PledPharma AB

Stockholm, Sweden

PledPharma AB

Stockholm, Sweden

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News Article | April 25, 2017
Site: globenewswire.com

Årsstämma i PledPharma AB (publ) har avhållits den 25 april 2017 varvid stämman beslutade enhälligt i enlighet med styrelsens framlagda förslag. De fullständiga beslutsförslagen framgår av kallelsen till stämman. Vid årsstämman fattades bland annat följande beslut: Årsstämman beslutade att fastställa resultaträkning och balansräkning för verksamhetsåret 2016. Årets förlust om 38 223 351 kr avräknas mot överkursfonden och kvarvarande överkursfond balanseras i ny räkning. Årsstämman bes


Methods for treatment of a pathological condition caused by oxidative stress in a patient comprise administering to the patient a mixed metal complex of a compound of Formula I, or a salt thereof, in an amount effective to reduce the oxidative stress. Pharmaceutical compositions are formed by suspending or dissolving a mixed metal complex of a compound of Formula I, or a salt thereof, in a liquid medium, optionally with one or more physiologically acceptable excipients. The mixed metals comprise calcium and manganese in a molar ratio of calcium to manganese in the range of 1-10: wherein X, R^(1), R^(2), R^(3), and R^(4 )are as defined herein.


News Article | February 15, 2017
Site: globenewswire.com

Extra bolagsstämma i PledPharma AB (publ) har avhållits den 10 februari 2017 varvid stämman beslutade i enlighet med valberedningens framlagda förslag till förändring av styrelsen. Stämman beslutade att, för tiden intill utgången av nästa årsstämma, till styrelseledamöter utse Gunilla Osswald och Elisabeth Svanberg. Styrelseledamöterna Håkan Åström (ordförande) och Sten Nilsson kvarstår i styrelsen. Gunilla Osswald (född 1961), apotekare och doktor i biofarmaci och farmakokinetik, är V


News Article | November 7, 2016
Site: globenewswire.com

Extra bolagsstämma i PledPharma AB (publ) har avhållits den 7 november 2016 varvid stämman beslutade i enlighet med styrelsens framlagda förslag. Det fullständiga beslutsförslaget framgår av kallelsen till stämman. Under sitt anförande på stämman redogjorde styrelseordförande Håkan Åström för bakgrunden till styrelsebeslutet om företrädesemission. Styrelsen och ledningen i PledPharma har beslutat att utveckla huvudprodukten, PledOx®, hela vägen fram till en ansökan om marknadsregistrering.


News Article | February 24, 2017
Site: globenewswire.com

Under 2016 beslutade vi att utveckla vår huvudprodukt PledOx® mot en marknadsregistrering. Detta innebär att vi under året kommer att påbörja fas III-studier i patienter med tjock- och ändtarmscancer. Studieresultaten ska sedan ligga till grund för en registreringsansökan hos det amerikanska läkemedelsverket FDA, samt dess europeiska motsvarighet EMA och även för samtal med potentiella samarbetspartners. För att säkra finansieringen av fas III-programmet fram till  ”top-line”-resultat genomförde vi under hösten en nyemission. Resultaten från fas IIb-studien PLIANT har mötts med stort intresse, både av kliniskt verksamma läkare och potentiella partners. Resultaten presenterades i juni på American Society of Clinical Oncology (ASCO) av studiens huvudprövare professor Bengt Glimelius. De uppföljningsdata som presenterades under året bekräftar att PledOx® ger en klinisk betydelsefull minskning av neuropati jämfört med placebogruppen. Långtidsuppföljningen visade dessutom att PledOx® inte till synes har någon negativ inverkan på cellgiftsbehandlingens anticancereffekt. Under året har vi även haft en bra diskussion med EMA avseende den fortsatta kliniska utvecklingen för PledOx® där vi fått bekräftat att PledOx® nu är redo att ta steget in i fas III. Flera potentiella licenspartners har uttryckt önskemål om kompletterande studier, med patientrapporterad neuropati som primär endpoint, innan de är redo för ett kommersiellt samarbete.  PledPharma har därför valt att gå vidare med den kliniska utvecklingen på egen hand och med detta skapa ett ökat värde i bolaget. När PledPharma under 2017 tar steget in i fas III med PledOx® och dessutom tar Aladote® vidare in i en proof of principle-studie innebär det att PledPharma kommer att ha två potentiella first in class-läkemedel i klinisk utvecklingsfas. Vi är övertygade om att detta kommer skapa betydande värden för våra aktieägare.


News Article | February 24, 2017
Site: globenewswire.com

Stockholm, 2017-02-24 08:00 CET (GLOBE NEWSWIRE) -- Preparations for the Phase III program with PledOx® ·       Net result for the year amounted to KSEK -38 223 (-43 836) ·       Cash equivalents at the end of the period amounted to KSEK 393 998 (50 360) ·       Net result for the quarter amounted to KSEK -11 462 (-8 794) ·       Cash equivalents at the end of the quarter amounted to KSEK 393 998 (50 360) ·       PledPharma completed a guaranteed rights issue of SEK 406 million in order to take         PledOx® into phase lll ·       Follow-up data indicates 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 Significant events after the end of the period ·       Gunilla Osswald and Elisabeth Svanberg were elected to the Board of Directors. Håkan         Åström and Sten Nilsson will remain on the board. In 2016 we decided to develop our main product, PledOx®, towards an application for market registration. This means that we will start pivotal clinical trials, i.e. phase III trials in patients with colorectal cancer during this year. The results from these studies will form the basis for a new drug application (NDA) to the Food and Drug Administration (“FDA”) in the US and for a marketing authorization application (MAA) to the European Medicines Agency (“EMA”) in Europe and as a base for discussions with potential partners. To finance the phase III studies up to top-line results we conducted a new rights issue during the fall. The results from the Phase IIb study PLIANT has been met with great interest by both clinicians and potential partners. The results were presented in June at the American Society of Clinical Oncology (ASCO), by the study's lead investigator Professor Bengt Glimelius. The follow-up data presented during the year confirms that PledOx® provides a clinically meaningful reduction of neuropathy compared with the placebo group. Long-term follow-up also showed that PledOx® has no apparent negative impact on the anti-cancer effect of the chemotherapy. During the year, we also had a constructive discussion with EMA regarding the continued clinical development of PledOx® where we received confirmation that the next development stage for PledOx® is Phase III.  Several potential partners have, however, expressed a wish for additional studies, with patient-reported neuropathy as the primary endpoint, before they are ready for further business discussions. PledPharma has therefore decided to move forward into clinical development by ourselves and thereby create added value in the company. Since last autumn, there are a series of ongoing activities in preparation for the start of the Phase III studies – that among other things include design of the studies, regulatory preparations and manufacturing. The previous studies with PledOx® were performed in patients with metastatic colorectal cancer but as we move into Phase III we will, in addition to metastatic colorectal cancer patients, also include patients treated adjuvantly for colorectal cancer. These patients have great potential to be cured from their cancer. PledOx® aims to prevent these patients from receiving chronic and debilitating chemotherapy induced nerve injury. In February this year Gunilla Osswald and Elisabeth Svanberg were elected as new board members to strengthen the expertise in phase III clinical development. Gunilla (PhD in Biopharmaceutics and Pharmacokinetics) has extensive experience in preclinical and clinical drug development, in big pharma and smaller biotech companies and is the CEO at BioArctic AB. Elisabeth (MD, PhD and associate professor of surgery) has extensive experience from leading positions at e.g. Bristol-Myers Squibb and Janssen Pharmaceuticals and is the Chief Development Officer at Ixaltis SA. In 2016, we furthermore worked on the preparations for the start of a proof of principle study with Aladote® - a drug candidate with the potential to prevent liver damage in connection with overdosing of paracetamol/acetaminophen. The study aims to identify the possibility to add Aladote® to the existing treatment for acetaminophen poisoning. In 2017, when PledPharma moves into Phase III with PledOx® and furthermore takes Aladote® into a proof of principle study, this means that PledPharma will have two potential first-in-class drugs in clinical development. We are confident that this will create significant value for our shareholders. For more information, please contact: 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® reduces nerve damage associated with chemotherapy. A phase IIb study has been conducted and will serve as the basis for the continued phase III 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 This information is information that PledPharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CET on February 24 2017


Methods for treatment of a pathological condition caused by oxidative stress in a patient comprise administering to the patient a mixed metal complex of a compound of Formula I, or a salt thereof, in an amount effective to reduce the oxidative stress. The mixed metals comprise calcium and manganese in a molar ratio of calcium to manganese in the range of 1-10: wherein X, R^(1), R^(2), R^(3), and R^(4 )are as defined herein.


Patent
PledPharma AB | Date: 2013-02-16

Pharmaceutical compositions comprise a first compound of Formula I or a physiologically acceptable salt thereof, and a cyto-protective amount of a manganese chelate of N,N-dipyridoxyl ethylenedianiine-N,N-diacetic acid (MnPLED): wherein R^(1), R^(2), R^(3), R^(4 )and X are defined in the specification.


A mixed metal complex of a compound of Formula I, or a salt thereof, wherein the mixed metals comprise a Group III-XII transition metal and a Group II metal: (Formula I) (I) wherein X, R^(1), R^(2), R^(3), and R^(4 )are as defined herein, is produced in a one step crystallization from a solution of the Group III-XII transition metal, the Group II metal, and a compound of Formula I. Methods for treatment of a pathological condition in a patient, for example, a pathological condition caused by the presence of oxygen-derived free radicals, comprises administering the mixed metal complex to the patient.


Patent
Pledpharma Ab | Date: 2013-10-31

Methods for treatment of cancer selected from lung cancer, ovarian cancer, squamous cell carcinoma, pancreas exocrine cancer, malignant melanoma, gastric cancer, esophageal cancer, a metastases thereof, and leukemia, in a human or non-human body, comprise administrating to the body a cancer-inhibiting amount of a first compound of Formula (I): or a physiologically acceptable salt thereof, wherein X, R^(1), R^(2), R^(3 )and R^(4 )are as defined herein.

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