Dilaforette Signs Collaboration Agreement With Arabian Gulf University (Bahrain) for Phase 2 Clinical Development of sevuparin for Sickle Cell Disease

STOCKHOLM and MANAMA, Bahrain, February 16, 2016 /PRNewswire/ --

 

Dilaforette AB, a Karolinska Development (KDEV.ST) portfolio company focused on innovative treatments for patients with sickle-cell disease, and Arabian Gulf University (AGU), based in Bahrain, today announced that they have signed a Clinical Collaboration agreement for the Phase 2 proof of concept trial of sevuparin in patients with Sickle Cell Disease (SCD) experiencing acute Vaso-Occlusive Crisis (VOC). 

Under the scope of the agreement, Dilaforette and AGU's collaboration will facilitate the development of Dilaforette's lead candidate, sevuparin, for patients with SCD. AGU will provide up to $1.2 million in non-dilutive funding for the study and assist with patient recruitment. This project will contribute to enhancing AGU's capabilities in clinical research  through training and engagement in phase 2 clinical trial. In return AGU will receive royalties on future product revenues which are capped at twice the financial support it provides to the Phase 2 proof of concept study.

The Phase 2 proof of concept sevuparin study is currently enrolling patients at several clinical sites in the Middle East, including Bahrain, where AGU is located.

Sevuparin is a novel polysaccharide drug candidate developed to treat vaso-occlusive crises (VOC) in SCD by normalizing the reduced blood flow. Dilaforette has signed a co-development partnership with Ergomed to develop sevuparin, and in October 2015, they announced the start of recruitment into a multi-centre, international, randomised Phase 2 study performed in Europe and the Middle East. Results from this Phase 2 proof of concept trial with sevuparin are expected in the second half of 2016.

Commenting on the announcement, Dr Khalid bin Abdul Rahman Al-Ohaly, President of the Arabian Gulf University said: "Our collaboration with Dilaforette is a landmark moment for both parties, in a deal which is a positive step forward in the fight for treatment for this widespread genetic disorder, which affects around 250,000 - 350,000 patients in the Gulf Co-operation Council (GCC) area alone. The collaboration also endorses AGU's position as an internationally recognized player in clinical research within the area of SCD."

 

Christina Herder, CEO of Dilaforette, added: "We are very pleased to collaborate with Arabian Gulf University on this important proof of concept Phase 2 study as we continue to develop sevuparin, which we firmly believe has the potential to improve the quality of life for millions of SCD sufferers around the globe."

About Dilaforette AB

Dilaforette is a Swedish biotech company developing sevuparin - a new drug to treat people suffering from Sickle Cell Disease - a painful, inherited blood disorder affecting millions of people around the globe. Sickle Cell Disease patients' blood cells form a sickled shape, which makes blood flow to vital organs difficult, causing severe pain and even premature death. Sevuparin has the potential to improve the SCD patients' blood flow reducing their pain for patients and the amount of time they will need to spend in hospital. Dilaforette plans to develop a formulation of sevuparin that the patient can self-administer allowing them to live a more normal life by preventing the painful episodes that result in them being hospitalised.

Dilaforette is predominantly owned by KDev Investments AB, part of Karolinska Development AB (Nasdaq Stockholm: KDEV) and Rosetta Capital. Other larger owners are The Foundation for Baltic and European Studies (Östersjöstiftelsen) and Praktikerinvest AB. For more information, please visit http://www.dilaforette.se

About Sevuparin

Sevuparin is an innovative, proprietary polysaccharide drug, which has the potential to restore blood flow and prevent further microvascular obstructions, caused by abnormal blood cells in SCD patients. With its anti-adhesive properties, sevuparin could thereby offer treatment of the underlying cause of vaso-occlusive crisis (VOC) in SCD patients, with earlier pain relief, shorter hospital stay, reduced need of opioids and improved quality of life. Dilaforette is currently enrolling patients in a Phase II study with the aim to present data during second half of 2016.

About Arabian Gulf University

The Arabian Gulf University is a regional, public, higher education institution established in 1980 by the six Arab countries of the Gulf Cooperation Council (GCC). The University was established to offer programs that complement those offered by the national universities of member states and to address strategic needs of the region. The university at present has two colleges, the College of Medicine and Medical Sciences, which offers a Problem-based learning  MD program, in addition to several Master and PhD programs in medical sciences, and the College of Graduate Studies, which offers ten programs at the Master and PhD levels, in two main domains, special education, and technology. In addition, the university has the French Arabian Business School (FABS) that currently offers an 18-month MBA program in cooperation with the leading European business school, ESSEC.