Wer hat denn das wieder mit Matrix gewußt

Patient benefit was also measured in these studies through the use of a treatment goal questionnaire. Of patients treated with IntraDose, 27% achieved a patient benefit, defined as the achievement of a single, pre-selected primary treatment goal. Overall, 34% of patients treated with IntraDose met a primary or secondary treatment goal and 21% of patients noted additional benefits (which were not pre-selected) such as improved swallowing, speech or psychological state and others benefits.

On November 2, 2001, Matrix received a non-approvable letter from the U.S. Food and Drug Administration (FDA) for its IntraDose New Drug Application (NDA) as a treatment for recurrent or refractory head and neck cancer. Matrix is currently evaluating the next steps for IntraDose in the U.S. with the FDA.

Clinical studies have shown IntraDose to be generally well tolerated. IntraDose has shown a favorable adverse event profile with a markedly lower incidence of systemic toxicities than are typically observed with intravenous chemotherapy administration. In studies of head and neck cancer, pain at the injection site that occurred during or immediately after injection was the most common side effect. Six cases of cerebrovascular events (CVEs) occurred early in the U.S. Phase III study of IntraDose for head and neck cancer. No further CVEs occurred after the protocol was changed to exclude tumors directly invading or in close proximity to the carotid artery.

About Matrix

Matrix Pharmaceutical, Inc. is headquartered in Fremont, California. The Company develops novel local and systemic cancer treatments that may improve or extend the lives of people living with cancer. In the field of systemic cancer treatment, Matrix is developing tezacitabine (FMdC), a next-generation nucleoside analogue for the treatment of solid tumors and hematologic malignancies. Matrix has also conducted studies of IntraDose, a novel drug system designed to provide local control of solid tumors through direct injection while reducing the systemic side effects associated with intravenous chemotherapy. Phase III studies of IntraDose have been conducted in head and neck cancer, and Phase II studies have been conducted in liver, breast, malignant melanoma, and esophageal cancer. Matrix is also actively seeking partnering opportunities for current and future products.

This press release contains, in addition to historical statements, certain forward-looking statements including whether the EMEA application will be approved and whether Matrix will continue to identify next steps for IntraDose in the U.S. Such statements are based on management's current expectations and are subject to a number of factors and uncertainties. Additional factors and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements are set forth under the heading ``Risk Factors'' in the Company's Annual Report on Form 10-K for the year ended December 31, 2000 and subsequent Form 10-Q's issued in 2001. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements, which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events except to the extent required under Federal Securities laws.

Matrix press releases are available at the Matrix web site www.matx.com .

SOURCE: Matrix Pharmaceutical, Inc.

ist natürlich hoch, aber es sei nicht daran zu denken was passiert wenn das klappt.

Wenn es sich als erfolgreich bei uns herausstellt, vielleicht überlegen die Amis es sich nochmal


Dann...

aber schau dir mal den Chart von Heute an   interressant  oder !!!????

Das biopharmazeutische Unternehmen Matrix Pharmaceutical, Inc. (NasdaqNM:MATX) gab Pläne bekannt, denenzufolge man um eine Zulassung eines experimentellen Wirkstoffes, zur Behandlung von Krebsarten im Kopf-/Halsbereich, in der Europäischen Union ersuche. Das Medikament mit der Bezeichung IntraDose Injizierbares Gel wurde erst kürzlich vom Beratergremium der US-Gesundheitsbehörde (FDA) abgelehnt. Das Beratergremium der FDA fordere, so hieß es, ausgedehntere klinische Versuche. Grund für diese Forderung des FDA-Gremiums waren die eher geringe Effektivität von IntraDose sowie die moderate bis schwere Toxizität des Wirkstoffes.

Matrix wird den Zulassungsantrag für IntraDose bei der EMEA (European Medicines Evaluation Agency) einreichen, um auf diese Weise in allen Ländern Europas eine Zulassung zu erhalten. Die Zulassungsdaten beruhen auf Ergebnissen zweier Studien mit Patienten, die an einem wiederkehrenden oder resistenten Tumor im Kopf-/Halsbereich erkrankt waren, wobei eine der Studien vorwiegend in Europa durchgeführt worden war. Die EMEA muss nun dem zentralisierten Zulassungsprozess für IntraDose noch zustimmen, sagte Michael Casey, Präsident und CEO der Firma Matrix.

Die zentralisierte Prozedur der Zulassung eines Wirkstoffes ist wesentlich rationeller und sollte sich IntraDose für diesen Prozess qualifizieren, würde es nach Genehmigung der Zulassung in ganz Europa auf den Markt kommen. Bei IntraDose handelt es sich um ein Kombinationsprodukt aus Cisplatin, einem herkömmlichen Zytostatikum, Epinephrin, einem Generikum eines Medikamentes, welches das Blut im Tumor hält, und einem Proteingel. Das Proteingel und Epinephrin wirken synergistisch und halten das Cisplatin im Tumor fest, um auf diese Weise eine verstärkte Wirkung zu garantieren. Matrix rechnet damit, den Zulassungsantrag noch im vierten Quartal 2001 an die EMEA zu überstellen.

"Matrix is very pleased that this important study of tezacitabine has been successfully completed," said Michael D. Casey, Chairman, President and CEO at Matrix. "We are eager to begin our new multi-center Phase II study in AML and plan to initiate additional Phase II studies of tezacitabine in esophageal and biliary cancer."

Tezacitabine is a novel nucleoside analog with a dual mechanism of action. It is both a potent inhibitor of ribonucleotide reductase and a DNA chain terminator. In pre-clinical studies, tezacitabine induces apoptosis and inhibits vascular endothelial growth factor (VEGF), which appears to be required for angiogenesis in many types of tumors. Tezacitabine has demonstrated synergism with radiation and with other marketed cytotoxic agents such as Ara-C and cisplatin.

Matrix has completed Phase I studies of tezacitabine in combination with cisplatin or 5-FU in solid tumors. Currently, Matrix is conducting Phase I studies of tezacitabine as monotherapy at different dosing schedules in a variety of solid tumors. Matrix anticipates these Phase I studies will be completed in the first half of 2002.

In the Phase I study of tezacitabine in acute leukemias, the most common tezacitabine-related adverse events were drug-related fever (48%), skin reactions (28%), chills (24%), and gastrointestinal events (nausea - 21%, diarrhea - 24%, constipation - 15%). Grade 3 and 4 mucositis occurred in only 3 patients; 1 patient experienced grade 3 neurotoxicity; and 1 patient experienced a grade 4 change in mental status. Tezacitabine was generally well-tolerated.

   About Matrix


Matrix Pharmaceutical, Inc. is headquartered in Fremont, California. The Company develops novel local and systemic cancer treatments that may improve or extend the lives of people living with cancer. In the field of systemic cancer treatment, Matrix is developing tezacitabine (FMdC), a next-generation nucleoside analogue for the treatment of solid tumors and hematologic malignancies. Matrix has also conducted studies of IntraDose, a novel drug system designed to provide local control of solid tumors through direct injection while reducing the systemic side effects associated with intravenous chemotherapy. Phase III studies of IntraDose have been conducted in head and neck cancer, and Phase II studies have been conducted in liver, breast, malignant melanoma, and esophageal cancer. Matrix is also actively seeking partnering opportunities for current and future products.

This press release contains, in addition to historical statements, certain forward-looking statements including whether Phase II studies of tezacitabine will be initiated. Such statements are based on management's current expectations and are subject to a number of factors and uncertainties. Additional factors and uncertainties which could cause actual results to differ materially from those described in the forward looking statements are set forth under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2000 and subsequent Form 10-Q's issued in 2001. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements, which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events except to the extent required under Federal Securities laws.

Matrix press releases are available at the Matrix web site www.matx.com .


mfg
Walter99