PledPharma initiates Phase III studies with PledOx® before year end 2017
November 16, 2017
PledPharma AB
Company Announcement
PledPharma initiates Phase III studies with PledOx® before year end 2017
Stockholm, 2017-11-16 08:00 CET (GLOBE NEWSWIRE) --
PledPharma AB announced today that the company, following interactions with the
European Medicines Agency EMA, has finalized the design of the global Phase III
program for the drug candidate PledOx®. The Phase III studies are expected to
be initiated before year end 2017. The company’s current funds are expected to
cover costs up to the planned read out of top line results in 2020.
PledPharma’s CEO Nicklas Westerholm is hosting a corporate presentation today,
November 16th at
12:00 CET, where the design of the Phase III program will be covered.
PledOx® is developed to prevent chemotherapy induced peripheral neuropathy
(CIPN) which affects between 40 to 60 percent of patients treated with standard
of care for colorectal cancer. This type of toxicities may lead to a dose
reduction of the chemotherapy or, in worst case, discontinuation of treatment.
Up to half of the affected patients develops chronic nerve damages, leading to
numbness, tingling and discomfort in hands and feet, and negative impact on
quality of life. There is currently no approved drug to prevent or treat
chemotherapy induced peripheral neuropathy.
The design of the Phase III program for PledOx®
The Phase III program has been designed based on interactions with the European
Medicines Agency (EMA), the US Food and Drug Administration (FDA) and
PledPharma’s Scientific Advisory Board.
It consists of two double-blind, randomized, placebo-controlled studies,
POLAR-M and POLAR-A:
-- POLAR-M includes 300 patients undergoing chemotherapy for metastatic
colorectal cancer and is planned to be conducted in Europe and the US. In
the study, 2 μmol/kg and 5 μmol/kg of PledOx® are compared to placebo.
-- POLAR-A includes 200 patients undergoing adjuvant chemotherapy for
colorectal cancer and is planned to be conducted in Europe. In the study, 2
μmol/kg and 5 μmol/kg of PledOx® are compared to placebo.
In both studies, patients will receive PledOx® or placebo as add-on to the
chemotherapy FOLFOX. The primary efficacy parameter is patient-reported
symptoms of CIPN nine (9) months after initiation of chemotherapy. Evaluation
of symptoms is performed using the validated FACT/GOG-NTx instrument. Secondary
efficacy parameters evaluate other aspects of CIPN, functional loss, the need
for dose adjustments of chemotherapy, pain and quality of life. Patients are
followed in the studies for two years after initiation of chemotherapy,
focusing on progression free survival and overall survival (POLAR-M) and
disease-free survival (POLAR-A). In the POLAR-M study, an additional follow-up
of overall survival is performed after three years.
PledPharma intends to initiate the Phase III studies before year end 2017 and
to have first patient in by early 2018. As previously announced, PledPharma's
funding is expected to cover costs for the Phase III program up to the read out
of top line results, which is estimated to occur in 2020.
"We are very pleased to have completed the dialogue with the European Medicines
Agency in a way that enables us to initiate the global Phase III program with
PledOx before year end. PledOx has the potential to address the significant
unmet medical need among colorectal cancer patients to prevent the potentially
debilitating chemotherapy induced neuropathy, "says PledPharma’s CEO, Nicklas
Westerholm.
Invitation to participate in a teleconference, November 16th at 12:00 CET.
Today, November 16th, PledPharma will host a corporate presentation at 12:00,
where Nicklas Westerholm, CEO, will describe the development plan for PledOx®
and cover the status of the Aladote® project. The presentation can be followed
by telephone, and the presentation material will be made available on the
corporate website, www.pledpharma.se.
Telephone numbers for participation in the presentation:
From Sweden: 08-503 365 91 or 020-088 3536 (toll-free)
From United Kingdom: +44 330 606 8318 or 0808-238 0274 (toll-free)
From United States: +1 631 621 5253 or +1 877 914 2018 (toll-free)
Participation Code: 669 182 8949
For more information, please contact:
Nicklas Westerholm, CEO
phone: +46 73 354 20 62
nicklas.westerholm@pledpharma.se
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 40-60% 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 www.pledpharma.se
