DGAP-Adhoc

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

PledPharma AB

29.03.2015 12:00

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PledPharma AB (publ) today announces top-line results from a randomized
double-blind placebo-controlled phase IIb study (PLIANT) with the drug
candidate PledOx(r). In the study, patients were treated with PledOx(r) to reduce
the risk of side effects associated with chemotherapy for advanced colorectal
cancer. The study showed a clinically relevant reduction in the incidence of
sensory nerve damage (neuropathy) of 43 percent compared to placebo. In
addition, the anti-cancer effect of the chemotherapy was not negatively
affected by the PledOx(r) treatment. Based on these positive data, discussions
with potential partners will be intensified. Additionally, registration studies
will be designed in dialogue with the U.S. Food Drug Administration (U.S. FDA).

Stockholm, 2015-03-29 12:00 CEST (GLOBE NEWSWIRE) --


PledPharma invites shareholders, analysts and media to a conference call (held
in Swedish only) on Monday, March 30, at 11.00 AM CET. Participants are asked
to call in on telephone number: [phone].

'An important milestone has been reached. The clear reduction in neuropathy
observed in this study has the potential to improve the quality of life and
outcomes for a large number of cancer patients. There is currently no
preventative treatment against this type of damage. We now look forward to,
based on the promising results of the study, intensifying discussions with
potential partners and to continue preparations for the next step in the
clinical development of PledOx(r), said Jacques Nasstrom, CEO of PledPharma.

Neuropathy in conjunction with chemotherapy can cause debilitating problems,
for example hypersensitivity to cold, disruption of fine motor skills and
severe pain especially in the hands and feet. This is one of the most common
serious side effects in the treatment of colorectal cancer with FOLFOX
combination chemotherapy. These side effects often require reduction of the
prescribed chemotherapy dose and in the most severe cases treatment must be
discontinued.

'This is, to my knowledge, the first study where a treatment has been shown to