LOUISVILLE, Colo., Oct. 18 /PRNewswire/ -- RxKinetix, Inc., a specialty pharmaceutical company developing new therapeutics focused in oncology care, today announced completion of their Phase 2 clinical trial of RK-0202 in oral mucositis. The Independent Data Monitoring Committee (IDMC) for the Phase 2 trial recommended stopping enrollment in order to expedite development of the drug. The IDMC found no significant safety issues associated with the use of RK-0202.
The Phase 2 trial was double-blind, randomized and placebo controlled, 114 out of a planned total of 130 patients receiving radiotherapy for head and neck cancer were enrolled. The preliminary data at 50 Gy cumulative radiation shows that, compared with placebo, RK-0202 showed a 32% reduction in the incidence of WHO Grade mucositis greater than or equal to 3, which is 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% in the placebo group compared with 3% in the group taking RK-0202.
"We were delighted to receive this recommendation to conclude our Phase 2 trial for RK-0202 in oral mucositis," said Harry Ross, M.D., CEO and President of RxKinetix, Inc. "These results provide a strong signal for RK-0202 against oral mucositis allowing us to move forward with our goal of achieving a safe and effective treatment for this debilitating disorder."
The Company will now complete the data gathering for the remaining patients who were active at the time of the IDMC review and move forward with plans for an End-of-Phase 2 meeting with the FDA to discuss the Phase 3 program.
About RK-0202 and oral mucositis
RK-0202 is comprised of the potent antioxidant N-acetylcysteine in a polymer matrix based on the Company's ProGelz(TM) technology. The oral mucositis market has the potential to be greater than $1 billion annually. Oral mucositis is a debilitating disease that occurs as a side effect of radio- and chemotherapies, estimated to affect more than 400,000 cancer patients in the US alone, annually. 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, re-hydration and/or total parenteral nutrition. Oral mucositis can be dose limiting, leading to reductions or delays in chemotherapeutic or radiation treatment, which in turn may adversely impact the curative potential of the patient's treatment.
RxKinetix, Inc. is a specialty pharmaceutical company developing new therapeutics focused in oncology care. Using proven pharmaceuticals and proprietary polymer-based drug delivery technologies, RxKinetix creates new drugs or enhances existing drugs. The Company's strategy improves timelines and reduces risk during clinical development. RxKinetix has a strong intellectual property portfolio in support of its products and technologies. More information regarding RxKinetix is available at www.rxkinetix.com.
CONTACT: Joanna Money, Ph.D., Vice President, Corporate Development,RxKinetix, Inc., +1-303-926-1900, firstname.lastname@example.org