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:5/12/2017)... TORONTO , May 12, 2017  The China and ... low-pressure washing technology that consumes less water, energy and detergent, and ... their first product LaughingU, a shoebox-sized washing machine that washes and ... ... First Product, LaughingU, is compact, and does not require an external ...
(Date:5/10/2017)... 2017 Hologic, Inc. (Nasdaq: HOLX ... fiscal second quarter ended April 1, 2017 .   ... 666.7% compared to the prior year period as the ... significant gain, while non-GAAP diluted EPS of $0.50 increased ... in constant currency terms.  Excluding the effects of blood ...
(Date:5/10/2017)... , May 10, 2017  The Corporate Whistleblower ... employees of sleep therapy clinics to call us ... therapy clinic is involved in a substantial scheme ... in hearing from an employee of a medical ... a kickback scheme to provide medical practice groups with ...
Breaking Medicine Technology:
(Date:5/21/2017)... Texas (PRWEB) , ... May 21, 2017 , ... ... International Conference has brought together a cross-disciplinary group of scholars, policymakers, and activists ... Breastfeeding, Social Justice, and Equity is the third book from a recent ...
(Date:5/21/2017)... ... May 21, 2017 , ... Following the tragic and ... became the first state to require that hospitals follow a protocol to quickly identify ... medical community as to whether such steps would have saved Rory or anyone else’s ...
(Date:5/19/2017)... NC (PRWEB) , ... May 19, 2017 , ... ... the Charlotte health community, Queens University of Charlotte recently began recruitment efforts for ... program’s curriculum arms students with the skills, knowledge and expertise to approach and ...
(Date:5/19/2017)... ... May 19, 2017 , ... Springfield, Vermont-based law firm of ... " Ten Good Reasons To Hire An Experienced Personal Injury Attorney, " the article ... accident or injury. As the article says. if someone is injured due to ...
(Date:5/19/2017)... ... May 19, 2017 , ... The Arnold and ... Investigators: , Victor Acosta, Ph.D. - University of New Mexico, Jeremy Baskin, Ph.D. ... University of Washington, Erik Grumstrup, Ph.D. - Montana Stata University, A. Fatih Sarioglu, ...
Breaking Medicine News(10 mins):