PLIANT study starts in the U.S.
PLIANT study starts in the U.S.
PledPharma expands recruitment to the dose-escalation phase of PLIANT study
with center in the U.S.
Stockholm, 2013-01-30 10:55 CET (GLOBE NEWSWIRE) -- To increase recruitment,
the study will also include the Cancer Therapy & Research Center at The
University of Texas Health Science Center at San Antonio., U.S. for the first
part of the study, the dose-escalation phase, together with the three centers
On January 18, 2103, PledPharma received an Investigational New Drug (IND)
approval from the FDA to conduct its Phase IIb study PLIANT in the U.S.
The purpose of the PLIANT study is to investigate PledPharma’s drugs in
development, PledOx™, for the ability to reduce the side effects caused by
treatment with the chemotherapy FOLFOX in patients with metastatic (spread)
”We are excited about evaluating a substance class that in earlier studies has
shown promising results in reducing dose-limiting side-effects of
chemotherapy,” said Devalingam Mahalingam, M.D., Ph.D., an oncologist at the
Cancer Therapy & Research Center at The University of Texas Health Science
Center at San Antonio.
“If this study shows positive results, it could mean a significant improvement
for the large number of patients being treated for the disease,” Dr. Mahalingam
Swedish MPA approves amendment of PLIANT study in Sweden
The Swedish Medicinal Products Agency (MPA) has also recently given its
approval for expanding the patient base in the PLIANT study. Now the inclusion
criteria include patients receiving FOLFOX also in the second and third line
settings. PledPharma applied for a broadening of inclusion criteria because the
PLIANT study initially only aimed for treatment in the first line setting with
"We appreciate that the FDA and the MPA quickly gave the authorization. This
means that significantly more patients can be recruited to the PLIANT study in
hopefully less time,” said Jacques Näsström, CEO PledPharma.
The PLIANT study is divided in two parts. The first part is a dose-escalation
phase in order to determine the correct dosage level directly followed by a
randomized phase with the purpose of establishing PledOx’s effect. In the
dose-escalation phase, 6-9 patients are included from three selected medical
centers in Sweden, Uppsala University Hospital, Karolinska University Hospital,
Solna and Linköping University Hospital. The Cancer Therapy & Research Center
at The University of Texas Health Science Center in San Antonio, Tx, USA, will
contribute also to the 6-9 patients without bevacizumab as well as add three
more in the high dose PledOx in pretreatment of FOLFOX in combination with
bevacizumab. In the randomized phase, planned for 126 patients from at least 28
centers in Europe and the United States, the patients will be divided into
three equal groups receiving either placebo or PledOx in two different doses.
For further details see www.ClinicalTrials.gov .
For further information please contact:
Jacques Näsström, CEO
+46 737 130979
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