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PledOx® shows favorable safety and tolerability profile in the SUNCIST Phase I study in Japanese subjects

February 9, 2018

PledPharma AB
Company Announcement

PledOx® shows favorable safety and tolerability profile in the SUNCIST Phase I
study in Japanese subjects

PledPharma AB (“PledPharma”) (STO: PLED) and Solasia Pharma K.K. (“Solasia”)
(TSE: 4597) today jointly announced the completion of a Phase I clinical study
(SUNCIST) of PledOx® in 24 Japanese and 24 Caucasian healthy volunteers. The
study was performed by PledPharma, and first patient in was reported on
December 1, 2017. PledOx showed a favorable safety and tolerability profile,
which merits further clinical development in Asian patients. 

Stockholm, 2018-02-09 07:34 CET (GLOBE NEWSWIRE) -- The Phase I study included
24 Japanese and 24 Caucasian healthy volunteers, which were randomly assigned
to study treatment with PledOx® in a single dose of 2-, 5- or 10 µmol/kg, or
placebo. The objective of the study is to gain sufficient safety, tolerability
and pharmacokinetic data for an expansion of the Phase III program to include
Asian patients. 

In November 2017, Solasia acquired exclusive development and marketing rights
for SP-04 (PledOx®) in Japan, China (including Hong Kong and Macau), Korea and
Taiwan from PledPharma. PledPharma has been conducting clinical development of
PledOx® in the US and Europe focusing on the use for prevention of chemotherapy
induced peripheral neuropathy as its initial indication. The US FDA, the
central ethics committee in the US and the health authority in the UK, MHRA,
have recently accepted the design of a phase III program, which is estimated to
commence in the second half of 2018. Solasia will continue preparing for the
participation in these global phase III clinical trials by including patients
in Japan as well as other Asian countries, subject to approvals from concerned
regulatory authorities. 

“We are very excited to have reached this first milestone in our collaboration
with Solasia. The study has been carried out with exceptional delivery focus in
a very short time. I’m looking forward to our continued collaboration and the
potential for extending the POLAR studies to include Asian patients,” said
Nicklas Westerholm, CEO, PledPharma. 

For more information, please contact:

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

Yilmaz Mahshid, CFO, phone: +46 72 231 68 00

About PledOx®

PledOx® is a “first in class” drug candidate developed to provide patients,
that are treated adjuvantly or for metastatic colorectal cancer, prevention
against the nerve damage that can occur in conjunction with chemotherapy
treatment. The results from a completed Phase IIb trial (PLIANT), where
patients with metastatic colorectal cancer were treated with the chemotherapy
combination FOLFOX and PledOx®, indicates that the patients who received
PledOx® had a lower risk than the placebo group to suffer from nerve damage
during the chemotherapy. The presence of the investigator reported sensory
nerve damage, the primary endpoint, was after treatment 38% lower in the group
of patients treated with PledOx® compared with the placebo group (p = 0.16).
This was not statistically significant, but a difference of this magnitude is
considered to be clinically relevant. After completion of chemotherapy, the
patient-reported incidence of moderate and severe neuropathy was 77% lower in
patients treated with PledOx® compared to the placebo group (exploratory
analysis; p = 0.014). This is considered valuable for the success of the
forthcoming POLAR studies, where patient-reported symptoms after completion of
treatment will be the primary efficacy parameter. No apparent negative effect
on the efficacy of the cancer treatment was observed. 

About chemotherapy induced peripheral neuropathy (CIPN)

Peripheral neuropathy symptoms are caused by damages to sensory nerves, most
commonly in hands and feet. Certain chemotherapies, including oxaliplatin, can
cause such damages, which is then called chemotherapy induced peripheral
neuropathy (CIPN). This can be a debilitating adverse reaction of the cancer
treatment and may occur at any time after the initiation of chemotherapy. The
symptoms often increase as the chemotherapy treatment continues and may often
causes discontinuation of the chemotherapy. In many patients, the symptoms are
resolved after discontinuing the chemotherapy, but up to 20-30% of the patients
have sustained symptoms such as numbness, tingling and pain in hands and feet.
Patients with CIPN may have difficulties with fine motor skill, such as
buttoning buttons, challenges using a computer key board and become
hypersensitive to cold. The sensory loss in the feet’s may increase the risk of
falls. There is currently no approved drug to prevent or treat CIPN. 

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 

About Solasia

Solasia is a specialty pharmaceutical company based in Asia, with a mission of
"Better Medicine for a Brighter Tomorrow". In order to address the unmet
medical needs within the oncology area, we develop innovative medicines to
contribute to the patient's healthy living and to provide treatment options for
the healthcare providers. Additional information is available at 

This information is information that PledPharma AB (publ) is obliged to make
public pursuant to the EU Market Abuse Regulation. The information was
submitted for publication, through the agency of the contact person set out
above, at 07:30 CET on Feb 2018.



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