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 PledOx® protects against white blood cell drop caused by the anticancer drug oxaliplatin

December 5, 2011

PledPharma AB
Company Announcement

PledPharma’s PledOx® protects against white blood cell drop caused by the
anticancer drug oxaliplatin

Stockholm, 2011-12-05 08:29 CET (GLOBE NEWSWIRE) -- 

PledPharma (STO:PLED) today announced positive results of PledOx in a
preclinical model. The chemotherapy drug oxaliplatin caused an 80% drop in the
number of white blood cells. The white blood cell drop was only 30% after
pretreatment with PledOx. This difference was statistically significant
(p=0.0012). Moreover, the anticancer effect of oxaliplatin was enhanced
following pretreatment with PledOx. 

The efficacy of PledPharma’s new PLED-derivative, PledOx, to reduce serious
side-effects of oxaliplatin has been compared with that of another
PLED-derivative, mangafodipir, in a preclinical model. The anticancer treatment
oxaliplatin is a commonly used drug in colorectal cancer. Mangafodipir has
previously been used in the clinic as an MRI contrast agent. We have earlier
found that mangafodipir reduces oxaliplatin induced white blood cell drop in
preclinical and clinical studies. The present preclinical results indicate that
the protective potential of PledOx is higher than that of mangafodipir. 

”The positive results of PledOx in the preclinical setting are very encouraging
since they support our goal of offering cancer patients undergoing chemotherapy
a strongly sought after supportive care. The preclinical studies are part of
the ongoing work ahead of the initiation of our clinical phase IIb study, which
is expected to start mid 2012. In addition, the new PLED-derivative
composition, PledOx, and the new results will strengthen our intellectual
property position”, says CEO Jacques Näsström. 

About PledOx®

PledOx, a PLED-derivative, is developed as a treatment against the side-effects
of chemotherapy treatment of cancer. PLED-derivatives reduce oxidative stress
by mimicking the naturally occurring superoxide dismutase enzyme. The side
effects of chemotherapy treatment often lead to a reduction of the planned
chemotherapy dose or in worst case, treatment discontinuation. In a clinical
study where we administered a similar PLED-derivative (mangafodipir) to
colorectal cancer patients undergoing chemotherapy treatment, a reduced number
of serious adverse events was observed. 

The primary focus of the company is to document the PledOx reduction of FOLFOX
(FOLinate, 5-Fluorouracil (5-FU), and OXaliplatin) induced side effects in the
treatment of colorectal cancer patients. The clinical phase IIb study, which is
expected to start mid 2012, will be done in patients with advanced colorectal
cancer where chemotherapy treatment is given to prolong survival and for
palliative purposes. The primary objective will be to evaluate the reduction of
side effects related to a drop of white blood cells (i.e. neutrophils), and
sensory nerve disturbances (sensory neuropathy). 

For further information please contact:

Jacques Näsström, CEO, cell: +46 73 713 0979

Erik Kinnman, Investor relations, cell: +46 73 422 1540

About PledPharma

PledPharma is a Swedish specialty pharma company, which develops new treatments
of life threatening diseases. PledPharma currently runs two projects in
clinical development phase II with the patented drug substance class,
PLED-derivatives. The preventive effect of PLED-derivatives on adverse effects
of chemotherapy in colon cancer is examined in one trial. Another trial
investigates the ability of PLED-derivatives to reduce reperfusion injuries in
myocardial infarction patients undergoing percutaneous coronary intervention
(PCI). PLED-derivatives protect the body’s normal cells against oxidative
stress, which is a condition due to overproduction of free oxygen radicals.
PLED-derivatives have in previous pre-clinical trials been shown to protect
against oxidative stress. Moreover, the PLED-derivative mangafodipir protected
against the side effects of chemotherapy in colorectal cancer. PledPharma
(STO:PLED) is listed on NASDAQ OMX First North. For more information, please



Contact us

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

Phone: +46 8 679 72 10