Aeterna Zentaris - positive Ergebnisse - 500 Beiträge pro Seite
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Feedback
http://ih.advfn.com/p.php?pid=nmona&article=52892092 vorbörslich 20% plus in USA
Hallo!
Für mich stellt sich die Frage, welches mögliche Potential das Medikament hat. Leider konnte ich hierzu bisher nichts herauslesen. Hast du irgendwelche Infos?
Gruß
Kimbel
Für mich stellt sich die Frage, welches mögliche Potential das Medikament hat. Leider konnte ich hierzu bisher nichts herauslesen. Hast du irgendwelche Infos?
Gruß
Kimbel
also alles was irgendwie mit erfolgreicher Krebstherapie und diesem Umfeld in Verbindung gebracht werden kann, ist ein Massen(Milliarden)markt, ergo ist hier ordentlich Potential und wahrscheinlich noch mehr Phantasie. Ansonsten mal deren Geschäftsbericht lesen.
Aeterna Zentaris: Partner Yakult Initiates Phase 1 Trial in Multiple Myeloma with Perifosine in Japan
QUEBEC CITY, June 28, 2012 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that its Japanese partner Yakult Honsha ("Yakult") (Tokyo: 2267) has initiated a Phase 1 trial in multiple myeloma, a form of blood cancer, with perifosine, the Company's oral Akt/PI3K inhibitor drug. Yakult, who are sponsoring and conducting this trial in Japan, reported that a first patient has been treated with perifosine.
This is an open-label, two step Phase 1 trial in which perifosine is combined with bortezomib (Velcade®) and dexamethasone in patients with refractory multiple myeloma who had previously been treated with bortezomib. The trial is expected to include a total of 18 patients (6 in step 1 and 12 in step 2). Patients will receive perifosine daily (50 mg, Days 1-21) in combination with bortezomib (1.3 mg/m2, Days 1, 4, 8 and 11) and dexamethasone (20 mg, Days 1, 2, 4, 5, 8, 9, 11 and 12) according to a three-week cycle (21 days ± 3 days). The primary endpoint is safety while secondary endpoints include response rate, progression-free survival, and time to tumor progression.
Juergen Engel, PhD, President and CEO at Aeterna Zentaris stated, "We would like to thank our partner Yakult for their close collaboration in initiating this important Phase 1 trial in multiple myeloma which is necessary at this time in order to comply with Japan's specific registration requirements. Perifosine, also currently in a Phase 3 trial in other parts of the world in multiple myeloma for which we expect to reach an interim analysis in the first quarter of next year, remains a key component of our deep pipeline focused on providing novel, targeted treatment options for cancer patients facing unmet medical needs".
About Perifosine
Perifosine is a novel, oral anticancer treatment that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. It has been granted orphan drug and orphan medicinal product designations from both the FDA and EMA for multiple myeloma. Perifosine has also received Fast Track designation from the FDA and positive Scientific Advice from the EMA with results from the Phase 3 trial in multiple myeloma expected to be sufficient for registration in Europe, as well as in North America. Perifosine is also being explored in combination therapy and in monotherapy in other cancer indications. Aeterna Zentaris holds rights to perifosine for North America and Europe, while rights have been licensed to Yakult Honsha for Japan, to Handok for Korea, and to Hikma Pharmaceuticals for the MENA (Middle East and North Africa) region.
About Aeterna Zentaris
Aeterna Zentaris is an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs. The Company's pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. For more information please visit www.aezsinc.com.
Forward-Looking Statements
QUEBEC CITY, June 28, 2012 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that its Japanese partner Yakult Honsha ("Yakult") (Tokyo: 2267) has initiated a Phase 1 trial in multiple myeloma, a form of blood cancer, with perifosine, the Company's oral Akt/PI3K inhibitor drug. Yakult, who are sponsoring and conducting this trial in Japan, reported that a first patient has been treated with perifosine.
This is an open-label, two step Phase 1 trial in which perifosine is combined with bortezomib (Velcade®) and dexamethasone in patients with refractory multiple myeloma who had previously been treated with bortezomib. The trial is expected to include a total of 18 patients (6 in step 1 and 12 in step 2). Patients will receive perifosine daily (50 mg, Days 1-21) in combination with bortezomib (1.3 mg/m2, Days 1, 4, 8 and 11) and dexamethasone (20 mg, Days 1, 2, 4, 5, 8, 9, 11 and 12) according to a three-week cycle (21 days ± 3 days). The primary endpoint is safety while secondary endpoints include response rate, progression-free survival, and time to tumor progression.
Juergen Engel, PhD, President and CEO at Aeterna Zentaris stated, "We would like to thank our partner Yakult for their close collaboration in initiating this important Phase 1 trial in multiple myeloma which is necessary at this time in order to comply with Japan's specific registration requirements. Perifosine, also currently in a Phase 3 trial in other parts of the world in multiple myeloma for which we expect to reach an interim analysis in the first quarter of next year, remains a key component of our deep pipeline focused on providing novel, targeted treatment options for cancer patients facing unmet medical needs".
About Perifosine
Perifosine is a novel, oral anticancer treatment that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. It has been granted orphan drug and orphan medicinal product designations from both the FDA and EMA for multiple myeloma. Perifosine has also received Fast Track designation from the FDA and positive Scientific Advice from the EMA with results from the Phase 3 trial in multiple myeloma expected to be sufficient for registration in Europe, as well as in North America. Perifosine is also being explored in combination therapy and in monotherapy in other cancer indications. Aeterna Zentaris holds rights to perifosine for North America and Europe, while rights have been licensed to Yakult Honsha for Japan, to Handok for Korea, and to Hikma Pharmaceuticals for the MENA (Middle East and North Africa) region.
About Aeterna Zentaris
Aeterna Zentaris is an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs. The Company's pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. For more information please visit www.aezsinc.com.
Forward-Looking Statements
Hot Stock: AEterna Zentaris, Shares Gain 8.8% (AEZS)
Written on Tue, 07/24/2012 - 12:46pm
By James Quinn
AEterna Zentaris (NASDAQ:AEZS) is one of today's best performing penny stocks, up 8.8% to $0.47 on 1.2x average daily volume. Thus far today, AEterna Zentaris has traded 1.3 million shares, vs. average volume of 1.0 million shares per day. The stock has outperformed the Dow (8.8% to the Dow's -1.1%) and outperformed the S&P 500 (8.8% to the S&P's -1.2%) during today's trading.
In the past 52 weeks, AEterna Zentaris share prices have been bracketed by a low of $0.38 and a high of $2.25 and are now at $0.47, 23% above that low price. The 200-day and 50-day moving averages have moved 1.25% lower and 1.62% lower over the past week, respectively.
Potential upside of 44.2% exists for AEterna Zentaris, based on a current level of $0.47 and analysts' average consensus price target of $0.68. The stock should run into initial resistance at its 50-day moving average (MA) of $0.47 and subsequent resistance at its 200-day MA of $1.23.
AEterna Zentaris Inc is a biopharmaceutical company focused in oncology and endocrine therapy. The Company's portfolio includes an orally-active inhibitor for multiple cancers, as well a product marketed for in vitro fertilization. AEterna Zentaris also develops and sells active ingredients, specialty chemicals, cosmetic, and nutritional products.
SmarTrend is tracking the current trend status for AEterna Zentaris and will alert subscribers who have AEZS in their portfolio or watchlist when shares have changed trend direction.
Written on Tue, 07/24/2012 - 12:46pm
By James Quinn
AEterna Zentaris (NASDAQ:AEZS) is one of today's best performing penny stocks, up 8.8% to $0.47 on 1.2x average daily volume. Thus far today, AEterna Zentaris has traded 1.3 million shares, vs. average volume of 1.0 million shares per day. The stock has outperformed the Dow (8.8% to the Dow's -1.1%) and outperformed the S&P 500 (8.8% to the S&P's -1.2%) during today's trading.
In the past 52 weeks, AEterna Zentaris share prices have been bracketed by a low of $0.38 and a high of $2.25 and are now at $0.47, 23% above that low price. The 200-day and 50-day moving averages have moved 1.25% lower and 1.62% lower over the past week, respectively.
Potential upside of 44.2% exists for AEterna Zentaris, based on a current level of $0.47 and analysts' average consensus price target of $0.68. The stock should run into initial resistance at its 50-day moving average (MA) of $0.47 and subsequent resistance at its 200-day MA of $1.23.
AEterna Zentaris Inc is a biopharmaceutical company focused in oncology and endocrine therapy. The Company's portfolio includes an orally-active inhibitor for multiple cancers, as well a product marketed for in vitro fertilization. AEterna Zentaris also develops and sells active ingredients, specialty chemicals, cosmetic, and nutritional products.
SmarTrend is tracking the current trend status for AEterna Zentaris and will alert subscribers who have AEZS in their portfolio or watchlist when shares have changed trend direction.
Trading Spotlight
AEZS wurde gestern hochgestuft.
Roth Capital sieht $1.75. Beginn der Phase III von AEZS-108 und FTS von AEZS-130.
Roth Capital sieht $1.75. Beginn der Phase III von AEZS-108 und FTS von AEZS-130.
Der Kurs fällt wie ein Stein und in meinem Depot steht gesperrter Bestand, ein Verkauf ist derzeit nicht möglich. 
http://finance.yahoo.com/news/aeterna-zentaris-granted-speci…
Bin mal auf die Kursentwicklung in den USA gespannt...
Bin mal auf die Kursentwicklung in den USA gespannt...
WoW!!!
Bombe hat eingeschlagen!
...agreement with the FDA on a Special Protocol Assessment ("SPA") for an upcoming Phase 3 registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108.
Bombe hat eingeschlagen!
...agreement with the FDA on a Special Protocol Assessment ("SPA") for an upcoming Phase 3 registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108.
AEZS heiss begehrt.
Funds füllen ab für den Multiple cancer Knaller AEZS-108!
Funds füllen ab für den Multiple cancer Knaller AEZS-108!
heute Hochstufung durch MLV
...und weiter geht's
...und weiter geht's
Mir scheint, dass Aeterna Zentaris für Ihren Marktwert von ca. 65 Mio Dollar einiges zu bieten hat:
1. Cetrotide, Ein zugelassenes Produkt, dass Revenues von ca. 35 Mio. Dollar jährlich erwirtschaftet.
2. Eine prall gefüllte Pipeline, mit Medikamenten, von denen sich drei in der Phase drei der Zulassungstests befinden, drei Medikamente in der Phase zwei und ein Medikament in der Phase eins, sowie mehrere vorklinische Tests.
3. über 30 Mio. Dollar cash auf der hohen Kante und keine Schulden
4. Nach einem gescheiterten Test hat die Aktie 2012 ca. 75% an Marktwert verloren. Der Chart sieht vielversprechend aus.
5. Neue Ergebenisse zu einem Phase drei Test sollen noch im ersten Quartal 2013 erscheinen.
Was denkt Ihr? Zeit um einzusteigen?!
1. Cetrotide, Ein zugelassenes Produkt, dass Revenues von ca. 35 Mio. Dollar jährlich erwirtschaftet.
2. Eine prall gefüllte Pipeline, mit Medikamenten, von denen sich drei in der Phase drei der Zulassungstests befinden, drei Medikamente in der Phase zwei und ein Medikament in der Phase eins, sowie mehrere vorklinische Tests.
3. über 30 Mio. Dollar cash auf der hohen Kante und keine Schulden
4. Nach einem gescheiterten Test hat die Aktie 2012 ca. 75% an Marktwert verloren. Der Chart sieht vielversprechend aus.
5. Neue Ergebenisse zu einem Phase drei Test sollen noch im ersten Quartal 2013 erscheinen.
Was denkt Ihr? Zeit um einzusteigen?!
Im Schatten von Keryx Pharmaceutical (KERX), die heute nach einer "Blockbuster" Zulassung um mehr als 90% zulegen konnten, hat der Partner Aeterna bis jetzt um kanpp 8% zugelegt. Mal schauen, welche Regionen wir bald sehen werden...
Was meint Ihr, sind diese Firmen einen Kauf Wert?!
Was meint Ihr, sind diese Firmen einen Kauf Wert?!
Bei KERX läuft die Rally jetzt. Die kommt wieder im freien Fall runter wenn's sein muss und dies nicht zu knapp. Ich trade hier nur mit kleinstem Einsatz. Bei 10 bin raus. Blockbuster hin oder her.
AEZS hat den Express noch vor sich....gute Aussichten auf Erholung in der nächsten Zeit. ...hat interessante Kandidaten und vor allem alleinige Verkaufsrechte. Gut gefällt auch der Fortschritt von TV AEZ-120 in der pre.
Wie immer eigene Ansichtssache.
AEZS hat den Express noch vor sich....gute Aussichten auf Erholung in der nächsten Zeit. ...hat interessante Kandidaten und vor allem alleinige Verkaufsrechte. Gut gefällt auch der Fortschritt von TV AEZ-120 in der pre.
Wie immer eigene Ansichtssache.
Nur zur info Aeterna ist kein Partner mehr von Kerx! Werde sie mir denoch mal anschaun.
KERX-Kurs derzeit voller Phantasie. Ich hoffe dennoch auf die 10.
Neben AEZS Auch anschauenswert ein weiterer Onco-express:
Oncothyreon wird gerade zur Startrampe getragen und die Zünder nächstens montiert.
Neben AEZS Auch anschauenswert ein weiterer Onco-express:
Oncothyreon wird gerade zur Startrampe getragen und die Zünder nächstens montiert.
Wird die Luft schon dünn bei Keryx, oder geht es noch weiter nach oben? Wieviel Umsatzpotential hat diese Aktie? Die Analysten bewegen sich in einem Bereich von 150 bis 800 Mio. Dollar Umsatz pro Jahr. Momentan hat der Markt eine Größe von etwa 1,5 Milliarden Dollar im Jahr. Welchen Anteil kann sich Keryx davon sichern? Aktuell liegt die Marktkapitaliserung bei ca. 610 Mio. Dollar.
Oncothyreon's (ONTY)hat mit Stimuvax einen interessanten Produktkandidaten in der Pipeline. Als Inhibitor wirkt es gegen Lungenkrebs. Momentan befindet es sich in der Phase drei, Ergebnisse werden für das 3. Quartal 2014 erwartet. Die Phase zwei hat die Überlebenszeit von 13 auf ca. 30 Monate verlängert. Bei 171 Teilnehmern ist der Wert schon als signifikant anzusehen. Gute Aussichten für die 3. Phase?! Weitere Kandidaten befinden sich in der Phase 2. Der Chart schaut super aus...
Achja, Aeterna möchte ich auch noch erwähnen: Der Countdown läuft!!!
Oncothyreon's (ONTY)hat mit Stimuvax einen interessanten Produktkandidaten in der Pipeline. Als Inhibitor wirkt es gegen Lungenkrebs. Momentan befindet es sich in der Phase drei, Ergebnisse werden für das 3. Quartal 2014 erwartet. Die Phase zwei hat die Überlebenszeit von 13 auf ca. 30 Monate verlängert. Bei 171 Teilnehmern ist der Wert schon als signifikant anzusehen. Gute Aussichten für die 3. Phase?! Weitere Kandidaten befinden sich in der Phase 2. Der Chart schaut super aus...
Achja, Aeterna möchte ich auch noch erwähnen: Der Countdown läuft!!!
Antwort auf Beitrag Nr.: 44.079.421 von jeo1 am 29.01.13 21:40:55Nachtrag zu meinem letzten Beitrag: ONTY´s Tests für Stuvimax als Produktkandidat zur Behandlung von Lungenkrebs sind erst einmal gescheitert.
Die Wirksamkeit liess sich nicht für alle Gruppen signifikant nachweisen. Stuvimax soll jedoch noch für einige Patientenuntergruppen getestet werden, da sich in diesen Signifikanzen gezeigt haben.
Ansonsten hat Oncothyreon noch vielversprechende Kandidaten in Phase zwei und der Chart sieht nach einem Rücksetzer vielversprechend aus.
Die Wirksamkeit liess sich nicht für alle Gruppen signifikant nachweisen. Stuvimax soll jedoch noch für einige Patientenuntergruppen getestet werden, da sich in diesen Signifikanzen gezeigt haben.
Ansonsten hat Oncothyreon noch vielversprechende Kandidaten in Phase zwei und der Chart sieht nach einem Rücksetzer vielversprechend aus.
Antwort auf Beitrag Nr.: 44.080.788 von jeo1 am 30.01.13 10:02:08Jeo1, Der therapeutische Impfstoff heisst Stimuvax und ist noch in zwei trials im Rennen. es "stimuliert" das Immunsystem um gegen die Krebszellen vorzugehen.
Nachfolger ONT-10 ist aktuell in safety-Phase 1 und nicht weniger interessant.
Nachfolger ONT-10 ist aktuell in safety-Phase 1 und nicht weniger interessant.
..kleine Spielereien.
next Aeterna Zentaris Events Q1 2013
AEZS expects to reach the Interim Analysis of Perifosine's Phase 3 clinical trial for Relapsed and Refractory Multiple Myeloma. The trial began in December of 2009, and AEZS decided to move ahead with this trial after it received the rights of Perifosine back from Keryx earlier this year, based on the strength of the Phase I/II trial results. The full trial is expected to be approximately 400 patients in 10 countries, including 40 to 50 sites in the U.S. The primary endpoint of the trial is progression free survival, with secondary endpoints of overall survival, overall response rate and safety. About 265 evens, categorized as disease progression or death, will trigger data to be unblinded.
The Interim Analysis of safety, efficacy and futility is scheduled after 80 events. The management expects this threshold to occur in the first quarter of 2013. If positive activity trends are identified, the trial can continue to add patients. If this occurs, the stock should have a positive reaction.
On Tuesday, analysts at Maxim has sent clients an initiation report covering Aeterna Zentaris with a BUY recommendation and a $9 price target for recently discounted shares. Given the historical data and the current design and execution of the phase III trial in multiple myeloma, the banking firm`s research team believes perifosine has a strong probability of meeting its SPA-approved primary endpoint. The analyst wrote:
"We are initiating coverage of AEterna Zentaris with a Buy rating and a 12-month price target of $9.00. We believe that Aeterna Zentaris is misunderstood as a result of the failed trial that partner Keryx (KERX-$2.78.NR) experienced with perifosine in colon cancer (the "X-PECT" trial). Data from phase I/II trials in multiple myeloma (MM) suggest that perifosine is an active molecule in this hematological malignancy. It is not uncommon in the cancer research paradigm to see a compound fail in one trial and then succeed in another when dosing and other parameters are varied, as was the case with Avastin (by Roche-RHHBY, $49.41, NR) and Nexavar (by Onyx-ONXX, $89.70, NR). "
Q1 2013
AEZS is expected to file a New Drug Application (NDA) "early next year" for its candidate AEZS-130. The company describes AEZS-130 as follows:
"AEZS-130, a ghrelin agonist, is a novel orally-active small molecule that stimulates the secretion of growth hormone. The company has completed a Phase III trial for use as an oral diagnostic test for AGHD. AEZS-130 has been granted orphan drug designation by the FDA for use in this indication. AEZS-130 is also in a Phase 2A trial as a treatment for cancer induced cachexia."
On September 26th, the company received notification from the FDA that Fast Track designation had not been granted for this indication of AEZS-130. Juergen Engel, PhD, President and CEO of AEterna Zentaris stated, "Although the FDA's decision will not allow us to submit our New Drug Application on a rolling basis, it should not affect the timing of our filing of the NDA for AEZS-130, which is expected early next year, nor should it affect the potential of obtaining priority review. We are actively pursuing our strategy to advance AEZS-130 towards regulatory approval for AGHD, as it could become the first orally administered test in this indication."
The company has nearly $40 million in cash and no debt, but analysts note that it has a healthy burn rate ($34M over the last 12 months), and while we aren't advocating a long term investment here quite yet, there are some reasons to think this may be a good time to buy while there is blood in the streets and trade the stock as investors should see share price increase as AEZS-130 moves through the approval process in anticipation of the potential final approval.
Other Upcoming Events
A Phase 3 clinical trial is planned for AEZS-108 in recurrent endometrial cancer, which effects about 20% of the woman with endometrial cancer. There is currently no approved drug for this indication in the U.S. or most of Europe.
AEZS is expected to initiate a Phase II clinical trial for AEZS-108 for triple-negative breast cancer.
Pipeline
AEterna Zentaris has a compound library of about 120,000 compounds to draw from moving forward. The company currently has 5 indications in preclinical studies, with AEZS-120 moving into phase 1 trials and one product in Phase I trials. AEZS also has 4 candidates in Phase 2 trials and two candidates in Phase III trials. Several of the candidates have multiple indications in clinical studies. Several of the early candidates are funded in part or in whole by partners and government grants, so the company will not see a large draw down on cash while advancing these products. The depth of AEterna Zentaris' pipeline should give investors comfort that they are getting value for their investment as the company moves forward on its many drug candidates.
(Quelle: http://www.biomedreports.com/20121008108428/keep-your-eye-on…
Nach dem 80. getesteten Patienten (von insgesamt 400) wird Aeterna mit hoher Wahrscheinlichkeit in den nächsten sechs Wochen Ergebnisse einer Zwischenstudie für Perifosine in der Phase 3 für MM herausgeben. Ich erwarte zumindest in einer Untergruppe positive,statistisch signifikante Ergebnisse. Dies sollte die positiven Ergebnisse der Phase 2 zementieren und ein Fundament für eine erfolgreiche Phase 3 bilden.
Des weiteren erwarte ich noch im 1. Quartal die Zulassung von AEZS-130 als Diagnosetest für AGHD durch die FDA.
Steht ihr dem genauso positiv gegenüber, oder gibt es irgendwelche Einwände?
AEZS expects to reach the Interim Analysis of Perifosine's Phase 3 clinical trial for Relapsed and Refractory Multiple Myeloma. The trial began in December of 2009, and AEZS decided to move ahead with this trial after it received the rights of Perifosine back from Keryx earlier this year, based on the strength of the Phase I/II trial results. The full trial is expected to be approximately 400 patients in 10 countries, including 40 to 50 sites in the U.S. The primary endpoint of the trial is progression free survival, with secondary endpoints of overall survival, overall response rate and safety. About 265 evens, categorized as disease progression or death, will trigger data to be unblinded.
The Interim Analysis of safety, efficacy and futility is scheduled after 80 events. The management expects this threshold to occur in the first quarter of 2013. If positive activity trends are identified, the trial can continue to add patients. If this occurs, the stock should have a positive reaction.
On Tuesday, analysts at Maxim has sent clients an initiation report covering Aeterna Zentaris with a BUY recommendation and a $9 price target for recently discounted shares. Given the historical data and the current design and execution of the phase III trial in multiple myeloma, the banking firm`s research team believes perifosine has a strong probability of meeting its SPA-approved primary endpoint. The analyst wrote:
"We are initiating coverage of AEterna Zentaris with a Buy rating and a 12-month price target of $9.00. We believe that Aeterna Zentaris is misunderstood as a result of the failed trial that partner Keryx (KERX-$2.78.NR) experienced with perifosine in colon cancer (the "X-PECT" trial). Data from phase I/II trials in multiple myeloma (MM) suggest that perifosine is an active molecule in this hematological malignancy. It is not uncommon in the cancer research paradigm to see a compound fail in one trial and then succeed in another when dosing and other parameters are varied, as was the case with Avastin (by Roche-RHHBY, $49.41, NR) and Nexavar (by Onyx-ONXX, $89.70, NR). "
Q1 2013
AEZS is expected to file a New Drug Application (NDA) "early next year" for its candidate AEZS-130. The company describes AEZS-130 as follows:
"AEZS-130, a ghrelin agonist, is a novel orally-active small molecule that stimulates the secretion of growth hormone. The company has completed a Phase III trial for use as an oral diagnostic test for AGHD. AEZS-130 has been granted orphan drug designation by the FDA for use in this indication. AEZS-130 is also in a Phase 2A trial as a treatment for cancer induced cachexia."
On September 26th, the company received notification from the FDA that Fast Track designation had not been granted for this indication of AEZS-130. Juergen Engel, PhD, President and CEO of AEterna Zentaris stated, "Although the FDA's decision will not allow us to submit our New Drug Application on a rolling basis, it should not affect the timing of our filing of the NDA for AEZS-130, which is expected early next year, nor should it affect the potential of obtaining priority review. We are actively pursuing our strategy to advance AEZS-130 towards regulatory approval for AGHD, as it could become the first orally administered test in this indication."
The company has nearly $40 million in cash and no debt, but analysts note that it has a healthy burn rate ($34M over the last 12 months), and while we aren't advocating a long term investment here quite yet, there are some reasons to think this may be a good time to buy while there is blood in the streets and trade the stock as investors should see share price increase as AEZS-130 moves through the approval process in anticipation of the potential final approval.
Other Upcoming Events
A Phase 3 clinical trial is planned for AEZS-108 in recurrent endometrial cancer, which effects about 20% of the woman with endometrial cancer. There is currently no approved drug for this indication in the U.S. or most of Europe.
AEZS is expected to initiate a Phase II clinical trial for AEZS-108 for triple-negative breast cancer.
Pipeline
AEterna Zentaris has a compound library of about 120,000 compounds to draw from moving forward. The company currently has 5 indications in preclinical studies, with AEZS-120 moving into phase 1 trials and one product in Phase I trials. AEZS also has 4 candidates in Phase 2 trials and two candidates in Phase III trials. Several of the candidates have multiple indications in clinical studies. Several of the early candidates are funded in part or in whole by partners and government grants, so the company will not see a large draw down on cash while advancing these products. The depth of AEterna Zentaris' pipeline should give investors comfort that they are getting value for their investment as the company moves forward on its many drug candidates.
(Quelle: http://www.biomedreports.com/20121008108428/keep-your-eye-on…
Nach dem 80. getesteten Patienten (von insgesamt 400) wird Aeterna mit hoher Wahrscheinlichkeit in den nächsten sechs Wochen Ergebnisse einer Zwischenstudie für Perifosine in der Phase 3 für MM herausgeben. Ich erwarte zumindest in einer Untergruppe positive,statistisch signifikante Ergebnisse. Dies sollte die positiven Ergebnisse der Phase 2 zementieren und ein Fundament für eine erfolgreiche Phase 3 bilden.
Des weiteren erwarte ich noch im 1. Quartal die Zulassung von AEZS-130 als Diagnosetest für AGHD durch die FDA.
Steht ihr dem genauso positiv gegenüber, oder gibt es irgendwelche Einwände?
Die Zittrigen sind bei Aeterna (AEZS) zur Zeit am Drücker. Offensichtlich gibt es einige Zweifler und Spekulanten, die es nicht mehr abwarten können und verkaufen. Momentan kommen keine Nachrichten und die Masse setzt sich in Bewegung, leider in die falsche Richtung.
Ich bleibe standhaft, da ich immer noch von dieser Aktie überzeugt bin. Bin ich naiv? Das werden wir spätestens noch in Q1 sehen, wenn die angekündigten Nachrichten zur Zulassung von AEZS-130 und die Daten zur Interimsanalyse von Perifosine in MM vorliegen.
Für Aeterna sprechen einige Gründe:
1. die breite Pipeline
2. ein zugelassenes Produkt mit revenues von etwa 30 Mio. $
3. Die Unterstützung der Forschungsinstitute
4. Die geringe Bewertung von 65 Mio. Dollar und einem hohen Cash
Die nächste Unterstützung liegt bei 2,49 $ - eine gute Einstiegschance!
Was meint ihr?
Was haltet ihr von Dynavax (DVAX) - Spekuliert ihr auf die FDA Entscheidung am 24.02.2013 ? Meiner Meinung sind noch Chancen vorhanden...
Ich bleibe standhaft, da ich immer noch von dieser Aktie überzeugt bin. Bin ich naiv? Das werden wir spätestens noch in Q1 sehen, wenn die angekündigten Nachrichten zur Zulassung von AEZS-130 und die Daten zur Interimsanalyse von Perifosine in MM vorliegen.
Für Aeterna sprechen einige Gründe:
1. die breite Pipeline
2. ein zugelassenes Produkt mit revenues von etwa 30 Mio. $
3. Die Unterstützung der Forschungsinstitute
4. Die geringe Bewertung von 65 Mio. Dollar und einem hohen Cash
Die nächste Unterstützung liegt bei 2,49 $ - eine gute Einstiegschance!
Was meint ihr?
Was haltet ihr von Dynavax (DVAX) - Spekuliert ihr auf die FDA Entscheidung am 24.02.2013 ? Meiner Meinung sind noch Chancen vorhanden...
[urlhttp://finance.yahoo.com/news/aeterna-zentaris-first-patient-treated-123000642.html][/url]
Aeterna hat heute etwa ein Viertel seiner Marktkapitalisierung verloren. Warum? Nach der Bekanntgabe von Daten der Interimsanalyse von Perifosine in MM, wurde von einem unabhängigen Data Safety Monitoring Board (DSMB) empfohlen, die Tests von Perifosine in MM einzustellen, da es höchst unwahrscheinlich ist, signifikante Verbesserungen zu erzielen.
Irgendwie war das ja schon fast eingepreist und keine große Überraschung. Damit der Wertverlust schnell wieder ausgeglichen wird, sollte AEZS-130 demnächst und wie angekündigt als Hormontest zugelassen werden.
Der Kaiser würde sagen: Schaun mir mal! Was denkt Ihr?
Irgendwie war das ja schon fast eingepreist und keine große Überraschung. Damit der Wertverlust schnell wieder ausgeglichen wird, sollte AEZS-130 demnächst und wie angekündigt als Hormontest zugelassen werden.
Der Kaiser würde sagen: Schaun mir mal! Was denkt Ihr?
More on AEterna Zentaris (AEZS): Q4 beats consensus estimates on both its EPS loss as well...
Endlich mal wieder gute Nachrichten zu Aeterna:
Thursday, March 21, 5:24 PM ET
(AEZS): Q4 beats consensus estimates on both its EPS loss as well revenue. Total sales declined 24% Y/Y, mainly due to the recording of a $2.6M milestone payment from Yakult for the initiation of Phase 1 trials for perifosine in Japan during Q411. Operational expenses declined due to lower employee compensation and benefit costs and a reduced headcount at the drug developer.
Endlich mal wieder gute Nachrichten zu Aeterna:
Thursday, March 21, 5:24 PM ET
(AEZS): Q4 beats consensus estimates on both its EPS loss as well revenue. Total sales declined 24% Y/Y, mainly due to the recording of a $2.6M milestone payment from Yakult for the initiation of Phase 1 trials for perifosine in Japan during Q411. Operational expenses declined due to lower employee compensation and benefit costs and a reduced headcount at the drug developer.
AEZS-130 sollte langsam was kommen!? sollte bis 31.3 eingereicht werden und is noch nix passiert!?
Aeterna Zentaris Presents Encouraging Updated Data on its LHRH Receptor-Targeted Disorazol Z Cytotoxic Conjugates at AACR Meeting
Press Release: AETERNA ZENTARIS INC. – 9 hours ago
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RELATED QUOTES
Symbol Price Change
AEZS 1.90 0.08
QUÉBEC CITY, April 10, 2013 /CNW Telbec/ - Aeterna Zentaris Inc. (AEZS) (TSX: AEZ) (the "Company") today presented encouraging updated proof-of-concept results for Disorazol Z cytotoxic conjugates, such as AEZS-125 and AEZS-138, in human ovarian and endometrial cancer xenograft models. Results further showed the compounds' high potential for the treatment of luteinizing hormone-releasing hormone ("LHRH") receptor positive tumors. Data were presented earlier today by Babette Aicher, PhD, the Company's Director of Preclinical Development, during a poster presentation at the American Association for Cancer Research ("AACR") annual meeting currently being held in Washington D.C. The study is funded through a grant from the German Ministry of Education and Research.
Juergen Engel, PhD, Aeterna Zentaris President and CEO stated, "Disorazol Z cytotoxic conjugates such as AEZS-125 and AEZS-138 are an extension of our AEZS-108 innovative LHRH-targeted platform in oncology. These results confirm the encouraging data presented at the ENA Symposium in November 2012 , and will enable us to better select a specific drug candidate for further preclinical development expected to start during this quarter."
Conclusions
Conjugates of D-Lys6-LHRH and Disorazol Z retained strong binding to the LHRH receptor and showed potent inhibition of tubulin polymerization. Cellular cytotoxicity of the conjugates was in the low nanomolar EC50 range. Increased cytotoxicity in cells over-expressing the LHRH receptor, support receptor targeting as a mechanism of action;
AEZS-125 and AEZS-138 have been identified as the most promising candidates;
The LHRH receptor-dependent efficacies of Disorazol Z - D-Lys6-LHRH conjugates in vitro and in mouse xenograft models that were presented, support the principle of tumor targeting by the LHRH receptor as already employed by the drug candidate AEZS-108, which is currently in a Phase 3 study in endometrial cancer and in Phase 2 studies in triple-negative breast cancer, bladder cancer and prostate cancer.
The poster, "LHRH receptor targeting as mechanism of anti-tumor activity for cytotoxic conjugates of Disorazol Z with the LHRH receptor agonistic peptide D-Lys6-LHRH", B. Aicher et al. can be viewed through this link.
About Disorazol Z
Disorazol Z is a novel natural compound, with outstanding cytotoxic activity, isolated from the myxobacterium Sorangium cellulosum. Disorazol Z, a macrocyclic polyketide, is produced by a fermentation process providing high yield and purity. Besides tubulin binding, Disorazol Z has pro-apoptotic properties and has been shown to arrest cancer cells in G2M stage of the cell cycle at subnanomolar concentrations. Disorazol Z is an ideal partner for the formation of cytotoxic conjugates with peptides, proteins, and antibodies to selectively target cancer cells.
About Disorazol Z cytotoxic conjugates such as AEZS-125 and AEZS-138
AEZS-125 and AEZS-138 are novel cytotoxic conjugates based on the natural compound Disorazol Z and the LHRH receptor agonist D-Lys6-LHRH. The peptide part directs the conjugates specifically to LHRH receptor expressing tumor cells, and mediates binding and uptake via endocytosis. Within the cancer cell, the conjugates are cleaved and Disorazol Z can deploy its potent anti-proliferative activity.
According to the literature, LHRH receptors occur in a number of human tumors, specifically in about 80% of ovarian and endometrial cancers. They are also expressed in prostate, urinary bladder and triple-negative breast cancer, while they are rarely found in normal tissues, except for the pituitary gland and reproductive organs. The LHRH receptor displays ideal properties for selective drug targeting.
About Aeterna Zentaris
Aeterna Zentaris is an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs. The Company's pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. For more information, visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbour provisions of the U.S. Securities Litigation Reform Act of 1995. 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, 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 take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to rely 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.
SOURCE: AETERNA ZENTARIS INC.
Contact:
Investor Relations
Ginette Beaudet Vallières
(418) 652-8525 ext. 265
gvallieres@aezsinc.com
Media Relations
Paul Burroughs
(418) 652-8525 ext. 406
pburroughs@aezsinc.com
Press Release: AETERNA ZENTARIS INC. – 9 hours ago
RELATED QUOTES
Symbol Price Change
AEZS 1.90 0.08
QUÉBEC CITY, April 10, 2013 /CNW Telbec/ - Aeterna Zentaris Inc. (AEZS) (TSX: AEZ) (the "Company") today presented encouraging updated proof-of-concept results for Disorazol Z cytotoxic conjugates, such as AEZS-125 and AEZS-138, in human ovarian and endometrial cancer xenograft models. Results further showed the compounds' high potential for the treatment of luteinizing hormone-releasing hormone ("LHRH") receptor positive tumors. Data were presented earlier today by Babette Aicher, PhD, the Company's Director of Preclinical Development, during a poster presentation at the American Association for Cancer Research ("AACR") annual meeting currently being held in Washington D.C. The study is funded through a grant from the German Ministry of Education and Research.
Juergen Engel, PhD, Aeterna Zentaris President and CEO stated, "Disorazol Z cytotoxic conjugates such as AEZS-125 and AEZS-138 are an extension of our AEZS-108 innovative LHRH-targeted platform in oncology. These results confirm the encouraging data presented at the ENA Symposium in November 2012 , and will enable us to better select a specific drug candidate for further preclinical development expected to start during this quarter."
Conclusions
Conjugates of D-Lys6-LHRH and Disorazol Z retained strong binding to the LHRH receptor and showed potent inhibition of tubulin polymerization. Cellular cytotoxicity of the conjugates was in the low nanomolar EC50 range. Increased cytotoxicity in cells over-expressing the LHRH receptor, support receptor targeting as a mechanism of action;
AEZS-125 and AEZS-138 have been identified as the most promising candidates;
The LHRH receptor-dependent efficacies of Disorazol Z - D-Lys6-LHRH conjugates in vitro and in mouse xenograft models that were presented, support the principle of tumor targeting by the LHRH receptor as already employed by the drug candidate AEZS-108, which is currently in a Phase 3 study in endometrial cancer and in Phase 2 studies in triple-negative breast cancer, bladder cancer and prostate cancer.
The poster, "LHRH receptor targeting as mechanism of anti-tumor activity for cytotoxic conjugates of Disorazol Z with the LHRH receptor agonistic peptide D-Lys6-LHRH", B. Aicher et al. can be viewed through this link.
About Disorazol Z
Disorazol Z is a novel natural compound, with outstanding cytotoxic activity, isolated from the myxobacterium Sorangium cellulosum. Disorazol Z, a macrocyclic polyketide, is produced by a fermentation process providing high yield and purity. Besides tubulin binding, Disorazol Z has pro-apoptotic properties and has been shown to arrest cancer cells in G2M stage of the cell cycle at subnanomolar concentrations. Disorazol Z is an ideal partner for the formation of cytotoxic conjugates with peptides, proteins, and antibodies to selectively target cancer cells.
About Disorazol Z cytotoxic conjugates such as AEZS-125 and AEZS-138
AEZS-125 and AEZS-138 are novel cytotoxic conjugates based on the natural compound Disorazol Z and the LHRH receptor agonist D-Lys6-LHRH. The peptide part directs the conjugates specifically to LHRH receptor expressing tumor cells, and mediates binding and uptake via endocytosis. Within the cancer cell, the conjugates are cleaved and Disorazol Z can deploy its potent anti-proliferative activity.
According to the literature, LHRH receptors occur in a number of human tumors, specifically in about 80% of ovarian and endometrial cancers. They are also expressed in prostate, urinary bladder and triple-negative breast cancer, while they are rarely found in normal tissues, except for the pituitary gland and reproductive organs. The LHRH receptor displays ideal properties for selective drug targeting.
About Aeterna Zentaris
Aeterna Zentaris is an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs. The Company's pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. For more information, visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbour provisions of the U.S. Securities Litigation Reform Act of 1995. 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, 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 take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to rely 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.
SOURCE: AETERNA ZENTARIS INC.
Contact:
Investor Relations
Ginette Beaudet Vallières
(418) 652-8525 ext. 265
gvallieres@aezsinc.com
Media Relations
Paul Burroughs
(418) 652-8525 ext. 406
pburroughs@aezsinc.com
Smaller Companies With Potential For Big Returns (Craig Keolanui -Seeking Alpha)
Marcet Cap: about 51 Mio. Dollar
"I have already mentioned the case for Aeterna Zentaris after it came crashing down in early March. Aeterna's stock is still reeling from the effects of failure from Perifosine, but that is something investors have been aware of for quite some time now. Currently, Aeterna has some positive signs of life coming from an agreement with Merck Serono and others for the manufacturing rights and obligations for Cetrotide along with a partnership with Ergomed to co-develop AEZS-108 which is entering Phase III trials for endometrial cancer. Cetrotide is the first luteinizing hormone (LHRH) antagonist treatment developed for use in in-vitro fertilization. AEZS-108 is a hybrid molecule composed of a synthetic peptide carrier and doxorubicin which basically acts to bind the compound to cancerous tumor cells allowing doxorubicin to accumulate in the malignant tissue and target the tumor cells.
Aeterna also has much more with AEZS-130 in Phase III trials for stimulating the secretion of growth hormone and also in Phase II trials for the treatment of cachexia. AEZS-108 is also in Phase II trials for the treatment of ovarian, prostate, bladder and breast cancers. Another candidate, Ozaralix, is in Phase II trials for the treatment of sexual hormone dependent malign and benign tumors like prostate cancer and endometriosis. This enormous pipeline also includes five more candidates in either pre-clinical stages or Phase I trials. For a company that has taken its share of bumps and bruises with Perifosine, there is plenty left for investors to get excited about.
Can Aeterna last long enough to get AEZS-108 and AEZS-130 to the endpoints of their trials? That is a big question, but Aeterna currently has about $33.2 million in cash and equivalents with a cash burn that was only $1.9 million last quarter. Revenue was up to $16.6 million for the first quarter of 2013 compared to only $9.5 million a year ago reflecting progress from the sale of Cetrotide. The partnership with Ergomed to develop AEZS-108 will have Ergomed reimbursing Aeterna with 30% of the clinical trial costs for endometrial cancer (up to $10 million) to help advance the drug through trials. The deal with Merck Serono and others will also add about $3.2 million with an upfront charge as well as other payments related to the transfer of manufacturing. These two moves bring in more money and helps Aeterna focus attention on developing more of its pipeline. Shares of Aeterna are currently trading at $1.91 a share (May 14th) and are down over 41% from a year ago and barely above the 52-week low of $1.70 a share. The 52-week high of Aeterna shares is $5.64 a share which was attained September of last year. The stock has room to move minus the issues with Perifosine and now might be a great time to take notice."
Marcet Cap: about 51 Mio. Dollar
"I have already mentioned the case for Aeterna Zentaris after it came crashing down in early March. Aeterna's stock is still reeling from the effects of failure from Perifosine, but that is something investors have been aware of for quite some time now. Currently, Aeterna has some positive signs of life coming from an agreement with Merck Serono and others for the manufacturing rights and obligations for Cetrotide along with a partnership with Ergomed to co-develop AEZS-108 which is entering Phase III trials for endometrial cancer. Cetrotide is the first luteinizing hormone (LHRH) antagonist treatment developed for use in in-vitro fertilization. AEZS-108 is a hybrid molecule composed of a synthetic peptide carrier and doxorubicin which basically acts to bind the compound to cancerous tumor cells allowing doxorubicin to accumulate in the malignant tissue and target the tumor cells.
Aeterna also has much more with AEZS-130 in Phase III trials for stimulating the secretion of growth hormone and also in Phase II trials for the treatment of cachexia. AEZS-108 is also in Phase II trials for the treatment of ovarian, prostate, bladder and breast cancers. Another candidate, Ozaralix, is in Phase II trials for the treatment of sexual hormone dependent malign and benign tumors like prostate cancer and endometriosis. This enormous pipeline also includes five more candidates in either pre-clinical stages or Phase I trials. For a company that has taken its share of bumps and bruises with Perifosine, there is plenty left for investors to get excited about.
Can Aeterna last long enough to get AEZS-108 and AEZS-130 to the endpoints of their trials? That is a big question, but Aeterna currently has about $33.2 million in cash and equivalents with a cash burn that was only $1.9 million last quarter. Revenue was up to $16.6 million for the first quarter of 2013 compared to only $9.5 million a year ago reflecting progress from the sale of Cetrotide. The partnership with Ergomed to develop AEZS-108 will have Ergomed reimbursing Aeterna with 30% of the clinical trial costs for endometrial cancer (up to $10 million) to help advance the drug through trials. The deal with Merck Serono and others will also add about $3.2 million with an upfront charge as well as other payments related to the transfer of manufacturing. These two moves bring in more money and helps Aeterna focus attention on developing more of its pipeline. Shares of Aeterna are currently trading at $1.91 a share (May 14th) and are down over 41% from a year ago and barely above the 52-week low of $1.70 a share. The 52-week high of Aeterna shares is $5.64 a share which was attained September of last year. The stock has room to move minus the issues with Perifosine and now might be a great time to take notice."
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