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PLEDPHARMA REPORTS CONSTRUCTIVE MEETING WITH THE FDA AND PRESENTS NEW FOLLOW-UP DATA

November 19, 2015

PledPharma AB
Company Announcement

PLEDPHARMA REPORTS CONSTRUCTIVE MEETING WITH THE FDA AND PRESENTS NEW FOLLOW-UP
DATA

PledPharma AB (Publ) today announced that the company has completed an end of
phase II/pre phase III-meeting with the U.S. Food and Drug Administration (U.S.
FDA), which provides guidance on how to perform the continued documentation of
the drug candidate PledOx®. A final protocol from the meeting is expected in
December 2015. During the meeting, new follow up-data from the final Phase
IIb-trial (PLIANT) with PledOx® was presented. The results from two follow-ups,
at 12 and 24 weeks after completed treatment, show that PledOx® reduces the
risk for persistent symptoms from nerve damage that occur in connection with
chemotherapy for advanced colorectal cancer in a statistically significant way 

Stockholm, 2015-11-19 08:45 CET (GLOBE NEWSWIRE) -- 

A large proportion of patients undergoing chemotherapy suffers from symptoms
(tingling, numbness and pain) caused by nerve damage that have occurred in
connection with the chemotherapy. After completing the treatment, it is common
that these symptoms linger and that, in many cases, they become more severe.
The long term follow-up that was presented during the meeting with the FDA
shows that PledOx® not only decreases the incidence of symptoms during the
treatment, but also statistically and significantly decreases these symptoms
after completion of the treatment. Furthermore, the study shows that the effect
of PledOx® is higher at the 24-week follow-up control after completed treatment
than at the corresponding 12-week control. 

“The FDA’s assessment of the clinical data and constructive advice regarding
the final trials are of great value to us, not least since it increases clarity
on what is expected in the next step. This is particularly important in the
context of discussions with potential commercial partners”, says Jacques
Näsström, CEO of PledPharma. 

PledPharma has, as announced previously, presented results that demonstrate
that PledOx® decreases the incidence of symptoms caused by nerve damage by 43
percent compared with placebo during ongoing treatment and that PledOx® does
not negatively affect the anti-cancer effect of the chemotherapy. 

“The new results give us a better picture of PledOx®‘s ability to improve
cancer patients’ quality of life in the long term. This is, as far as we know,
the first time that a controlled trial has been able to show that a treatment
can reduce the risk for persistent problems with sensory impairments after
completing chemotherapy”, says Prof. Sten Nilsson. 

FOR FURTHER INFORMATION, PLEASE CONTACT:

Jacques Näsström, CEO PledPharma AB

Tel: +4673-713 09 79

E-post: [email protected]

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 (a small portion of the
patients were treated with 10 µmol/kg). 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. The incidence of
neuropathy was evaluated using three testing methods - Oxaliplatin Sanofi
Specific Scale, Cold Allodynia Test and Leonard Questionnaire. Secondary
endpoints included changes in the number of neutrophil granulocytes (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 very commonly used 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 ingredient calmangafodipir is a New Chemical Entity (NCE)
and has been shown 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, often causes neuropathy i.e. hypersensitivity to
cold, problems with fine motor skills and pain. This side effect leads to
reduction in chemotherapy dose in approximately 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 the 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 (phone: +46 8-463 80 00). 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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