LifeCycle Pharma To Present Data At American Transplant Congress (ATC) In Toronto

Main Category: Transplants / Organ Donations
Also Included In: Conferences
Article Date: 02 Jun 2008 - 1:00 PDT

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LifeCycle Pharma A/S announced that it will present clinical trial data on LCP-Tacro tablets at the 2008 American Transplant Congress to be held in Toronto, Canada, on May 31 through June 4. LifeCycle Pharma will present its data on Monday, June 2.

"The results of these two trials met all of our expectations, and we look forward to sharing the data with the medical community at the prestigious 2008 American Transplant Congress in Toronto," said Dr. Michael Beckert, LifeCycle Pharma's Chief Medical Officer and Executive Vice President.

Forty-seven kidney transplant patients contributed to a three-sequence, open-label, multi-center, prospective, conversion study to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets once-a-day versus Prograf® (tacrolimus, Astellas Pharma) capsules twice-a-day. LCP-Tacro given once-a-day increased the bioavailability of tacrolimus by about 40% allowing reduced total daily doses by about 30% compared to Prograf twice-a-day. Trough blood levels at 24 hours post-dose were well-correlated with total exposure to tacrolimus (AUC). Results will be presented by Rita R. Alloway, PharmD, Research Professor and Director of Transplant Clinical Research at the University of Cincinnati.

In a Phase I study, the bioavailability of LCP-Tacro tablets was compared to Advagraf® (MR4, Astellas Pharma) capsules in a two-sequence crossover study in 20 normal volunteers. Subjects received LCP-Tacro (one 2 mg tablet) or Advagraf (two 1 mg capsules) once daily for 10 days. After a two-week washout period, subjects then received the alternative treatment for 10 days. The overall systemic exposure of tacrolimus from the LCP-Tacro 2 mg tablets was significantly higher compared to Advagraf 1 mg capsules. At steady state, the bioavailability (AUCτ and Cmin) of tacrolimus from one LCP-Tacro 2 mg tablet was 49% and 66% higher than that of two Advagraf 1 mg capsules. LCP-Tacro tablets were well-tolerated without serious adverse events. Results will be given in an oral presentation by Robert D. Gordon, MD, Sr. Director of Medical and Clinical Research, LifeCycle Pharma, Inc.

About LCP-Tacro & Tacrolimus

Tacrolimus is a leading immunosuppressive drug 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 in absorption when compared to both Astella Pharma's twice daily version of tacrolimus (Prograf worldwide) and its once-daily version of tacrolimus (Advagraf® in Europe). Clinical trials have demonstrated that LCP-Tacro has a higher bioavailability and improved pharmacokinetics when compared to Prograf, hence it is expected to provide significant improvements for the patients.

Transplant patients need to maintain a minimum level of tacrolimus in the blood to prevent organ rejection, but excessive levels increase the risk of serious side effects such as kidney damage. 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. LifeCycle Pharma believes that management of the tacrolimus levels is complicated by the relatively low bioavailability of Prograf, its variable absorption and interaction with food and other drugs.

In 2005, the transplantation immunosuppression market in the 7 major markets (US, Japan, France, Germany, Italy, Spain, and the United Kingdom) is approximately $3.3B (source: Datamonitor, IMS Health; all rights reserved) and in the year 2015, it is estimated this marked will be US$4.3B (source: Datamonitor).

About LifeCycle Pharma A/S ("LCP")

LCP is an emerging specialty pharmaceutical 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. LCP has a cholesterol lowering product, FenoglideTM, currently on the US market and a diversified near- and medium-term pipeline, including four product candidates in clinical trials and two in preclinical stages of development. LCP is listed on the OMX Nordic Exchange Copenhagen under the trading symbol (OMX: LCP).

http://www.lcpharma.com

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