Stockholm, 2016-08-25 08:30 CEST (GLOBE NEWSWIRE) --
Important steps taken with the drug candidates PledOx® and Aladote®
January – June summary
· Net result for the first half year amounted to SEK -18 829 (-23 610) k
· Cash equivalents at the end of the period amounted to SEK 31 666 (69 586) k
· Cash flow from operating activities amounted to SEK -18 695 (-31 927) k
· Result per share amounted to SEK -0.7 (-0.8)
Second quarter summary
· Net result for the quarter amounted to SEK -11 984 (-11 447) k
· Cash equivalents at the end of the quarter amounted to SEK 31 666 (69 586) k
· Cash flow from operating activities amounted to SEK -12 018 (-17 942) k
· Result per share amounted to SEK -0.4 (-0.4)
Significant events during January - June
· PledPharma conducted a constructive meeting with the European Medicines Agency (EMA)
· Follow-up data confirms that PledOx® does not negatively interfere with the anti-cancer effect of chemotherapy
· PledPharma presented the Phase IIb PLIANT study data at the American Society of Clinical Oncology (ASCO) cancer meeting
· During the AGM the CEO reported that active discussions are being held with a number of potential partners in the ongoing process of finding one or more appropriate commercial partners for the continued development of PledOx®.
CEO comment
During the second quarter, we continued our work to strengthen the projects through a number of important steps with our drug candidates PledOx® and Aladote®. In the PledOx project we have demonstrated additional clarifying data and made progress in our regulatory discussions.
The Aladote® project is progressing according to plan and a clinical study, with the aim to prevent liver damage associated with acetaminophen overdose, is expected to start in late 2016.
During the spring we completed a constructive meeting with the European Medicines Agency (EMA) regarding the remaining development and potential market introduction of PledOx®. The meeting was a joint meeting attended by representatives from NICE in the UK and NOMA in Norway, two national authorities who are responsible for health economic evaluations of new drugs. We conclude that the European Medicines Agency share our view regarding the structure and scope of the remaining clinical development of PledOx®.
We have previously completed a so-called end-of-Phase II/pre-Phase III meeting with the FDA. Also this meeting was held in a constructive and positive spirit and altogether has the contacts with the regulatory authorities established a basis for a clear regulatory strategy for the two largest markets, US and Europe and a good basis for the continued development. PledPharma’s view is that these meetings have created a foundation for the way forward towards a market approval of PledOx® for the prevention of chemotherapy induced nerve damage in patients treated for colorectal cancer.
At ASCO in June, PledPharma presented the Phase IIb PLIANT study data demonstrating the preventing effect on chemotherapy-induced nerve damage of PledOx®. The results were presented in a Poster Discussion Session by the study's coordinating primary investigator, Professor Bengt Glimelius.
During the quarter we presented positive follow-up data from the Phase IIb study PLIANT where we reported that the so called Progression Free Survival (PFS) i.e., survival time without tumor growth after the end 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. The results confirm that treatment with PledOx® has no negative effect on the efficacy of the cancer treatment.
As previously announced, active discussions are held with a number of potential partners for PledOx®.
In conclusion, we have strengthened the conditions for the drug candidates PledOx® and Aladote®.
Jacques Näsström
CEO, PledPharma AB (publ)
For more information, please contact:
Jacques Näsström, CEO, phone: +46 737 130 979
jacques.nasstrom@pledpharma.se
Michaela Gertz, CFO, phone: +46 709 26 17 75
About PledPharma
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
