Stockholm, 2014-08-28 08:30 CEST (GLOBE NEWSWIRE) --
Over 100 patients included in the PLIANT cancer study
“70 patients have so far been treated with the new dosing in the PLIANT study. Together with the already treated 39 patients according to previous protocol, a total of over 100 patients have now been treated in Part 2 of the study. " says CEO Jacques Näsström
Quarter summary
- Net result amounted to SEK -12 674k (-6 048k)
- Cash and cash equivalents on June 30 amounted to SEK 47 799k (59 116k)
- Cash flow from operating activities amounted to SEK -13 770k (-7 708k)
- Result per share amounted to SEK -0.5 (-0.3)
Significant events during April – June
- Approval from the DSMB (Drug Safety Monitoring Board) to also include Avastin (bevacizumab) patients in Part 2 of the PLIANT study
- A rights issue was conducted which generated approximately 20 MSEK
- Patent approved in Hong Kong for the use of PLED-substances in the treatment of cancer
- Martin Nicklasson was elected to the board of directors
Significant events after the end of the period
- Futility analysis in PLIANT study completed and approved by the DSMB
- Positive data from patients treated with the FOLFOX in combination with bevacizumab in the first part of the PLIANT study
CEO comments
We have now been able to significantly increase the recruitment rate in the PLIANT study and to date we have included 70 of the 126 patients that need to be included.
Additionally, 39 patients were treated according to the previous protocol (where about one third of the patients received a dose of 10 μmol/kg). This means that within the PLIANT study's second part, we have up until today treated at least 109 patients. The results from these first 39 patients will help us to build up a better dose-response curve and also strengthens the statistical evaluation together with the other 126 patients.
Recently the DSMB reported that the futility analysis for the first 30 patients in the study who have completed four treatment cycles with the chemotherapy mixture FOLFOX after pretreatment with either PledOx or placebo has been completed and that no negative impact on the anti-cancer effect of the chemotherapy was observed. This approval means that the PLIANT trial can proceed as planned. The safety analysis is important since there has been a concern that the PledOx drug not only protects healthy cells but also the cancer cells. The DSMB has therefore had an extra focus on this during the analysis but no negative impact on the anti-cancer effect of the chemotherapy has been observed. Additional safety analyzes will be conducted for every 30 patients enrolled that have completed four treatment cycles with chemotherapy. The next analysis will be preformed in the beginning of September.
We have now received data from an additional 5 patients in the first part of the PLIANT study. The data showed that PledOx was well tolerated by these 5 patients who were treated with the antibody Avastin (bevacizumab) in combination with FOLFOX chemotherapy. In total 11 patients have been treated in this open part of the study and preliminary analysis of the raw data indicated that PledOx® reduced the severe chemotherapy-induced side effects. Nine of these 11 patients underwent at least 6 treatment cycles of FOLFOX and none of these patients showed any grade 2 or worse neuropathy against an expected outcome of at least two patients. These data also indicated a reduction of serious blood-related side effects with the 5 μmol/kg dose of PledOx.
In summary, I feel that we have now taken a major step forward in our main study PLIANT and I'm confident that we will keep the goal that all patients should be included in the study at the end of the year. We now look forward to an exciting fall for PledPharma.
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. 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
