PledPharma AB (publ) Full Year Report 2012
February 21, 2013
PledPharma AB
Interim information
PledPharma AB (publ) Full Year Report 2012
First patient treated in the PledOx™ phase IIb study, PLIANT
Stockholm, 2013-02-21 08:30 CET (GLOBE NEWSWIRE) --
Significant events after the end of the period
-- First patient treated at Uppsala University Hopsital (UAS) in the PledOx™
phase IIb study PLIANT
-- Patent application regarding the use of PLED compounds in cancer treatment
approved and issued in the US
-- FDA approved the IND application for the clinical trial PLIANT in the US
-- Addition of Linköping University Hospital and the University of Texas
Health Science Center, San Antonio, USA, to the first part of the PLIANT
study
-- The Swedish Medicinal Products Agency (MPA) approved expanding the patient
base in the PLIANT study
Significant events during 2012
-- Conducted four preclinical safety studies
-- Manufactured Active Pharmaceutical Ingredient (API) with GMP standard
-- Developed and manufactured finished product formulation of PledOx for
clinical trials
-- Negotiated contract with CRO to run the clinical trial PLIANT
-- Appointed professor Bengt Glimelius, UAS, as coordinating principal
investigator
-- Received regulatory approval for the PLIANT study by the Swedish MPA as
well as regional ethics committees
-- Recruited approximately 30 clinical trial centres in EU and US for the 126
patients to be recruited in the randomized phase of the study
-- Screened patients at UAS and Karolinska University Hospital (KS) for the
initial dose-escalation phase of the PLIANT study
-- Published three key papers on PLED compounds in Translational Oncology
-- Filed PCT compositional matter patent application on PledOx
(calmangafodipir)
The period October – December
-- Net result amounted to SEK -8 389k (-25 426k)
-- Cash and cash equivalents on Dec 31 amounted to SEK 58 808k (90 548k)
-- Cash flow from operating activities amounted to SEK -6 679k (-7 112k)
-- Result per share amounted to SEK -0.4 (-1.3)
Full Year 2012
-- Net result amounted to SEK -33 857k (-33 246k)
-- Cash flow from operating activities amounted to SEK -31 690k (-14 396k)
-- Result per share amounted to SEK -1.7 (-2.0)
CEO comments
"The first patient is now treated at Uppsala University Hospital (UAS), which
is the result of intense work in 2012 where the focus has been on starting the
PLIANT study.
During the year we conducted four preclinical safety studies, manufactured API
with GMP standard and developed a finished product formulation of PledOx for
clinical trials.
We have entered into an agreement with a CRO to run the PLIANT study and have
obtained regulatory approval for the study in Sweden and the US.
Clinical trial centers are recruited in Sweden and the US for the initial
dose-escalation phase of the study, and we have also recruited approximately 30
centers internationally for the 126 patients in the subsequent randomized part
of the study.
Professor Bengt Glimelius at UAS, a world authority in research and treatment
of colorectal cancer, has been appointed coordinating principal investigators.
During the autumn we initiated screening of patients at UAS and Karolinska
University Hospital (KS) for inclusion in the initial part of PLIANT study.
Measures to expand the patient base by adjustments to the study design have
been implemented.
Progress has also been made on the company's patent position. A compositional
matter patent application for PledOx has been submitted to strengthen and
expand the patent protection and in February a patent in the US market was
approved for the use of PLED compounds in cancer treatment.
During the year, three key papers on PLED compounds have been published in
Translational Oncology.
We expect to be able to include the remaining 8-11 patients in the initial
dose-escalation phase of the study in the next 4-5 months. Thereafter patients
will be included at all clinics in the subsequent randomized portion of the
study during mid-2013.
By the measures taken to broaden the patient base and by adding more clinics in
the study, we hope to counteract the delay in the start of the study.
We have also gained an increasing awareness regarding PLED-compounds potential
use in other medical indications which look very promising. "
Company profile
PledPharma is a Swedish specialty pharma company, which develops improved
treatments of life-threatening diseases. We are focused on developing a
medicine that reduces the serious side effects, which occur in connection with
chemotherapy treatment In addition, we are evaluating an existing medicine’s
ability to limit the reperfusion injuries to the heart after acute myocardial
infarction treated with coronary angioplasty. Our projects meet significant
medical needs and we have the opportunity to offer patients valuable supportive
treatments in serious life-threatening diseases. This means that we also have
the potential of offering our shareholders favorable value growth.
Considerable market potential
PledOx belongs to the group lowMEM (low Molecular Enzyme Mimetics) that mimic
the endogenous enzyme Manganese Super Oxide Dismutase (MnSOD) which is our
body’s key protection against oxidative stress. Oxidative stress is caused by
overproduction of harmful oxygen/nitrogen molecules, e.g. as a result of
chemotherapy treatment. Oxidative stress occurs in many diseases, and since
PLED-compounds reduce the oxidative stress there is a potential to use these
compounds in many different diseases. The global market in supportive cancer
treatment alone is more than USD 10 billion.
Ongoing clinical programs
PledOx is developed to reduce chemotherapy-induced side effects in cancer
treatment. The chemotherapy-induced side effects lead to a dose-reduction of
the prescribed chemotherapy or, in the worst case, that the treatment must be
discontinued completely. PLED-compound has previously shown to protect healthy
cells and tissues in conjunction with chemotherapy and thus reducing the side
effects. In the ongoing Phase IIb study, PledOx ability to prevent
chemotherapy-induced side effects for colorectal cancer will be investigated.
The ability to complete the planned treatment may lead to improved treatment
results of cancer patients treated with chemotherapy.
The PLIANT study is divided in two parts with an initial dose-escalation phase,
in order to determine the correct dose level, and a randomized phase, with the
goal to establish PledOx’s effect. The dose-escalation phase comprises of 9-12
patients from three selected medical centers in Sweden and one in the US – the
Oncology clinic at Uppsala University Hospital, Karolinska University Hospital,
Department of Oncology, Linköping University Hospital and the Cancer Therapy &
Research Center at The University of Texas Health Science Center in San
Antonio, USA. In the next phase, the randomized phase, aiming at 126 patients
from approximately 30 centers in Europe and the United States, the patients
will be divided into three equal groups to receive either placebo or PledOx in
two different doses. For further details please see www.clinicaltrials.gov
In a small, externally financed, clinical Phase IIa study, we are examining
another PLED-compound’s ability to limit reperfusion injuries in patients with
acute myocardial infarction treated with coronary angioplasty. Results are
expected during 2013. The development risks in this study are significantly
higher than in the cancer study as this study constitutes an initial limited
patient study for this indication, in an indication which also is difficult to
study.
Our business model
We are developing drugs in areas where there are high medical needs and a good
opportunity for investment returns. We focus on developing the existing
clinical projects through Phase IIb and then out-license the continued
development and commercialization for a consideration that includes upfront,
milestone and royalty payments. Our technology is based on a proprietary and
clinically proven PLED-compound.
Our vision
We will be the leading specialty pharma company, which develops medicines that
protect healthy cells from oxidative stress during treatment of
life-threatening diseases.
Business goal
Out-licensing discussions of the PledOx project will be initiated in 2013. In
the clinical program where PledOx preventive effects of chemotherapy induced
side-effects in colorectal cancer treatment patients is investigated, we are
now in clinical phase IIb.
PledPharma (STO:PLED) is listed on NASDAQ OMX First North. For more
information, please visit: www.pledpharma.se
Or contact:
Jacques Näsström, CEO cell +46 73 713 09 79
Johan Stuart, CFO, cell +46 70 66 44 096
