Progenics and oxytrol Salix Announce Positive Highly Statistically Significant Phase 3 Trial Results
|By Staff and Wire Reports|
|Tuesday, 20 December 2011 08:39|
The trial whichwas designed to evaluate three once-daily oral methylnaltrexone dosing regimens (150, 300 and 450mg), demonstrated highly statistically significant results for the primary endpoint in two of the three treatment arms when compared to the placebo treatment arm.
In addition, the 300 and 450 mg treatment arms demonstrated highly statistically significant improvements in RFBM within 4 hours of administration following the first dose when compared to placebo treatment.
Overall, efficacy of oral methylnaltrexone in this study was comparable to that reported in clinical studies of subcutaneous methylnaltrexone in subjects with chronic, non-cancer pain. The overall observed safety profile seen in patients treated with oral methylnaltrexone was comparable to placebo in this study.
Today's announcements add a couple of new 2012 milestone catalyst entires to our FDA Calendar and Regulatory Catalyst Calendar for Progenics, who's clinical programs are focused on gastroenterology, virology, and oncology areas. Its Relistor® (methylnaltrexone bromide) is used for the treatment of opioid-induced constipation (OIC). It selectively displaces opioids from the mu-opioid receptors outside the CNS, including those located in the gastrointestinal tract, thereby decreasing their constipating effects.
Progenics' product pipeline includes: Methylnaltrexone indicated for the treatment of opioid-induced constipation and post-operative ileus, debilitating medical conditions; PRO 140, a humanized monoclonal antibody designed to block HIV infection by inhibiting the virus' ability to bind to and enter immune system cells; PSMA ADC an antibody-drug conjugate ("ADC") therapy for prostate cancer that binds to PSMA as well as to cells in the newly formed blood vessels of major solid tumors; PSMA Vaccines, are vaccines based on the prostate cancer biomarker, prostate-specific membrane antigen (PSMA), to induce antibodies to prostate cancer cells (PSMA subunit vaccine); HCV-entry inhibition based treatments of hepatitis C virus (HCV) infection; and others.