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
Jacques.nasstrom@pledpharma.se
Michaela Gertz, CFO
+46 709 26 17 75
Michaela.gertz@pledpharma.se
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
