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

March 29, 2015

PledPharma AB
Company Announcement

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

PledPharma AB (publ) today announces top-line results from a randomized
double-blind placebo-controlled phase IIb study (PLIANT) with the drug
candidate PledOx®. In the study, patients were treated with PledOx® 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® 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: +46 (0) 8 519 990 31. 

"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®, said Jacques Näsström, 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
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® or placebo. Treatment with PledOx®
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®. The anti-cancer effect of the chemotherapy was not
negatively affected by the PledOx® 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:

Håkan Åström, Chariman of the Board PledPharma

Tel: +46 (0) 70-374 72 13

E-mail: [email protected]

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® at a dose of 2 µmol/kg, 5 µmol/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® 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® treatment did not decrease the
effect of the chemotherapy. 

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

ABOUT PLEDOX®

PledOx® is developed to prevent nerve damage caused by chemotherapy in cancer
treatment. The active substance calmangafodipir is a New Chemical Entity (NCE)
and has been shown in preclinical studies to protect human cells against
oxidative stress; a condition caused by formation of reactive oxygen and
nitrogen compounds during e.g. chemotherapy. Oxidative stress may, among other
things, cause damage to the sensory nerves (neuropathy). PledOx® mimics the
endogenous enzyme MnSOD, which represents the cell's intrinsic protection
against oxidative stress. 

ABOUT NERVE DAMAGE CAUSED BY CHEMOTHERAPY IN COLORECTAL CANCER

Treatment with the cytotoxic drug oxaliplatin, one of the components in FOLFOX
combination chemotherapy, will often cause neuropathy i.e. hypersensitivity to
cold, problems with fine motor skills and pain. This side effect leads to
reduction in chemotherapy dose in 40 percent of patients and is the most common
reason for premature discontinuation of this cancer chemotherapy. Neuropathy is
often transient, but about 15-20 percent of patients experience persistent
problems, especially severe pain in hands and feet. There is currently no cure
for neuropathy. 

ABOUT PLEDPHARMA
Pledpharma develops new drugs that protect the body against oxidative stress –
a condition that can be caused by chemotherapy and acetaminophen (paracetamol)
poisoning. The company's most advanced project PledOx® reduces nerve damage
associated with chemotherapy. The drug candidate Aladote™ is being developed to
reduce the risk of acute liver failure associated with acetaminophen poisoning.
The project PP-099 seeks to limit the damage that occurs to the heart muscle
during myocardial infarction. PledPharma’s drug candidates are based on the
further development of a substance that, for completely different purposes,
already has been used by more than 200 000 patients. This may limit the
development risk and simplify the approval process. Pledpharma (STO: PLED) is
listed on Nasdaq First North. Erik Penser Bankaktiebolag is the company’s
Certified Adviser. For more information, see www.pledpharma.se 

PledPharma AB discloses the information provided herein pursuant to the Swedish
Securities Markets Act and/or the Swedish Financial Instruments Trading Act

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