A drug that may have been used to treat a rare condition that affects bone marrow transplant patients has failed to meet the main study goals in two late-stage trials.
The drug, Prochymal, failed to demonstrate any statistical benefit over a dummy drug in either of the trials that were evaluating the drug in acute Graft versus Host Disease (GvHD), adult stem cell research firm Osiris Therapeutics Inc has said.
GvHD occurs when immune cells from a transplanted bone marrow recognise the recipient’s body as foreign and begin to attack it and the affects can be potentially fatal. Prochymal was designed to work with the immune cells in the body and assist in tissue repair and reducing inflammation.
Acute GvHD and steroid-resistant GvHD patients were tested with the drug in the two trials. The patients in the acute setting, of who most had skin GvHD, showed a good response rate to the standard of care and reduced Prochymal’s chance to show an effect.
“(Prochymal) may just come down to be just a liver GvHD or gastrointestinal GvHD drug… but in skin GvHD, as a first-line treatment, it does not have a benefit,” said Osiris Therapeutics Inc chief executive Randal Mills.
Copyright Press Association 2009