Navigation Links
LifeCycle Pharma Announces Positive Phase I Clinical Results for,its Transplantation Product Candidate, LCP-Tacro

Heads into US Phase II Clinical Trials for Organ Transplantation

HORSHOLM, Denmark, May 31, 2007 /PRNewswire-FirstCall/ -- LifeCycle Pharma announces positive Phase I clinical results for its transplantation product candidate, LCP-Tacro - Heads into US Phase II clinical trials for organ transplantation.

Today LifeCycle Pharma A/S (OMX:LCP) announces positive results from its Phase I clinical trial program of LCP-Tacro, a proprietary, once-daily tacrolimus tablet.

A series of Phase I trials, involving more than 150 healthy volunteers demonstrate that LCP-Tacro:

- Has a once-daily profile.

- Delivers consistently higher bioavailability of about 50% compared to Prograf(R).

- Reduces peak levels (Cmax) and reduces peak (Cmax) / trough (Cmin) fluctuation compared to Prograf(R).

"The once-daily profile and significant increase in bioavailability, compared to Prograf(R), that has been demonstrated for our LCP-Tacro product candidate in an extensive Phase I program is encouraging, and provides the foundation to quickly advance it into Phase II trials for organ transplantation, said Dr. Flemming Ornskov, President and CEO of LifeCycle Pharma". LifeCycle Pharma's long-term strategy is to concentrate on and commit significant resources to the development of a number of product candidates for organ transplantation as it moves towards becoming a fully integrated specialty pharmaceutical company" added Dr. Ornskov.

About the studies:

LifeCycle Pharma has conducted a series of Phase I studies in more than 150 healthy volunteers to demonstrate the profile of LCP-Tacro under single-dose and multi-dose (steady-state) conditions. In addition to this, dose-linearity, food-effect and diurnal pharmacokinetic studies have been completed.

About transplantation:

In order to prevent the patient's immune system from rejecting the transplanted organ, immunosuppression t herapy is required for the lifetime of the graft with a base maintenance drug and adjunctive therapies. In 2005, over 50,000 solid organ transplants were conducted in the 7 major markets (US, Japan, France, Germany, Italy, Spain and UK). The number of transplant procedures is expected to grow steadily every year; however, the number of patients waiting for transplants is predicted to grow even faster, as there is a lack of organs. The current market size for immunosuppresssants used in transplantation in the 7 major markets is approximately $3.3bn and is estimated to grow by approximately 5-10% per year.

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(R)) and its modified-release version of tacrolimus for organ transplants. This is expected to represent significant improvements for the 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 and transplant patients typically are 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(R), its variable absorption and interaction with food and other drugs.

About LifeCycle Pharma A/S:

LifeCycle Pharma, headquartered in H0rsholm, 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 product ca ndidates are proprietary and designed to improve the quality of existing drugs by enhancing the release and absorption of drugs in the human body. LifeCycle Pharma's proprietary technology platform, MeltDose(R) 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.

CONTACT: For further information please contact: LifeCycle Pharma A/S,Michael Wolff Jensen, Executive Vice President and CFO, Tel.+45-40-74-62-44

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Sygnis Pharma AG announces date for presentation of clinical results
2. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
3. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
4. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
5. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
6. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
7. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
8. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
9. Array BioPharma to Present at the C.E Unterbeg, Towbin Emerging Growth Conference
10. AM-Pharma Announces Positive Results of Phase IIa Clinical Trial with Alkaline Phosphatase For Ulcerative Colitis
11. TransPharma Medical Announces Positive Results of Phase I Clinical Trials for Transdermal Delivery of hPTH (1-34) for Osteoporosis Treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... -- Innophos Holdings, Inc. (NASDAQ: IPHS ), a leading international ... it will host a live conference call on Tuesday, February ... quarter and full year 2015 results. ... quarter and full year results will be issued on Monday, ... --> --> The conference call can be ...
(Date:2/12/2016)... Kalifornien, 12. Februar 2016  Sequent Medical, Inc. ... von Patienten für eine Studie zur Sicherheit und ... speziell für die Behandlung von rupturierten intrakraniellen Aneurysmen ... Leiter der Neuroradiologie an der Universitätsklinik Bicètre in ... der CLARYS-Studie hat den ersten Patienten aufgenommen. ...
(Date:2/12/2016)... -- Eli Lilly and Company (NYSE: LLY ) today announced ... vitamin regimen patent would not presently be infringed by Actavis ... , Italy and Spain ... dextrose solution.  --> --> ... held that Lilly,s patent would be indirectly infringed by Actavis ...
Breaking Medicine Technology:
(Date:2/13/2016)... Tennessee (PRWEB) , ... February 13, 2016 , ... ... the Infusion Nurses Society (INS) states that vein visualization technology should be used ... by healthcare facilities around the world, the INS Standards mandate the use of ...
(Date:2/13/2016)... Canada (PRWEB) , ... February 13, 2016 , ... In ... foot forward. They’ll groom themselves to perfection, go out of their way to be ... date – just take a look at any online dating profile. , A ...
(Date:2/12/2016)... San Antonio, TX (PRWEB) , ... February 12, 2016 , ... ... of love, as expressed in Blue SKies Buddha, the biography of Rama - Dr. ... in fact a love story, the love of a Buddhist teacher for teaching and ...
(Date:2/12/2016)... ... February 12, 2016 , ... ... exclusively to funding innovative lymphoma research and serving the lymphoma community through a ... 250 members of South Florida’s philanthropic community at its 10th anniversary Fashion Luncheon ...
(Date:2/12/2016)... ... ... Each year, the American Physical Therapy Association (APTA) offers a Combined Sections ... Center. Almost 10,000 physical therapists across the country are expected to attend this annual ... chosen field and network with their colleagues. As in years past, HydroWorx is ...
Breaking Medicine News(10 mins):