RxKinetix, Inc. Completes Its End Of Phase 2 Meeting With The FDA For RK-0202 In Oral Mucositis And Is Moving Into Phase 3
Published: Mar 01, 2006
BOULDER, Colo., March 1 /PRNewswire/ -- RxKinetix, Inc., a specialty pharmaceutical company developing new therapeutics focused in oncology care, today announced it had concluded its End of Phase 2 meeting with the FDA for RK-0202 in oral mucositis and is proceeding with plans for Phase 3 development.
RxKinetix recently completed a Phase 2 trial of RK-0202 in patients with head and neck cancer. The Phase 2 trial was double-blind, randomized and placebo controlled. The trial successfully demonstrated the drug's efficacy, with patients receiving RK-0202 having a 29% lower incidence of WHO Grade 3 or greater oral mucositis versus placebo at 50 Gy (p = 0.041) and a 46% lower incidence of NCI Grade 3 or greater oral mucositis versus placebo at 50 Gy (p = 0.0052). In addition, significantly fewer patients on RK-0202 required the use of an external feeding tube compared with placebo (p = 0.037). Patients receiving RK-0202 also had lower incidence of adverse events such as weight loss, anorexia, dry mouth, nausea and dehydration.
"I am happy with the results of the Phase 2 trial for RK-0202." said Stephen Sonis, D.M.D, D.M.Sc., Professor, Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine. "I continue to be encouraged with the efficacy of RK-0202 and I am hopeful it will be an important drug for the treatment of oral mucositis."
"Completion of Phase 2 for oral mucositis represents a key milestone for RxKinetix," said Harry Ross, Chairman and CEO. "The results have demonstrated that we have a drug candidate that is both safe and efficacious and we are looking forward to confirming that in our Phase 3 trial."
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.RxKinetix, Inc.
CONTACT: Joanna Money, Ph.D., Vice President, Corporate Development ofRxKinetix, Inc., +1-303-541-1812, email@example.com
Web site: http://www.rxkinetix.com/