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

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 2,400+ scientific posters on ePosters
  • More than 3,700+ 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 TechnologyNetworks.com 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
Liquid Biopsies: Utilization of Circulating Biomarkers for Minimally Invasive Diagnostics Development
Market Trends in Biofluid-based Liquid Biopsies: Deploying Circulating Biomarkers in the Clinic. Enal Razvi, Ph.D., Managing Director, Select Biosciences, Inc.
Study Questions Presence in Blood of Heart-Healthy Molecules from Fish Oil Supplements
A new study from the Perelman School of Medicine at the University of Pennsylvania questions the relevance of fish oil-derived SPMs and their purported anti-inflammatory effects in humans.
Experimental MERS Vaccine Shows Promise in Animal Studies
A two-step regimen of experimental vaccines against Middle East respiratory syndrome (MERS) prompted immune responses in mice and rhesus macaques, report National Institutes of Health scientists who designed the vaccines.
Young South African Women can Adhere to Daily PrEP Regimen as HIV Prevention
NIH-funded study finds men in Bangkok, Harlem also successful in taking daily dose.
Key Player in Diabetic Kidney Disease Revealed
Discovery could lead to new and better diagnostic marker for chronic kidney disease.
Immunotherapy Shows Promise for Myeloma
A strategy, which uses patients’ own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable.
Santhera Announces First Patient Dosing with Omigapil in CMD
Company announces full patient recruitment of CALLISTO study.
Study Shows Promise of Precision Medicine for Most Common Type of Lymphoma
The study appeared online July 20, 2015, in Nature Medicine.
HIV Control Through Treatment Durably Prevents Heterosexual Transmission of Virus
NIH-funded trial proves suppressive antiretroviral therapy for HIV-infected people effective in protecting uninfected partners.
Adaptimmune's Novel Cancer Therapeutics Show Positive Clinical Trial Results
The company has announced that positive data from its Phase I/II study of its affinity enhanced T-cell receptor (TCR) therapeutic targeting the NY-ESO-1 cancer antigen in patients with multiple myeloma has been published.
Scroll Up
Scroll Down
SELECTBIO

Skyscraper Banner
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
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!