Dilaforette has announced that the company has approval from the regulatory authority in India to start a Phase II study with sevuparin in patients with moderate to severe malaria.
Dilaforette and its collaborator, The Mahidol Oxford Tropical Medicine Research Unit (MORU), plan to enroll 50 patients in India, where severe malaria remains an important problem.
The primary objective of the study is to evaluate safety along with several efficacy parameters. The study design has been discussed at a pre-IND meeting with the US Food and Drug Administration (FDA).
The first study site is open for enrollment and the first patients are expected in connection with the coming rain season. A separate clinical trial in uncomplicated falciparum malaria is already on-going in Thailand since 2011.
"The initiation of the Phase II trial at the ISPAT General Hospital in Rourkela in India constitutes a major step in the development of sevuparin for severe malaria. We are proud of the continued support we are receiving from world leading expertise in the field of malaria", says Pirkko Sulila Tamsen, CEO, Dilaforette.
"I have continued high expectations on sevuparin which interferes with a pivotal culprit in malaria pathophysiology; blockage of the smallest blood vessels in vital organs. It can potentially help to reduce mortality in cases of severe malaria where antimalarial treatment alone is not sufficient", says Prof Arjen Dondorp, Coordinating Principal Investigator, Department Head and Deputy Director of the MORU.
There are about 10 million severe falciparum malaria cases every year resulting in close to one million deaths, mostly children, despite optimal antimalarial treatment.
Sevuparin is a potential new adjunctive treatment of severe malaria that acts by preventing and reversing the infected cells' ability to block blood vessels.
"We have high hopes that sevuparin will make a difference in the treatment of severe malaria. We also appreciate that Dilaforette has access to world leading clinical expertise”, says Torbjörn Bjerke, CEO, Karolinska Development.