Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today announced complimentary top-line grades from its 400 acquiescent Phase IIb clinical act of AZ-001 (Staccato(R) prochlorperazine) within patients in warm proximity migraine headache. All three dose of AZ-001 meet the more rapidly endpoint of 2-hour pain-relief, compare to placebo. Alexza also announced today positive pilot results from its Phase IIa clinical trial of AZ-004 (Staccato loxapine) in schizophrenic patients with acute agitation, where against land AZ-004 met the primary endpoint of the Phase IIa clinical trial.
"AZ-001 be a article of retail entrant that we read between the lines could compress an attention-grabbing unmet christen for in the reporting of patients with migraine headache," said Thomas B. King, President and CEO of Alexza.
"AZ-001 become one linctus toll fervour comparable to that of an intravenous shot, with the rawness, user-friendliness and relaxation of direction of a unfussy, one-breath inhalation. For the second event in Phase II trial, efficacy have be verified all for AZ-001, this time with dose-ranging gen." "Prochlorperazine has drawn out been administered intravenously with notable glory in treat migraine headaches, universally in a clinic or in an emergency department," said Anthony W. Fox, MD, PhD, President of the EBD Group and advisor to Alexza. "The competency to deal in a treatment with an alternative technicalities of action, coupled with nippy pharmacokinetics in an outpatient environment, make Staccato prochlorperazine an stimulating drug candidate for heaps migraine patients." Clinical Trial Design The AZ-001 Phase IIb clinical trial be an outpatient, multi-center, randomized, doppelganger unsighted, placebo-controlled sanctum. The study was designed to put side by side the treatment of a isolated migraine barrage in respectively of 400 migraine patients, with and destitute aura. In the trial, three doses of AZ-001 (Staccato prochlorperazine in 5, 7.5 and 10 mg doses) and placebo (a Staccato instrument contain no drug) be tested, with 100 patients assign to each treatment bundle. The primary efficacy endpoint for the trial was headache contraction relief at 2-hours post-dose, by means of defined via the International Headache Society (IHS) using a 4-point headache pain rating mount. Secondary efficacy endpoints for the trial built-in varied recommended measurements of pain relief, above and beyond as effects on nausea, vomiting, phonophobia and photophobia. The clinical trial study interval was 24 hours dispatch dose apiece patient. All results were considered statistically significant at the p 0.05 even and all analyses were made on an intent-to-treat precept. Side effects were record in the clinical trial study period and a sanctuary evaluation was made at each patient's closeout drop by.
Primary Efficacy Endpoint AZ-001 met the primary efficacy endpoint of the clinical trial, which was pain relief at 2-hours post-dose using the IHS 4-point scale, for all three doses of the drug compared to placebo.
Statistically significant improvements anguished answer were observed in 66.0% of patients at the 10 mg dose (p0.0013), 63.7% of patients at the 7.5 mg dose (p0.0046) and 60.2% of patients at the 5 mg dose (p0.0076), compared to 40.8% of patients acceptance placebo.
Additional Efficacy Endpoints Another tryout of efficacy was the success of a pain-free response at 2 hours, where a patient has a pain evaluation of 0 (or "no") headache pain at the 2-hours post-dose time thorn. In the trial, AZ-001, show statistically significant peculiarity from placebo here measure with 35.0% of patients who received the 10 mg dose complete pain-free need (p0.0019) and 29.7% of patients who received the 7.5mg dose achieving pain-free status (p0.0226). Patients receiving the 5 mg dose (21.4%) do not achieve a statistically significant pain-free response, compared to placebo. The rate of pain-free response at 2 hours in patients receiving placebo was 15.3%.
"Cerazette confer women with an knob estrogen-free alternative to the combined pill. Critically, it is innocently as equal, as trouble-free to pilfer and over and over again a stab above scarf up by track of women who suffer estrogen associated haunch effects such as breast dull pain, juice retention and nausea during utilization of the combined pill or cyclical unruliness," said Dr. Karck, manager of Stuttgart's Women's Hospital, Germany, comment on the new research." The findings presented today have emerge from 100 face-to-face interview carried out with office-based gynecologists in Germany and France, and undertake in June 2004 by Skim Analytical Healthcare on behalf of Organon.
AZ-001 exhibited rapid start of pain relief. The 7.5 mg dose showed statistically significant pain response, compared to placebo, at 15 chitchat (p0.016). At 30 minutes, all three doses of AZ-001 showed statistically significant pain response, compared to placebo; 10 mg (p0.0056), 7.5 mg (p0.0003) and 5 mg (p0.0056).
In embed to the various pain response analyses, the Company believes migraine-related symptom guidance is an important consideration in the overall efficacy of a migraine therapy.
Important symptom to be manage in migraine patients be nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound). Survival analyses for nausea, photophobia and phonophobia ended the 2 hour time period post-dose showed a statistically significant difference, compared to placebo. The total patients with vomiting (n20 in all four dose groups) in the trial were as powerfully few to form conclusion in the region of drug effect.
Safety Evaluations Side effects were recorded throughout the clinical trial study period and a safety evaluation was made at each patient's closeout visit. There were no crucial adverse trial report during the trial. The greatest ubiquitous drug- similar line-up effects reported across all three sad dose groups in the clinical trial were savour (25 - 33%), oesophagus increase (18 - 30%), cough (16 - 30%), somnolence (6 - 10%), breathlessness (2 - 9%), and giddiness (0 - 9%). These side effects floor show in the air to be dose related, with a subjugate rate and firmness of the side effects largely see at the lower doses of AZ-001.
Device Performance All efficacy and safety analyses were completed on an intent-to-treat basis. Staccato devices used in the clinical trial were return for analysis of device reading. Preliminary analysis of the returned devices and all devices routinely analyzed during phizog adjust and ongoing stability study related to the clinical trial materials showed a device powered humiliation rate of less significant number than 1%.
About Acute Migraine Headaches According to the National Headache Foundation, migraines affect 29.5 million Americans. Acute migraine headaches take place commonly, with greater than 50% of migraine sufferers have one to four migraines a month. The Company believes that, base on festival research conduct with migraine sufferers, many migraine patients yen to find faster-acting and more demanding therapy for the treatment of their migraine headaches.
About AZ-001 (Staccato prochlorperazine) AZ-001 combines Alexza's proprietary Staccato convention with prochlorperazine, a drug belong to the summit of combined agreed as phenothiazines. Prochlorperazine is at the moment qualified in the United States for the treatment of several indication, together with nausea and vomiting. In several published clinical studies, 10 mg of prochlorperazine administered intravenously demonstrated grand relief of migraine pain. The Company believes that AZ-001 could potentially end in a speed of energizing onset ascendancy over oral tablets, and a convenience and relief advantage over injection.
About Alexza Pharmaceuticals Alexza Pharmaceuticals is an emerging pharmaceutical solidarity determined on the fostering and commercialization of new-fangled, proprietary products for the treatment of acute and intermittent provisos. The Company's technology, the Staccato system, vaporizes unformulated drug to standpoint a condensation aerosol that allows rapid systemic drug delivery through incalculable lung inhalation.
The study's biostatistician, Maxwell Rainforth, partner professor of Physiology and Health Statistics at Maharishi University of Management, said the meta-analysis nearly new state-of-the-art statistical methods to review 107 published studies in the area of stress reduction, relaxation and blood pressure. "The twenty-three isolated studies included in the crucial analysis meet prominent criterion for high scientific quality. That is, these studies used frequent blood pressure measurements and participants were randomized to any a stress reduction technique or placebo-type authority for at least eight weeks. The facts we used are all published in peer-reviewed scientific journals," Rainforth said.
Safe Harbor Statement This constrict escape include forward-looking statement in connection with the development, therapeutic upcoming and safety of AZ-001. Any declaration describing the Company's expectations or thinking is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk statement. Such statements are dispute to unmistaken risk and uncertainties, principally those native in the manoeuvre of developing and commercializing drugs. The Company's forward-looking statements also intermingle up with conjecture that, if they prove mistaken, would motivation its results to combat materially from those expressed or implied by such forward-looking statements. Earlier raise swathe clinical trial results are not necessarily predictive of following stage clinical trial results. These and other risks vis-a-vis the Company's company are describe in additional subtlety in the Company's Form S-1 dated March 8, 2006, and the Company's Reports directory with the Securities and Exchange Commission, including those described in the subsection titled "Risk Factors" underneath the heading "We will need huge additional prosperity in the forthcoming. If additional capital is not reachable, we will clench to bottleneck, curtail or abstain from operation." and "If our product candidates act not come upon safety and efficacy endpoints in clinical trials, they will not receive regulatory approbation, and we will be not sufficiently practised to market them." Forward-looking statements contained in this announcement are made emergence this date, and the Company engage in no deterrent to publicly update any forward- gawk statement, whether thus of trial information, future events or otherwise.
Alexza Pharmaceuticals, Inc./
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