Company Announcement no. 01/2008
To: OMX Nordic Exchange Hørsholm, Denmark, January 2, 2008
LifeCycle Pharma Initiates Phase II Clinical Trial of LCP-Tacro for the
Treatment of Autoimmune Hepatitis
Hørsholm, Denmark, January 02, 2008; LifeCycle Pharma A/S (OMX: LCP) (the
“Company” or “LCP”), an emerging specialty pharmaceutical company, today
announced that it has initiated a Phase II clinical trial of LCP-Tacro for the
treatment of autoimmune hepatitis (“AIH”), also referred to as chronic active
hepatitis, a disease which causes a person's body to reject its own liver. The
clinical trial is expected to enroll up to 60 patients in up to 12 centers
throughout the US and Canada. The Company expects to report top-line clinical
trial results in the first half of 2009 (1H09).
"We are excited about participating in the first clinical trial of LCP-Tacro in
patients with autoimmune hepatitis (AIH),” said Gerald Y. Minuk, MD, Professor
of Medicine & Pharmacology and Head of the Section of Hepatology at the
University of Manitoba Health Sciences Centre in Winnipeg. "It's important that
physicians have new options for the management of AIH and we think LCP-Tacro
could make a real difference in patients' lives."
The clinical trial is a phase II, open-label, multi-center, prospective,
randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro
tablets given once daily vs. azathioprine (“AZA”), each in combination with
prednisone, for the treatment of AIH. Up to 60 patients will be randomized (1:1)
to receive treatment with LCP-Tacro + prednisone vs. AZA + prednisone.
The Company is pursuing LCP-Tacro for what could be the first FDA-approved drug
indicated for the treatment of AIH.
About Autoimmune Hepatitis (AIH)
AIH is a form of hepatitis or liver disease in which the body's immune system
attacks liver cells, causing inflammation and a rejection of one's own liver. If
untreated, the inflammation can lead to cirrhosis (scarring and hardening) of
the liver and eventually liver failure. AIH mainly affects women with a bimodal
age distribution (10 - 30 y and 40 - 50 y). However infants, young children and
older adults are also affected.
AIH Current Standard of Treatment
AIH is currently treated with corticosteroids (usually prednisone or
prednisolone) and azathioprine in order to reduce the autoimmune reaction and
inflammation. Nearly 25% of patients achieve only partial remission with
standard treatment or cannot tolerate AZA for various reasons. Disease relapse
is frequent after AZA is withdrawn. Other, newer, immunosuppressive drugs in
clinical development, such as tacrolimus, are showing promise for people who do
not respond to this standard treatment.
About LifeCycle Pharma A/S (“LCP”)
LCP is an emerging specialty pharmaceuticals company that, through innovative
technologies, is able to rapidly develop a portfolio of differentiated products
to meet the unique needs of key therapeutic markets and patient populations.
This includes products for immunosuppression, specifically organ
transplantation, and to combat certain cardiovascular diseases. By using its
unique and patented delivery technology, MeltDose®, LCP is able to develop drugs
with enhanced absorption and thereby increased bioavailability. Currently, the
Company has a diversified near- and medium-term pipeline, including a product
ready for US commercialization, five product candidates in clinical trials and
three in preclinical stages of development. LCP is listed on the OMX Nordic
Exchange under the trading symbol (OMX: LCP). For further information, please
visit www.lcpharma.com.
Contact:
LifeCycle Pharma A/S
Michael Wolff Jensen, EVP and CFO
+45 4074-6244; MWJ@lcpharma.com
Francesca M. DeMartino
Director, Investor Relations & Corporate Communications
(917) 747-4938; FDM@lcpharma.com
LifeCycle Pharma Initiates Phase II Clinical Trial of LCP-Tacro for the Treatment of Autoimmune Hepatitis
| Source: Veloxis Pharmaceuticals A/S
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