Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Advertising

Press Release

Vasopharm GmbH Provides Update on Phase III Traumatic Brain Injury Trial 50% of patients enrolled in trial triggers interim data review

Vasopharm
Posted on: 15 Mar 18

Würzburg, Germany – March 15, 2018: Vasopharm GmbH, a privately held biopharmaceutical company, today announced that it has recruited half of the 220 patients in the ongoing, pivotal European NOSTRA III (NO Synthase in TRAumatic Brain Injury) clinical trial. This milestone triggers an interim review by the Data Monitoring Committee (DMC) in line with the agreed study protocol. Allowing for the six month extended Glasgow Outcome Scale (eGOS) evaluation for the 110th eligible patient recruited, the company expect feedback from the DMC in Q4 2018.

 

NOSTRA III is designed to assess the efficacy and safety of Ronopterin (VAS203) for the treatment of moderately to severely injured closed head traumatic brain (TBI) injury patients, for which there is no existing drug treatment. Traumatic Brain Injury is the leading cause of death and disability among young adults in the developed world. Annually, within the US alone, head trauma is the cause of about two million emergency room visits, roughly 475,000 hospital admissions, nearly 52,000 deaths and approximately 80,000 cases of severe long-term disability (e.g. functional and cognitive disorders, learning disabilities). Direct costs attributed to the treatment of TBI exceed $10bn p.a. in the US alone.

 

NOSTRA III is a randomised, double-blind, placebo-controlled trial. The study will enroll 220 patients who have suffered a moderate to severe TBI resulting in hospitalisation and who have received an intra-cranial pressure probe. Currently, 35 European neuro-trauma centres in Germany, Austria, France, UK and Spain are participating. The primary endpoint is the eGOS evaluated at six months after the injury. Secondary efficacy assessments include Quality of Life (QOLIBRI) as well as Therapy Intensity Level (TIL) over 14 days after brain injury. NOSTRA III is a registration trial which seeks to validate the data from the highly significant NOSTRA II trial.* The study aims to confirm the data from a Phase II trial in which VAS203 has shown a (2 point) improvement in the extended Glasgow Outcomes Score.

 

Christian Wandersee, Chief Executive Officer of Vasopharm, commented: “We are delighted to have reached such a significant milestone in the development of Ronopterin for the treatment for moderate to severe TBI. If NOSTRA III confirms the highly significant data seen in our NOSTRA II trial, we believe we can offer patients and physicians a therapeutic option to ameliorate the devastating and life-long consequences of TBI, where no such option currently exists.”

 

In addition, Vasopharm announces the successful completion of a Phase Ic trial characterising Ronopterin´s pharmacology in the kidney. This study was conducted in support of the ongoing (NOSTRA III) trial in moderate to severe TBI. Ronopterin is a selective iNOS inhibitor and the kidney is the only organ in which this enzyme plays a constitutive role. The kidney is therefore the most sensitive barometer of undesirable side effects of the drug. The study enrolled 16 healthy male volunteers in a single centre, double-blind, randomised, placebo controlled, cross-over study. Ronopterin was infused over 6 hours with a 4-fold higher infusion rate than that being used in the on-going NOSTRA III trial. There were no drug related adverse events and the safety profile of Ronopterin as examined in this study was excellent. These data indicated no clinically relevant systemic effects following treatment with Ronopterin, in particular tubular function was not affected.

 

Ronopterin is administered by venous infusion over 48 hours post trauma. Prior to commencing clinical studies the company undertook an extensive formulation program which resulted in a drug formulation that is a highly stable lyophilised powder, easily re-constituted to an isotonic, pH neutral solution for infusion. The company is pleased to announce the granting of worldwide patent protection for several key steps in the synthesis and formulation of Ronopterin.

 

*Journal of Neurotrauma 31:1599-1606 (October1 2014).

 

 

 

       For further information, please contact:

 

Vasopharm GmbH

Christian Wandersee, CEO

Tel: +49-931-359099-0

Email: wandersee@vasopharm.com

 

Optimum Strategic Communications

Mary Clark, Eva Haas, Hollie Vile

Tel: +44 (0) 203 174 1789

Email: healthcare@optimumcomms.com

 

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 15/03/2018

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.