Der Handel mit den CDIs der pSivida Corp. beginnt
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Stay long (seit nicht so ungeduldig)
Gruß
cheche
Global drug delivery company, pSivida Corp. (NASDAQ: PSDV)(ASX: PVA)(FSE: PSI) today reported the interim three-month safety and efficacy results from the first human pharmacokinetic(1) (PK) study of Medidur™ FA, in patients with Diabetic Macular Edema (DME). This Phase II study is designed to support the ongoing pivotal Phase III clinical trial of Medidur in DME.
Medidur releases the drug Fluociniolone acetonide (FA) directly into the eye to treat DME. The Phase II study described here is primarily designed to assess systemic exposure to that drug after administration of Medidur into the eye. The study is secondarily designed to provide information on the safety and efficacy of Medidur in a DME population.
A total of 37 subjects were enrolled in this trial, 20 patients on the low dose (an approximate 0.23µg per day dose) of Medidur and 17 patients on the high dose (an approximate 0.45µg per day dose) with the same inclusion/exclusion criteria as the ongoing Phase III study.
The three month interim readout from the PK study indicated 20 percent of the low dose patients and 18 percent of the high dose patients showed an improvement in best-corrected visual acuity (BCVA) of 15 letters or greater from baseline on an eye chart. In addition, both the low dose and the high dose of Medidur resulted in a significant reduction in retinal thickness as compared to the baseline.
From a safety perspective, no adverse events related to intraocular, or inner eye, pressure were seen in the low dose patients, while 12 percent of the high dose patients experienced intraocular pressure increases of greater than 30 mmHg. Additionally, the only adverse event related to cataract formation was reported in a patient in the high dose group.
The early readout from this PK study provides further insight into the dose-response of FA in the treatment of DME. By comparison, Retisert® intravitreal implant, which releases FA at an initial rate of 0.6 µg per day, was also studied in a DME population. Retisert data presented at the ARVO conference in 2004 and 2005 showed that at 6 months between 15% and 20% of DME patients receiving Retisert gained 15 letters from baseline on an eye chart and after 2 years this increased to 27% but there were some steroid related side effects, particularly cataract and elevation of IOP.
Our next generation product Medidur was designed to achieve similar efficacy to Retisert while reducing the side effects and to be easier to administer. This preliminary data indicates similar efficacy at 3 months with few side effects. Additional data from the PK study will be available at 6, 12, 18, 24 and 36 months. The first efficacy and safety assessment on the fully recruited pivotal Phase III study will be conducted after the last patient completes their 2 years assessment in late 2009.
DME is a disease of the retina which affects individuals with diabetes and can lead to severe vision loss and blindness. Medidur is designed to provide a sustained therapeutic effect, up to 24 months for the low dose and up to 36 months for the high dose. Medidur is inserted into the patient’s eye with a 25-gauge needle in an office visit in a procedure very similar to intravitreal injections, commonly employed by retinal specialists.
“We are very excited by the early results of this study which supports our hypothesis that lower doses of FA delivered via our Medidur system will provide visual acuity improvements whilst reducing the risk of ocular side effects commonly associated with the use of corticosteroids,” said Dr Paul Ashton, Managing Director, pSivida Corp.
If approved, it is anticipated Medidur will be marketed under the name Iluvien.
(1) The study of absorption, distribution, metabolism and excretion of a drug.
Danke für Info
Rätselnd
Skid
Kursverfsall auch sehr drastisch,hat sich ja von dem Hoch (0,084) fast
halbiert...,aber wenn ich nun die Marktkapitalisierung betrachte,so wird uns
Psivida,bei dem einen oder anderen gelingen,in Zukunft viel Freude bereiten.
Bleibt wohl nur Geduld
Danke
Skid
Da kommt noch was. Ich glaube, den ganz dicken Brocken haben wir insgesamt noch nicht hochgewürgt- :-(
Ran!
Skid
Siehe folgenden Link:
http://www.finanznachrichten.de/...chten-2008-07/artikel-11218043.asp
Ich werde immer noch nicht schlau draus.
Frohes Zocken
Skid
Aktueller Kurs 2,30 US Dollar.
Keine negativen News eher positive und so ein Kursabschlag,sehr seltsam finde ich!
Was geht da ab?
Leerverkäufe?
Da ausser mir keiner mehr postet.denke ich das ich hier wohl alleine bin,oder?
Meinungen würden interessieren.
denke mal da ist vielleicht noch ein bisschen abwärtspotential möglich
die gestrigen us verkäufe müssen nichts mit psd zu tun haben
wir sehen es ja überall,
notleidende banken und fonds verkaufen auf teufel komm raus.... ;-(
und zur rechten zeit gleich eine news ;-)
(von heute morgen)
pSivida Corp: DSMB Supports continuation of the Phase III clinical trial of Iluvien for the treatment of DME
Brian Leedman
Details anzeigen 07:10 (Vor 2 Stunden)
Global drug delivery company, pSivida Corp. (NASDAQ: PSDV, ASX: PVA, FF: PV3) today announced that after completing its review of safety and efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has once again recommended that the two pivotal Phase III clinical trials, known collectively as the FAME™ (Fluocinolone Acetonide in Diabetic Macular Edema) Study continue under the current protocol, without change. The trial is studying the use of MedidurTM FA for the treatment of diabetic macular edema (DME) being conducted by our licensing partner, Alimera Sciences. MedidurTM FA will be marketed under the name IluvienTM.
FAME are two, duplicate, double-masked, randomized, multi-center studies following 956 patients in the U.S., Canada, Europe and India for 36 months in support of a planned global registration filing, with safety and efficacy assessed after two years of follow-up.
Enrolment for the FAME study was completed in October 2007.
All patients have now been followed for at least approximately one year and many have been followed for two or more years.
Currently, nearly 8 percent of the US population has diabetes. Over time, almost all diabetics will develop some form of diabetic retinopathy, of which diabetic macular edema is the primary cause of vision loss. Based on published data, pSivida estimates that in the United States as many as 300,000 people are diagnosed with DME each year and an estimated 1,000,000 people suffer from DME. Currently, there are no FDA approved drug treatments for DME.
“pSivida is very pleased that the DSMB has once again supported the continuation of this pivotal trial and remain on track to file an NDA for this product in early 2010,” said pSivida Managing Director, Dr. Paul Ashton.
Kind regards
Brian Leedman
Vice President, Investor Relations
pSivida Corp.
Tel: +61 8 9227 8327 Fx: +61 8 9227 6838 Mb: +61 (0) 412 281 780
brianl@psivida.com www.psivida.com
PSDV z.Z. minus 19 % auf 1,80 Dollar.
Mein Depot kann ich mir nicht mehr angucken ohne Schweissausbrüche zu bekommen,
dabei sind da Werte wie Intel,Cisco Nokia und Oracle üsw. drin,die können natürlich auch schwanken
aber nicht so radikal.
Wie geht das weiter?
Weltwirtschaftskrise?
Keiner sagt es aber alle wissen es.
Wie seht ihr das?
Ich sehe die Entwicklung mittlerweile sehr sehr kritisch!!
Es ist nicht zu fassen!
Ehrlich gesagt finde das alles andere als in Ordnung.
Aber da hier keine Posts kommen,wirds wohl keinen interessieren.
ja es sind wirklich ausverkaufspreise
aber fast jeder befürchtet es könnte noch weiter fallen....