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Egetis is an innovative and integrated pharmaceutical company, focusing on projects in late-stage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment

New data strengthens claim that PledOx® does not negatively interfere with the anti-cancer effect of chemotherapy

May 16, 2016

PledPharma AB
Company Announcement

New data strengthens claim that PledOx® does not negatively interfere with the
anti-cancer effect of chemotherapy

Stockholm, 2016-05-16 08:30 CEST (GLOBE NEWSWIRE) -- 
PledPharma today announced follow-up data from the Phase IIb study PLIANT with
PledOx® - a drug candidate that reduces the incidence of chemotherapy induced
nerve damage. Progression-free survival (PFS) 48 weeks after completion of
treatment does not differ between the patients who received PledOx® and the
placebo group. These results confirm the previously reported tumor measurements
during chemotherapy treatment showing that PledOx® does not negatively
interfere with the anti-cancer effect of chemotherapy. 

The follow-up results presented today are based on an assessment of how long it
takes before the tumor starts to grow again after completion of chemotherapy.
The results show that the progression-free survival (PFS) after completion of
treatment is approximately seven months, which is in line with what can be
expected from this group of patients. No difference in PFS was noted between
the patients who received PledOx® and those who received placebo. It can
therefore be concluded that treatment with PledOx® has no negative effect on
the efficacy of the cancer treatment. 

Regarding the preventive effect on chemotherapy induced nerve damage at 12 and
24 weeks after treatment, the results are in line with previously presented
preliminary results. 

As can be expected for this seriously ill patient population, there were
significant rates of patient dropout at 36 and 48 weeks respectively after end
of treatment, with the consequence that it is difficult or almost impossible to
evaluate the effect of chemotherapy induced nerve damage at these late time
points. However, it can be concluded that the chemotherapy induced nerve damage
in the PledOx® group with 5 µmol/kg remains at the same low level. 


For more information, please contact:

Jacques Näsström, CEO, phone: +46 737 130 979

jacques.nasstrom@pledpharma.se

Michaela Gertz, CFO, phone: +46 709 26 17 75

michaela.gertz@pledpharma.se



About PledPharma

PledPharma develop new drugs that protect the body against oxidative stress - a
potentially disabling and sometimes life-threatening condition that can be
caused by chemotherapy and acetaminophen poisoning. The company's most advanced
project PledOx® reduces nerve damage associated with chemotherapy. Positive
results from phase IIb study PLIANT were presented in the spring of 2015. The
drug candidate Aladote® is developed to reduce the risk of acute liver failure
associated with acetaminophen poisoning. The project PP-099 aims to limit the
damage that occurs to the heart muscle during a heart attack. PledPharma
(STO:PLED) is listed on Nasdaq First North. Erik Penser Bank is the Certified
Adviser. For further information, please visit www.pledpharma.se

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