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Article on Aladote:
This week is the Peripheral Neuropathy Awareness Week. Peripheral neuropathy is a set of symptoms caused by damage to the nerves in the arms and legs. These distant nerves are called peripheral nerves. They carry sensations to the brain and control our arms and legs. Some of the chemotherapy, for example oxaliplatin, and other drugs used to treat cancer can damage peripheral nerves. When this happens, it is called chemotherapy -induced peripheral neuropathy (CIPN) and can be a debilitating side effect of cancer treatment.
PledPharma develops PledOx® to provide patients, undergoing cancer treatment, protection against these nerve damage.
Read the full article here: FirstWorldPharma
PledPharma initiates clinical study on new treatment for paracetamol poisoning
PledPharma has recieved approval from the MHRA, the UK’s medicines regulatory body, to undertake a clinical trial for Aladote®, a new treatment for reducing liver damage from paracetamol (acetaminophen) poisoning. Paracetamol poisoning affects approximately 50,000 people the UK every year[i]. The trial will evaluate the safety and tolerability of Aladote® in combination with the current standard treatment (N-acetylcysteine) for the prevention of acute liver failure due to paracetamol poisoning.
Preclinical animal studies have suggested that Aladote® may be effective at reducing liver damage in the period more than eight hours after a paracetamol overdose, where N-acetylcysteine is minimally effective. The clinical study will be conducted in collaboration with the University of Edinburgh under the direction of Dr James Dear, Reader in Pharmacology at the University of Edinburgh, and specialist in paracetamol poisoning.
Paracetamol is the most commonly used drug in the world for the treatment of fever and pain, and is considered to be safe in therapeutic doses. However, toxic doses of more than four grams per day can cause severe, and sometimes fatal, liver damage. It is the drug most commonly taken in overdose in the UK[ii], and there are an estimated 50,000 emergency hospital admissionsi, and approximately 200 deaths[iii], due to paracetamol poisoning in the UK every year. Intentional overdose of paracetamol is the most common method for suicide attempts among adolescents aged 10-19 years. Many people also accidentally overdose on paracetamol, usually by taking multiple medicines without realising that they all contain paracetamol.
The current standard treatment for paracetamol poisoning is N-acetylcysteine, which is very effective at reducing liver damage in the period up to eight hours after an overdose. However, N-acetylcysteine’s efficacy drops off considerably after eight hours, becoming almost totally ineffective 24 hours after an overdose. Unfortunately, many paracetamol poisoning patients do not present at hospital until more than eight hours after their overdose, leaving them at considerable risk of severe liver damage. If the liver damage becomes too severe, the only remaining treatment option is a costly and invasive liver transplant. Promising preclinical data for calmangafodipir (active ingredient in Aladote®) has suggested that it may be effective at reducing liver damage from paracetamol in the period between eight and 24 hours after an overdose.
Dr James Dear, principal investigator and Reader in Pharmacology at the University of Edinburgh, commented, ˝During the first 24 hours after paracetamol poisoning people usually experience few or no symptoms. Therefore, many patients come to hospital at such a late stage that the current standard treatment is not sufficient to prevent acute liver failure. Calmangafodipir has in preclinical studies demonstrated impressive results even in the late stages of the poisoning process, and I look forward to leading the evaluation of the drug candidate in this important proof-of-principle study”.
PledPharma develops new drugs that protect the body against oxidative stress – a potentially debilitating and sometimes life-threatening condition that can be caused by chemotherapy treatment and following acetaminophen (paracetamol) overdose. The company’s most advanced project PledOx® is being developed to reduce nerve damage associated with chemotherapy. A phase IIb study has been conducted and will serve as the basis for the continued development. The drug candidate Aladote® is being developed to reduce the risk of acute liver failure associated with acetaminophen poisoning.
PledPharma (STO: PLED) is listed on Nasdaq First North. Erik Penser Bank is the company’s Certified Adviser (tel +46 8 463 80 00). For more information, see www.pledpharma.se
For more information, please contact:
Jacques Näsström, CEO, phone: +46 737 130 979
Michaela Gertz, CFO, phone: +46 709 26 17 75
[i] “Target biomarker profile for the clinical management of paracetamol overdose” http://onlinelibrary.wiley.com/doi/10.1111/bcp.12699/pdf
[ii] ”Death from paracetamol overdose despite appropriate treatment with n‐acetylcysteine” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2658515/
[iii] ”Deaths related to drug poisoning in England and Wales: 2015 registrations” https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/bulletins/deathsrelatedtodrugpoisoninginenglandandwales/2015registrations#paracetamol-related-deaths-remain-stable-in-2015
We welcome Nicklas Westerholm as the new CEO of PledPharma. Nicklas will take office on June 16.
Nicklas Westerholm, is a business leader with extensive management experience (20 years) across multiple geographies within the pharmaceutical industry. Management experience gained from a broad range of senior executive management roles globally within Research & Development, Manufacturing & Supply Chain and Finance/Investor relations, AstraZeneca.Nicklas Westerholm has studied analytical and organic chemistry at Stockholm University, and Chemical Engineering at KTH Royal Institute of Technology. He has also participated in Post graduate programs at the University of Warwick, INSEAD and Harvard Business School.
Read the latest analysis of PledPharma here: Redeye analysis
PledPharmas poster of PLIANT study at ASCO meeting
Information from National Cancer Institute on how to manage chemotherapy side effects: Managing Chemotherapy Side Effects
PledPharma presents new in-depth follow-up data from PLIANT study – PledOx® shown to reduce chemotherapy-induced peripheral neuropathy by 75 percent, see detailed presentation of PledPharma data 151201 v3
Link to article on PledPharma in BWT 111915 Pledpharma
with a brief update in BWT 112015 Pledpharma brief
Please find link to analysis update_20151111_30385
Link to the latest Redeye analysis update_20150929_29798
See PledPharma’s presentation at Pareto Securities’ 6th Annual Health Care Seminar, August 28, 2015.
Link to the slides PledPharma Company Presentation Pareto Aug 28 2015
Please view Dr. Mahalingam’s presentation of the PLIANT study and Prof Loprinzi’s expert opinion Link to the presentation (choose agenda for Friday)
Please find link to updated Redeye analysis after MASCC presentation: Update MASCC Pledpharma-eng
PledPharma AB (publ) presents additional topline results from PLIANT – a Phase IIb study with the drug candidate PledOx® – at the scientific conference MASCC (Multinational Association of Supportive Care in Cancer) in Copenhagen, Denmark. The results confirm that PledOx® can reduce the risk of symptoms caused by sensory nerve damage associated with chemotherapy treatment of advanced colorectal cancer in a clinically relevant manner. Click here to see the pictures that were presented.
The top-line results from the PLIANT study will be presented at the MASCC meeting in Copenhagen on June 26 at 08:30 am – link to the abstract (enter PledOx as keyword )
Please find link to updated Redeye analysis: update_20150422_27758
Two recent updates from Redeye
Click on the links below for two new publications on PledPharma drug development
Drug Discovery Today: Breaking away from the norm: a new perspective on cancer therapeutics
View presentation slides from today’s presentation at BIO Europe in Frankfurt: Presentation BIO Europe PledOx_November 5
Can PledPharma safely reduce the serious side effects of chemotherapy treatment?
Watch this interview with CEO Jacques Näsström: Pharma Television interview
Information video about PLIANT study
PledPharma has interviewed three doctors involved in the ongoing colorectal cancer study PLIANT. The three oncologists Professor Bengt Glimelius, Professor Per Pfeiffer and Dr. Jitendra Gandhi share their experiences of the study and give their views on why this study is interesting and important.
Analysis of PledPharma: Time to act – Redeye July 2014
Article on PledPharma in BioPharm Insight: PledPharma seeks partner for chemotherapy protective agent PledOx
Poster on MANAMI study presented at Frontiers in CardioVascular Biology in Barcelona, Spain 4th of July: Poster MANAMI Study
Results from a pilot study in Jonkoping, Sweden into the use of PLED-substance mangafodipir as a cardioprotective adjunct to balloon dilution (PCI) are to be presented at Frontiers in CardioVascular Biology 2014 in Barcelona. 20 patients with their first acute ST-elevation MI (STEMI) were assigned into two groups receiving an intravenous bolus dose of mangafodipir, 2 µmol per kilogram of body weight, or saline (control group) immediately before performing PCI. On cardiac MRI, the mangafodipir group revealed a tendency towards smaller mean infarct size (26.2% scar vs 32.5%) and a higher mean ejection fraction (47.7 % vs 41.8 %), despite a significant prolonged ischemia time (205 min vs 144 min). ST-segment elevation also regressed more rapidly in the mangafodipir group, whereas there were no apparent differences in biomarker release. There were no reported side effects. These results lead the investigators running the pilot to believe that mangafodipir may reduce infarct size in STEMI patients, with the proviso that a larger clinical trial is needed to provide confirmation.
Patent from PledPharma’s second series of applications approved in South Africa, as the first country.
PledPharma has filed 3 series of worldwide patent applications aiming to achieve exclusive and broad commercial rights for manufacturing and use of PLED-compounds, including among others PledOx® (calmangafodipir).
The company has until now achieved approval for its first series of patent applications in USA, Russia and China, and expects to soon achieve approval in other countries.
“It is really good news that we now start to achieve approval of our second series of patent applications”, says Jan Olof G. Karlsson, Chief Scientific Officer and responsible for patents in PledPharma.
Click on the link to access the analysis; EP Access Analysis 2013
PledOx® registered trademark in the U.S.
United States Patent and Trademark Office approved PledOx® as a registered trademark in April 2013. PledOx® has been a registered trademark in EU since May 2010
PledOx® is developed to prevent severe chemotherapy-induced side effects in cancer patients. PledOx® protects normal cells against oxidative stress. It belongs to a group of compounds named lowMEM (low Molecular Enzyme Mimetics), and mimics the enzyme Manganese SuperOxide Distmutase (MnSOD) – the most important endogenous cellular protectant against devastating oxidative stress.
Read profile on PledPharma in Genetic Engineering & Biotechnology News (GEN) click on link to access article
Link to downloadable printer friendly version click here
We have chosen Pharma Consulting Group and Viedoc™ for our clinical phase IIb cancer study. The study will investigate the preventive effect of PledOx® on chemotherapy-induced side effects in colorectal cancer treatment. We will recruit approximately 120 subjects from several sites in Europe and North America. More information here…