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PledPharma Broadens Patient Base for the PLIANT Study

December 19, 2012

PledPharma AB
Company Announcement

PledPharma Broadens Patient Base for the PLIANT Study

The recruitment of patients for the Phase IIb study PLIANT is ongoing. To
broaden the patient population and to ensure that the end result is optimal for
clinical practice a request for extension of the eligibility criteria for the
study has been submitted to the Swedish Medical Products Agency. The study is
also expanded with an additional center, the Department of Oncology, Linköping
University Hospital. Thus the patient population broadens and recruitment
conditions improve. 

Stockholm, 2012-12-19 08:30 CET (GLOBE NEWSWIRE) -- Colorectal cancer is the
third most common cancer-related cause of death in the Western world. Standard
treatment for metastatic colorectal cancer is the chemotherapy FOLFOX but
serious side effects lead to that less than half of the patients receive the
recommended dose, and thus are unlikely to fully benefit from the treatment. 

The PLIANT study is based on a patient population receiving the chemotherapy
FOLFOX in the first line of the spread (metastatic) colorectal cancer.
Information from authorities and study investigators reveal that due to the
severe side effects (nerve damage) that comes with FOLFOX approximately 70% of
the patients are treated with FOLFIRI, with fewer serious side effects, as the
first-line treatment despite the fact that FOLFIRI is not as effective as
FOLFOX. This shift to FOLFIRI varies from country to country and from clinic to
clinic in Sweden. As the study originally only was aimed for patients receiving
FOLFOX in the first line setting it has become clear that certain patients were
not available for inclusion in the study. With the altered inclusion criteria
patients treated with FOLFOX in the second and third line will also be eligible
to participate in the study. 

- FOLFOX is a proven effective treatment that more patients would benefit from,
and we now see that the medical need to reduce the side effects of FOLFOX is
greater than we previously estimated. Our ambition is that the PLIANT study
will show that PledOx™ allows for a more effective treatment with fewer side
effects, says Jacques Näsström, CEO PledPharma. 

About the PLIANT-study
The phase IIb study PLIANT will investigate PledPharma’s substance PledOx
possibility to reduce side effects of treatment with the chemotherapy FOLFOX in
patients with metastatic colorectal cancer. 

The PLIANT study is divided in two parts. A dose escalation phase in order to
determine the correct dose and after that a randomization phase with the goal
to establish the effect of PledOx. In the dose escalation phase, 6-9 patients
from two selected medical centers in Sweden, The Oncology Clinic, Uppsala
University Hospital and Karolinska University Hospital, Solna, are included
together with the new site, the Oncology Clinic at Linköping University
Hospital. The next phase, randomization, is carried out on 126 patients from at
least 28 centers in Europe and USA. Patients are randomized into three equal
groups to receive either placebo or PledOx in two different doses. 

For further information please contact:
Jacques Näsström, CEO PledPharma, +46 737 130979

[email protected]

About PledPharma

PledPharma is a Swedish specialty pharma company that develops a new medicine,
PledOx™, for prevention of the severe side effects that patients develop as a
consequence of chemotherapy treatment of cancer. Many times the treatment
cannot be carried out as planned due to very difficult side effects. The
current market for supportive cancer care is some SEK 72 billion. PledOx is a
medicine within the patent protected substance class PLED, which protects the
body’s normal cells against oxidative stress. Oxidative stress is a condition
where an overabundance of harmful oxygen molecules (free oxygen radicals) has
been formed. We are also evaluating opportunities with PLED substances for
other diseases. PledPharma (STO:PLED) is listed on NASDAQ OMX First North. Erik
Penser Bankaktiebolag is the Certified Adviser. For further information, please



Contact us

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

Phone: +46 8 679 72 10

E-mail: [email protected]