Navigation Links
Arpida Receives Green Light From US FDA for Phase II Efficacy Trial With Oral Iclaprim
Date:1/15/2008

REINACH, Switzerland, January 15 /PRNewswire-FirstCall/ -- Arpida Ltd. (SWX: ARPN) today announced that it has received authorisation from the U.S. Food and Drug Administration (FDA) to conduct a Phase II 'intravenous-to-oral' switch trial with iclaprim in patients with complicated Skin and Skin Structure Infections (cSSSI).

The key objective of the study is to assess the clinical efficacy of an oral capsule formulation of iclaprim as step-down therapy in comparison with intravenous (IV) vancomycin in the treatment of cSSSI. The primary endpoint will be the clinical cure rate at the Test-of-Cure (TOC) visit. Secondary objectives include bacteriological outcomes as well as safety and tolerability.

This Phase II trial is designed as a multi-centre, double-blind comparative study. Patients suffering from cSSSI will receive IV vancomycin for the first two days of treatment and will then be randomised to either continue to receive IV vancomycin or be switched to oral iclaprim for eight additional days. A total of 60 patients will be randomised for this study.

Iclaprim is also being developed as an intravenous formulation for two indications: cSSSI and nosocomial pneumonia. In the cSSSI indication the drug candidate has completed its pivotal Phase III trial programme and is currently in an NDA-filing process. In the nosocomial pneumonia indication, the drug candidate is currently in Phase II.

Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "Among the hospital anti-MRSA drugs that are currently in filing or late-stage development, only iclaprim shows good oral bioavailability and consequently offers the potential for intravenous-to- oral switch therapy. We believe that intravenous-to-oral switch therapy is important as it could provide a means to enhance patient comfort, reduce risk of spread of infection and reduce hospital-associated healthcare costs. In parallel with this Phase II trial, we are continuing our work on th
'/>"/>

SOURCE Arpida Ltd.
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related biology technology :

1. Arpida-Supported CME Symposium Available Online
2. Arpida Presents Data on Iclaprim at Scientific Congress in Germany
3. Arpida Presents Preclinical Data on AR-2474 at ICAAC
4. Arpida Presents Preclinical and Clinical Data on Iclaprim at ICAAC
5. Arpida Invited to Present Preclinical Data on Novel Topical Antibiotic AR-2474 at ICAAC
6. Arpida Interim Results for six Months to 30 June 2007
7. Genta Receives Notice of Non-Compliance With NASDAQ Rule
8. Texas Boy Receives Wheelchair From New Hampshire Couples Recently Deceased Granddaughter
9. Harborview Medical Center in Seattle Receives Prestigious $100,000 Foster G. McGaw Prize for Excellence in Community Service
10. EaglePicher Technologies Receives Battery Power Products and Technologys First Annual Innova Award
11. Aida Receives Chinese Government Innovation Award
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/1/2008)...-FirstCall/ -- Novavax, Inc.,(Nasdaq: NVAX ) a ...at Dr.,Rahul Singhvi, President and Chief Executi...ay 20th Annual Healthcare Conference at 11:00 a.m....vi will provide an overview of the,company,s stra... the live,presentation can be accessed via the Co...
(Date:12/1/2008)...all/ -- The Female Health Company,(Amex: FHC ),...om(R),today reported record operating results fo... 2008. , For the three months ended Septemb...illion, compared with $5.2 million in the quarter ...t income attributable to common stockholders of,$...
(Date:12/1/2008)...swire/ -- Regado Biosciences, Inc.,announced tod...utive Officer,will present at the 20th Annual Pi...Y, on Tuesday, December 2, 2008, at 10:10am (Easte...pany,s development pipeline, in addition to,revie... About Regado Biosciences , Regado Bi...
(Date:12/1/2008)...rom a California company aided in the research of ...ociate professor of biomedical engineering. Hyun u... which he will present this summer to his research... Macon, GA (PRWEB) December 1, 2008-- A gi... of vein treatment methods led by Dr. Sinjae Hyu...
Breaking Biology Technology:The Female Health Company Reports Record Results for Fiscal Year 2008, at High End of Guidance 2The Female Health Company Reports Record Results for Fiscal Year 2008, at High End of Guidance 3The Female Health Company Reports Record Results for Fiscal Year 2008, at High End of Guidance 4The Female Health Company Reports Record Results for Fiscal Year 2008, at High End of Guidance 5The Female Health Company Reports Record Results for Fiscal Year 2008, at High End of Guidance 6The Female Health Company Reports Record Results for Fiscal Year 2008, at High End of Guidance 7The Female Health Company Reports Record Results for Fiscal Year 2008, at High End of Guidance 8Gift Aids Professor's Research into Vein Treatment 2Gift Aids Professor's Research into Vein Treatment 3Gift Aids Professor's Research into Vein Treatment 4
...lation , Kits , , , , ,... Isolation Kits are designed to generate , ...r automated fluorescent , sequencing, trans...ream , applications. , In order to ...mpetitor, , side-by-side extractions were...
... Other important parameters for optimizing electro... , Field strength , ... Number of , field pulses , ...n buffer , Influence , of ...emperature , Influence , o...
... Other important parameters for optimizing electro... , Field strength , ... Number of , field pulses , ...n buffer , Influence , of ...emperature , Influence , o...
... Other important parameters for optimizing electro... , Field strength , ,... Number of , field pulses , ... buffer , Influence , of D...mperature , Influence , of...
Other Biology Technology:Eppendorf Perfectprep Plasmid DNA Isolation , Kits 2Eppendorf Perfectprep Plasmid DNA Isolation , Kits 3Optimizing electroporation parameters 2Optimizing electroporation parameters 3
(Date:12/1/2008)... research leading to the development of flood-tole...areas worldwide, Julia Bailey-Serres of UC River...ll of the International Rice Research Institute i...rtment of Agriculture (USDA) with the 2008 USDA Na...e three scientists are, or have been, principle in...
(Date:12/1/2008)...ournal of the American Dietetic Association featu...ng habits of consumers. Researchers look at why fa...methods for adding healthier foods to a person,s d...Journal of the American Dietetic Association inclu... Reasons among Frequent Consumers, Menu Modeling ...
(Date:12/1/2008)...earch Hospital have discovered that a certain diff...ntity that it requires the constant expression of ...rchers showed that Prox1 acts as a two-way switch ...ialized type of cell, called a lymphatic endotheli... LEC actually loses its identity and assumes chara...
(Date:12/1/2008)...tight junction protein called claudin 11 makes the... be published in the December 1, 2008 issue of the...ke the rubber coating on a copper wire, the myelin...irals around the axons of neuronscreates an insula...s and aids electrical conduction along the length ...
Breaking Biology News(10 mins):UC Riverside rice geneticist receives high honor from US Department of Agriculture 2UC Riverside rice geneticist receives high honor from US Department of Agriculture 3News from the December 2008 Journal of the American Dietetic Association 2Reprogrammable cell type depends on a single gene to keep its identity 2Older Patients Less Likely to Be Taken to Trauma Centers 25508 1Older Patients Less Likely to Be Taken to Trauma Centers 25508 2Older Patients Less Likely to Be Taken to Trauma Centers 25508 3Olympic Gold Medalist Inspires Cancer Patients Through Blog 25506 1Olympic Gold Medalist Inspires Cancer Patients Through Blog 25506 2New Intensive Care Unit at Gilbert Hospital Sees First Patient 25504 1New Intensive Care Unit at Gilbert Hospital Sees First Patient 25504 2Prescription Sleeping Pill Use Tied to Cancer 2852 1Prescription Sleeping Pill Use Tied to Cancer 2852 2
...icians detect the very earliest stages of serious ...ould do so by improving the quality of images prod...ed in doctors, offices ?the ultrasound machine. ,...nd that nano-sized particles injected into the ani...one of the first reports showing that ultrasound c...
...ity have successfully "knocked down" the expressio...at fetus, perhaps paving the way for breeding dise...that might cause bovine spongiform encephalopathy ...chers Mark Westhusin and Charles Long in Texas A&a...ical Sciences, working with fellow scientists Greg...
... imaging study of the travels of the malaria paras...rs at the Pasteur Institute in Paris found the par...h nodes. , The parasites, presence in the lymph no...alian immune response, said Robert Ménard, a Howar...search scholar who led the study. , Ménard and ...
...e they have finished the first complete analysis o...t important model organisms: S. cerevisiae (baker,... Cellzome, in collaboration with the European Mole...eek,s online edition of Nature. , "To carry out th... that may contain dozens of molecules," says Giuli...
Other Biology News:Nanotechnology may find disease before it starts 2Nanotechnology may find disease before it starts 3Successful cell engineering may lead to mad cow prevention, say researchers 2Malaria parasites develop in lymph nodes 2Malaria parasites develop in lymph nodes 3The closest look ever at the cell's machines 2The closest look ever at the cell's machines 3
Human GATA-2 Affinity Purified Polyclonal Ab
...s the lowest priced, full ring small animal imagin...4 low retail price, it outperfoms every competing ...performance, energy resolution, timing resolution,... animal PET (Positron Emission Tomography) imaging...
REC. PROTEIN G from Invitrogen
... I provides a convenient and affordable alternativ...d with an eight-port disposable manifold, the Stat... with multi-channel pipettes. The eight-port manif...uids in volumes of 100, 200, 250, or 300mL with we...
Biology Products: