Stockholm, 2015-04-21 08:03 CEST (GLOBE NEWSWIRE) --
Significant events during January- March
- Top-line results from phase IIb study - PledOx® reduces nerve damage in conjunction with chemotherapy by 43 percent
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Net result for the period amounted to SEK -12 151 (-6 775)k
- Cash and cash equivalents at the end of the period amounted to SEK 86 070 (41 388)k
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Cash flow from operating activities amounted to SEK -13 972 (-7 914)k for the quarter
- Result per share amounted to SEK -0.4 (-0.3) for the period.
Significant events after the end of the period
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Annual General Meeting was held on April 14, 2015 where the General Meeting resolved in accordance with the submitted proposals. As members of the Board, Håkan Åström, Andreas Bunge, Martin Nicklasson, Sten Nilsson and Eva Redhe Ridderstad were elected.
CEO comment
We are now an important step closer to our ultimate goal of improving the lives of a large number of cancer patients.
At the end of the quarter, we finally had confirmation that PledOx® has the potential to reduce the serious nerve damage caused by chemotherapy, in patients treated for colorectal cancer. This nerve damage (chemotherapy induced peripheral neuropathy, CIPN) is, as we have previously described the most troublesome side-effect of chemotherapy. Chemotherapy can cure cancer, but a large proportion of patients suffer from nerve damage. Such nerve damage can cause debilitating problems that in many cases become chronic and irreversible. This may involve extreme sensitivity to cold, serious disturbances in fine motor skills or severe pain, particularly in the hands and feet, and there is currently no effective treatment available.
This is also the main reason that clinicians are forced to reduce the chemotherapy dose, temporarily cease or completely discontinue the treatment. So apart from these injuries, the patients also risk losing out on the needed chemotherapy. In addition to the suffering and problems, CIPN patients also incur significantly larger healthcare costs. Calculations have been made in the United States showing that the CIPN resulted in additional healthcare costs of over USD 17 000 per patient during the first year only. This was in addition to the workloss burden and cost for the cancer treatment in general.
This means that the positive outcomes (top-line) we presented on March 29 forms the so far most important milestone in PledPharma’s history. The Phase IIb study PLIANT showed that our drug candidate PledOx® can prevent nerve damage arising from chemotherapy, without negatively affecting the anti-cancer effect of chemotherapy. This is something that no one else so far has succeeded with.
Patients were pretreated with PledOx® or placebo in the randomized, double-blind, placebo-controlled study, in order to reduce the risk of side effects associated with chemotherapy treatment of advanced colorectal cancer. The study showed a clinically relevant decrease of 43 percent compared to placebo in the incidence of neuropathy. In addition, it was found that the anti-cancer effect of the chemo was not negatively affected by PledOx®-pretreatment.
Bengt Glimelius, professor emeritus of oncology at Uppsala University and principal investigator of the study, commented the PLIANT top-line results; "This is to my knowledge the first study in which a treatment has shown to reduce this type of side effects in a clinically meaningful way, without any seemingly negative impact on the anti-cancer effects of the chemotherapy."
The study results will form the basis for the continued development plans, which according to plan will be discussed at an end of Phase II meeting with the FDA (US Food and Drug Administration). We now look forward to, based on the promising results of the study, intensify discussions with potential partners and continue preparations for the next step in the clinical development of PledOx®.
In addition to our progress with the PLIANT study, we have continued the work with the drug candidate Aladote™. This project is also based on the PLED platform, but is focused on reducing or preventing acute liver failure as a result of an overdose of acetaminophen, one of the most common drug poisonings. After having secured the development of the project through a rights issue at the end of 2014, the goal is now implementing a phase II study in preparation for future licensing.
PledPharma stands stronger than ever before. We have further strengthened our project portfolio and with the clinical data for PledOx® we have reduced the risk and increased the opportunities in future discussions with potential partners and regulatory authorities. In addition, we have a stable financial base for the further development of the equally important Aladote™.
Jacques Näsström
CEO, PledPharma AB (publ)
PledPharma in brief
PledPharma develops new drugs that protect the body against oxidative stress – a 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. 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’s drug candidates are based on the further development of a compound that, for completely different purposes, already has been used by more than 200 000 patients. This may limit the development risk and simplify the approval process. Pledpharma (STO: PLED) is listed on Nasdaq First North. Erik Penser Bankaktiebolag is the company’s Certified Adviser. For more information, see www.pledpharma.se
For further information contact:
Jacques Näsström, CEO cell +46 73 713 09 79
Johan Stuart, CFO cell +46 70 66 44 096
