Traumhaft, aber es ist erst der Anfang - 500 Beiträge pro Seite
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Meistdiskutierte Wertpapiere
| Platz | vorher | Wertpapier | Kurs | Perf. % | Anzahl | ||
|---|---|---|---|---|---|---|---|
| 1. | 1. | 18.659,00 | -0,43 | 87 | |||
| 2. | 2. | 10,330 | +0,19 | 69 | |||
| 3. | 3. | 9,5175 | -0,13 | 61 | |||
| 4. | 4. | 180,11 | -3,48 | 56 | |||
| 5. | 5. | 6,3590 | -0,61 | 52 | |||
| 6. | 6. | 15,700 | +5,30 | 48 | |||
| 7. | 7. | 102,30 | +11,11 | 48 | |||
| 8. | 8. | 2.369,36 | -0,39 | 38 |
Feedback
Na - wie schon so oft gepostet in letzter Zeit, Genaera explodiert und dies war erst der Anfang.
Derzeitiger Kurs heute plus 33% auf 2,48 USD (Volumen 15.05 MIO) - Kursziel bei 8 USD (glaubt mir endlich sowie auch SwissMedica explodieren wird)
Derzeitiger Kurs heute plus 33% auf 2,48 USD (Volumen 15.05 MIO) - Kursziel bei 8 USD (glaubt mir endlich sowie auch SwissMedica explodieren wird)
Bei Genaera glaube ich auch an sehr großes Potential, zumal hier Insiderkäufe erfolgt sind:
http://finance.yahoo.com/q/it?s=GENR
Bei SwissMedica sind dagegen nur Insiderverkäufe erfolgt, die werden schon wissen wieso:
http://finance.yahoo.com/q/it?s=SWME.OB
Gruß Cyberhai
http://finance.yahoo.com/q/it?s=GENR
Bei SwissMedica sind dagegen nur Insiderverkäufe erfolgt, die werden schon wissen wieso:
http://finance.yahoo.com/q/it?s=SWME.OB
Gruß Cyberhai
Zu Swiss Medica möchte ich dir nur sagen, schaue einmal auf dessen Homepage und verfolge die News bzw. schau dir einmal genau die zahlen an. Werden irre Erfolge haben mit ihren "Verkaufsschlagern" - deshalb mußt du hier natürlich long schauen, aber glaub mir diese Aktie wird mir auch noch viel Freude bereiten - wie eben auch Genaera.
kurs pari zu us...
Auch hier werde ich heute dabei sein.
good trades
good trades
Trading Spotlight
Quelle: DEL LA RUE - Investment Team
www.dellarue.de
Genaera (883210) Update
Nach unserer Erstempfehlung bei 1.37 EURO, konnte der Wert zeitweise um 70% zulegen. Die Analysten gehen immer mehr davon aus, dass Evizon bald die Zulassung von der FDA erhalten könnte. Eine Kursrally sollte ab dem Bekanntwerden der Zulassung zu neuen Höhen um die 7 USD führen. Wir können spekulativen Anlegern daher nur weiter zum Kauf der Aktie raten.
www.dellarue.de
Genaera (883210) Update
Nach unserer Erstempfehlung bei 1.37 EURO, konnte der Wert zeitweise um 70% zulegen. Die Analysten gehen immer mehr davon aus, dass Evizon bald die Zulassung von der FDA erhalten könnte. Eine Kursrally sollte ab dem Bekanntwerden der Zulassung zu neuen Höhen um die 7 USD führen. Wir können spekulativen Anlegern daher nur weiter zum Kauf der Aktie raten.
Genaera Announces Senior Management Changes. July 28, 2005. Genaera Corporation
Presents Clinical Results for EVIZON™ for Treatment of Age-Related Macular
Presents Clinical Results for EVIZON™ for Treatment of Age-Related Macular
ROUND-UP: SAFETY OF PAIN RELIEVERS
Experts discuss the state of pain relief in the U.S. Ever since the debate over the safety of COX-2 inhibitors began, there have been numerous studies, opinions, and suggestions concerning the best OTC alternatives, and whether these drugs are indeed any safer to use than prescription drugs. (This round-up originated in February 2005 with a focus on the safety and efficacy of Cox-2 inhibitors).
GRANT JOHNSON, president and COO of SWISS MEDICA INC., maker of pain relief products: "In the wake of a jury finding Merck & Co. guilty for the death of a man who took Vioxx, consumers are seeking safer alternative pain- relief treatments. The verdict comes as the industry and the FDA struggle to respond to criticism that they`re not putting enough emphasis on the safety of prescription drugs. This, coupled with past FDA warnings about the safety and side effects of Vioxx, Celebrex, and Bextra, has fueled sales and requests for information on alternative pain products."
Quelle: www.RagingBull.de
Experts discuss the state of pain relief in the U.S. Ever since the debate over the safety of COX-2 inhibitors began, there have been numerous studies, opinions, and suggestions concerning the best OTC alternatives, and whether these drugs are indeed any safer to use than prescription drugs. (This round-up originated in February 2005 with a focus on the safety and efficacy of Cox-2 inhibitors).
GRANT JOHNSON, president and COO of SWISS MEDICA INC., maker of pain relief products: "In the wake of a jury finding Merck & Co. guilty for the death of a man who took Vioxx, consumers are seeking safer alternative pain- relief treatments. The verdict comes as the industry and the FDA struggle to respond to criticism that they`re not putting enough emphasis on the safety of prescription drugs. This, coupled with past FDA warnings about the safety and side effects of Vioxx, Celebrex, and Bextra, has fueled sales and requests for information on alternative pain products."
Quelle: www.RagingBull.de
Falsches Thread!
Bin wohl heute nicht voll dabei! Sorry
Bin wohl heute nicht voll dabei! Sorry
eine weiterer artikel über amd und genaera. die aussichten sind weiterhin rosig...
http://yahoo.reuters.com/financeQuoteCompanyNewsArticle.jhtm…
http://yahoo.reuters.com/financeQuoteCompanyNewsArticle.jhtm…
klappt was mit dem link nicht... hier der artikel
By Martinne Geller
NEW YORK, Aug 26 (Reuters) - Wall Street`s negative reaction to an eye care deal this week is another sign investors view Genentech Inc.`s (DNA.N: Quote, Profile, Research) experimental drug Lucentis as the favored treatment for a leading cause of blindness once approved.
But industry analysts say there`s still room in the market for other players to treat the "wet" form of age-related macular degeneration (AMD) -- which causes central vision loss in the elderly.
Investors embraced preliminary data in May showing Lucentis improved vision to a greater extent than the current standard of care, Eyetech Pharmaceuticals Inc.`s (EYET.O: Quote, Profile, Research) Macugen.
Shares of OSI Pharmaceuticals Inc. (OSIP.O: Quote, Profile, Research) fell more than 20 percent on Monday to a new low on news it would buy Eyetech for $953 million. Analysts said sales of Lucentis, expected to debut in late 2006, could exceed $1 billion by 2010 and steal market share from Macugen.
"There`s room in the market for other drugs, in case Lucentis fails" to help certain patients, said Infinium Capital research associate Bernadine Leung.
"I can`t say carte blanche I`ll always start with Lucentis," said Norman Saffra, chairman of ophthalmology at Maimonides Medical Center in New York. "No two patients are ever the same so custom tailoring is mandatory," he said.
Seven similar drugs to treat AMD are in the works, and their makers, which include Pfizer Inc. (PFE.N: Quote, Profile, Research) , Genaera Corp. (GENR.O: Quote, Profile, Research) and Regeneron Pharmaceuticals Inc. (REGN.O: Quote, Profile, Research) , are optimistic.
AMD is the leading cause of blindness in adults over 60 and will affect 1 million people this year. Annual incidence of the disease is expected to grow as the population ages.
"Different drugs can be used in combination therapy," said Jesse Cedarbaum, vice president of clinical affairs for Regeneron.
Cedarbaum believes his company`s experimental drug should work longer than Lucentis and Macugen, even if it does not work better, decreasing the number of required doses.
This is important since the medicine is given through an injection directly into the eye, which itself can cause serious eye inflammation or infection.
Genaera, a small biotech with no marketed products, is in late-stage development of an AMD drug called Evizon, which is instead given intravenously.
"This less invasive treatment allows physicians to treat both eyes at once and avoid dangerous side effects," said Genaera chief executive Roy Levitt. Half of all patients have the disease in both eyes, but the risks prevent doctors from treating them together.
All these medicines belong to a class of drugs that block proteins responsible for angiogenesis, or the production of blood vessels. AMD is caused by an over-proliferation behind the eye of delicate vessels that leak and damage the surrounding tissue of the retina.
Leung estimates the $750 million AMD drug market will reach $3 billion by 2010 as drug innovations keep increasing the pool of patients eligible for treatment.
"Right now, angiogenesis is the cat`s meow," said Saffra. "But I`m hoping that in 5 years there will be something else that will make me this excited."
By Martinne Geller
NEW YORK, Aug 26 (Reuters) - Wall Street`s negative reaction to an eye care deal this week is another sign investors view Genentech Inc.`s (DNA.N: Quote, Profile, Research) experimental drug Lucentis as the favored treatment for a leading cause of blindness once approved.
But industry analysts say there`s still room in the market for other players to treat the "wet" form of age-related macular degeneration (AMD) -- which causes central vision loss in the elderly.
Investors embraced preliminary data in May showing Lucentis improved vision to a greater extent than the current standard of care, Eyetech Pharmaceuticals Inc.`s (EYET.O: Quote, Profile, Research) Macugen.
Shares of OSI Pharmaceuticals Inc. (OSIP.O: Quote, Profile, Research) fell more than 20 percent on Monday to a new low on news it would buy Eyetech for $953 million. Analysts said sales of Lucentis, expected to debut in late 2006, could exceed $1 billion by 2010 and steal market share from Macugen.
"There`s room in the market for other drugs, in case Lucentis fails" to help certain patients, said Infinium Capital research associate Bernadine Leung.
"I can`t say carte blanche I`ll always start with Lucentis," said Norman Saffra, chairman of ophthalmology at Maimonides Medical Center in New York. "No two patients are ever the same so custom tailoring is mandatory," he said.
Seven similar drugs to treat AMD are in the works, and their makers, which include Pfizer Inc. (PFE.N: Quote, Profile, Research) , Genaera Corp. (GENR.O: Quote, Profile, Research) and Regeneron Pharmaceuticals Inc. (REGN.O: Quote, Profile, Research) , are optimistic.
AMD is the leading cause of blindness in adults over 60 and will affect 1 million people this year. Annual incidence of the disease is expected to grow as the population ages.
"Different drugs can be used in combination therapy," said Jesse Cedarbaum, vice president of clinical affairs for Regeneron.
Cedarbaum believes his company`s experimental drug should work longer than Lucentis and Macugen, even if it does not work better, decreasing the number of required doses.
This is important since the medicine is given through an injection directly into the eye, which itself can cause serious eye inflammation or infection.
Genaera, a small biotech with no marketed products, is in late-stage development of an AMD drug called Evizon, which is instead given intravenously.
"This less invasive treatment allows physicians to treat both eyes at once and avoid dangerous side effects," said Genaera chief executive Roy Levitt. Half of all patients have the disease in both eyes, but the risks prevent doctors from treating them together.
All these medicines belong to a class of drugs that block proteins responsible for angiogenesis, or the production of blood vessels. AMD is caused by an over-proliferation behind the eye of delicate vessels that leak and damage the surrounding tissue of the retina.
Leung estimates the $750 million AMD drug market will reach $3 billion by 2010 as drug innovations keep increasing the pool of patients eligible for treatment.
"Right now, angiogenesis is the cat`s meow," said Saffra. "But I`m hoping that in 5 years there will be something else that will make me this excited."
Waren heute schon ca. 8 % im Minus, jetzt wieder im Plus unter relativ hohen Umsätzen:
Last Trade: 2.56
Trade Time: 12:36PM ET
Change: Up 0.13 (5.35%)
Prev Close: 2.43
Open: 2.41
Bid: 2.55 x 3800
Ask: 2.57 x 700
1y Target Est: 6.75
Gruß Cyberhai
Last Trade: 2.56
Trade Time: 12:36PM ET
Change: Up 0.13 (5.35%)
Prev Close: 2.43
Open: 2.41
Bid: 2.55 x 3800
Ask: 2.57 x 700
1y Target Est: 6.75
Gruß Cyberhai
Hallo!Kann mir jemand den gestrigen Kursverlauf erklären?
Ich hatte gestern nachträglich einen Stopp-Loss bei 1,92 gesetzt.
Kurz danach gings auch schon runter. Und natürlich wieder hoch. Aber ich war raus.
Da stimmt doch was nicht?!
MfG
Der SL war auch viel zu Knapp!!!
Das DEL LA RUE - Investment Team empfahl ein SL bei 1.70 zu setzen! War wohl richtig auf die Zuhören!
Die haben ein gutes News Forum unter www.dellarue.de und dann unter Forum (ist ja klar)!
Das DEL LA RUE - Investment Team empfahl ein SL bei 1.70 zu setzen! War wohl richtig auf die Zuhören!
Die haben ein gutes News Forum unter www.dellarue.de und dann unter Forum (ist ja klar)!
GENR macht sich nicht schlecht!
Bisher konnte die Marke um 2.40USD immer recht gut halten.
Trotz der kurzen up and down, pendelt sich der Kurs immer wieder ein. Ein Zeichen für bestehendes Interesse und gleichzeitige Vorsicht, indem man abwartet (auf News!).
Ich wünsch uns allen noch viel Freude an GENR!
Bisher konnte die Marke um 2.40USD immer recht gut halten.
Trotz der kurzen up and down, pendelt sich der Kurs immer wieder ein. Ein Zeichen für bestehendes Interesse und gleichzeitige Vorsicht, indem man abwartet (auf News!).
Ich wünsch uns allen noch viel Freude an GENR!
Schitttt mir gings genau so hatte den Stopp bei 1,90 platziert und wurde natürlich ausgestoppt, und jetzt ?
DA gibts doch nur eins; wieder einsteigen.
Unter 2 EURO würde ich wieder nachkaufen!!!
Unter 2 EURO würde ich wieder nachkaufen!!!
08.09.2005 14:32
Genaera Receives Patent for a Method for the Synthesis of Squalamine and Other Aminosterol Compounds
PLYMOUTH MEETING, Pa., Sept. 8 /PRNewswire-FirstCall/ -- Genaera Corporation (Nachrichten) today announced issuance by the United States Patent and Trademark Office of patent number 6,933,383 entitled "Regioselective and Steroselective Oxidation of Fused Ring Systems Useful for the Preparation of Aminosterols." The patent covers a method for the synthesis of aminosterol compounds, such as EVIZON(TM) (squalamine lactate), squalamine for cancer and trodusquemine (MSI-1436). These compounds have been identified as anti-angiogenic agents, antibiotics and sodium hydrogen anti-porter (NHE) inhibitors. Patent expiry occurs in April 2021.
Genaera Receives Patent for a Method for the Synthesis of Squalamine and Other Aminosterol Compounds
PLYMOUTH MEETING, Pa., Sept. 8 /PRNewswire-FirstCall/ -- Genaera Corporation (Nachrichten) today announced issuance by the United States Patent and Trademark Office of patent number 6,933,383 entitled "Regioselective and Steroselective Oxidation of Fused Ring Systems Useful for the Preparation of Aminosterols." The patent covers a method for the synthesis of aminosterol compounds, such as EVIZON(TM) (squalamine lactate), squalamine for cancer and trodusquemine (MSI-1436). These compounds have been identified as anti-angiogenic agents, antibiotics and sodium hydrogen anti-porter (NHE) inhibitors. Patent expiry occurs in April 2021.
Na dann mal abwarten, ob dies der Grund für den Anstieg gestern war oder nicht!
Wapiya
Wapiya
Genaera (883210) Update
10.09.2005
Die Experten vom "DEL LA RUE - Investment Team" sehen für Genaera weiterhin ein Kursziel in Höhe von 7 USD
Quelle: www.dellarue.de
10.09.2005
Die Experten vom "DEL LA RUE - Investment Team" sehen für Genaera weiterhin ein Kursziel in Höhe von 7 USD
Quelle: www.dellarue.de
aktuelle Empfehlung des HOT STOCKS INVESTOR:
Genaera nicht aus der Hand geben
Die Experten von "Hot Stocks Investor" raten die Aktie von Genaera (ISIN US36867G1004/ WKN 883210) nicht aus der Hand zu geben. Der Titel habe jüngst ein spontanes Plus von 75 Prozent auf Zwischenhochs bis 2,80 USD erzielt, ohne Neuigkeiten vom Unternehmen. Hintergrund sei die Spekulation einer möglichen Übernahme und dafür könnte nicht nur die aktuell losgebrochene massive Übernahmewelle im Segment sprechen. Ein konkretes Vorbild sei dabei der jüngste Zugriff von OSI Pharma bei Eyetech. Eyetech sei einer der schärfsten Konkurrenten von Genaera in der AMD-Therapie und habe mit Macugen bereits ein Präparat am Markt. Ein Unterschied sei, dass bei Macugen eine direkte Injektion in das Auge erfolge, während Evizon von Genaera normal intravenös appliziert werden könne. Die Chancen auf eine Zulassung von Evizon würden recht gut stehen. Dies lasse die intensive Kooperation und Sonderbehandlung des Präparats durch die FDA erkennen. Durch die starken Kurssprünge sei Genaera aktuell mit knapp 150 Mio. USD bewertet. In zwei unabhängigen Studien von RBC Capital und Fortis würden der Aktie Kursziele von 7 bis 8,50 USD zugebilligt. Nach Ansicht der "Hot Stocks Investor"-Experten müsste bei einer erfolgreichen Zulassung hier aber noch nicht das Ende der Fahnenstange erreicht sein. Die Experten von "Hot Stocks Investor" empfehlen die Genaera-Aktie nicht aus der Hand zu geben.Quelle: AKTIENCHECK.DE
Genaera nicht aus der Hand geben
Die Experten von "Hot Stocks Investor" raten die Aktie von Genaera (ISIN US36867G1004/ WKN 883210) nicht aus der Hand zu geben. Der Titel habe jüngst ein spontanes Plus von 75 Prozent auf Zwischenhochs bis 2,80 USD erzielt, ohne Neuigkeiten vom Unternehmen. Hintergrund sei die Spekulation einer möglichen Übernahme und dafür könnte nicht nur die aktuell losgebrochene massive Übernahmewelle im Segment sprechen. Ein konkretes Vorbild sei dabei der jüngste Zugriff von OSI Pharma bei Eyetech. Eyetech sei einer der schärfsten Konkurrenten von Genaera in der AMD-Therapie und habe mit Macugen bereits ein Präparat am Markt. Ein Unterschied sei, dass bei Macugen eine direkte Injektion in das Auge erfolge, während Evizon von Genaera normal intravenös appliziert werden könne. Die Chancen auf eine Zulassung von Evizon würden recht gut stehen. Dies lasse die intensive Kooperation und Sonderbehandlung des Präparats durch die FDA erkennen. Durch die starken Kurssprünge sei Genaera aktuell mit knapp 150 Mio. USD bewertet. In zwei unabhängigen Studien von RBC Capital und Fortis würden der Aktie Kursziele von 7 bis 8,50 USD zugebilligt. Nach Ansicht der "Hot Stocks Investor"-Experten müsste bei einer erfolgreichen Zulassung hier aber noch nicht das Ende der Fahnenstange erreicht sein. Die Experten von "Hot Stocks Investor" empfehlen die Genaera-Aktie nicht aus der Hand zu geben.Quelle: AKTIENCHECK.DE
heute könnt ihr nochmals günstig nachkaufen.
hier der grund, warum genr heute schwächelt...
PLYMOUTH MEETING, Pa., Sept 12, 2005 /PRNewswire-FirstCall via COMTEX/ --
Genaera Corporation (Nasdaq: GENR) announced today that it has received signed securities purchase agreements from unaffiliated institutional investors for the purchase of an aggregate of approximately 11.4 million shares at $2.15 per share of registered common stock for aggregate proceeds of $24.5 million. The shares were offered through a prospectus supplement pursuant to the Company`s effective shelf registration statement. In addition, warrants to purchase 3,420,000 shares of common stock were issued to the institutional investors. The warrants have an exercise price of $3.15 per share. The offering is expected to close on or about September 13, 2005.
RBC Capital Markets Corporation acted as lead placement agent and Fortis Securities LLC acted as co-placement agent for the offering. The shares of common stock may only be offered by means of a prospectus. Copies of the final prospectus supplement and accompanying base prospectus can be obtained from RBC Capital Markets Corporation at 165 Broadway, New York, NY 10006, Fortis Securities LLC at 520 Madison Avenue, New York, New York 10022, or directly from the Company.
A registration statement relating to these securities has been filed with and declared effective by the Securities and Exchange Commission. This press release does not constitute an offer to sell or the solicitation of an offer to buy, and these securities cannot be sold in any state in which this offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
Genaera Corporation is a biopharmaceutical company committed to developing medicines to address substantial unmet medical needs in major pharmaceutical markets. The Company has four products in development for the treatment of eye, cancer and respiratory disorders. EVIZON(TM) (squalamine lactate) is Genaera`s lead product in development for ophthalmic indications, specifically "wet" age-related macular degeneration (AMD). Genaera`s other programs include: squalamine for the treatment of cancer; interleukin-9 antibody, a respiratory treatment based on the discovery of a genetic cause of asthma; and LOMUCIN(TM), a mucoregulator to treat the overproduction of mucus and secretions involved in many forms of chronic respiratory disease.
This announcement contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties, known and unknown. Forward-looking statements reflect management`s current views and are based on certain expectations and assumptions. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "believe," "continue," "develop," "expect," "plan" and "potential" or other words of similar meaning. Genaera`s actual results and performance could differ materially from those currently anticipated and expressed in these and other forward-looking statements as a result of a number of risk factors, including, but not limited to: Genaera`s history of operating losses since inception and its need for additional funds to operate its business; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; the risk that clinical trials for Genaera`s product candidates, including EVIZON and squalamine, may be delayed or may not be successful; the risk that Genaera may not obtain regulatory approval for its products, whether due to adequacy of the development program, the conduct of the clinical trials, changing regulatory requirements, different methods of evaluating and interpreting data, regulatory interpretations of clinical risk and benefit, or otherwise; the risk that EVIZON ceases to meet the criteria for CMA2 Pilot or Fast Track designation at some point in the future; Genaera`s reliance on its collaborators, in connection with the development and commercialization of Genaera`s product candidates; market acceptance of Genaera`s products, if regulatory approval is achieved; competition; general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industry; and the other risks and uncertainties discussed in this announcement and in Genaera`s filings with the U.S. Securities and Exchange Commission, all of which are available from the Commission in its EDGAR database at www.sec.gov as well as other sources. You are encouraged to read these reports. Given the uncertainties affecting development stage pharmaceutical companies, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Genaera does not intend (and it is not obligated) to publicly update, revise or correct these forward-looking statements or the risk factors that may relate thereto.
SOURCE Genaera Corporation
Jennifer Bilotti of Genaera Corporation +1-610-941-4020; or Jonathan Fassberg, investor inquiries, ext. 16, or Brad Miles, media inquiries, ext. 17, both of The Trout Group http://www.prnewswire.com
Copyright (C) 2005 PR Newswire. All rights reserved.
hier der grund, warum genr heute schwächelt...
PLYMOUTH MEETING, Pa., Sept 12, 2005 /PRNewswire-FirstCall via COMTEX/ --
Genaera Corporation (Nasdaq: GENR) announced today that it has received signed securities purchase agreements from unaffiliated institutional investors for the purchase of an aggregate of approximately 11.4 million shares at $2.15 per share of registered common stock for aggregate proceeds of $24.5 million. The shares were offered through a prospectus supplement pursuant to the Company`s effective shelf registration statement. In addition, warrants to purchase 3,420,000 shares of common stock were issued to the institutional investors. The warrants have an exercise price of $3.15 per share. The offering is expected to close on or about September 13, 2005.
RBC Capital Markets Corporation acted as lead placement agent and Fortis Securities LLC acted as co-placement agent for the offering. The shares of common stock may only be offered by means of a prospectus. Copies of the final prospectus supplement and accompanying base prospectus can be obtained from RBC Capital Markets Corporation at 165 Broadway, New York, NY 10006, Fortis Securities LLC at 520 Madison Avenue, New York, New York 10022, or directly from the Company.
A registration statement relating to these securities has been filed with and declared effective by the Securities and Exchange Commission. This press release does not constitute an offer to sell or the solicitation of an offer to buy, and these securities cannot be sold in any state in which this offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
Genaera Corporation is a biopharmaceutical company committed to developing medicines to address substantial unmet medical needs in major pharmaceutical markets. The Company has four products in development for the treatment of eye, cancer and respiratory disorders. EVIZON(TM) (squalamine lactate) is Genaera`s lead product in development for ophthalmic indications, specifically "wet" age-related macular degeneration (AMD). Genaera`s other programs include: squalamine for the treatment of cancer; interleukin-9 antibody, a respiratory treatment based on the discovery of a genetic cause of asthma; and LOMUCIN(TM), a mucoregulator to treat the overproduction of mucus and secretions involved in many forms of chronic respiratory disease.
This announcement contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties, known and unknown. Forward-looking statements reflect management`s current views and are based on certain expectations and assumptions. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "believe," "continue," "develop," "expect," "plan" and "potential" or other words of similar meaning. Genaera`s actual results and performance could differ materially from those currently anticipated and expressed in these and other forward-looking statements as a result of a number of risk factors, including, but not limited to: Genaera`s history of operating losses since inception and its need for additional funds to operate its business; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; the risk that clinical trials for Genaera`s product candidates, including EVIZON and squalamine, may be delayed or may not be successful; the risk that Genaera may not obtain regulatory approval for its products, whether due to adequacy of the development program, the conduct of the clinical trials, changing regulatory requirements, different methods of evaluating and interpreting data, regulatory interpretations of clinical risk and benefit, or otherwise; the risk that EVIZON ceases to meet the criteria for CMA2 Pilot or Fast Track designation at some point in the future; Genaera`s reliance on its collaborators, in connection with the development and commercialization of Genaera`s product candidates; market acceptance of Genaera`s products, if regulatory approval is achieved; competition; general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industry; and the other risks and uncertainties discussed in this announcement and in Genaera`s filings with the U.S. Securities and Exchange Commission, all of which are available from the Commission in its EDGAR database at www.sec.gov as well as other sources. You are encouraged to read these reports. Given the uncertainties affecting development stage pharmaceutical companies, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Genaera does not intend (and it is not obligated) to publicly update, revise or correct these forward-looking statements or the risk factors that may relate thereto.
SOURCE Genaera Corporation
Jennifer Bilotti of Genaera Corporation +1-610-941-4020; or Jonathan Fassberg, investor inquiries, ext. 16, or Brad Miles, media inquiries, ext. 17, both of The Trout Group http://www.prnewswire.com
Copyright (C) 2005 PR Newswire. All rights reserved.
Genaera (883210) Unser Favorite
16.09.2005
Der jüngste Kurseinbruch ist auf die Ausgabe von 11,4 Mio. neuen Aktien und 3,42 Mio. Otionen, an institutionelle Investoren zurückzuführen. Das Unternehmen sichere sich damit die zukünftige Forschung und Vermarktung. Das DEL LA RUE - Investment Team geht aber weiterhin davon aus, dass die Produktpipeline sehr lukrativ erscheint und Evizon bald die Zulassung erhalten wird. Es ergeben sich daher momentan günstige Nachkaufgelegenheiten.
Wir bekräftigen das Kursziel von 7 USD.
Quelle: www.dellarue.de
16.09.2005
Der jüngste Kurseinbruch ist auf die Ausgabe von 11,4 Mio. neuen Aktien und 3,42 Mio. Otionen, an institutionelle Investoren zurückzuführen. Das Unternehmen sichere sich damit die zukünftige Forschung und Vermarktung. Das DEL LA RUE - Investment Team geht aber weiterhin davon aus, dass die Produktpipeline sehr lukrativ erscheint und Evizon bald die Zulassung erhalten wird. Es ergeben sich daher momentan günstige Nachkaufgelegenheiten.
Wir bekräftigen das Kursziel von 7 USD.
Quelle: www.dellarue.de
Genaera (883210) Update
16.09.2005
Aufgrund unser erneuten Kaufempfehlung, raten wir sich mit Aktien bei Kursen bis 2.10 EURO einzudecken.
Quelle: www.dellarue.de
16.09.2005
Aufgrund unser erneuten Kaufempfehlung, raten wir sich mit Aktien bei Kursen bis 2.10 EURO einzudecken.
Quelle: www.dellarue.de
GENR: Initiates Pivotal Phase II Clinical Trial of LOMUCIN(TM) for Cystic Fibrosis
Genaera Corporation (GENR) announced the start of its pivotal Phase II clinical trial for the mucoregulator drug, LOMUCIN(TM), in people with cystic fibrosis (CF). Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation, is supporting this pivotal trial with study-specific funding of up to $2.35 million in milestone-driven, matching funds through a Therapeutics Development Award. This study, which will be initiated in Ireland, will evaluate the use of LOMUCIN in two hundred individuals with cystic fibrosis (CF) through a multi-center, randomized, double-blind, placebo-controlled trial.
Genaera Corporation (GENR) announced the start of its pivotal Phase II clinical trial for the mucoregulator drug, LOMUCIN(TM), in people with cystic fibrosis (CF). Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation, is supporting this pivotal trial with study-specific funding of up to $2.35 million in milestone-driven, matching funds through a Therapeutics Development Award. This study, which will be initiated in Ireland, will evaluate the use of LOMUCIN in two hundred individuals with cystic fibrosis (CF) through a multi-center, randomized, double-blind, placebo-controlled trial.
Hallo Genaerafreunde...
schaufelt Euch nochmals die Hütte voll,mitte Oktober ist
Zahltag.Bin seit 3Jahren investiert bin mit GENR bis auf 0.40€ in den Keller gegangen und dann meine Hütte vollgeschaufelt,nun wird geerntet.
Ähnlich ist es mir mit der Biotechfirma Amylin (AMLN)gegangen.Der wert der Firma war vor 4 Jahren bei 0,20€
unten ,habe aber immer an die Firma und ihr Podukt von künstlichen Insulin geglaubt besonders als der neue Aufsichtsrat unser aller bekannter Rumsfeld geworden ist,da kann eigentlich nix mehr schief gehen.Der augenblickl.Kurs von AMLN ist bei 30 US$,neueste Analystenbewertung,heraufgesetzt auf 36US$.Also mei Fazit wenn man selbst von einem Wert überzeugt ist geh ich mit ihm durch Dick und Dünn.So long Freunde ..HotteB
schaufelt Euch nochmals die Hütte voll,mitte Oktober ist
Zahltag.Bin seit 3Jahren investiert bin mit GENR bis auf 0.40€ in den Keller gegangen und dann meine Hütte vollgeschaufelt,nun wird geerntet.
Ähnlich ist es mir mit der Biotechfirma Amylin (AMLN)gegangen.Der wert der Firma war vor 4 Jahren bei 0,20€
unten ,habe aber immer an die Firma und ihr Podukt von künstlichen Insulin geglaubt besonders als der neue Aufsichtsrat unser aller bekannter Rumsfeld geworden ist,da kann eigentlich nix mehr schief gehen.Der augenblickl.Kurs von AMLN ist bei 30 US$,neueste Analystenbewertung,heraufgesetzt auf 36US$.Also mei Fazit wenn man selbst von einem Wert überzeugt ist geh ich mit ihm durch Dick und Dünn.So long Freunde ..HotteB
Vor einem Monat machte uns noch die 1,50 EURO Grenze nach oben hin schwierigkeiten!
Diesmal sollten wir eine Bodenbildung bei 1,50 EURO sehen!
Also, good trades
mal sehen, wo uns der 17. Oktober hintreibt!
Diesmal sollten wir eine Bodenbildung bei 1,50 EURO sehen!
Also, good trades
mal sehen, wo uns der 17. Oktober hintreibt!
Source : Dawson James
GENR $1,98 Spec. Buy $5,00
26 september 2005
Paul hastings, CEO of QLT (Nasdaq:QLTI), makers of Visudyne, resigned abruptly due to differences with the board regarding the vision of the company. This announcement follows QLT`s news that Visudyne failed in the Phase III trial for Occult Wet AMD after 24 months last Thursday. Robert Butchofsky, SVP Marketing and Sales, was named acting CEO.
During the conference call yesterday, Mr. Butchofsky stated "We believe the future of AMD management is combination therapy with Visudyne as the initial treatment and follow-up with the anti-VEGF to prevent progressive loss of vision."
Genaera`s Evizon is currently in Phase II trials in combination with Visudyne with unblinded data exprcted in mid-October.
Genaera, with a market cap of only $113 M, is the only stand-alone company in the Wet AMD space in Late-Stage trials. Last month, OSI Pharmaceuticals (Nasdaq-OSIP) announced they are paying $935M for Eyetech (Nasdaq:EYET).
Investor`s should note that QLT has plenty of cash for an acquisition of Genaera with QLT`s guidance yesterday of $425M-450M cash by year-end.
In addition to QLT being a potential acquirer of Genaera, we also believe QLT`s marketing partner for Visudyne, Novartis (NYSE-NVS) (through their Ciba Vision division), is a potential buyer of Genaera.
[Dieser Beitrag wurde am 02.10.2005 - 14:55 von DELLARUE aktualisiert]
GENR $1,98 Spec. Buy $5,00
26 september 2005
Paul hastings, CEO of QLT (Nasdaq:QLTI), makers of Visudyne, resigned abruptly due to differences with the board regarding the vision of the company. This announcement follows QLT`s news that Visudyne failed in the Phase III trial for Occult Wet AMD after 24 months last Thursday. Robert Butchofsky, SVP Marketing and Sales, was named acting CEO.
During the conference call yesterday, Mr. Butchofsky stated "We believe the future of AMD management is combination therapy with Visudyne as the initial treatment and follow-up with the anti-VEGF to prevent progressive loss of vision."
Genaera`s Evizon is currently in Phase II trials in combination with Visudyne with unblinded data exprcted in mid-October.
Genaera, with a market cap of only $113 M, is the only stand-alone company in the Wet AMD space in Late-Stage trials. Last month, OSI Pharmaceuticals (Nasdaq-OSIP) announced they are paying $935M for Eyetech (Nasdaq:EYET).
Investor`s should note that QLT has plenty of cash for an acquisition of Genaera with QLT`s guidance yesterday of $425M-450M cash by year-end.
In addition to QLT being a potential acquirer of Genaera, we also believe QLT`s marketing partner for Visudyne, Novartis (NYSE-NVS) (through their Ciba Vision division), is a potential buyer of Genaera.
[Dieser Beitrag wurde am 02.10.2005 - 14:55 von DELLARUE aktualisiert]
GENR: Data Showing EVIZON(TM) w/ Visudyne(R) Demonstrate Safety and Stabilization of Vision
Genaera Corporation (GENR) announced that an exploratory, multi-center, randomized, double-masked, U.S. Phase II clinical trial (MSI-1256F-208) of EVIZON(TM) (squalamine lactate) in 45 subjects met its primary goal of demonstrating safety when dosed concomitantly with photodynamic therapy with Visudyne(R) (PDT) (QLT Incorporated, Vancouver, Canada). EVIZON with concomitant PDT was well tolerated in all subjects with no drug-related serious adverse events reported to date. The most common adverse events involved infusion site reactions. These events were generally mild and were distributed evenly across the EVIZON plus PDT treatment groups.
Preliminary analyses showed that subjects treated with 40mg EVIZON plus PDT at 29 weeks had a slight increase in mean visual acuity compared to visual acuity at study entry, an important secondary endpoint, while the PDT-alone group demonstrated a decrease in mean visual acuity from baseline to 29 weeks. Moreover, approximately 90% of subjects maintained vision (defined as a gain or loss of less than 15 letters in visual acuity) when treated with 40mg of EVIZON plus PDT. Additionally, of the subjects treated with the combination of 40mg of EVIZON plus PDT, 10% required a second PDT treatment compared to 47% of those in the PDT-alone arm. Preliminary data from this trial will be presented at the American Academy of Ophthalmology`s 109th Annual Meeting from October 15 to 18 in Chicago, IL.
Quelle: www.dellarue.de
Genaera Corporation (GENR) announced that an exploratory, multi-center, randomized, double-masked, U.S. Phase II clinical trial (MSI-1256F-208) of EVIZON(TM) (squalamine lactate) in 45 subjects met its primary goal of demonstrating safety when dosed concomitantly with photodynamic therapy with Visudyne(R) (PDT) (QLT Incorporated, Vancouver, Canada). EVIZON with concomitant PDT was well tolerated in all subjects with no drug-related serious adverse events reported to date. The most common adverse events involved infusion site reactions. These events were generally mild and were distributed evenly across the EVIZON plus PDT treatment groups.
Preliminary analyses showed that subjects treated with 40mg EVIZON plus PDT at 29 weeks had a slight increase in mean visual acuity compared to visual acuity at study entry, an important secondary endpoint, while the PDT-alone group demonstrated a decrease in mean visual acuity from baseline to 29 weeks. Moreover, approximately 90% of subjects maintained vision (defined as a gain or loss of less than 15 letters in visual acuity) when treated with 40mg of EVIZON plus PDT. Additionally, of the subjects treated with the combination of 40mg of EVIZON plus PDT, 10% required a second PDT treatment compared to 47% of those in the PDT-alone arm. Preliminary data from this trial will be presented at the American Academy of Ophthalmology`s 109th Annual Meeting from October 15 to 18 in Chicago, IL.
Quelle: www.dellarue.de
Hallo,
kann mich jemand aufklären über den Zusammenhang zwischen Genaera und Qlt Inc.? Sehe ich das richtig, daß Evizon nur mit dem anderen Medikament Visudyne funktioniert und dabei eine signifikante Verbesserung gegenüber der Behandlung nur mit Visudyne allein zeigt. Visudyne wird offenbar bereits von Qlt Inc. bzw. Novartis kommerziell vertrieben. Dann verstehe ich nicht, warum der Kurs von Genaera so bröckelt und warum Qlt bzw. Novartis kein Interesse an Genaera haben. Oder kommt das jetzt erst, wenn die Ergebnisse bekannt sind?
kann mich jemand aufklären über den Zusammenhang zwischen Genaera und Qlt Inc.? Sehe ich das richtig, daß Evizon nur mit dem anderen Medikament Visudyne funktioniert und dabei eine signifikante Verbesserung gegenüber der Behandlung nur mit Visudyne allein zeigt. Visudyne wird offenbar bereits von Qlt Inc. bzw. Novartis kommerziell vertrieben. Dann verstehe ich nicht, warum der Kurs von Genaera so bröckelt und warum Qlt bzw. Novartis kein Interesse an Genaera haben. Oder kommt das jetzt erst, wenn die Ergebnisse bekannt sind?
Nein. Evizon muss natürlich nicht gemeinsam mit Visudyne eingesetzt werden.
Es sind ja komplett verschiedene Wirkansätze.
Visudyne ist halt im Moment, weil allein, das State of the Art Medikament.
Aber da tut sich ja bald einiges.
In den USA ist ja bereits Macugen auf dem Markt!
Bis Evizon so weit ist, wird es allerdings noch ein wenig dauern. Sind ja erst in Phase II.
Es sind ja komplett verschiedene Wirkansätze.
Visudyne ist halt im Moment, weil allein, das State of the Art Medikament.
Aber da tut sich ja bald einiges.
In den USA ist ja bereits Macugen auf dem Markt!
Bis Evizon so weit ist, wird es allerdings noch ein wenig dauern. Sind ja erst in Phase II.
Und Qlt Inc. wurde als Interessent zur Übernahme gehandelt. Wobei Qlt. nach meinem erachten nicht die nötigen Cashbestände hat üm Genaera für einen guten Preis aufzukaufen. Größere Pharmariesen würde das schon leichter fallen. Evizon muss jetzt nur noch beweisen, dass es nicht nur sicher, sondern auch wirkungsvoll gegen AMD ist! Im Trial 208 wurde hauptsächlich die Sicherheit(keine Nebenwirkungen) getestet, wobei der Test AMD wohl nur verbessert, aber nicht ganz verhindert haben soll. Daher die schlechte Kursentwicklung. Trial 211 was jetzt am WE präsentiert wird, soll schon mehr Infos über die Wirkung haben! Da bin ich echt gespannt drauf.
Es wird spannend
Trial 211 wird am WE präsentiert und ist wohl ausschlaggebend für den Kursverlauf in nächsten Zeit!
Trial 211 wird am WE präsentiert und ist wohl ausschlaggebend für den Kursverlauf in nächsten Zeit!
hallo
Hat jemand aktuelle news.
Hat jemand aktuelle news.
Die sollen heute erscheinen!
Neuigkeiten:
Die Infos über Genaera hab ich nicht kopiert, sonst wird`s zu lang:
Press Release Source: Genaera Corporation
Genaera Presents Positive Preliminary Clinical Results for EVIZON(TM) for Treatment of Age-Related Macular Degeneration at the Annual AAO Meeting
Wednesday October 19, 8:30 am ET
PLYMOUTH MEETING, Pa., Oct. 19 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR - News) today announced positive preliminary results from a U.S. Phase II clinical trial (MSI-1256F-208) of EVIZON(TM) (squalamine lactate) with concomitant photodynamic therapy with Visudyne® (PDT) (QLT Incorporated, Vancouver, Canada) compared to PDT alone in 45 subjects with wet age-related macular degeneration (AMD). EVIZON with concomitant PDT was well tolerated in all subjects with no drug-related serious adverse events reported to date. The most common adverse events involved infusion site reactions. These events were generally mild and were distributed evenly across the EVIZON plus PDT treatment groups. Preliminary data were presented for 40mg or 20mg of EVIZON with concomitant PDT compared with PDT-alone at the 109th Annual Meeting of the American Academy of Ophthalmology (AAO) in Chicago, Illinois.
At twenty-nine weeks, in addition to meeting the study`s primary goal of demonstrating safety, secondary endpoint results showed a 5.2 letter difference in mean change in visual acuity from study entry between subjects treated with 40mg of EVIZON plus PDT and PDT-alone as measured by the Early Treatment of Diabetic Retinopathy (ETDRS) protocol. Subjects treated with 40mg of EVIZON and concomitant PDT gained an average of 0.4 letters in visual acuity compared to study entry while those treated with PDT alone lost an average of 4.8 letters. Of the subjects treated with the combination of 40mg of EVIZON plus PDT, 10% (1/10) required a second PDT treatment compared to 47% (8/17) of those in the PDT-alone arm.
At twenty-nine weeks, 90% (9/10) of subjects treated with 40mg of EVIZON with concomitant PDT had stable vision (defined as a gain or loss of less than 15 ETDRS letters). Seventy-one percent of subjects treated with PDT-alone had stable vision. Twelve percent (2/17) of subjects treated with PDT alone had a gain of 15 letters or more from study entry. Ten percent (1/10) of the subjects treated with 40mg of EVIZON plus PDT lost greater than 15 letters from study entry compared to 18% (3/17) in the PDT-alone arm, of which 12% (2/17) lost 30 letters or more. No subjects in the 40mg EVIZON plus PDT group lost 30 letters or more. Subjects treated with 20mg of EVIZON plus PDT had results similar to those treated with PDT-alone with 78% (7/9) of subjects with stable vision.
"We are pleased that we have confirmed the safety of the use of EVIZON with concomitant PDT," commented John (Jack) L. Armstrong, President and Chief Operating Officer of Genaera Corporation. "Additionally, we are encouraged by the stabilization of vision shown in this small study, as well as the lower incidence of the need for retreatment with PDT in those subjects treated with EVIZON."
MSI-1256F-208 is a Phase II trial designed to evaluate in 45 subjects with wet AMD the safety and clinical effects of three different doses of EVIZON (10mg, 20mg or 40mg) along with initial concomitant PDT treatment in 10 subjects per group, or PDT-alone in 15 control subjects. Specifically, this study is designed to evaluate the safety and effects of systemically administered EVIZON before and after PDT. The multi-center, randomized, controlled, masked study also includes monthly EVIZON maintenance therapy through six months, along with an additional twelve months of open-label treatment and follow-up for each patient.
Other Ongoing Clinical Trials
Genaera is currently conducting a Phase III and multiple Phase II trials of EVIZON in wet AMD at multiple investigational sites. In January 2005, the Food and Drug Administration (FDA) selected EVIZON for participation in the Continuous Marketing Application (CMA) Pilot 2 program. In October 2004, the FDA granted EVIZON Fast Track designation.
MSI-1256F-301 is a Phase III international trial designed to enroll subjects with predominantly classic, minimally classic and occult forms of wet AMD. The multi-center, randomized, double-masked, controlled trial will evaluate two doses of EVIZON (40mg and 20mg) versus placebo, given once weekly for four weeks followed by maintenance doses every four weeks until week 104. PDT is allowed as background therapy for all subjects in this study if deemed necessary and appropriate by the study physician. Enrollment in this trial is ongoing.
MSI-1256F-209 is the cornerstone and largest of Genaera`s three Phase II studies and is designed to evaluate the safety and efficacy of EVIZON over a two-year period in 100 subjects with wet AMD. This Phase II multi-center, randomized, double-masked, controlled study will evaluate two dose levels of EVIZON (20mg or 40mg) given once weekly for four weeks, followed by maintenance doses once every four weeks until week 48. At the end of 48 weeks of therapy, each subject will be followed for a further twelve months. PDT is allowed as background therapy for all subjects in this study if deemed necessary and appropriate by the study physician. Enrollment in this trial is closed.
MSI-1256F-207 was a Phase II pharmacokinetic and safety trial that evaluated 18 subjects with AMD at three different doses of EVIZON (10mg, 20mg or 40mg) over four months. In this multi-center, open-label, parallel group study, EVIZON was given once weekly for four weeks, and then all subjects were followed out to month 4 with no further treatment after week four. All subjects in the 207 trial have completed therapy and follow up and depending on their response, subjects may have continued to receive EVIZON as needed for up to one additional year in a separate study (MSI-1256F-211).
For information about participation in EVIZON clinical trials, subjects and physicians may call Genaera`s Clinical Trial Hotline at (800) 299-9156.
About EVIZON(TM)
EVIZON is a unique first in class synthetic small molecule administered systemically that directly interrupts and reverses multiple facets of the angiogenic process. Working within activated endothelial cells, EVIZON inhibits growth factor signaling including VEGF, integrin expression, and reverses cytoskeletal formation, thereby resulting in endothelial cell inactivation and apoptosis. Systemically administered EVIZON inhibits abnormal angiogenesis in rodent models of retinopathy of prematurity, and the development of choroidal neovascular membranes in rat models of AMD. Additional preclinical studies have demonstrated that systemic EVIZON administration is effective in reaching abnormal ocular blood vessels in primates, and leads to partial regression and inhibition of new abnormal vessels in the eye. These results support that EVIZON may have a role in the treatment of human choroidal neovascular membrane formation that underlies the pathology of wet AMD.
About AMD
Wet AMD resulting from angiogenesis is the leading cause of legal blindness among adults age 50 or older in the Western world. Approximately 25 to 30 million people are affected globally and this number is expected to triple over the next 25 years.
AMD occurs in two types: the "dry" form and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels, or choroidal neovascularization, under the central part of the retina, the macula. Dry AMD, or the avascular form is the more common and milder form of AMD, accounting for 85% to 90% of all cases. Dry AMD results in varying forms of sight loss and may or may not eventually develop into the wet form. Although the wet form of AMD accounts for only 10% to 15% of all AMD, the chance for severe sight loss is much greater. It is responsible for 90% of severe vision loss associated with AMD. Approximately 500,000 new cases of wet AMD are diagnosed annually worldwide. In North America alone, approximately 200,000 new cases of wet AMD are diagnosed each year.
Die Infos über Genaera hab ich nicht kopiert, sonst wird`s zu lang:
Press Release Source: Genaera Corporation
Genaera Presents Positive Preliminary Clinical Results for EVIZON(TM) for Treatment of Age-Related Macular Degeneration at the Annual AAO Meeting
Wednesday October 19, 8:30 am ET
PLYMOUTH MEETING, Pa., Oct. 19 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR - News) today announced positive preliminary results from a U.S. Phase II clinical trial (MSI-1256F-208) of EVIZON(TM) (squalamine lactate) with concomitant photodynamic therapy with Visudyne® (PDT) (QLT Incorporated, Vancouver, Canada) compared to PDT alone in 45 subjects with wet age-related macular degeneration (AMD). EVIZON with concomitant PDT was well tolerated in all subjects with no drug-related serious adverse events reported to date. The most common adverse events involved infusion site reactions. These events were generally mild and were distributed evenly across the EVIZON plus PDT treatment groups. Preliminary data were presented for 40mg or 20mg of EVIZON with concomitant PDT compared with PDT-alone at the 109th Annual Meeting of the American Academy of Ophthalmology (AAO) in Chicago, Illinois.
At twenty-nine weeks, in addition to meeting the study`s primary goal of demonstrating safety, secondary endpoint results showed a 5.2 letter difference in mean change in visual acuity from study entry between subjects treated with 40mg of EVIZON plus PDT and PDT-alone as measured by the Early Treatment of Diabetic Retinopathy (ETDRS) protocol. Subjects treated with 40mg of EVIZON and concomitant PDT gained an average of 0.4 letters in visual acuity compared to study entry while those treated with PDT alone lost an average of 4.8 letters. Of the subjects treated with the combination of 40mg of EVIZON plus PDT, 10% (1/10) required a second PDT treatment compared to 47% (8/17) of those in the PDT-alone arm.
At twenty-nine weeks, 90% (9/10) of subjects treated with 40mg of EVIZON with concomitant PDT had stable vision (defined as a gain or loss of less than 15 ETDRS letters). Seventy-one percent of subjects treated with PDT-alone had stable vision. Twelve percent (2/17) of subjects treated with PDT alone had a gain of 15 letters or more from study entry. Ten percent (1/10) of the subjects treated with 40mg of EVIZON plus PDT lost greater than 15 letters from study entry compared to 18% (3/17) in the PDT-alone arm, of which 12% (2/17) lost 30 letters or more. No subjects in the 40mg EVIZON plus PDT group lost 30 letters or more. Subjects treated with 20mg of EVIZON plus PDT had results similar to those treated with PDT-alone with 78% (7/9) of subjects with stable vision.
"We are pleased that we have confirmed the safety of the use of EVIZON with concomitant PDT," commented John (Jack) L. Armstrong, President and Chief Operating Officer of Genaera Corporation. "Additionally, we are encouraged by the stabilization of vision shown in this small study, as well as the lower incidence of the need for retreatment with PDT in those subjects treated with EVIZON."
MSI-1256F-208 is a Phase II trial designed to evaluate in 45 subjects with wet AMD the safety and clinical effects of three different doses of EVIZON (10mg, 20mg or 40mg) along with initial concomitant PDT treatment in 10 subjects per group, or PDT-alone in 15 control subjects. Specifically, this study is designed to evaluate the safety and effects of systemically administered EVIZON before and after PDT. The multi-center, randomized, controlled, masked study also includes monthly EVIZON maintenance therapy through six months, along with an additional twelve months of open-label treatment and follow-up for each patient.
Other Ongoing Clinical Trials
Genaera is currently conducting a Phase III and multiple Phase II trials of EVIZON in wet AMD at multiple investigational sites. In January 2005, the Food and Drug Administration (FDA) selected EVIZON for participation in the Continuous Marketing Application (CMA) Pilot 2 program. In October 2004, the FDA granted EVIZON Fast Track designation.
MSI-1256F-301 is a Phase III international trial designed to enroll subjects with predominantly classic, minimally classic and occult forms of wet AMD. The multi-center, randomized, double-masked, controlled trial will evaluate two doses of EVIZON (40mg and 20mg) versus placebo, given once weekly for four weeks followed by maintenance doses every four weeks until week 104. PDT is allowed as background therapy for all subjects in this study if deemed necessary and appropriate by the study physician. Enrollment in this trial is ongoing.
MSI-1256F-209 is the cornerstone and largest of Genaera`s three Phase II studies and is designed to evaluate the safety and efficacy of EVIZON over a two-year period in 100 subjects with wet AMD. This Phase II multi-center, randomized, double-masked, controlled study will evaluate two dose levels of EVIZON (20mg or 40mg) given once weekly for four weeks, followed by maintenance doses once every four weeks until week 48. At the end of 48 weeks of therapy, each subject will be followed for a further twelve months. PDT is allowed as background therapy for all subjects in this study if deemed necessary and appropriate by the study physician. Enrollment in this trial is closed.
MSI-1256F-207 was a Phase II pharmacokinetic and safety trial that evaluated 18 subjects with AMD at three different doses of EVIZON (10mg, 20mg or 40mg) over four months. In this multi-center, open-label, parallel group study, EVIZON was given once weekly for four weeks, and then all subjects were followed out to month 4 with no further treatment after week four. All subjects in the 207 trial have completed therapy and follow up and depending on their response, subjects may have continued to receive EVIZON as needed for up to one additional year in a separate study (MSI-1256F-211).
For information about participation in EVIZON clinical trials, subjects and physicians may call Genaera`s Clinical Trial Hotline at (800) 299-9156.
About EVIZON(TM)
EVIZON is a unique first in class synthetic small molecule administered systemically that directly interrupts and reverses multiple facets of the angiogenic process. Working within activated endothelial cells, EVIZON inhibits growth factor signaling including VEGF, integrin expression, and reverses cytoskeletal formation, thereby resulting in endothelial cell inactivation and apoptosis. Systemically administered EVIZON inhibits abnormal angiogenesis in rodent models of retinopathy of prematurity, and the development of choroidal neovascular membranes in rat models of AMD. Additional preclinical studies have demonstrated that systemic EVIZON administration is effective in reaching abnormal ocular blood vessels in primates, and leads to partial regression and inhibition of new abnormal vessels in the eye. These results support that EVIZON may have a role in the treatment of human choroidal neovascular membrane formation that underlies the pathology of wet AMD.
About AMD
Wet AMD resulting from angiogenesis is the leading cause of legal blindness among adults age 50 or older in the Western world. Approximately 25 to 30 million people are affected globally and this number is expected to triple over the next 25 years.
AMD occurs in two types: the "dry" form and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels, or choroidal neovascularization, under the central part of the retina, the macula. Dry AMD, or the avascular form is the more common and milder form of AMD, accounting for 85% to 90% of all cases. Dry AMD results in varying forms of sight loss and may or may not eventually develop into the wet form. Although the wet form of AMD accounts for only 10% to 15% of all AMD, the chance for severe sight loss is much greater. It is responsible for 90% of severe vision loss associated with AMD. Approximately 500,000 new cases of wet AMD are diagnosed annually worldwide. In North America alone, approximately 200,000 new cases of wet AMD are diagnosed each year.
Wann kommen bloß endlich die Trial 211 Resultate?
Die Trial 208 sind ja schon grob bekannt, die genauen Details wurden ja heute veröffentlicht, Trial 211 aber immer noch nicht!
Die Trial 208 sind ja schon grob bekannt, die genauen Details wurden ja heute veröffentlicht, Trial 211 aber immer noch nicht!
Genr hat die letzten Tage die Kraft gehabt die wichtige Marke von 1,60 zu halten, viele wollen noch in den Markt, daher bewegt sich die Aktie immer zwischen 1,60 und 1,70, ist völlig überverkauft, das Volumen wird immer geringer, schlägt immer weniger aus, d.h.für mich im KLartext, im Zeitraum von 4 Wochen mit einer postiven Meldung zu Trial 211 ergibt das ein Kursfeuerwerk zuerst Richtung 2 Dollar die sehr schnell überwunden sein wird, um dann alte Höchststände von knapp 3 Dollar zu erreichen.
Bin gespannt ob meine Prognose eintritt aber Evizon hat das Potenzial ein ganz großes Produkt zu werden und viele Menschen zu helfen um auch gut zu sehen im hohem Alter.
Bin gespannt ob meine Prognose eintritt aber Evizon hat das Potenzial ein ganz großes Produkt zu werden und viele Menschen zu helfen um auch gut zu sehen im hohem Alter.
Wie komme ich Esel dazu eine Aktie mit so einem klaren Abwärtstrend zu kaufen? 
Mal wieder auf alle schlauen Sprüche hier reingefallen
Mal wieder auf alle schlauen Sprüche hier reingefallen
demnächst gibt es News. Und das Teil steigt. Alleine heute mit der Mitteilung dass News kommen....
Da dürfen wir ja mal gespannt sein.......
Da dürfen wir ja mal gespannt sein.......
Hier die Meldung:
Genaera Corporation (Nasdaq: GENR) today announced that John L. Armstrong, Jr., the Company`s President and Chief Operating Officer, will give a presentation on Monday, November 7, 2005 at 11:55 a.m. EST at the Rodman and Renshaw Techvest 7th Annual Healthcare Conference. The conference is being held November 7-9, 2005 at the Palace Hotel in New York City.
The presentation will review highlights related to Genaera`s development programs, including EVIZON(TM) (squalamine lactate), the Company`s lead development program and first in class anti-angiogenic small molecule for the treatment of "wet" age-related macular degeneration (AMD). Genaera`s other development programs, squalamine for cancer, mucoregulator program LOMUCIN(TM) and the IL9 antibody, will also be discussed.
Genaera Corporation (Nasdaq: GENR) today announced that John L. Armstrong, Jr., the Company`s President and Chief Operating Officer, will give a presentation on Monday, November 7, 2005 at 11:55 a.m. EST at the Rodman and Renshaw Techvest 7th Annual Healthcare Conference. The conference is being held November 7-9, 2005 at the Palace Hotel in New York City.
The presentation will review highlights related to Genaera`s development programs, including EVIZON(TM) (squalamine lactate), the Company`s lead development program and first in class anti-angiogenic small molecule for the treatment of "wet" age-related macular degeneration (AMD). Genaera`s other development programs, squalamine for cancer, mucoregulator program LOMUCIN(TM) and the IL9 antibody, will also be discussed.
Mch dir da mal nicht zuviel Hoffnung.
GENR Oräsentation ist jediglich eine Art Roadshow iher bisherigen Testergebnisse. Diese werden wie in San Francisco jetzt Vorgestellt. Neuigkeiten gibts ed aber keine.
Mich würde vielmehr Interessieren, was mit Trial 211 ist! Der wurde auf der AAO vorgestellt. Eine Ofizielle Veröffentlichung gab es aber nur für Trial 208! Und die gleich zweimal!
GENR Oräsentation ist jediglich eine Art Roadshow iher bisherigen Testergebnisse. Diese werden wie in San Francisco jetzt Vorgestellt. Neuigkeiten gibts ed aber keine.
Mich würde vielmehr Interessieren, was mit Trial 211 ist! Der wurde auf der AAO vorgestellt. Eine Ofizielle Veröffentlichung gab es aber nur für Trial 208! Und die gleich zweimal!
Verlust: $(0.13) per share basic and diluted
Ist das jetzt Viel?
Premarket 0,01 im Minus
Ist das jetzt Viel?
Premarket 0,01 im Minus
Denke jetzt hat Genr das letztemal 1,50 getestet ab Montag gehts ganz steil bergauf, Montag kommen die News und da wirds ordentlich krachen, Ende nächste Woche stehen wir bei 2,50....
sehr optimistisch! Wohl zu optimistisch, oder gibt es Insider-infos?
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