DGAP-Adhoc

PLEDPHARMA PRESENTS TOP-LINE RESULTS FROM ITS PHASE IIb STUDY - PLEDOX(r) REDUCES NERVE DAMAGE IN CONJUNCTION WITH CHEMOTHERAPY BY 43 PERCENT - Seite 2

reduce this kind of side effects in a clinically meaningful manner, but with no
apparent negative impact on the efficacy of the chemotherapy', said Bengt
Glimelius, professor emeritus in oncology at Uppsala University and principal
investigator of the PLIANT-study.

This randomized double-blind placebo-controlled phase IIb study (PLIANT)
includes 173 patients with advanced colorectal cancer who, in connection with
chemotherapy received treatment with PledOx(r) or placebo. Treatment with PledOx(r)
in one of the two studied doses resulted in a 43 percent decrease in the
incidence of neuropathy compared to placebo. The difference did not reach
statistical significance, which is also not a requirement at this stage of
development. However, no clinically relevant reductions of two other common
side effects - thrombocytopenia and neutropenia - were observed in patients
treated with PledOx(r). The anti-cancer effect of the chemotherapy was not
negatively affected by the PledOx(r) treatment. No differences in side effects
between the treatment groups were noted in the study.

The study results will provide the basis for the continued development plan,
which will be discussed at a so called end of phase II-meeting with the U.S.
Food and Drug Administration, FDA.

FOR MORE INFORMATION, PLEASE CONTACT:

Hakan Astrom, Chariman of the Board PledPharma

Tel: [phone]

E-mail: [e-mail]

TO THE EDITORS:

ABOUT THE STUDY

PLIANT is a randomized double-blinded placebo-controlled phase IIb study with
three parallel groups in which patients with advanced colorectal cancer
received FOLFOX6 chemotherapy for up to eight treatment cycles and either
PledOx(r) at a dose of 2 umol/kg, 5 umol/kg or placebo. The study was conducted
at about thirty centres in Europe and the US, and included a total of 173
patients. The purpose of this study was to investigate whether pre-treatment
with PledOx(r) decreased the frequency and severity of side effects related to
FOLFOX6 treatment. The primary endpoint was the incidence of neuropathy
(sensory disturbances), which was evaluated every two weeks during the first 16
weeks. Secondary endpoints included changes in the number of neutrophils (a
type of white blood cells) and thrombocytes (platelets). In addition, the
patients were monitored to ensure that PledOx(r) treatment did not decrease the
effect of the chemotherapy.

FOLFOX is a combination of the drugs folinic acid, 5-fluorouracil and