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Recent News and Articles on the Keywords: phase iii + pivotal + sugammadex  Related to the article below (Last Update: 5/12/2008)

Schering-Plough Reports Financial Results for First Quarter of 2008
PR Newswire (press release), NY - Apr 23, 2008
"When we began this journey in 2003, Schering-Plough had five new molecular entity projects or novel combination products in Phase III clinical trials or in ...SGP - SGP-B
Source: Google News

Pivotal Phase III Trial of Two Dose Levels of Denileukin Diftitox for the Treatment of Cutaneous T- … -
E Olsen, M Duvic, A Frankel, Y Kim, A Martin, E … - Journal of Clinical Oncology, 2001 - jco.ascopubs.org
... Oncology Pivotal Phase III Trial of Two Dose Levels of Denileukin Diftitox
for the Treatment of Cutaneous T-Cell Lymphoma. By Elise ...

[CITATION] IDEC-C2B8 anti-CD20 antibody: Final report on a phase III pivotal trial in patients with relapsed …
P McLaughlin, F Cabanillas, AJ Grillo-Lopez, BK … - Blood, 1996

… for carcinoma of the colon and rectum: results of a pivotal, phase III trial. The Immunomedics … -
FL Moffat Jr, CM Pinsky, L Hammershaimb, NJ … - Journal of Clinical Oncology, 1996 - jcojournal.org
... the IMMU-4 technetium-99m Fab' antibody fragment in patients undergoing surgery
for carcinoma of the colon and rectum: results of a pivotal, phase III trial. ...

… of Oral Tolerization with Myelin Antigens in Multiple Sclerosis and Design of a Phase III Pivotal … -
MJ HOHOL, SJ KHOURY, SL COOK, EJ ORAV, DA HAFLER, … - Annals of the New York Academy of Sciences, 1996 - Blackwell Synergy
... Page 7. HOHOL et oL: CONTINUATION STUDY 249 TABLE 5. Design of Phase III Pivotal
Trial Male Female Treated vs. Placebo Treated vs. Placebo DR2- 84/84 84/28 ...

A WORLDWIDE, PHASE III, RANDOMIZED, CONTROLLED, SAFETY AND EFFICACY STUDY OF A SIROLIMUS/ … -
AS MacDonald - Transplantation, 2001 - transplantjournal.com
... The phase III study described here, one of two pivotal, double-blind, controlled
studies of sirolimus in combination with CsA microemulsion/corticosteroids in ...

Lessons from phase III clinical trials on anti-VEGF therapy for cancer -
RK Jain, DG Duda, JW Clark, JS Loeffler? - Nat Clin Pract Oncol, 2006 - nature.com
... In a pivotal phase III trial, trastuzumab (Herceptin?; Genentech, Inc., South San
Francisco, CA) administered in combination with chemotherapy (anthracycline ...

… in Patients With Breast Cancer: A Multicenter, Double-Blind, Placebo-Controlled Phase III Study -
CL Vogel, MZ Wojtukiewicz, RR Carroll, SA … - Journal of Clinical Oncology, 2005 - jco.ascopubs.org
... 2 Patients who received placebo in the pivotal phase III trial for filgrastim were
reported to have a 77% incidence rate of febrile neutropenia compared with a ...

Ranibizumab: Phase III clinical trial results.
PJ Rosenfeld, RM Rich, GA Lalwani - Ophthalmol Clin North Am, 2006 - ncbi.nlm.nih.gov
... Although the pivotal phase III trials (MARINA and ANCHOR) used monthly injections
of ranibizumab for 2 years, the ongoing PIER, PrONTO, and SAILOR trials are ...

Pivotal phase III study: safety of polymerized bovine hemoglobin (HBOC-201, Hemopure?) as compared …
… LM Stewart, C MacKenzie, D Bourke, JP Williams III - Anesthesiology, 2002 - asaabstracts.com
... A-243 2002. Pivotal Phase III Study: Safety of Polymerized Bovine Hemoglobin
(HBOC-201, Hemopure?) as Compared to RBC in Patients Undergoing Orthopedic Surgery. ...

… with technetium 99m-labeled totally human monoclonal antibody 88BV59: results of pivotal, phase III … -
AN Serafini, JL Klein, BG Wolff, R Baum, A … - J Clin Oncol, 1998 - ncbi.nlm.nih.gov
... metastatic, or occult colorectal cancer with technetium 99m-labeled totally human
monoclonal antibody 88BV59: results of pivotal, phase III multicenter studies ...

Source: Google Scholar

Organon's Sugammadex Demonstrated A 9-12 Times Faster Recovery In Phase III Pivotal Trial Compared To Neostigmine
The Aurora trial compared the efficacy of sugammadex and neostigmine for the reversal of shallow neuromuscular blockade induced by single or multiple doses of either rocuronium (Esmeron®/Zemuron®) or vecuronium (Norcuron®).

"Sugammadex has shown a rapid and complete reversal in this pivotal trial without evidence of PORC or re-occurrence of neuromuscular blockade. Effective reversal is critically important to ensure that patients recover quickly and completely, without the risk of breathing difficulties," commented one of the lead investigators involved in the Aurora trial, Professor M. Blobner from the Klinik für Anästhesiologie der Technischen Universität München, Germany.
Reversal agents are used during general anesthesia to reverse the effects of muscle relaxants, also called neuromuscular blocking agents (NMBAs). Reversal of neuromuscular blockade is used to reduce the risk of PORC or re-occurrence of muscle relaxation.

Phase III Trial Overview

The international, randomised, multicenter, parallel-group Aurora trial was conducted at 13 European centers and enrolled 198 patients. In the trial sugammadex was administered at reappearance of T2 and achieved significantly faster recovery of the T4/T1 ratio to 0.9 compared with neostigmine. Median time to recovery was 1.4 minutes (0.9-5.4; p<0.0001) for sugammadex versus 17.6 minutes (3.7-106.9; p<0.0001) for neostigmine following rocuronium administration; and 2.1 minutes (1.2-64.2; p<0.0001) versus 18.9 minutes (2.9-76.2); p<0.0001) respectively following vecuronium administration. There were no clinical events due to PORC or re-curarization reported for either group.1, 2

In total 34 patients from this trial experienced one or more adverse events (AE) that were considered at least possibly related to the study drugs: 14 in the sugammadex group and 20 in the neostigmine group. Most drug-related AEs were mild or moderate. The most commonly reported AEs (>4%) with sugammadex included dry mouth, nausea, vomiting, chills and procedural hypertension. Neostigmine was most commonly associated (>4%) with prolonged neuromuscular blockade, dry mouth, nausea, procedural complication and albumin present in urine.[1, 2]

During the congress, results from three additional Phase III trials - Libra, Spring and Crystal trials - were presented. These trials demonstrated that sugammadex was effective and well tolerated in pediatric patients, in patients with mild or moderate impaired renal function and in comparison with neostigmine-glycopyrrolate after cisatracurium. Most common AEs (>4%) considered at least possibly related to sugammadex in these studies were diarrhoea, anesthetic complication and increased D-glucosaminidase.[3, 4, 5]

In the clinical trials conducted to date, sugammadex has generally demonstrated the ability to reverse shallow and profound depths of rocuronium-induced neuromuscular blockade within 3 minutes, thereby enabling unprecedented control of the onset and offset of skeletal muscle relaxation through the use of both drugs. Sugammadex's global Phase III development program consisting of 5 US trials and 5 European trials - completed recruitment in late 2006. The submission of the registration files for the USA, Europe and Japan are on schedule.
About Organon

Organon creates, manufactures and markets innovative prescription medicines that improve the health and quality of human life. Through a combination of innovation and business partnerships, Organon seeks to leverage its position as a leading biopharmaceutical company in each of its core therapeutic fields: fertility, gynecology and selected areas of anesthesia. It has extensive expertise in neuroscience and a rich and focused R&D program. Research areas also include immunology and specific areas of oncology. Organon products are distributed in over 100 countries worldwide, of which more than 50 have an Organon subsidiary. Organon is the human healthcare business unit of Akzo Nobel.

Organon
http://www.organon.com/authfiles/index.asp
 
 
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