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Feb
17
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Dilaforette, AGU ink pact for phase 2 proof of concept trial of sevuparin for sickle cell disease
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Stockholm, Manama
Wednesday, February 17, 2016, 10:00 Hrs  [IST]

Dilaforette AB, a Karolinska Development portfolio company focused on innovative treatments for patients with sickle-cell disease, and Arabian Gulf University (AGU), based in Bahrain, 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.”

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 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.

 Courtesy – Pharmabiz


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