|
| |
LifeCycle Pharma to Initiate Phase II Clinical Trial
of LCP-Tacro for Organ Transplantation
Protocol Agreement with the FDA for First Phase II Trial in Kidney Transplant
Recipients
Summary: 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.
Hørsholm, Denmark, 21 June 2007; 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®
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 Mulgaonkar,
Chief of the Transplant Division at St. Barnabas Healthcare System, Livingston,
New Jersey, USA and a clinical investigator in the first Phase II study.
About transplantation and kidney transplantation:
In order to prevent the patient's immune system from rejecting the transplanted
organ, immunosuppression therapy is required for the lifetime of the graft in
conjunction with a base maintenance drug and adjunctive therapies. In 2005, over
50,000 solid organ transplants were conducted in seven major markets (U.S.,
Japan, France, Germany, Italy, Spain, and the United Kingdom). The number of
transplant patients waiting for organs is expected to continue to outpace the
number of organs available. The current market size for immunosuppressants used
in transplantation in the seven major markets is approximately $3.3bn, and is
estimated to grow by approximately 5-10% per year.
Kidney transplantation is normally recommended for patients with end-stage
kidney disease or kidney failure caused by severe, uncontrolled hypertension,
diabetes, infections, intoxication, or inflammation.
Kidney transplants account for approximately 60% of all transplants performed
annually in the seven major markets, and kidney transplants generally offer the
best outlook for patients with end-stage kidney disease. Most centers have
patient and organ survivals of over 90% at one year, and more than 80% at three
years. Approximately 50% of transplanted kidneys are still functional after 10
to 15 years.
About LCP-Tacro:
Tacrolimus is a leading immunosuppressive medication to prevent rejection after
organ transplantation. LCP-Tacro is being developed as a once-daily tablet
version of tacrolimus, with improved bioavailability and reduced variability;
compared to both Astellas’ twice daily version of tacrolimus (Prograf®), and its
modified-release version of tacrolimus for organ transplants. This is expected
to represent significant improvements for patients.
Transplant patients need to maintain a minimum level of tacrolimus in the blood
to prevent organ rejection, but too high levels increase the risk of serious
side effects such as, kidney damage or hypertension. Therefore, tacrolimus
levels need to be managed carefully. Transplant patients are typically obliged
to make frequent visits to the hospital for monitoring and dose adjustments for
months after receiving a new organ. Management of the tacrolimus levels is
complicated by the low bioavailability of Prograf, its variable absorption, and
its interaction with food and other drugs.
For further information please contact:
LifeCycle Pharma A/S
Michael Wolff Jensen
Executive Vice President and CFO
Tel. +45 40 74 62 44
---oo0oo---
About LifeCycle Pharma A/S:
LifeCycle Pharma, headquartered in Hørsholm, Denmark, is an emerging
pharmaceutical company with a broad and late stage product pipeline in
therapeutic areas of cholesterol management, hypertension, organ transplant and
autoimmune diseases. LifeCycle Pharma’s proprietary technology platform,
MeltDose® technology, offers lower dosing, reduced side effects and improved
safety and patient compliance, as well as reduced product development time and
development costs. LifeCycle Pharma is listed on the OMX Nordic Exchange under
the trading symbol (LCP). Please visit www.lcpharma.com for further information
about LifeCycle Pharma A/S.
| |
|
