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Aeterna Zentaris Concludes Successful Meeting of Clinical Investigators for Confirmatory Phase 3 Trial of Macrilen
ih.advfn.com/...047540&xref=newsalerttweet&adw=1126416
ih.advfn.com/...047540&xref=newsalerttweet&adw=1126416
Hat jemand News? Woher kommt dieser Kurssprung?
In eine parallelforum gibt es aktuell folgende Meldung:
finance.yahoo.com/news/...es-successful-meeting-133000601.html
Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the Company) announced today that it concluded a successful meeting of the clinical investigators for the confirmatory Phase 3 trial of Macrilen (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency (AGHD). As a result, the Company is confident that it will complete the confirmatory trial by year-end 2016.....
In eine parallelforum gibt es aktuell folgende Meldung:
finance.yahoo.com/news/...es-successful-meeting-133000601.html
Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the Company) announced today that it concluded a successful meeting of the clinical investigators for the confirmatory Phase 3 trial of Macrilen (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency (AGHD). As a result, the Company is confident that it will complete the confirmatory trial by year-end 2016.....
$3.20 // +19.85%
www.nasdaq.com/de/symbol/aezs/premarket
WKN: A1439Z
ISIN: CA0079754028
Symbol: AEZS
Typ: Aktie
Aufnehmen in Watchlist/Depot
Aeterna Zentaris Concludes Successful Meeting of Clinical Investigators for Confirmatory Phase 3 Trial of Macrilen™
14:35 19.01.16
FRANKFURT, Germany --(BUSINESS WIRE)--
Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the “Company”) announced today that it concluded a successful meeting of the clinical investigators for the confirmatory Phase 3 trial of Macrilen™ (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency (“AGHD”). As a result, the Company is confident that it will complete the confirmatory trial by year-end 2016.
Dr. Richard Sachse, the Company’s Chief Scientific Officer stated, “On January 16, we held an Investigators’ Meeting for our multi-center confirmatory Phase 3 clinical trial of Macrilen™. The purpose of the meeting was to review Macrilen™ with the investigators, as well as the clinical trial protocol. The 77 investigators and site personnel who attended the meeting included Jose Manuel Garcia, MD, PhD, Associate Professor of Medicine at University of Washington School of Medicine, Seattle, who is serving as coordinating investigator. Dr. Garcia expressed his commitment to the development of Macrilen™ because of the medical need for such a convenient test in the absence of an FDA-approved diagnostic test for AGHD.”
Patients who are believed to have AGHD are now very often evaluated by means of the insulin tolerance test (“ITT”). The ITT is the historical gold standard for the evaluation of AGHD because of its high sensitivity and specificity. However, the ITT is inconvenient to the patients and physicians and contra-indicated in certain patients, such as patients with coronary heart disease or seizure disorder, because it requires the patient to experience hypoglycemia to obtain a result. Some physicians will not induce full hypoglycemia, intentionally compromising accuracy to increase safety and comfort for the patient. Furthermore, administration of the ITT is expensive because the patient must be constantly monitored by a physician for the 2-4 hour duration of the test and the test must be administered in a setting where emergency equipment is available and where the patient may be quickly hospitalized. The ITT is not used for patients with co-morbidities, such as CV, seizure disorder or a history of brain cancer or for patients who are elderly and frail, due to safety concerns.
The Company believes that Macrilen™, if it is approved, is likely to be rapidly adopted by physicians as the preferred means of evaluating AGHD for the following reasons:
it is safer than the ITT because it does not require the patient to become hypoglycemic;
Macrilen™ is administered orally, while the ITT requires an intravenous infusion of insulin;
the evaluation of AGHD using Macrilen™ is much less time consuming and labor intensive than the ITT and, therefore, it is less expensive to conduct; and
the evaluation can be conducted in the physician’s office rather than in a hospital setting.
About the Study
The confirmatory Phase 3 clinical study of Macrilen™, entitled Confirmatory validation of oral macimorelin as a growth hormone (GH) stimulation test (ST) for the diagnosis of adult growth hormone deficiency (AGHD) in comparison with the insulin tolerance test (ITT), is designed as a two-way crossover study with the insulin tolerance test as the benchmark comparator and will involve some 30 sites in the United States and Europe. The study population will consist of approximately 110 subjects (at least 55 ITT-positive and 55 ITT-negative) with a medical history documenting risk factors for AGHD, and will include a spectrum of subjects from those with a low risk of having AGHD to those with a high risk of having the condition. The primary endpoint is validation of a single oral dose of macimorelin for the diagnosis of AGHD, using the ITT as a comparator. Based on meetings with the US Food and Drug Administration (“FDA”) as well as the European Medicines Agency (“EMA”) and subsequent written scientific advice, the Company believes that the study meets the FDA’s and the EMA’s study-design expectations allowing US and European approval, if successful. As of the date of this release, five patients at three separate centers have been enrolled in the study. For more details on the trial, please consult this link:
www.clinicaltrial.gov/ct2/show/...erm=macimorelin&rank=1.
Based on the current rate of enrollment, the Company expects the confirmatory Phase 3 clinical study of Macrilen™ to be concluded by the end of 2016. The Company further expects to be able to submit a New Drug Application for Macrilen™ to the FDA by mid-year 2017 and, if the study is successful in meeting its primary endpoint, to obtain approval of the drug by year-end 2017.
About MacrilenTM (macimorelin)
Macimorelin, a ghrelin agonist, is a novel orally-active small molecule that stimulates the secretion of growth hormone. Macimorelin, under the trade name MacrilenTM, has been granted orphan drug designation by the FDA for diagnosis of AGHD. The Company owns the worldwide rights to this novel patented compound.
About AGHD
AGHD affects approximately 75,000 adults across the US, Canada and Europe. Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status. AGHD mostly results from damage to the pituitary gland. It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. We are engaged in drug development activities and in the promotion of products for others. We are now conducting Phase 3 studies of two internally developed compounds. The focus of our business development efforts is the acquisition of licenses to products that are relevant to our therapeutic areas of focus. We also intend to license out certain commercial rights of internally developed products to licensees in territories where such out-licensing would enable us to ensure development, registration and launch of our product candidates. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. For more information, visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the US Securities Litigation Reform Act of 1995. Forward-looking statements may include, but are not limited to statements preceded by, followed by, or that include the words “expects,” “believes,” “intends,” “anticipates,” and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects and clinical trials, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to efficiently commercialize one or more of its products or product candidates, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process, the ability to protect our intellectual property, the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and US securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.
View source version on businesswire.com: www.businesswire.com/news/home/20160119005463/en/
(c)Business Wire. All of the news releases contained herein are protected by copyright and other applicable laws, treaties and conventions. Information contained in the releases is furnished by Business Wire's members, who warrant that they are solely responsible for the content, accuracy and originality of the information contained therein. All reproduction, other than for an individual user's personal reference, is prohibited without prior written permission.
ISIN: CA0079754028
Symbol: AEZS
Typ: Aktie
Aufnehmen in Watchlist/Depot
Aeterna Zentaris Concludes Successful Meeting of Clinical Investigators for Confirmatory Phase 3 Trial of Macrilen™
14:35 19.01.16
FRANKFURT, Germany --(BUSINESS WIRE)--
Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the “Company”) announced today that it concluded a successful meeting of the clinical investigators for the confirmatory Phase 3 trial of Macrilen™ (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency (“AGHD”). As a result, the Company is confident that it will complete the confirmatory trial by year-end 2016.
Dr. Richard Sachse, the Company’s Chief Scientific Officer stated, “On January 16, we held an Investigators’ Meeting for our multi-center confirmatory Phase 3 clinical trial of Macrilen™. The purpose of the meeting was to review Macrilen™ with the investigators, as well as the clinical trial protocol. The 77 investigators and site personnel who attended the meeting included Jose Manuel Garcia, MD, PhD, Associate Professor of Medicine at University of Washington School of Medicine, Seattle, who is serving as coordinating investigator. Dr. Garcia expressed his commitment to the development of Macrilen™ because of the medical need for such a convenient test in the absence of an FDA-approved diagnostic test for AGHD.”
Patients who are believed to have AGHD are now very often evaluated by means of the insulin tolerance test (“ITT”). The ITT is the historical gold standard for the evaluation of AGHD because of its high sensitivity and specificity. However, the ITT is inconvenient to the patients and physicians and contra-indicated in certain patients, such as patients with coronary heart disease or seizure disorder, because it requires the patient to experience hypoglycemia to obtain a result. Some physicians will not induce full hypoglycemia, intentionally compromising accuracy to increase safety and comfort for the patient. Furthermore, administration of the ITT is expensive because the patient must be constantly monitored by a physician for the 2-4 hour duration of the test and the test must be administered in a setting where emergency equipment is available and where the patient may be quickly hospitalized. The ITT is not used for patients with co-morbidities, such as CV, seizure disorder or a history of brain cancer or for patients who are elderly and frail, due to safety concerns.
The Company believes that Macrilen™, if it is approved, is likely to be rapidly adopted by physicians as the preferred means of evaluating AGHD for the following reasons:
it is safer than the ITT because it does not require the patient to become hypoglycemic;
Macrilen™ is administered orally, while the ITT requires an intravenous infusion of insulin;
the evaluation of AGHD using Macrilen™ is much less time consuming and labor intensive than the ITT and, therefore, it is less expensive to conduct; and
the evaluation can be conducted in the physician’s office rather than in a hospital setting.
About the Study
The confirmatory Phase 3 clinical study of Macrilen™, entitled Confirmatory validation of oral macimorelin as a growth hormone (GH) stimulation test (ST) for the diagnosis of adult growth hormone deficiency (AGHD) in comparison with the insulin tolerance test (ITT), is designed as a two-way crossover study with the insulin tolerance test as the benchmark comparator and will involve some 30 sites in the United States and Europe. The study population will consist of approximately 110 subjects (at least 55 ITT-positive and 55 ITT-negative) with a medical history documenting risk factors for AGHD, and will include a spectrum of subjects from those with a low risk of having AGHD to those with a high risk of having the condition. The primary endpoint is validation of a single oral dose of macimorelin for the diagnosis of AGHD, using the ITT as a comparator. Based on meetings with the US Food and Drug Administration (“FDA”) as well as the European Medicines Agency (“EMA”) and subsequent written scientific advice, the Company believes that the study meets the FDA’s and the EMA’s study-design expectations allowing US and European approval, if successful. As of the date of this release, five patients at three separate centers have been enrolled in the study. For more details on the trial, please consult this link:
www.clinicaltrial.gov/ct2/show/...erm=macimorelin&rank=1.
Based on the current rate of enrollment, the Company expects the confirmatory Phase 3 clinical study of Macrilen™ to be concluded by the end of 2016. The Company further expects to be able to submit a New Drug Application for Macrilen™ to the FDA by mid-year 2017 and, if the study is successful in meeting its primary endpoint, to obtain approval of the drug by year-end 2017.
About MacrilenTM (macimorelin)
Macimorelin, a ghrelin agonist, is a novel orally-active small molecule that stimulates the secretion of growth hormone. Macimorelin, under the trade name MacrilenTM, has been granted orphan drug designation by the FDA for diagnosis of AGHD. The Company owns the worldwide rights to this novel patented compound.
About AGHD
AGHD affects approximately 75,000 adults across the US, Canada and Europe. Growth hormone not only plays an important role in growth from childhood to adulthood, but also helps promote a hormonally-balanced health status. AGHD mostly results from damage to the pituitary gland. It is usually characterized by a reduction in bone mineral density, lean body mass, exercise capacity, and overall quality of life.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. We are engaged in drug development activities and in the promotion of products for others. We are now conducting Phase 3 studies of two internally developed compounds. The focus of our business development efforts is the acquisition of licenses to products that are relevant to our therapeutic areas of focus. We also intend to license out certain commercial rights of internally developed products to licensees in territories where such out-licensing would enable us to ensure development, registration and launch of our product candidates. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. For more information, visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the US Securities Litigation Reform Act of 1995. Forward-looking statements may include, but are not limited to statements preceded by, followed by, or that include the words “expects,” “believes,” “intends,” “anticipates,” and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects and clinical trials, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to efficiently commercialize one or more of its products or product candidates, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process, the ability to protect our intellectual property, the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and US securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.
View source version on businesswire.com: www.businesswire.com/news/home/20160119005463/en/
(c)Business Wire. All of the news releases contained herein are protected by copyright and other applicable laws, treaties and conventions. Information contained in the releases is furnished by Business Wire's members, who warrant that they are solely responsible for the content, accuracy and originality of the information contained therein. All reproduction, other than for an individual user's personal reference, is prohibited without prior written permission.
als echte Potentiale von Wissenschaftlern hervorgehoben. Scheint in dem Fall das Bild kompletiert zu haben, dass man hier zwar die Finanzierungsmentalität des Boards in die tonne kloppen kann, dies aber nichts an dem Wert der Pipeline ändert.
Und der liegt in der abstrakten Betrachtung halt ne ganze Ecke höher als die MK dies jetzt hergibt...warten wir ab ,wohin das führt.
Und der liegt in der abstrakten Betrachtung halt ne ganze Ecke höher als die MK dies jetzt hergibt...warten wir ab ,wohin das führt.
100 % food speculation free - Don`t let your money kill people ! Respect Africa !
wir befinden uns immer noch auf untersten niveau. was bedeutet da schon so ein hüpferchen, wenn selbst 100% nur ein schritt in die richtige richtung wäre. trotzdem ist der downtrend (vor)erst einmal gebrochen...
trash: pipeline bedarf eigentlich keiner weiteren bestätigung, trotzdem kann es nicht schaden, dass die letzten zweifel an der wertigkeit, immer wieder mal ausgeräumt werden...
trash: pipeline bedarf eigentlich keiner weiteren bestätigung, trotzdem kann es nicht schaden, dass die letzten zweifel an der wertigkeit, immer wieder mal ausgeräumt werden...
wie man wieder merkt: Mit gescheitem Volumen geht's auch hoch...
100 % food speculation free - Don`t let your money kill people ! Respect Africa !
Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the "Company") announced today that it concluded a successful meeting of the clinical investigators for the confirmatory Phase 3 trial of Macrilen™ (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency ("AGHD"). As a result, the Company is confident that it will complete the confirmatory trial by year-end 2016.
Erst bis Ende 2016 fliesst noch viel Wasser durchs Land und KApitalerhöhungen kommen sicher auch noch ein paar.
Erst bis Ende 2016 fliesst noch viel Wasser durchs Land und KApitalerhöhungen kommen sicher auch noch ein paar.
Das ist nach der Meldung der Hüpfer, der aussagt: "Achja, Macrilen haben die ja auch noch..."
zeitpunkt erwischt.
Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the "Company") announced today that it concluded a successful meeting of the clinical investigators for the confirmatory Phase 3 trial of Macrilen™ (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency ("AGHD"). As a result, the Company is confident that it will complete the confirmatory trial by year-end 2016.
Erst bis Ende 2016 fliesst noch viel Wasser durchs Land und Kapitalerhöhungen kommen sicher auch noch ein paar.
Erst bis Ende 2016 fliesst noch viel Wasser durchs Land und Kapitalerhöhungen kommen sicher auch noch ein paar.
die macht gleich wieder 250%... um dann wieder auf den Boden zu fallen :)
Das hier einfach noch Aktie abgeladen werden. Die aktuelle Aktienanzahl kennt hier wohl auch nicht und die letzte KE ist wohl auch noch nicht abgeschlossen.
Oder gibt es dazu schon irgendwelche Informationen?!
Grüße
Oder gibt es dazu schon irgendwelche Informationen?!
Grüße
diese Bestätigungen sind und waren immer schon das einzige Gegengewicht zum völligen Vertrauensdebakel hier.
Aber erstmal piano...eine warme Brise macht noch keinen Sommer
Aber erstmal piano...eine warme Brise macht noch keinen Sommer
100 % food speculation free - Don`t let your money kill people ! Respect Africa !
wird schon wieder massiv zum abladen genutzt.
Durch stop-buy hineingespült
Wieder rausgespült durch trailing-stop-loss
17% sind cool und cash is fesch :-)
auf zum GAP-close....
Durch stop-buy hineingespült
Wieder rausgespült durch trailing-stop-loss
17% sind cool und cash is fesch :-)
auf zum GAP-close....
wenn am ende der woche wir noch in plus sind ,dann stimmt event.nachhaltig die richtung.
Und dabei nur 1$ nach oben - bin mal gespannt
..und das Entlein kackt zweistellig in die andere Richtung. Und es gibt ja noch viele Möglichkeiten für Meldungen in nächster Zeit. Man stelle sich nur mal vor,da ist eine noch substanzhaltigere Meldung dabei.. :-))
hoffentlich mal einen Tenbagger aus ;-)
Die Longs gucken in die Röhre - so ein riesiges Volumen
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