickelt und dann eine Lizenz an Aventis vergeben. Die neue Übereinkunft sieht vor, dass Aventis die Vermarktung in den USA weiter behält und Transkaryotic außerhalb der USA diese Arbeit in die eigene Hand nimmt.

Die Aktien von Trankaryotic schießen um 43,00 Prozent auf 17,16 Dollar in die Höhe. Aventis schloss in Frankfurt mit einem Plus von 1,06 Prozent bei 61,90 Euro.

Wertpapiere des Artikels:
TRANSKARYOTIC THERAPIES INC
AVENTIS SA