A1M Pharma initiates its clinical program - enters into collaboration to study harmful effects during PRRT radiation therapy

A1M Pharma has initiated a collaboration with Antaros Medical to conduct a study in humans undergoing radiation therapy (Peptide Receptor Radionuclide Therapy, PRRT) of neuroendocrine tumours. The purpose of the study is to examine - using magnetic resonance imaging (MRI) and positron emission tomography (PET) - the harmful effects that the radiation in PRRT has on the kidneys and the bone marrow. Data from the study will form the basis of the company's upcoming clinical studies.

- With this study, we are now initiating our clinical program which is an important step forward. The study will provide us with valuable data, which will enable us to design our upcoming clinical phase I/II study in the best way possible. We continue to prepare for the clinical study according to plan, says A1M Pharma's Head of Development, Eddie Thordarson.

The study will be conducted at the Uppsala University Hospital, on patients that are treated with the targeted radiation therapy PRRT. The radiation therapy puts a strain on the patient's kidneys, with the risk of kidney injuries at a later stage. Today, kidney injuries and bone marrow injuries are the limiting factors of the maximum radiation dose that can be used during the radiation treatment, as well as the frequency of the treatments. On several occasions during the study, the patients will be examined with a magnetic resonance (MRI) and PET scanner for quick detection of changes in the organs occurring during the radiation therapy.

- PRRT causes kidney injuries, but the effects are usually not detectable right away and can stay hidden until later. If we can detect these harmful effects early on, using advanced imaging techniques, we will be able to predict the future more accurately. Our goal is to detect the harmful effects at an early stage, so that we can see the effects of our drug candidate ROSgard™ as early as possible in phase I/II, says Eddie Thordarson.

The study is scheduled to start during the first quarter of 2018, and it is expected to be completed in last quarter of 2019. A1M Pharma will receive frequent updates during the course of the study.

About Antaros Medical
Antaros Medical is a clinical research company, focusing on developing innovative techniques and tailor-made studies within imaging. The aim is to study pharmaceutical effects on different organ systems in the human body, and the company specializes in cardiometabolic diseases (including NAFLD/NASH and chronic kidney disease) and oncology, which will enable improved evidence based decision making in clinical drug development. The company has a global network of partners and clients, including large and small pharmaceutical companies, and is also a partner in several European research centers, such as Innovative Medicine Initiative (IMI) and European Cooperation in Science and Technology (COST). More information is available at: www.antarosmedical.com

For more information, please contact johannes.hulthe@antarosmedical.com

2018-01-05

For more information, please contact
Tomas Eriksson, CEO
Telephone: +46 46-286 50 30
Email: te@a1m.se

This information is information that A1M Pharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was provided, through the above contact, for publication on the 5 January 2018 at 08.10

About A1M Pharma Several preclinical studies indicate that A1M Pharma's candidate drug, ROSgard™, based on the endogenous protein Alpha- 1-Microglobulin, restores impairments to kidney function by repairing damaged tissue and protecting against oxidative stress. Kidney injury is a condition which often occurs in connection with preeclampsia and which often limits the possibilities of using radiation therapies as a treatment for cancer. The company's two indications are kidney protection in connection with Peptide Receptor Radionuclide Therapy (PRRT) - a targeted radiation therapy for cancer - with the aim of opening the possibility of increasing treatment levels and so fight metastatic cancer more effectively as well as treatment of preeclampsia. Every year, over 12 million people are affected by acute kidney injuries that can lead to permanent kidney damage. Preeclampsia affects around 10 million pregnant women worldwide and is responsible for 76,000 maternal and 500,000 infant deaths each year. A1M Pharma is listed on Nasdaq First North Stockholm since 20 June 2017. A1M Pharma's Certified Adviser at Nasdaq First North is Erik Penser Bank AB, +46 8-463 80 00.

A1M Pharmas forskningsresultat för ROSgard uppmärksammas på världens största kongress inom njurmedicin

A1M Pharma meddelar idag att American Society of Nephrology (ASN) har valt ut prekliniska studier av läkemedelskandidaten ROSgard™ för presentation vid organisationens internationella kongress Kidney Week i Washington DC den 5 - 10 november 2019.


A1M Pharma erhåller besked om kommande godkännande av patent i USA

A1M Pharma har erhållit besked om ett kommande godkännande av bolagets patentansökan för "Medicinsk användning av A1M" från det amerikanska patentverket, USPTO. 


A1M Pharma utser ny Chief Financial Officer

A1M Pharma meddelar idag att Torun Labedzki rekryterats till positionen som Chief Financial Officer. Hon tillträder tjänsten den 1 augusti 2019.


A1M Pharma genomför riktad nyemission om cirka 27,2 mkr för att finansiera utökade kliniska studier

Styrelsen för A1M Pharma AB (publ) ("A1M Pharma" eller "Bolaget") har, med stöd av emissionsbemyndigandet från årsstämman den 29 maj 2019, beslutat att genomföra en riktad nyemission om cirka 27,2 mkr. A1M Pharma har nyligen initierat en fas 1-studie i friska försökspersoner av läkemedelskandidaten ROSgard™ - en potentiell ny behandling av akuta njurskador. Likviden från nyemissionen avses att användas för förberedelse och genomförande av en efterföljande fas 1b-studie i patienter som riskerar att drabbas av njurskador i samband med hjärtkirurgiska ingrepp.


A1M Pharmas CFO lämnar sin position

A1M Pharma meddelar idag att Gunnar Telhammar lämnar sin position som bolagets Chief Financial Officer.


Kommuniké från årsstämma 29 maj 2019 i A1M Pharma AB

Idag, den 29 maj 2019, hölls årsstämma i A1M Pharma AB. Nedan följer en sammanfattning av de beslut som fattades. Samtliga beslut fattades med erforderlig majoritet.


A1M Pharmas styrelseordförande avböjer omval

A1M Pharma meddelar idag att bolagets styrelseordförande Anders Ermén har beslutat sig för att av personliga skäl inte ställa upp till omval vid den ordinarie bolagsstämman.


Delårsrapport 2019-01-01 till 2019-03-31

Sammanfattning av delårsrapport

Första kvartalet (2019-01-01 - 2019-03-31)

  • Intäkterna uppgick till 0 KSEK (0).
  • Resultatet efter finansiella poster uppgick till -13 944 KSEK (-15 106).
  • Resultatet per aktie* uppgick till -0,13 SEK (-1,82).
  • Soliditeten** uppgick per den 31 mars 2019 till 69 (51) %.

Belopp inom parentes: Jämförande period föregående år.
* Resultat per aktie: Periodens resultat dividerat med 103 734 196 utestående aktier per den 31 mars 2019 (8 297 440).
** Soliditet: Eget kapital dividerat med totalt kapital.


A1M Pharma förstärker organisationen inför den fortsatta kliniska utvecklingen av läkemedelskandidaten ROSgard

A1M Pharma meddelar idag att bolaget förstärkt sin organisation inför den fortsatta kliniska utvecklingen av läkemedelskandidaten ROSgard™. Magnus Gram har utsetts till Chief Scientific Officer, Ronny Renfurm har anlitats som ansvarig för klinisk utveckling, Fredrik Lehmann som CMC-rådgivare och Elisabeth Augustsson som regulatorisk rådgivare. Vidare meddelas att Gunnar Telhammar efterträder Fredrik Werner som Chief Financial Officer.



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