Company News: Micromet Initiates Pivotal Study of Lead Compound Blinatumomab

Micromet Inc (NASDAQ:MITI), a biotech company located in the US and in Germany, today announced the start of two Phase II trials of Blinatumomab, a so-called BiTE antibody which is designed to recruit T killer cells of the patient’s body to the cancer cells.

The so-called BLAST study (Blinatumomab Adult ALL MRD Study of T cell engagement) is designed to evaluate the efficacy, safety and tolerability of blinatumomab in up to 130 adult patients suffering from B-precursor acute lymphoblastic leukemia (ALL) who received chemotherapy but still have leukemia cells in the bone marrow (so-called minimal residual disease – MRD). About 70 centers in Europe and the US will take part in the study which will take about 2 years to complete. Primary endpoint is MRD response, i.e. disappearance of leukemia cells in the bone marrow.

If successful, the study could  serve as the basis for filing for approval.

A further Phase II study initiated today is designed to evaluate the efficacy, safety and tolerability of blinatumomab in 20 adult patients suffering from B-precursor acute lymphoblastic leukemia (ALL) who are resistant or intolerant to standard chemotherapy.

Details can be found in the press releases describing the BLAST trial and the refractory ALL trial.

Food for Thought: BioCentury goes TV; Mike Ward leaves

Mike Ward, long-time European Editor of BioCentury, has left the trade publication to take up a new position at Scrip, where he will head a small team that will focus on European companies, funds and regulatory issues. At present, there is no successor at BioCentury.

While the closing of the Oxford office is likely to weaken the position of BioCentury in Europe, the publication will start a policy talk show on Washington’s WUSA channel. The “BioCentury This Week” show will air every Sunday from 8:30-9:00am on Channel 9 in the Washington, DC, area and on Channel 25 Fox Boston. It will be hosted by Eric Pierce, Publisher and Steve Usdin, Senior Editor. The focus is on key issues affecting the science, business and social impact of biotechnology and in particular will feature the perspective of biotechnology policy makers. For a global audience, the show will also be streamed every Sunday from 9:00 am from the new BioCentury This Week website and will be archived thereafter for later viewing.

The first broadcast will deal with risks and benefits of drug safety measures; guests include Robert Temple, FDA’s Deputy Director for Clinical Science, Bill Vaughan, Senior Health Policy Analyst, Consumers Union, Marc Boutin, Executive Vice president and Chief Operating Officer, National Health Council, Tim Coetzee, President and Executive Director of Fast Forward, Affiliate of National MS Society, and Rep. Bart Stupak (Democrats, Mich.), Chairman of the House Energy and Commerce Committee’s subcommittee on oversight and investigations.

Company News: MediGene Obtains Additional US Patent Protection for EndoTAG-1

September 16, 2010 – MediGene AG (Frankfurt: MDG, Prime Standard) has obtained a patent on the manufacturing process for the drug candidate EndoTAG(TM)-1 from the US patent office. Patent no. 7,794,747 protects the manufacturing process used for EndoTAG-1 as well as the product manufactured by this process. The term of the patent “Method of producing a cationic liposomal preparation comprising a lipophilic compound” will end on January 25, 2024.

More information after the jump

Company News: Okairos Raises €16 Million in Series B Financing

Swiss-Italian vaccine play Okairos today announced the closing of a €16 million series B financing round. The proceeds will be used to further advance Okairos’ product portfolio. The vaccines developed by Okairos are based on new, potent adenovirus vectors that can engage the cellular arms of the immune system to elicit a strong immune response involving T cells. The company is addressing major infectious diseases, e.g. malaria, HIV, hepatitis C and universal influenza. The financing was led by Versant Ventures and joined by the Boehringer Ingelheim Venture Fund. All existing investors – BioMedPartners, LSP and Novartis Venture Funds – also participated in the round. For further information, please visit the company’s website.

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