GENAERA CORP

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RLDJA
Genaera Corporation Presents Encouraging Data
Genaera Corporation Presents Encouraging Data on Bilateral Visual Acuity in Subjects From EVIZON Phase II Trials PLYMOUTH MEETING, Pa., March 29 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR) today presented a new subset analysis of EVIZON(TM) (squalamine lactate) clinical data at the IBC Third Annual Ocular Anti- angiogenesis Conference in Cambridge, MA, that suggests the treatment may benefit patients with wet age-related macular degeneration (AMD) whose vision has already significantly deteriorated. In an overview of Phase II clinical trial data, including recently announced 24-week interim results from Study 209 (MSI-1256F-209), Michael J. Gast, M.D., Ph.D., Senior Vice President, Clinical Research and Development, described outcomes for subjects in these studies with fellow affected eyes (i.e., documented disease in the second eye) and poor vision at study entry. "These data, which are consistent across our Phase I/II program, suggest that intravenous EVIZON safely stabilizes or improves vision in both the study eye and the fellow affected eye in a dose responsive fashion," said Dr. Gast. "What is particularly intriguing is that this effect appears to be most marked in subjects with poorer vision in fellow affected eyes, many of whom, as a result of their low visual acuity, would not currently be considered good candidates for treatment. We look forward to confirming this benefit in ongoing studies." Dr. Gast reviewed new analyses of fellow affected eyes from Study 207 (MSI-1256F-207), an 18 patient, multicenter, open-label pharmacokinetic trial and from Study 209, a 108 patient, randomized, masked, controlled trial. In Study 207, mean best corrected visual acuity in fellow affected eyes across all EVIZON dose groups improved over baseline by as many as 8 letters following 4 weekly treatments with EVIZON in subjects with poorer vision (defined as < 50 ETDRS letters at study entry). This effect was also seen in the larger Study 209, where a dose response across EVIZON treatment groups was evident. An analysis of all fellow affected eyes at 24 weeks showed that the 40 mg EVIZON dose improved vision by 4 letters on average from baseline and the 20 mg dose improved vision by approximately 2 letters, with the placebo group declining from baseline by an average of 3 letters. In subjects with very poor vision in the fellow affected eye (defined as < 34 ETDRS letters at study entry), the improvement by dose group was more pronounced. At 24 weeks, best corrected visual acuity in the 40 mg dose group had improved by 8 letters and by more than 5 letters in the 20 mg dose group. Dr. Gast reported that the potential of EVIZON in fellow eyes would also be carefully evaluated in Study 212 (MSI-1256F-212), a planned, multicenter, randomized, open-label, pharmacodynamic and safety study designed to determine if higher dose levels of EVIZON will produce greater improvements in visual acuity. The study will evaluate four intravenous doses of EVIZON, 40 mg, 80 mg, 120 mg, and 160 mg, over 16 weeks of treatment (4 weekly doses followed by 3 monthly doses). Genaera expects to initiate the study in the second quarter of 2006.
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RLDJA
Genaera Appoints Michael J. Gast
Genaera Appoints Michael J. Gast, MD, PhD to Lead Clinical Research and Development PLYMOUTH MEETING, Pa., March 21 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR) today announced the appointment of Michael J. Gast, MD, PhD, as Senior Vice President, Clinical Research and Development. Dr. Gast served as Chief Medical Officer of Genaera during the first half of 2005 and left briefly to pursue personal interests. He has been a full-time consultant to the Company since November of 2005. "We are very pleased to have Mike return to the Genaera management team," said Jack Armstrong, President and CEO of Genaera Corporation. "Mike's guidance has been invaluable as we have adapted and refined our clinical strategy for EVIZON(TM) (squalamine lactate) over the past year. In his new role he will provide strong leadership and essential expertise for the next development phase of this product and all of our programs moving forward. His appointment is part of my commitment to expanding our management and advisory resources in areas critical to our success." "This is an exciting time for Genaera, and I'm pleased to be rejoining this talented and committed team," said Dr. Gast. "I'm very enthusiastic about the clinical potential of each of the drug candidates in our broad development portfolio, particularly EVIZON, which I believe represents a unique and highly differentiated treatment option for wet age-related macular degeneration (AMD). My focus now is to ensure that the design and execution of our clinical strategy fully demonstrates to both regulators and clinicians EVIZON's value as a systemic, bilateral therapy for exudative AMD." Dr. Gast brings more than 30 years of medical and pharmaceutical industry experience to Genaera. Prior to joining the Company, he spent 11 years at Wyeth Pharmaceuticals, most recently serving as Vice President, Scientific Affairs within Wyeth Global Medical Affairs, where he was responsible for oversight of Phase IV clinical research programs. Prior to that, Dr. Gast served as Wyeth's Vice President, Women's Health Clinical Research and Development. Dr. Gast joined Wyeth after spending 21 years at the Washington University School of Medicine. During his tenure on the faculty at the Washington University Department of Obstetrics and Gynecology, Dr. Gast served as Director of the Division of Reproductive Endocrinology and Infertility and Director of the department's Endocrine Clinical Laboratories. Dr. Gast received his MD from The Ohio State University College of Medicine and a PhD in Molecular Biology from Washington University.
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RLDJA
Insider kaufen ein...
Trotz der guten Forschungsergebnisse ist der Kurs eingebrochen, vermutlich weil eine Auslizensierung noch etwas länger dauern wird als vermutet, wobei es sich nur um Monate handelt. Ende 2006 sollen die entscheidenden Ergebnisse aus dem Trial 212 vorliegen. Daher nutzen momentan Insider die Situation und kaufen ordentlich ein. Nach den letzten Käufen im Oktober 2005, haben gleich drein, den März zum Nachkaufen genutzt. Insgesamt gingen 54.285 Aktien in die Hände von Insidern. Wenn das kein gutes Zeichen ist. Vielleicht war auch gerade das wichtig, damit die Anleger wieder Vertrauen und Hoffnung in den Maßlos unterbewerteten Wert bekommen.
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RLDJA
rasanter Anstieg
in den nächsten drei Tagen heisst es jetzt den Durchbruch der 200 Tagelinie bei 1.68 USD zu bestätigen und damit ein Ende des Abwärtstrends einzuleiten. Dann können auch endlich Fundamentale Nachrichten den Kurs positive antreiben. Ob ein hausse anliegt oder erstmal eine Seitwärtsbewegung bleibt abzuwarten. Ende nä. Woche sollten wir mehr wissen!
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