DGAP-News: LifeCycle Pharma Announces Positive One-year Top-Line Results of Phase 2 Clinical Trial For LCP-Tacro? in De Novo Liver Transplant Patients
ID: 320026
22.12.2010 14:35
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Company Announcement no. 28/2010
To: NASDAQ OMX Copenhagen A/S Horsholm,
Denmark, December 22, 2010
LifeCycle Pharma Announces Positive One-year Top-Line Results of Phase 2
Clinical Trial For LCP-Tacro? in De Novo Liver Transplant Patients
LifeCycle Pharma A/S (OMX:LCP) today announced positive top-line results from a
Phase 2 clinical trial involving 58 patients comparing LCP-Tacro? tablets
administered once-daily versus Prograf(r) (tacrolimus) capsules (Astellas Pharma)
administered twice-daily in de novo liver transplant patients for one year.
These data confirm the previous positive experience with LCP-Tacro? in stable
kidney and liver transplant patients and support comparability of LCP's
extended release tablet formulation of tacrolimus when compared to twice-daily
Prograf(r) capsules. Further, the results indicate that LCP-Tacro? tablets may be
safely and efficaciously administered once-daily immediately following a liver
transplant.
Results from the 14 day pharmacokinetic (PK) portion of this Phase 2 study have
previously been reported in August 2009. After the initial 14 day PK period,
patients were maintained on either LCP-Tacro? or Prograf(r) for one year to
assess longer-term safety and efficacy in a comparative setting. While not
sized and powered to demonstrate safety and efficacy at a statistically
relevant level, once-daily LCP-Tacro? appears to be as well tolerated as the
currently approved, immediate release, twice-daily product Prograf(r).
'This study was an important milestone for the company as it provides
additional evidence of the comparable safety and efficacy of LCP-Tacro? versus
the twice-daily form of tacrolimus,' said Dr. William J. Polvino, President and
CEO of LifeCycle Pharma. 'It is also very encouraging that the safety and
efficacy data compared to twice-daily tacrolimus obtained from this trial are
very consistent with results seen in prior studies in kidney transplant
patients. We are looking forward to completing our two Phase 3 trials in kidney
transplant patients and announcing the data from those studies in 2011 and
2012.'
LCP-Tacro? Phase 3 clinical program in kidney transplant patients
The Phase 3 development program for LCP-Tacro? consists of an ongoing,
fully-enrolled study in 326 patients with stable kidney transplants along with
an ongoing Phase 3 study in 540 de novo kidney transplant patients under a
Special Protocol Assessment (SPA) that was agreed to with the U.S. FDA in
August 2010. Data from the fully enrolled Phase 3 study in stable kidney
transplant patients is expected to be announced mid-2011. Treatment of the
first patient in the de novo kidney transplant study was announced in October
2010, and results are expected in 2012.
Summary of LCP-Tacro? (de novo Liver) Phase 2 Clinical Trial Design
The above Phase 2 clinical trial was an open-label, multi-center, prospective,
parallel group study in de novo liver transplant patients. The objectives of
the study were to determine the pharmacokinetic profile (AUC0-24, Cmax, Cmin,
and Tmax), safety and efficacy of LCP-Tacro? tablets once-daily versus Prograf(r)
capsules twice-daily. De novo liver transplant candidates who fulfilled all
inclusion/exclusion criteria were randomized to receive either LCP-Tacro? or
Prograf(r) following their liver transplantation. A 24-hour pharmacokinetic (PK)
profile assessment was performed on Study Days 1, 7 and 14. Patients continued
in the one year maintenance stage of the study to evaluate the long-term safety
and efficacy of LCP-Tacro? versus Prograf(r).
For more information, please contact:
LifeCycle Pharma A/S
Johnny Stilou
John Weinberg, Senior VP, Commercial
CFO
Development and Strategic Planning
Phone: +45 20 55 38 52 Phone:
+1 732 321 3208
Email: JST@lcpharma.com Email:
JDW@lcpharma.com
About LCP?Tacro? and tacrolimus
Tacrolimus is a leading immunosuppression drug used for the prevention of
transplant allograft rejection after organ transplantation. LCP?Tacro? is being
developed as a once?daily tablet version of tacrolimus, with improved
bioavailability, consistent pharmacokinetic performance and reduced
peak?to?trough variability when compared to currently approved tacrolimus
products. Transplant patients need to maintain a minimum blood level of
tacrolimus for the prevention of transplant allograft rejection, but excessive
levels may increase the risk of serious side effects such as nephrotoxicity and
opportunistic infections. Therefore, tacrolimus levels need to be managed
carefully, and transplant patients are typically obliged to make frequent
visits to the hospital for monitoring and dose adjustments after receiving a
new organ.
About LifeCycle Pharma A/S (LCP)
Based in Horsholm, Denmark, with an office in New Jersey, LCP is a specialty
pharmaceutical company. Clinical development is the core of LCP's efforts to
develop a product portfolio which includes the Company's lead product
candidate, LCP?Tacro?, for immunosuppression, specifically organ
transplantation, and products to combat certain cardiovascular diseases. LCP
adapts new technologies on a fast commercial timetable. LCP's unique, patented
delivery technology, MeltDose(r), can improve absorption and bioavailability ? at
low?scale up costs ? not only for a broad spectrum of drugs already on the
market but also for new chemical entities. LCP has a lipid lowering product,
Fenoglide(r), currently on the U.S. market and a diversified near and medium term
pipeline with three clinical stage product candidates and a number of projects
in preclinical development. LCP is listed on the NASDAQ OMX Copenhagen under
the trading symbol OMX: LCP.
For further information, please visit www.lcpharma.com
News Source: NASDAQ OMX
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Language: English
Company: LifeCycle Pharma A/S
DK
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ISIN: DK0060048148
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