Stockholm, 2016-02-29 08:30 CET (GLOBE NEWSWIRE) --
Significant events during the quarter
· Interim data from PLIANT study –PledOx® shown to reduce long-lasting
chemotherapy-induced peripheral neuropathy by up to 75 percent
· Constructive End of phase II/pre phase III-meeting with the U.S. Food and
Drug Administration (U.S. FDA)
· PledPharma's key patent application for the active pharmaceutical ingredient
of the drug candidates PledOx® and Aladote® approved in the US
· Transition to financial reporting according to IFRS standards.
The transition has no effect on reported numbers
Quarter and full year summary
· Net result for the quarter amounted to SEK -8 794 (-17 687) k and to
-43 836 (-48 420) k for the year
· Cash equivalents at the end of the year amounted to SEK 50 360 (100 304) k
· Cash flow from operating activities for the quarter amounted to
SEK -8 953 (-12 573) k and to -51 153 (-41 405) k for the year
· Result per share for the quarter amounted to SEK -0.3 (-0.7) and to
-1.5 (-2.1) for the year
Other significant events during 2015
-
Top-line results from phase IIb study presented in March - PledOx® reduces nerve
damage in conjunction with chemotherapy by 43 percent
· Aladote® approved as a trademark in the EU and the US
· Results from the Phase IIb study with PledOx® presented at the MASCC
scientific congress.
· Patent for the anticancer-effect of PLED compounds approved by the European
Patent Office and an use patent for PLED compounds granted by authorities
in Canada, Russia, Mexico, Japan and Australia.
CEO comment
In the spring of 2015, we completed the treatment phase of a comprehensive clinical trial, PLIANT, with good results. The study showed that PledOx® can prevent the emergence of nerve damage caused by chemotherapy in a clinically significant way in patients with colorectal cancer. Furthermore, it was noted that PledOx® does not impair the effect of the chemotherapy and that the safety profile is favorable. Interim data also shows that the preventive effect against nerve damage is more pronounced six months after completion of treatment - the difference in symptom score between the patients treated with the dose PledOx® 5 µmol / kg and placebo was 75 per cent. This difference is both clinically relevant and statistically significant (p <0.01). Annually about 1.5 million people are affected by colorectal cancer and up to half of the patients treated with oxaliplatin get long-lasting nerve damage after chemotherapy. Overall, our results indicate that PledOx® may be an important treatment for facilitating desired chemotherapy courses and reduce the risk of long-term, sometimes crippling, nerve injury.
In November, we conducted an end of Phase II meeting with the FDA, where we presented follow-up data from the completed PLIANT study and had the opportunity to discuss the further development of PledOx®. The FDA gave constructive advice, based on a careful review of the available documentation.
During the year, patent protection for both PledOx® and Aladote® was strengthened, when the US Patent Office approved our patent covering the active ingredient in these two products. This patent is the most central in our broad portfolio with protection extending to December 2032.
In 2015, we have been preparing for the start of a Phase II study of Aladote®. This work has included study design, discussions with key opinion leaders and preparations for the development of an automated production process. Aladote® is being developed to provide medical services with an efficient way of treating acetaminophen poisoning irrespective of when treatment is initiated.
During the past year, we have successfully completed the treatment phase of the PLIANT study, strengthened our patent portfolio and conducted a constructive meeting with the FDA. All of this means that the conditions for PledOx® to become a valuable drug for cancer patients have been significantly improved, while we have received clarity on the next steps towards market approval.
I am proud of our achievements in 2015, which significantly increase the chances of PledPharma to provide patients and healthcare providers with better treatments for serious conditions caused by oxidative stress, and I look forward to an equally productive 2016.
Jacques Näsström
CEO, PledPharma AB (publ)
PledPharma in brief
PledPharma develops new drugs that protect the body against oxidative stress – a potentially disabling and sometimes life-threatening condition that can be caused by chemotherapy treatment and acetaminophen (paracetamol) poisoning. The company's most advanced project PledOx® reduces nerve damage associated with chemotherapy and positive
results from the Phase IIb study PLIANT were presented during the spring of 2015. The drug candidate Aladote® is being developed to reduce the risk of acute liver failure associated with acetaminophen poisoning. The project PP-099 seeks to limit the damage that occurs to the heart muscle during myocardial infarction.
PledPharma (STO: PLED) is listed on Nasdaq First North. Erik Penser Bankaktiebolag is the company’s Certified Adviser (tel +46 8 463 80 00). For more information, see www.pledpharma.se
For further information contact:
Jacques Näsström, CEO cell +46 73 713 09 79
Michaela Gertz, CFO cell: +46 70 926 17 75
