berlin pharma announcement

Basically a rehash of the Eastland announcement, but nevertheless it may garner some more interest in the trial

http://www.ad-hoc-news.de/dgap-news-hc-berlin-pharma-ag-clinical-field-trial-of--/de/Unternehmensnachrichten/20713908


HC Berlin Pharma AG / Miscellaneous
17.11.2009

Dissemination of a Corporate News, transmitted by DGAP - a company of EquityStory AG. The issuer / publisher is solely responsible for the content of this announcement.


Berlin, November 17, 2009 - HC Berlin Pharma AG, listed on the Open Market of the Frankfurt Stock Exchange, announces today, that the ethics committee of the Kigali University Teaching Hospital in Rwanda has approved the clinical field trial of the anti-malaria treatment ArTiMistTM in children. The primary objective of this trial is to establish the efficacy of ArTiMistTM - when compared to intravenous quinine - in children with severe or complicated malaria, or uncomplicated malaria with gastrointestinal complications. The open label trial will commence later this month at sites that had been audited earlier this year and will enrol children from a number of satellite clinics for referral to the clinical trial site in Rwanda.

Approval for the trial follows meetings earlier this year with the medical and governmental authorities in Kigali Rwanda by Mr. Calvin Ross, R&D Director of ProtoPharma Ltd., and OnQ Consulting, a South African based Clinical Research Organisation, during which the trial design and endpoints were confirmed. The trial is being conducted under the International Conference on Harmonisation (ICH) Guidelines for technical requirements for registration of pharmaceuticals for human use and has been designed to support the registration of the product.

A marketing application to the host country and a WHO pre-qualification programme for essential medicines are scheduled for the second quarter 2010.

Executive Board and Supervisory Board are very proud of this significant advancement of the clinical programme with ArTiMistTM. 'ArTiMistTM has the potential to make a real difference to the lives of those children who suffer from malaria', explains Ottfried W. Geiger, CEO of HC Berlin Pharma AG.

Malaria is one of the most prevalent infectious diseases in tropical and subtropical regions of the world and remains a major global health problem with almost 40 % of the world's population exposed to Malaria transmission. Each year malaria costs Africa approx. USD12bn in lost Gross Domestic Product (GDP).

More information concerning HC Berlin Pharma AG can be found at www.hcberlinpharma.ag.

For more detailed information please directly contact our Investor Relations Team:

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