Kategorie "alxa"

22
Oct

22:47 Uhr - zu alxa

Thema: alxa
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zu alxa noch einige Daten aus dem Quartalsbericht vom 13.Aug:

Der Verlust betrug 10,3 Mio und im ganzen 1HJ 2007 21,2 Mio

der Cash-Bestand beträgt 134 Mio,das soll nach alxa-Angaben bis Mitte 2009 reichen

Im Juni gab es noch einen Studienstart:
– In June, Alexza announced the initiation of a Phase IIa proof-of- concept clinical trial with AZ-104 (Staccato loxapine) in patients with migraine headache.  AZ-104 is a lower dose version of AZ-004, which is being developed to treat acute agitation in patients with schizophrenia. AZ-104 is being developed through Symphony Allegro. The Phase IIa clinical trial is an in-clinic, multi-center, randomized, double blind, single-administration, placebo-controlled study in approximately 160 migraine patients with or without aura.  Three doses of AZ-104 (1.25, 2.5 and 5 mg) will be evaluated against placebo in the clinical trial.  Using the IHS (International Headache Society) 4-point rating scale, the primary efficacy endpoint will be pain-relief response at 2 hours post-administration.  Secondary efficacy endpoints for the trial include additional pain response assessments and other symptom assessments at various time points. Safety evaluations will also be made throughout the clinical trial period. – Alexza completed a pre-IND meeting with the U.S. Food and Drug Administration for AZ-007 (Staccato zaleplon) and has named AZ-007 as its next product candidate targeted for clinical development.  The Company plans to develop AZ-007 for the treatment of sleep disorder in patients who have difficulty falling asleep, including those patients with middle of the night awakening who have difficulty falling back asleep.

Die Substanz AZ-007 ist die inhalierbare Version des Schlafmittels Sonata von King Pharm. Die IND soll im 4.Quartal 2007 beatragt werden

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Alexza selbst schätzt, dass etwa 200 bereits vermarktete Substanzen für die Aerosol-Technologie geeignet sind.
Wegen dem Cash und dem Vertrauen der Anleger in das Marktpotential der verbesserten Substanzen wir es für alxa wichtig sein, gute Entwicklungs-Partnerschaften zu erreichen.

Für Ende 2007 wird ein solcher Deal angestrebt. Die Qualität des Deals wird auch für den Kurs wichtig sein.

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Im 1.Quartal 2008 soll nun die erste Phase III Studie von Alexza`s vorderster Substanz AZ-004 beginnen. Die Studie soll in etwa 18 Monaten beendet sein, so dass Daten bzw. Ergebnisse für die zwiete Jahreshäfte 2009 zu erwarten sind. Die Frage wird auch sein, ob es wirklich Sinn macht und praktikabel ist, oft unwilligen Schizophrenie-Patienten die unter diesen Umständen schwieriger zu applizierende Inhalation zu verabreichen gegenüber der bisherigen Injektion. Durch die grössere Anzahl an Patienten in der Phase III könnte es hier aufschlussreiche Erkenntnisse geben.

Alexza to Initiate the First Phase 3 Trial for AZ-004 (Staccato(R) Loxapine) in Late Q1 2008
Tuesday September 18, 4:37 pm ET

PALO ALTO, Calif., Sept. 18 /PRNewswire-FirstCall/ — Alexza Pharmaceuticals, Inc. today announced that it expects to begin the first of two Phase 3 trials for AZ-004 (Staccato® loxapine) late in the first quarter of 2008. AZ-004 is initially being developed for the treatment of acute agitation in patients with schizophrenia or bipolar disorder. The two Phase 3 trials are anticipated to each enroll approximately 300 patients. AZ-004 is being developed through Symphony Allegro, a product development collaboration formed between Alexza and Symphony Capital, LLC.

AZ-004 is the combination of Alexza’s proprietary Staccato system with loxapine, a drug belonging to the class of compounds known as antipsychotics. AZ-004 combines drug delivery speed comparable to that of an intravenous injection, but with the simplicity, convenience and ease of administration of a simple, one-breath inhalation. In March 2007, Alexza reported the initial results of its Phase IIa clinical trial of AZ-004 in 129 schizophrenic patients with acute agitation. In that trial, the 10 mg dose of AZ-004 met the primary endpoint of the clinical trial, showing a statistically significant (p < 0.05) reduction in agitation compared to placebo. The primary endpoint in the trial was the change in the PANSS (Positive and Negative Symptom Scale) Excited Component (PEC) score at the 2-hour post-dose time point.

PEC Scores (Mean Values)
p-value
Study Arm        Baseline        2-hour Post-Dose       vs. placebo
10 mg AZ-004       17.3                 8.8               0.0001
5 mg AZ-004        17.6                10.8               0.088
Placebo            17.7                12.7                 -

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