To continue providing education and awareness about the need for organ and tissue donors in Pennsylvania, faith-based organizations throughout the commonwealth will support the 15th Annual National Donor Sabbath Weekend, Nov. 12-14, 2010.

Endorsed by the U.S. Department of Health and Human Services to promote the interfaith celebration of life and the importance of organ and tissue donation, the three-day observance is intended to educate area residents about the process for becoming an organ and tissue donor and transplant.

“The faith-based community provides vital support to our donor registration initiative. National Donor Sabbath weekend is an opportunity to dispel myths and help individuals learn how their religion supports organ donation so they can make the spiritual decision to help save lives,” said Center for Organ Recovery and Education (CORE) president and CEO Susan A. Stuart. “We urge residents to talk to their respective religious leaders and consider making the decision to become an organ and tissue donor.”

Every 11 minutes, a new name is added to the national organ waiting list, and each day 18 people die because of the shortage of available organs for transplant.

“The need for organ and tissue donors in Pennsylvania is great. Right now nearly 8,500 people in Pennsylvania are awaiting an organ or tissue transplant, yet only 44.9 percent of eligible residents have placed the organ donor designation on their learner’s permit, driver’s license or state identification card,” said Howard M. Nathan, Gift of Life’s (GOL) president and CEO. “When faith-based organizations across the state join together, it sends an important message about the need for donation and the overwhelming support of such a decision by all major religions.”

Houses of worship interested in participating in National Donor Sabbath weekend can visit www.donor1.org or www.core.org or call 800-DONORSPA. Each site lists a number of outreach programs including It’s About Life grants for donor registration awareness programs and also includes additional information to request a program speaker or to receive free materials for National Donor Sabbath.

On November 4, CORE will hold a Celebrate Life Candlelight Vigil honoring those who have experienced the wonder of the gift of life and for those who want to know more about the truth and power of donation. The event features Reverend Paul Johnson, a kidney recipient, Eighteenth Street Community Church, as well as liver recipient Dino Persio, an attorney in Ebensburg. The event will take place at the Altoona Discovery Center on Nov. 4, 2010.

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Adolor Corporation today announced the initiation of a Phase 2 proof-of-concept (PoC) study of ADL5945 in patients suffering from opioid-induced constipation (OIC).

“We are pleased to announce the initiation of our Phase 2 proof-of-concept study,” said Michael R. Dougherty, President and Chief Executive Officer. “We begin this study having just completed a single-ascending dose (SAD) study of ADL5945 in healthy volunteers and a multiple-ascending dose (MAD) study in OIC patients with chronic non-cancer pain. The results were highly encouraging on all fronts: PK profile, tolerability and efficacy. Adolor has a wealth of expertise in this indication, and we look forward to the completion of this trial next summer.”

The Phase 2 PoC trial will evaluate two doses of ADL5945 (0.10mg and 0.25mg given twice daily) versus placebo in patients with OIC over a four week period. Approximately 120 patients will be enrolled. The primary endpoint of the study will be change from baseline in the weekly average of spontaneous bowel movements (SBMs) during treatment.

The recently completed SAD and MAD studies of ADL5945 and ADL7445 enrolled both healthy volunteers and non-cancer pain patients on long-term opioid therapy with OIC. Both compounds were well-tolerated and, in the patients with OIC, produced increases in weekly average SBMs compared to placebo. Notably, the 0.10mg and 0.25mg doses of ADL5945 being tested in the PoC study were successfully evaluated in extended cohorts in the MAD study against placebo. The most commonly reported side effects were dose-dependent gastrointestinal-related effects such as abdominal cramping and nausea. There were no serious adverse events reported.

“The data from this recent trial validate both ADL5945 and ADL7445 for the treatment of OIC in patients with chronic non-cancer pain,” said Richard M. Mangano, Ph.D., Vice President of Clinical Research & Development at Adolor. “The safety and efficacy of these doses of ADL5945 are encouraging and clearly warrant continued clinical development.”

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