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:4/28/2016)... (PRWEB) , ... April 28, 2016 , ... ... on the world stage this week. A group of researchers and leaders from ... the Progress of Regenerative Medicine and Its Cultural Impact ” and receive the ...
(Date:4/28/2016)... (PRWEB) , ... April 28, 2016 , ... ... accessories, is proud to partner with AquaShieldUSA, the country's oldest waterproof cast ... clinic and medical supply stores, the largest selection of daily, night, weatherproof and ...
(Date:4/28/2016)... ... April 28, 2016 , ... ... the open availability of a new CDISC standard, Clinical Trial Registry (CTR) ... trials. This innovative standard will make it possible to build applications that ...
(Date:4/28/2016)... ... April 28, 2016 , ... Trinity ... Tobacco-Free Kids, a leading force in the fight to reduce tobacco use and ... policies that can help reduce tobacco use. The initiative brings together two organizations ...
(Date:4/28/2016)... ... 28, 2016 , ... In 2011, TIME magazine named Herr the “Leader of ... technology that marries human physiology with electromechanics. He continues that work as Director of ... of BionX , a leader in the field of prosthetic devices. , After ...
Breaking Medicine News(10 mins):
(Date:4/28/2016)...  The blood testing market in China ... Information and The Freedonia Group in a recent report.  ... The healthcare research firm said that China ... stations and in improving testing at the provincial level.  ... Blood Testing Market in China , which ...
(Date:4/28/2016)... 2016 , Net Sales of $1.90 billion ... the prior year period, and an increase of 1.2% on ... EPS for the first quarter were $0.52 reported, a decrease ... an increase of 29.9% over the prior year period ... guidance for 2016 Zimmer Biomet Holdings, Inc. (NYSE ...
(Date:4/28/2016)... Oramed Pharmaceuticals Inc. (NASDAQ: ... on the development of oral drug delivery systems, announced today ... conference, presented by Joseph Gunnar & Co. LLC, ... York . Nadav Kidron , CEO of Oramed, ... Presentation Details:   PIONEERS 2016, presented by ...
Breaking Medicine Technology: