Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
Become a Member | Sign in
Home>News>This Article

Dilaforette Presents Results from Exploratory Phase I/II Clinical Trial in Uncomplicated Malaria

Published: Saturday, May 31, 2014
Last Updated: Saturday, May 31, 2014
Bookmark and Share
Aim of the trial was to study sevuparin in adult patients with uncomplicated falciparum malaria.

Dilaforette AB has announced the results from an exploratory Phase I/II clinical trial in malaria with its candidate drug sevuparin. Sevuparin was studied in adult patients with uncomplicated falciparum malaria as adjunct treatment and was found to be safe and well tolerated.

The study results indicates important early anti-adhesive effects with a potential to improve the outcome for patients with severe malaria, even though the primary efficacy endpoint was not met. Karolinska Development owns 69 percent of Dilaforette.

The study was conducted by Dilaforette in close collaboration with The Mahidol Oxford Tropical Medicine Research Unit (MORU), at the Mae Sot and Mae Ramat Hospitals in Thailand.

“The effect seen in this study is promising and warrants quick assessment whether sevuparin should be added to the treatment regime in severe malaria”, says Professor Arjen Dondorp, Coordinating Principal Investigator, Department Head and Deputy Director of the MORU.

Sevuparin is a potential novel adjunctive treatment for severe malaria pre-clinically developed in the laboratory of Professor Mats Wahlgren, one of the co-founders of Dilaforette, at Karolinska Institutet. The aim of the present trial was to study sevuparin in adult patients with uncomplicated falciparum malaria prior to studies in patients with severe malaria.

The trial was divided into two parts, the objective of the first part was to assess safety and tolerability of sevuparin. The objective of the second part was, in addition to safety, to measure reversal of sequestration of mature parasitized red blood cells in the smallest blood vessels.

In the second part of the trial, which was open labeled, the patients were randomized into two groups; one group received standard-of-care (SoC), atovaquone/proguanil, and the other group received a combination of SoC and sevuparin.

Due to slow recruitment and in order to progress the program into severe malaria, it was decided to prematurely terminate the study when a total of 53 of the planned 89 patients had been treated. Among the 53 patients that were treated, 23 patients received SoC and 30 patients received SoC plus sevuparin. The study results showed that sevuparin is safe and well-tolerated in adult patients with uncomplicated falciparum malaria.

The study did not reach statistical significance on its primary efficacy endpoint, i.e. an increase in appearance of mature parasitized red blood cells into the blood circulation over the first 11 hours after start of sevuparin treatment. However, due to the premature termination of the trial, the results do not suffice as the basis for conclusive determination of the effect of sevuparin.

Furthermore, exploratory analyses indicates a higher number of mature parasites in the circulating blood already one hour after the first dose of sevuparin. This observation is consistent with the intended effect of sevuparin, which is to reverse blockage of blood vessels by mature parasitized red blood cells which normally stick to the vessel wall and obstruct the blood flow.

In addition, the number of young parasitized cells consistently decreased over the early time period after the initial sevuparin injection which is in line with the assumed capacity of sevuparin to block parasite invasion into red blood cells. As patients with uncomplicated malaria have a much lower parasite load than patients with severe disease, the exploratory analysis supports further clinical studies in severe malaria with the aim to show that sevuparin can reverse the binding, which should improve blood flow and clinical outcome.

“Based on these findings, we intend to approach relevant stakeholders in the malaria community with the aim to progress the program into the intended patient group, patients with severe malaria”, says Christina Herder, CEO, Dilaforette.

“These data with sevuparin indicates its potential to improve microvascular blood flow and thereby address unmet medical needs for several diseases including severe malaria and sickle cell disease”, says Torbjörn Bjerke, CEO, Karolinska Development.

The Indian part of the clinical development program will due to unforeseen changes in local legislation not continue.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Dilaforette Receives Positive COMP Opinion
Positive opinion on orphan drug designation in the EU for sevuparin in sickle-cell disease.
Thursday, January 22, 2015
Dilaforette is Granted SEK 2.85m from Vinnova
Development of sevuparin for the treatment of severe malaria.
Tuesday, November 06, 2012
Scientific News
Promising Drug Combination for Advanced Prostate Cancer
A new drug combination may be effective in treating men with metastatic prostate cancer. Preliminary results of this new approach are encouraging and have led to an ongoing international study being conducted in 196 hospitals worldwide.
Lucentis Effective for Proliferative Diabetic Retinopathy
NIH-funded clinical trial marks first major advance in therapy in 40 years.
Blocking the Transmission Of Malaria Parasites
Vaccine candidate administered for the first time in humans in a phase I clinical trial led by Oxford University’s Jenner Institute, with partners Imaxio and GSK.
First Therapy Appearing to Reverse Decline in Parkinson’s
An FDA-approved drug for leukemia improved cognition, motor skills and non-motor function in patients with Parkinson’s disease and Lewy body dementia in a small clinical trial, say researchers at Georgetown University Medical Center (GUMC).
Gene Therapy Staves Off Blindness from Retinitis Pigmentosa in Canine Model
NIH-funded study suggests therapeutic window may extend to later-stage disease.
Treatment for Rare Bleeding Disorder is Effective
Researchers in Manchester have demonstrated for the first time the relative safety and effectiveness of treatment, eltrombopag, in children with persistent or chronic immune thrombocytopenia (ITP), as part of an international duo of studies.
HIV Vaccine Human Trials Begin
Baltimore-based Institute has begun enrolling volunteers for initial phase 1 clinical trials.
New Therapy Reduces Symptoms of Inherited Enzyme Deficiency
A phase three clinical trial of a new enzyme replacement medication, sebelipase alfa, showed a reduction in multiple disease-related symptoms in children and adults with lysosomal acid lipase deficiency, an inherited enzyme deficiency that can result in scarring of the liver and high cholesterol.
Fixing Holes in the Heart Without Invasive Surgery
UV-light enabled catheter is a medical device which represents a major shift in how cardiac defects are repaired.
Atriva Therapeutics GmbH Develops Innovative Flu Drug
Highly effective against seasonal and pandemic influenza.
Scroll Up
Scroll Down

SELECTBIO Market Reports
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos