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PledPharma’s clinical myocardial infarction study restarted after approval from the Medical Products Agency

December 15, 2011

PledPharma AB
Company Announcement

PledPharma’s clinical myocardial infarction study restarted after approval from
the Medical Products Agency

Stockholm, 2011-12-15 14:28 CET (GLOBE NEWSWIRE) -- 

PledPharma (STO:PLED) today announced that the new production of mangafodipir
clinical trial substance has been approved by the Swedish Medical Products
Agency. The clinical phase IIa study will consequently be restarted early 2012.
In the (MANAMI) study mangafodipir’s ability to improve the treatment outcome
in acute myocardial infarction patients treated with angioplasty. 

Patient recruitment was discontinued since there was no available clinical
trial substance as GE Healthcare stopped its production of Teslascan, a
contrast agent used in magnetic resonance imaging (MRI). Recipharm has
manufactured new trial substance and this has passed an approval process at the
Swedish Medical Products Agency since the manufacturer is new. 

”The restart of the MANAMI study is very positive. This is a great opportunity
to help myocardial infarction patients who are treated with angioplasty to an
even better function by reducing the size of the infarction further.
Furthermore, we are expecting to have two clinical phase II studies ongoing
next year, since we are in the final stage of the preparatory work ahead of our
clinical phase IIb study in colorectal cancer patients”, says CEO Jacques

About the MANAMI study

Mangafodipir is given just prior to angioplasty treatment in connection with
treatment of acute myocardial infarction. The study will include in total 20
patients, whereof 10 patients will receive active substance and 10 patients
will receive placebo. 8 patients are included so far. The mangafodipir effect
is assessed through measurement of enzyme levels and magnetic resonance imaging
(MRI) analysis. The study is done in the County hospital Ryhov under the
supervision of Senior Consultant and PhD Jan-Erik Karlsson. Previous
pre-clinical studies have shown that PLED-derivates can reduce the size of the
remaining infarction after reperfusion of an acute myocardial infarction. 

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. Erik Penser Bankaktiebolag is
the Certified Adviser. For more information, please visit



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Phone: +46 8 679 72 10