The Principal Investigator (PI) for this study will be Dr Peter Dewland BSc, MA, MBBS, FFPM, DCPSA. Dr Peter Dewland has had a career in Early Phase research which spans 40 years. During this time he has been Medical Director of several Phase 1 Organisations as well as Head of Clinical Pharmacology in major Pharma. During his 40 years he has been Principal Investigator on over 200 first-in-man studies and over 1000 studies in total including studies in a number of erectile dysfunction drugs. Dr Dewland will be ably assisted on the study by his current team of medical sub-investigators.
“We are confident with the selection of MAC Clinical Research Unit as our collaborator for the upcoming clinical development of IPED2015. It is a very well proven and highly capable Clinical trial CRO that will play an important role in the transformation of Initiator Pharma into a clinical stage company. Furthermore, we are extremely pleased having the experienced Dr. Peter Dewland as PI and his clinical and operational team onboard and look forward to initiate the first clinical trials.” says Claus Elsborg Olesen, CEO of Initiator Pharma.
Initiator Pharma filed its Clinical Trial Application (CTA) for IPED2015 to Medicines & Healthcare products Regulatory Agency, MHRA, UK and anticipates to obtain an approval to initiate the first clinical trial during the late summer of 2018.
For additional information about Initiator Pharma, please contact:
Claus Elsborg Olesen, CEO
Telephone: +45 6126 0035 E-mail: email@example.com
This information is information that Initiator Pharma A/S is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on June 4th, 2018.
About Initiator Pharma
Initiator Pharma is a Biotech company established in Aarhus, Denmark. Its main asset IPED2015 represents a novel treatment paradigm for patient suffering from Erectile Dysfunction (ED) and will improve the quality of life for the growing number for patients (and their partners) that do not respond to the current market PDE5i medications like Viagra, Cialis and Levitra. Initiator Pharma is listed on AktieTorget, Sweden and has about 3400 shareholders. The company’s share is traded under the ticker INIT. Learn more at initiatorpharma.com
About Erectile dysfunction
Erectile dysfunction is characterized by the inability to develop or maintain an erection of the penis during sexual activity. ED affects more than 150 million men worldwide and that number is expected to increase to more than 320 million by 2025, fueled by aging demographics and increasing prevalence of life style diseases such as diabetes. The large diabetic ED patient segment is often responding poorly to the current medication and is therefore of particular interest for Initiator Pharma. ED patients have decreased quality of life due to various psychosocial factors such as low self-esteem, depression, sadness, anger, frustration, anxiety, relationship problems etc. (Althof, 2002; Shabsigh et al., 1998, Tsai, 2008; Litwin et al., 1998).