RxKinetix has announced that it has begun patient enrollment in a Phase 2 clinical trial of its proprietary compound, RK-0202, in oral mucositis, a common, painful and debilitating side effect of cancer treatment.
The randomized, double-blind, placebo-controlled study is designed to include approximately 100 patients from about 15 cancer centers in the United States in the coming year. The objectives of the trial are to demonstrate that RK-0202 is well tolerated in this patient population and can reduce the incidence and severity of oral mucositis in patients undergoing radiotherapy for head and neck cancer.
"This current study represents a logical outcome of extensive laboratory development as well as a recently-completed Phase I trial," according to Dr. Douglas Peterson of the University of Connecticut Health Center. "Oral mucositis in many oncology patients currently represents a clinically significant consequence of cancer therapy. There is a strategic need to develop novel, evidence-based interventions that will minimize this toxicity in these individuals."
In animal models, RK-0202 significantly reduced the incidence and severity of oral mucositis, most likely through its ability to attenuate the inflammatory consequences of radiotherapy. Animals that were treated with RK-0202 did not develop the ulcerative lesions that were seen in the control groups.
"RK-0202 was effective in preclinical studies," said Dr. Stephen Sonis of Brigham and Women's Hospital and the Harvard School of Dental Medicine. "If we see similar efficacy in attenuating mucositis in this Phase 2 clinical trial, it would suggest that RK-0202 could be of significant benefit for patients at risk."
Should the results of this trial be positive, RxKinetix would anticipate starting an additional Phase 2 trial in bone marrow and stem cell transplant patients. "While you can't predict results in drug development," said Dr. Harry Ross, President and CEO of RxKinetix, "we are extremely pleased with the clinical progress of our lead candidate."
RxKinetix and Elan Corporation, Plc. initiated a collaboration for the prevention and treatment of oral mucositis in April 2000. RK-0202 is the lead candidate to emerge from that collaboration. Elan is currently in the process of restructuring its business, focusing on neurology, autoimmune disease and pain management. Consequently, RxKinetix and Elan are in discussions with each other relating to strategic alternatives to maximize the commercial value of RK-0202.
RK-0202 is based on the company's ProGelz(TM) technology and is comprised of the potent antioxidant N-acetylcysteine in a polymer matrix. Market estimates for oral mucositis in the United States range from $300 million to $1 billion annually, and there are no approved treatments.
