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 http://www.rxkinetix.com.
SOURCE RxKinetix, Inc.
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Related links:
http://www.rxkinetix.com
CONTACT:
Joanna Money, Ph.D., Vice President,
Corporate Development of RxKinetix, Inc., +1-303-541-1812,
jmoney@rxkinetix.com
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