Tag: Christian Wandersee

Company News: vasopharm Reports Endorsement of Phase III Trial Design in Traumatic Brain Injury by European Medicines Agency

– Company receives protocol assistance from the EMA

– Agreement on endpoint, dosing scheme, trial size and use of Phase II dataset

vasopharm GmbH, a privately held biopharmaceutical company focusing on novel therapeutics for the treatment of cerebro- and cardiovascular diseases, today announced the positive outcome of a scientific advice meeting with the European Medicines Agency (EMA). The EMA’s Committee for Medicinal Products for Human Use (CHMP) has agreed to all major items of vasopharm’s proposed protocol for the realisation of a European Phase III study of VAS203 in patients suffering from traumatic brain injury (TBI).

In essence, the CHMP agreed on the primary endpoint, the proposed dosing scheme and the trial size. For the final evaluation, the CHMP further agreed to include the available Phase II dataset as supportive information for a potential approval of VA203 in the treatment of TBI patients. VAS203, the company’s lead compound, is an allosteric nitric oxide synthase inhibitor and in development for the treatment of TBI patients. The compound met all clinical endpoints for safety and demonstrated strong evidence of clinical benefit in the explorative Phase IIa NOSTRA trial in TBI patients. The trial was completed in 2012.

The company is also seeking advice from the U.S. Food and Drug Administration (FDA) in order to include U.S.-based clinic trial centres in a single Phase III trial in patients with TBI.

Company News: vasopharm Closes Series F Financing Round

– Company receives additional €5 million for preparation of Phase III study –

vasopharm GmbH, a privately held biopharmaceutical company focusing on novel therapeutics for the treatment of cerebro- and cardiovascular diseases, today announced the successful completion of a Series F financing round totalling €5 million (~ US$6.5 million). The round was led by existing investors HeidelbergCapital Private Equity and Entrepreneurs Fund (EF Investments S.à.r.l.). Bayern Kapital, another existing investor, also participated in the Series F round. The consortium was joined by new investors Hanseatic Asset Management LBG and Dr Andrew Clark, Chairman of the Board of vasopharm. The new consortium also acquired the shares of one of the founding investors seeking to exit.

The proceeds of this round will be used primarily for the preparation of a Phase III clinical study of the company’s lead compound VAS203, an allosteric nitric oxide synthase inhibitor under development for the treatment of traumatic brain injury (TBI). The compound has met all clinical endpoints for safety and demonstrated strong evidence of clinical benefit in the Phase IIa European NOSTRA trial completed in 2012. Detailed results of the trial will be published soon in a peer-reviewed journal.