New delivery methods for old drugs offer excellent investment opportunities IMO. ALXA has good pedigree with the founder being behind the old ALZA company. Guess this explains the close association in the two company names. Anyway, with two Phase II trial results to be announced next month it is worth paying close attention to these results as they have several projects under development with another planned for later this year. Stock is currently trading at $10.65 and I own a very small position in the stock.
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Recent Alexza Development Pipeline Highlights and Updates (2-07)
AZ-001 (Staccato prochlorperazine) for the treatment of migraine. In December 2006, Alexza announced the completion of enrollment in its 400 patient Phase IIb clinical trial with AZ-001. Initial results are expected to be reported in late March 2007. Using the International Headache Society 4-point rating scale, the primary efficacy endpoint for the trial is headache pain relief at 2 hours post-dose. Secondary efficacy endpoints for the trial include pain relief and other symptom assessments at various time points. Safety evaluations were made throughout the clinical trial. After the trial results are released, Alexza expects to provide information on specific 2007 development activities for AZ-001, based upon the efficacy and safety findings from the clinical trial.
AZ-004 (Staccato loxapine) for the treatment of acute agitation in schizophrenia. In January 2007, Alexza announced the completion of enrollment in its 120 patient, in-clinic Phase IIa clinical trial with AZ-004. The clinical trial enrolled faster than originally projected and initial results are now expected to be reported in late March 2007. The primary aim of the clinical trial was to assess the safety and efficacy of a single dose of AZ-004 in acutely treating agitation in schizophrenic patients. Assessments of a patient's agitation state were conducted at serial time points using both standard agitation scales and objective measures of patient's movement over a 4-hour period, with follow-up assessments for the next 20 hours. The change in the PANSS Excited Component (PEC) scale is the primary efficacy endpoint for the clinical study. Safety evaluations were made throughout the clinical trial period.
AZ-003 (Staccato fentanyl) for the treatment of acute pain episodes. In December 2006, the Company completed enrollment and announced initial results from its Phase I clinical trial with AZ-003. The clinical trial was conducted in opioid naive healthy volunteers in two stages. In Stage 1, the arterial pharmacokinetics (PK) of 25 .g of AZ-003 was compared to a 25 .g dose of fentanyl administered intravenously (IV). The AZ-003 PK was equivalent to the IV fentanyl PK, with similar peak plasma concentration (Cmax), time to maximum plasma concentration (Tmax), and area under the curve concentration (AUC). These data suggest complete bioavailability of the inhaled dose. Mean peak arterial plasma concentrations were observed within 30 seconds for both administration routes. In Stage 2 of the clinical trial, ascending doses of AZ-003, controlled by the Staccato system, exhibited dose-proportionality of fentanyl throughout the dosing range from 50 .g to 300 .g, following an AUC analysis. There were no serious adverse events attributable to AZ-003 and the results from the clinical study showed that AZ-003 was generally safe and well tolerated at all doses. During 2007, final study reports will be completed and Alexza plans to present data from this study in both scientific and medical forums. This is the first product candidate under development utilizing Alexza's Staccato Electric Multiple Dose (EMD) system, and Alexza plans no additional clinical development of AZ-003 during 2007, unless it is able to secure a corporate partner to support continued clinical and device development.
AZ-002 (Staccato alprazolam) for the treatment of acute panic. During 2006, Alexza initiated a Phase IIa proof-of-concept clinical trial with AZ-002 in patients with panic disorder. The primary aim of the clinical trial is to assess the safety and efficacy of a single dose of AZ-002 in treating a pharmacologically-induced panic attack. Changes in the intensity and the duration of the induced panic attack, using psychological and physiological measurements, are being evaluated at multiple time points during the study. Some of the first patients dosed in the study exhibited a higher level of sedation than had been observed at the same dose in healthy volunteers in the AZ-002 Phase I study. In consultation with the clinical investigator, Alexza modified the protocol to reduce the dose of AZ-001 and to include an open label lead-in stage of the study in which patient sedation will be assessed. Once an acceptable dose of AZ-002 is determined from this lead-in stage, the randomized, double-blind proof-of-concept stage of the study will begin, as originally designed. To facilitate patient enrollment in the clinical trial, Alexza has also recruited two additional clinical sites to conduct the study. In the manufacture of the new dosage strengths required for the amended protocol, a higher variability of the alprazolam emitted dose was observed. Further testing showed that alprazolam aerosols are electrically charged leading to variable deposition on the internal airway housing of the device. This aerosol characteristic is unique to alprazolam and is not observed in other Alexza development product candidates. Consequently, the manufacturing process for AZ-002 was modified to incorporate a conductive airway housing to reduce the effects of the electrically charged aerosol. Alexza has manufactured AZ-002 using the new airway housing, which the Company believes resolves the aerosol variability. Alexza is currently projecting that the AZ-002 Phase IIa study will be completed by the end of 2007.
Symphony Allegro. In December, Alexza announced a $50 million development agreement for AZ-002 and AZ-004. Under the terms of the development agreement, Alexza and Symphony Capital, a private equity firm, have established Symphony Allegro, Inc., which will provide funding to Alexza to support clinical and other related development activities of the two product candidates. The primary goal of the development agreement is to complete successful end-of-Phase II meetings with the U.S. Food and Drug Administration for both product candidates. Key planned development activities during 2007 for AZ-002 include the completion of the Phase IIa proof-of-concept study, the initiation of an abuse liability study and supporting ongoing non-clinical studies. Key planned development activities during 2007 for AZ-004 include the data analysis and release of initial results of the Phase IIa proof-of-concept study in agitated schizophrenic patients, the initiation of a multiple-dose pharmacokinetic study and supporting ongoing non-clinical studies. Symphony Allegro will also support the evaluation of additional indications for both product candidates resulting from the Staccato-based pharmacology of alprazolam and loxapine. |
