RXKINETIX CONCLUDES PHASE II TRIAL IN ORAL MUCOSITIS

RxKinetix has ended a Phase II clinical trial of RK-0202 in oral mucositis, a debilitating disease that occurs as a side-effect of chemotherapy. The independent data monitoring committee for the trial recommended stopping enrollment in order to expedite development of the drug. The committee found no significant safety issues associated with the use of RK-0202.

The trial was double-blind, randomized and placebo controlled, with 114 out of a planned total of 130 patients receiving radiotherapy for head and neck cancer. The preliminary data showed that, compared with placebo, RK-0202 showed a 32 percent reduction in the incidence of WHO Grade mucositis greater than or equal to 3 -- a measure of the patient's inability to eat solid food. Furthermore, the percentage of patients requiring nutritional support via external feeding tubes was 21 percent in the placebo group compared with 3 percent in the group taking RK-0202.

Oral mucositis affects more than 400,000 cancer patients annually in the U.S. alone. Common symptoms of oral mucositis include ulcerations, redness and swelling in the mouth. In severe cases, mucositis can prevent patients from eating, require them to take opiates and necessitate hospitalization for pain management.