RxKinetix Successfully Concludes Its Phase 2 Trial in Oral Mucositis

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RxKinetix Successfully Concludes Its Phase 2 Trial in Oral Mucositis
          Trial Demonstrates RK-0202 Decreases Severe Oral Mucositis

    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 http://www.rxkinetix.com.
SOURCE RxKinetix, Inc.
http://www.rxkinetix.com
CONTACT:
Joanna Money, Ph.D., Vice President,
Corporate Development, RxKinetix, Inc., +1-303-926-1900,
jmoney@rxkinetix.com