Stockholm, 2014-02-19 08:39 CET (GLOBE NEWSWIRE) --
Significant events after the end of the period
· Positive data from the first part of the PLIANT study
· A continuation in part of the first U.S. patent has been approved.
· A patent for the use of PLED pharmaceuticals in cancer treatment was approved in Japan
Significant events during January- December
· The first patient in the second part of the Phase IIb study PLIANT has been included
· Promising results from the acute myocardial infarction study MANAMI
· Patent application for the use of PLED pharmaceuticals in the treatment of cancer
approved and issued in the US, China and Russia
· FDA approved IND application for the clinical trial PLIANT in the US
· Rights issue provided the company with 18.6 million SEK.
· IMS Consulting Group appointed advisor for the commercialization of PledOx®
· Sten Nilsson, MD, PhD Professor of Oncology at Karolinska University Hospital and
Institutet in Stockholm elected as member of the board.
· PledOx® registered as a trademark in the US, Switzerland, Japan and Australia
· Patent approved in South Africa
· Net result amounted to SEK -6 961k (-8 389k)
· Cash and cash equivalents on December 31 amounted to SEK 49 302k (58 808k)
· Cash flow from operating activities amounted to SEK -5 607k (-6 679k)
· Result per share amounted to SEK -0.3 (-0.4)
January – December
· Net result amounted to SEK -25 549k (-33 857k)
· Cash flow from operating activities amounted to SEK -28 066k (-31 957k)
· Result per share amounted to SEK -1.2 (-1.7)
Our focus during 2013 has been on the oncology study PLIANT. The study examines whether PledOx® can reduce serious side effects in the treatment of colorectal cancer using the chemotherapy FOLFOX. During the first quarter of 2013 the first patient in the PLIANT study (part one) was included and all patients have now been treated. Part two of the study, where roughly 126 patients will be included started in November and a number of patients have now been treated according to plan and the majority of centers are actively recruiting patients.
As previously has been reported, the results of the first part of the PLIANT study shows that PledOx was well tolerated by patients treated with FOLFOX. Furthermore, the peripheral sensory disorders that may occur as a consequence of chemotherapy treatment did not occur in the patients pretreated with PledOx. The fact that it appears as PledOx can reduce the chemotherapy induced peripheral sensory nerve disorders known as neuropathies was what impressed most on the oncologists we talked to. The reason being that chemotherapy induced neuropathy is a major clinical problem and the main reason for discontinuing oxaliplatin-based chemotherapy.
We observed that patients pretreated with the lower dose of PledOx had fewer events of serious white blood cell-related side effects than patients treated with oxaliplatin normally are expected to get. Based on these positive data, PledPharma has applied to the regulatory authorities for reduction of the higher dose of 10 μmol/kg to 5 μmol/kg. The reduction is primarily based on the apparent better effect on white blood cell-related side effects with the lower dose of PledOx. This change in dose also means that the full number (i.e. 42) randomized patients must be included in order to be able to statistically evaluate the new dose, which results in an expansion of the study and an extension of the trial period. The current estimate is that all patients should be included in the study before the end of 2014 and that overall (top-line) data should be available towards the end of the first quarter of 2015. We will also investigate the possibility of getting a quicker registration in the United States for neuropathy indication by so called "breakthrough therapy designation" This means that PledOx has the potential to get registered as a pharmaceutical in the US based on the preliminary clinical top-line results from the PLIANT study.
During 2013 IMS Consulting Group (IMSCG) has been working to investigate the commercialization strategy for PledOx. IMSCG have concluded that PledOx will most likely be subsidized the U.S. and in the five largest European markets (EU5) and that PledOx will gain wide access to these markets, a major uptake and attractive pricing, meaning a potential multi-billion dollar market which can also be expanded with additional use in other types of cancers using other chemotherapies or radiotherapy.
During 2013, the myocardial infarction study MANAMI was completed and the results show that the PLED pharmaceutical was well tolerated by patients in the study and can be given safely to seriously ill cardiac patients without any side effects. Despite the study's limited size, a tendency towards clinical effect in reducing infarct size and improving the heart's pump function was seen. We are currently evaluating the commercial opportunity of this project (PP-099) and looking forward to an exciting 2014, says CEO Jacques Näsström.
For further information please contact:
Jacques Näsström, CEO
+46 737 13 09 79
PledPharma is a Swedish pharmaceutical company that develops new for prevention of life threatening diseases related to oxidative stress. The initial objective is to develop a drug that reduces the serious 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 a patient suffers from myocardial infarction. In addition to these projects, the company is also evaluating opportunities of using the technology platform in other medical areas where there is a significant unmet medical need in other diseases. PledPharma has the potential to offer patients valuable and unique treatments for serious life-threatening diseases where there is an opportunity for "breakthrough therapy" designation. It also 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