Navigation Links
LifeCycle Pharma to Initiate Phase II Clinical Trial of LCP-Tacro for Organ Transplantation

LifeCycle Pharma will initiate a Phase II clinical trial of LCP-Tacro for the prevention of organ rejection in kidney transplant patients following the update of its initial Investigational New Drug Application (IND) in the United States (U.S.)

LifeCycle Pharma has also reached protocol agreement with the U.S. Food and Drug Administration (FDA) for its first Phase II trial in kidney transplant recipients.

LifeCycle Pharma A/S (OMX:LCP) today announced it will initiate a Phase II clinical trial program using LCP-Tacro to prevent organ rejection in kidney transplant patients. The clinical trial protocol has been reviewed by the FDA, and LifeCycle Pharma has revised it to be in line with FDA recommendations. As a result, LifeCycle Pharma expects to initiate a Phase II clinical trial soon.

The trial is designed as a conversion study in stable kidney transplant recipients, with patients being switched to LCP-Tacro once-a-day from Prograf(R) twice-a-day. Up to 60 patients will be investigated at 10-12 sites in the U.S. and Canada, and the initial clinical trial results are expected by year end 2007, or early 2008. This study is considered to form the basis for initiation of a subsequent Phase III program in de-novo kidney transplant recipients.

A Phase II clinical study in liver transplant recipients is expected to follow this year.

"The initiation of the Phase II study using LCP-Tacro is a step forward in the development of our organ transplantation franchise," said Dr. Flemming Ornskov, President and CEO of LifeCycle Pharma. "We are encouraged by the progress LifeCycle Pharma has made, and eager to advance LCP-Tacro to Phase II clinical trials," added Dr. Ornskov.

"This is the start of an exciting clinical development program. LCP-Tacro will bring the convenience of once-daily administration of tacrolimus and may optimize outcomes after kidney transplantation," said Dr. Shamkant Mulg aonkar, Chief of the Transplant Division at St. Barnabas Healthcare System, Livingston, New Jersey, USA and a clinical investigator in the first Phase II study.


'"/>




Related medicine news :

1. LifeCycle Pharma Forms Scientific Advisory Board in Solid Organ Transplantation
2. Pharmaceutical giant offers AIDS related antifungal drug free to 50 countries
3. Pharmaceutical giant offers AIDS related antifungal drug free to 50 countries
4. Pharma cos must forge Strategic alliances
5. Medicis Pharmaceutical company enters pediatric market
6. Pharma majors gear to supply anti-anthrax drug
7. Pharmacies in for a dose of bitter medicine
8. Andhra Pradesh to set up Pharma City
9. Sun Pharma to launch chiral version of omeprazole soon
10. AAI Pharma Files Lawsuit Against Dr. Reddys Laboratories
11. Pharmacia may take 51.5 percent Abbott stake
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:1/23/2017)... ... January 23, 2017 , ... ... and localization services for life science companies, has achieved ISO 17100:2015 certification ... SÜD America. ISO 17100 is the globally recognized standard that establishes guidance ...
(Date:1/23/2017)... ... January 23, 2017 , ... The iaedp Foundation, ... healthcare treatment providers who treat the full spectrum of eating disorder problems, proudly ... Presidents Council consists of the leading eating disorder treatments centers located throughout the ...
(Date:1/23/2017)... (PRWEB) , ... January 23, 2017 , ... Sharon Kleyne, ... the air to educate listeners about the benefits of making new water infrastructure a ... Kleyne said, “it’s appropriate that we expect water infrastructure to become a top priority ...
(Date:1/23/2017)... ... 2017 , ... METTLER TOLEDO has announced the availability of ... PAT Tools . , Crystallization is a common step used during ... Chemists now spend more time developing better intermediate and final crystallization steps. ...
(Date:1/23/2017)... ... January 23, 2017 , ... "ProRandom is a set of camera tools that allow ... looks in Final Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. ... layers of text with video footage. ProRandom works by using a virtual camera to ...
Breaking Medicine News(10 mins):
(Date:1/23/2017)... -- ResMed (NYSE : RMD), BMC (Pékin, Chine) et 3B Medical ... se sont mis d,accord sur le règlement mondial de ... 3B seront autorisés à vendre leurs produits existants en ... effectuera le paiement de la décision en une seule ... entre les deux parties. Le règlement n,inclut pas l,admission ...
(Date:1/23/2017)... Spain , January 23, 2017 /PRNewswire/ ... biopharmaceutical company focused on treatments for calcification disorders, ... enrolled in the Phase IIb "CaLIPSO Study" clinical ... of cardiovascular calcification (CVC) in end-stage-renal-disease (ESRD) patients ... in the last stage of chronic kidney disease, ...
(Date:1/23/2017)... InDex Pharmaceuticals Holding AB (publ) today announced ... of the European Crohn,s and Colitis Organisation (ECCO). The ECCO congress ... on inflammatory bowel disease (IBD). The congress is held in ... ... again having been selected to present data at the largest IBD ...
Breaking Medicine Technology: