Stockholm, 2016-05-16 08:30 CEST (GLOBE NEWSWIRE) --
PledPharma today announced follow-up data from the Phase IIb study PLIANT with PledOx® - a drug candidate that reduces the incidence of chemotherapy induced nerve damage. Progression-free survival (PFS) 48 weeks after completion of treatment does not differ between the patients who received PledOx® and the placebo group. These results confirm the previously reported tumor measurements during chemotherapy treatment showing that PledOx® does not negatively interfere with the anti-cancer effect of chemotherapy.
The follow-up results presented today are based on an assessment of how long it takes before the tumor starts to grow again after completion of chemotherapy. The results show that the progression-free survival (PFS) after completion of treatment is approximately seven months, which is in line with what can be expected from this group of patients. No difference in PFS was noted between the patients who received PledOx® and those who received placebo. It can therefore be concluded that treatment with PledOx® has no negative effect on the efficacy of the cancer treatment.
Regarding the preventive effect on chemotherapy induced nerve damage at 12 and 24 weeks after treatment, the results are in line with previously presented preliminary results.
As can be expected for this seriously ill patient population, there were significant rates of patient dropout at 36 and 48 weeks respectively after end of treatment, with the consequence that it is difficult or almost impossible to evaluate the effect of chemotherapy induced nerve damage at these late time points. However, it can be concluded that the chemotherapy induced nerve damage in the PledOx® group with 5 µmol/kg remains at the same low level.
For more information, please contact:
Jacques Näsström, CEO, phone: +46 737 130 979
Michaela Gertz, CFO, phone: +46 709 26 17 75
PledPharma develop new drugs that protect the body against oxidative stress - a potentially disabling and sometimes life-threatening condition that can be caused by chemotherapy and acetaminophen poisoning. The company's most advanced project PledOx® reduces nerve damage associated with chemotherapy. Positive results from phase IIb study PLIANT were presented in the spring of 2015. The drug candidate Aladote® is developed to reduce the risk of acute liver failure associated with acetaminophen poisoning. The project PP-099 aims to limit the damage that occurs to the heart muscle during a heart attack. PledPharma (STO:PLED) is listed on Nasdaq First North. Erik Penser Bank is the Certified Adviser. For further information, please visit www.pledpharma.se