PledPharma AB
Interim information
PledPharma AB (publ) Interim report first quarter 2014
Stockholm, 2014-04-25 08:00 CEST (GLOBE NEWSWIRE) --
Recruitment of patients in the PLIANT study proceeds according to expectations
"25 patients have so far been treated in Part 2. With the approval from the
DSMB, we can now also include patients receiving the add-on therapy
bevacizumab, which will increase the inclusion base " says CEO Jacques Näsström
Significant events during January- March
-- Positive data from the first part of the PLIANT study
-- Net result amounted to SEK -6 775k (-8 032k)
-- Cash and cash equivalents on March 31 amounted to SEK 41 388k (48 264k)
-- Cash flow from operating activities amounted to SEK -7 914k (-10 544k)
-- Result per share amounted to SEK -0.3 (-0.4)
Significant events after the end of the period
-- Approval from the DSMB (Drug Safety Monitoring Board) to also include
Avastin (bevacizumab) patients in Part 2 of the PLIANT study
-- Martin Nicklasson, Certified pharmacist, PhD and Associate Professor at the
Department of Pharmaceutics at University of Uppsala was elected to the
board of directors
-- The extra general meeting approved a new share issue which can generate a
maximum of 20,25 MSEK
-- Patent approved in Hong Kong for the use of PLED drugs in the treatment of
cancer
CEO comments
Our ongoing cancer study PLIANT is running smoothly and currently all
participating countries are actively recruiting patients to Part 2 of the
study. At present, 25 patients have been treated in addition to those already
treated the first part of the study.
The results from the first part of the study, in which 11 patients were
included, show that PledOx was well tolerated by patients undergoing standard
chemotherapy with FOLFOX. Furthermore, results indicate that the severe sensory
disturbances, which may occur during FOLFOX chemotherapy, did not occur in the
patients pretreated with PledOx in Part 1 of the study. That PledOx appears to
reduce the risk on chemotherapy-induced sensory nerve disorders, known as
neuropathies, is what impresses most on the oncologists we talked to since this
is a major clinical problem and the main reason for oxaliplatin-based
chemotherapy being discontinued. We also noted that patients who received the
lower dose of PledOx displayed fewer serious blood cell-related adverse events
than patients treated with FOLFOX normally are expected to get.
Based on these positive data, we have lowered the highest dose in this study to
optimize the effect of PledOx on both blood cells and sensory disturbances,
which results in an expansion of the study and hence increased costs. We are
therefore conducting a smaller rights issue of 20.25 million SEK (if fully
subscribed) at a price 12 SEK/share mainly to finance the additional patients
in the study. We have beforehand received subscription commitments equivalent
to more than 50% of the issued amount from some of the major shareholders.
Furthermore, it’s positive that we have received approval from the independent
Drug Safety Monitoring Board, to also include patients receiving the add-on
therapy bevacizumab. This will increase the recruitment base, as this
adjunctive therapy to chemotherapy is common.
For further information, please contact:
Jacques Näsström, CEO
+46 737 13 09 79
[email protected]
Michaela Gertz, CFO
+46 709 26 17 75
[email protected]
About PledPharma
PledPharma is a Swedish pharmaceutical company that develops new therapies for
the treatment of life threatening diseases. The initial objective is to develop
a drug, PledOx®, which reduces severe side-effects associated with
chemotherapy. The current market for supportive cancer care is some USD 10
billion. PledPharma also evaluates an existing medicines possibility to reduce
the damage that occurs on the heart muscle when patients suffer from acute
myocardial infarction. In addition to these projects, the company is also
evaluating opportunities of using our technology platform in additional areas
where there is a significant unmet medical need. PledPharma has the potential
to offer patients valuable and unique treatments for serious life-threatening
diseases where there is an opportunity fast registration in the US through
"breakthrough therapy" designation. This means that the company has the
potential to offer shareholders a good return on their investment. PledPharma
(STO:PLED) is listed on NASDAQ OMX First North. Erik Penser Bankaktiebolag is
the Certified Adviser. For further information, please visit www.pledpharma.se
