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Clinical Trials

Date: 2012-07-09

Type of information:

phase: preclinical

Announcement: publication in the July edition of Nature Medicine of preclinical results on treatment of radiation injury
(Pharmacological targeting of the thrombomodulin–activated protein C pathway mitigates radiation toxicity. Hartmut Geiger et al. Nature Medicine 18, 1123–1129 (2012) doi:10.1038/nm.2813)

Company: Paion (Germany)

Product: solulin

Action mechanism: Solulin is an improved variant of the human protein thrombomodulin, an important natural regulator of the clotting system. One of the functions of thrombomodulin is to stabilize the initial fibrin clot to stop bleeding. Other than native thrombomodulin which is anchored in the wall of blood vessels, solulin can enter the blood stream to reach its potential site of action. In low concentrations solulin is able to stabilise blood clots and to support coagulation.

Disease: treatment and prevention of radiation injury

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news: Paion has announced that Nature Medicine has published results of preclinical studies on treatment of radiation injury, in which also PAION\'s product, Solulin, has been successfully put to use. In this multi-site project, investigators of eight universities and research institutions in the United States and Germany, including Paion Deutschland GmbH, have joined forces.
The results show that protection of the cells engaged in blood production against otherwise lethal levels of radiation can be achieved by using certain proteins endogenous to the body. In mice, who had received whole body radiation at lethal levels, such treatment effected a substantial acceleration of recovery of blood progenitor cells in the bone marrow. This also explains an impressive improvement of survival rates, even when treatment was given later than radiation. According to the scientists, these results open new avenues towards treatment of toxic effects of radiation, as may be encountered in cancer treatment or after accidents in nuclear power plants.
\'Our study identifies a target-specific intervention that protects the hematopoietic system against radiation toxicity, which largely is an unmet challenge,\' the scientists explained. \'Current treatments for radiation injury, such as blood transfusions or certain growth factors, do not meet this requirement.\'
Protection was achieved using the proteins thrombomodulin and activated protein C, which are endogenous to the body and known to be involved in a number of regulatory actions in a sequential way. Here they proved to provide important signals in production and function of blood forming cells. The form of thrombomodulin used in these studies was solulin, a recombinant protein, which is being developed by Paion for treatment of haemophilia and is currently being tested in a Phase Ib study (See http://biopharmanalyses.fr/clinical-trails/?pageid=337). Solulin possesses improved resistance against loss of potency by radiation versus the naturally occurring thrombomodulin. This also opens the option of a prophylactic treatment, for example in cancer therapy.
To Paion, the publication in Nature Medicine means an important scientific recognition and encouragement to further develop solulin for treatment of radiation injury. To move the clinical development of solulin in this important field forward, the company is seeking further financial support after completion of the on-going clinical study in haemophilia.

Is general: Yes