News room

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

PledPharma’s Phase IIb study with PledOx® (PLIANT) published in Acta Oncologica

November 17, 2017

PledPharma AB
Company Announcement

PledPharma’s Phase IIb study with PledOx® (PLIANT) published in Acta Oncologica

Stockholm, 2017-11-17 08:02 CET (GLOBE NEWSWIRE) -- 
PledPharma AB today announces that data from the Phase IIb study PLIANT has
been published in the well renowned scientific journal Acta Oncologica. The
results indicate that PledOx® can prevent the occurrence of patient reported
symptoms of chemotherapy-induced peripheral nerve damage (CIPN) during and
after treatment of colorectal cancer with oxaliplatin. The sufficiently strong
effect, and absence of any apparent evidence of a tumor protective effect from
the chemotherapy treatment, warrants initiation of Phase III studies. 

The randomized, double-blind, placebo-controlled Phase IIb study (PLIANT)
included 173 patients with advanced colorectal cancer who received treatment
with PledOx® or placebo in conjunction with the FOLFOX chemotherapy. Treatment
with PledOx® resulted in that the incidence of investigator reported nerve
damage decreased during treatment by 38 percent (p=0.16) compared with placebo.
Patient-reported symptoms six months after end of treatment were approximately
75 percent lower in the PledOx® group compared with placebo (p <0.01). In
addition, the results indicated that the symptoms occur later and disappear
faster after pre-treatment with PledOx®. The anti-cancer effect of the FOLFOX
chemotherapy was not apparently affected by the PledOx® treatment, and no
differences in serious adverse events were seen between the treatment groups.
In addition to PledOx® effect on CIPN, a statistically significant reduction (p
<0.05) of all degrees of neutropenia was observed with PledOx® treatment. 

"We are pleased to announce the publication of these unique results for PledOx®
in the well renowned scientific journal Acta Oncologica. The results support
the recently communicated clinical development plan, and we look forward to
continuing the project into Phase III studies" says PledPharma’s CEO Nicklas

Nerve damage associated with chemotherapy treatment may cause serious disabling
conditions, such as increased cold sensitivity, fine motor disorders, and loss
of sensation in hands and feet, which can lead to problems with the balance and
consequential injuries. This is one of the most common dose-limiting
side-effects in the treatment of colorectal cancer with FOLFOX. These
side-effects often lead to a reduction in the prescribed chemotherapy dose or,
in the worst-case treatment discontinuation. 

"The effects of PledOx are sufficiently strong and the lack of any indications
of a tumor protective effect reassuring, motivating initiation of conclusive
phase III trials" says the Principal investigator of the PLIANT study,
Professor emeritus Bengt Glimelius. 

The scientific article "Persistent prevention of oxaliplatin-induced peripheral
neuropathy using calmangafodipir (PledOx®): a placebo-controlled randomized
phase II study (PLIANT)" is available on Acta Oncologica's website: 

For further information, please contact:

Nicklas Westerholm, CEO
phone: +46 73 354 20 62

About PledPharma

PledPharma develops new drugs that protect the body against oxidative stress –
a potentially debilitating and sometimes life-threatening condition that can be
caused by chemotherapy treatment and following acetaminophen (paracetamol)
overdose. The company's most advanced project PledOx® is being developed to
reduce nerve damage associated with chemotherapy. A phase IIb study has been
conducted and will serve as the basis for the continued development. The drug
candidate Aladote® is being developed to reduce the risk of acute liver failure
associated with acetaminophen poisoning. PledPharma (STO: PLED) is listed on
Nasdaq First North. Erik Penser Bank is the company’s Certified Adviser (tel
+46 8 463 80 00). For more information, see



Contact us

Address: Klara Norra Kyrkogata 26, SE 111 22 Stockholm, Sweden

Phone: +46 8 679 72 10