Amylin Ph.(WKN 883303) strong buy!
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Eröffnet am: | 11.12.01 10:46 | von: Calibra21 | Anzahl Beiträge: | 13 |
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Den ersten wichtigen Phase III Versuch mit seinem experimentellen Diabetes Wirkstoff AC2993 (Synthetisches Exendin-4)gab das US-Biotechunternehmen Amylin Parmaceuticals, Inc. (Nasdaq: AMLN) aus San Diego, Kalifornien, nun bekannt. AC2993 wird als potenzielle Therapiemöglichkeit für Typ 2 Diabetes Patienten gehandelt. Die geplante Studie zielt auf die Evaluierung des Wirkstoffes hinsichtlich der Kontrolle des Blutzuckerspiegels in Patienten mit Typ 2 Diabetes. In Patienten, die an Typ 2 Diabetes leiden ist es derzeit nicht möglich durch die alleinige Behandlung mit Metformin die gewünschte Blutzuckerkonzentration zu erreichen.
Die Studie soll an etwa 400 Personen durchgeführt werden. Die Patienten werden dabei nach dem Zufallsprinzip in drei Gruppen eingeteilt, zwei Gruppen erhalten den Wirkstoff AC2993, die dritte Gruppe erhält ein wirkstofffreies Ersatzpräparat, ein sogenanntes Placebo. Die beiden AC2993 Gruppen erhalten im ersten Monat zweimal täglich 5 Mikrogramm Wirkstoff subkutan verabreicht. Während der folgenden sechs Monate erhält eine Gruppe weiterhin 5, die zweite Gruppe 10 Mikrogramm zweimal täglich subkutan.
Die Studie ist eine von drei geplanten klinischen Versuchen des AMIGO Programmes mit AC2993. Das AMIGO (Diabetes Management for Improving Glucose Outcomes) Programm des Unternehmens zielt darauf, zu zeigen, dass AC2993 das Potenzial besitzt die Kontrolle des Blutzuckerspiegels in Typ 2 Patienten, die mit Metformin und/oder Sulfonylharnstoffen therapiert werden, zu verbessern. Die zweite Studie soll im Januar 2002 beginnen und soll die Effekte von AC2993 in Kombination mit Sulfonylharnstoff evaluieren. Die dritte Studie wird dann die Wirksamkeit von AC2993 in Kombination mit Metformin und Sulfonylharnstoff überprüfen und soll noch im ersten Quartal 2002 beginnen.
Hier die gestrige Meldung:
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Amylin Pharmaceuticals Initiates First Phase 3 Pivotal Trial of AC2993 (Synthetic Exendin-4) in Type 2 Diabetes
MONDAY, DECEMBER 10, 2001 7:30 AM
- PRNewswire
Amylin Pharmaceuticals Initiates First Phase 3 Pivotal Trial of AC2993 (Synthetic Exendin-4) in Type 2 Diabetes
12/10/2001 7:30:00 AM
SAN DIEGO, Dec 10, 2001 /PRNewswire via COMTEX/ -- Amylin Pharmaceuticals, Inc. (AMLN) today announced the initiation of the first Phase 3 pivotal trial of AC2993 (synthetic exendin-4), following a meeting with approximately 80 investigators this past weekend. AC2993 is a compound being studied as a potential treatment for people with type 2 diabetes. This study will evaluate the ability of AC2993 to improve glucose control in people with type 2 diabetes who are currently not achieving target blood glucose levels with metformin alone.
The study will include approximately 400 subjects. Study participants will be randomized into three groups, two on AC2993 and one on placebo. Those on drug will receive an introductory 5 microgram dose of AC2993 for one month, given by subcutaneous injection twice a day at breakfast and dinner. This will be followed by six-months of exposure to doses of either 5 micrograms or 10 micrograms given twice a day at breakfast and dinner. Participants who complete the study will be given the opportunity to enter an open-label extension.
This study is one of three planned Phase 3 studies in the Company's "AC2993: Diabetes Management for Improving Glucose Outcomes" (AMIGO) development program. The AMIGO studies are aimed at demonstrating AC2993's ability to improve glucose control in people with type 2 diabetes who are currently not achieving target blood glucose levels with metformin and/or sulfonylureas. The second study, planned to begin in January 2002, will evaluate the effects of AC2993 when added to sulfonylureas alone. The third study will evaluate the effects of AC2993 when added to the combination of metformin and sulfonylureas, and is planned to begin in the first quarter of 2002.
AC2993 is a 39-amino acid peptide being studied for the treatment of type 2 diabetes. AC2993 has been shown in clinical studies to stimulate secretion of insulin in the presence of elevated blood glucose concentrations, but not during periods of low blood glucose concentrations (hypoglycemia). AC2993 has also been shown in clinical studies to reduce both post-meal and fasting blood glucose levels.
Amylin Pharmaceuticals is engaged in the discovery and development of potential drug candidates for the treatment of metabolic disorders. The Company's lead drug candidate, SYMLIN(TM) (pramlintide acetate), is targeted as a treatment for people with diabetes who use insulin. In October 2001, the Company received an FDA approvable letter for SYMLIN; however, approval is subject to additional clinical work. Marketing Authorization Applications for SYMLIN were submitted in Europe in May 2001 and have since been accepted for filing by the EMEA and Swiss Regulatory Authorities. The Company has adopted a commercialization plan for SYMLIN that includes establishment of an internal commercial organization. Amylin Pharmaceuticals' second diabetes drug candidate, AC2993, is targeted for the treatment of type 2 diabetes. A long-acting release formulation of AC2993, or AC2993 LAR, is in Phase 1 development. The Company's third drug candidate, AC3056, is currently in Phase 1 evaluation as a potential treatment for metabolic disorders relating to cardiovascular disease. The Company is evaluating arrangements with companies that may add value to its development and commercialization efforts for SYMLIN and AC2993 in the US as well as in Europe, Japan and other markets. Amylin Pharmaceuticals is based in San Diego, California and currently has approximately 220 employees. Further information on Amylin Pharmaceuticals and its pipeline in metabolism is available at www.amylin.com.
This press release contains forward-looking statements about the Company, which involve risks and uncertainties. The Company's actual results could differ materially from those forward-looking statements discussed in this press release, due to a number of risks and uncertainties, including risks and uncertainties in the FDA's review of NDAs generally, risks and uncertainties in FDA requirements for SYMLIN approval, including risks and uncertainties that approval, if any, may be delayed and/or limited by indications, risks and uncertainties in the review of the Company's European Marketing Authorization Applications for SYMLIN, risks and uncertainties regarding the drug discovery and development process, uncertainties regarding the Company's ongoing clinical studies of its drug candidates and the ability of the Company to commercialize its drug candidates, whether through sales, distribution, marketing and/or corporate partnering agreements, on terms acceptable to the Company or otherwise. Additional risks and uncertainties are described more fully in the Company's most recently filed SEC documents, such as its Annual Report on Form 10-K for the fiscal year ended December 31, 2000 under the heading "Risk Factors," and its subsequently filed
R.
Aber die FDA beriet ja schon im September über das neue Medikament
Symilin. Die FDA unterstrich grundsätzlich ihre positive Haltung gegenüber
Symilin. Noch ist das Medikament nicht zugelassen. Entscheidend für die Zulassung sind neue Studien und eine neue Überprüfung durch die FDA.
Aber auch europäische Zulassungsbehörden diskutieren bereits über die Freigabe.
Ein paar Stücke kann man sich deshalb schon ins Depot legen.
Denn wenn die Zulassung kommt kann es schon zu spät für den Einstieg sein
Gruß DB
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Das Bessere ist des Guten Feind!!
http://phx.corporate-ir.net/...&p=irol-newsArticle&ID=1653756
Wie gehts weiter?
pkera