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Beacon NewsFlashes – June 20, 2011

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Published: Jun 20, 2011 11:08 am

NICE Does Not Change Assessment Of Velcade For Myeloma – The National Institute of Clinical Excellence (NICE), the agency that decides which treatments will be funded for patients in England and Wales, announced last week that it will not change its assessment of Velcade (bortezomib) for use in multiple myeloma. In its draft guidance issued last August, NICE recommended Velcade and thalidomide (Thalomid) as first-line treatments for multiple myeloma patients ineligible for stem cell transplant or high-dose chemotherapy. However, Velcade was only recommended as a first-line treatment for patients who cannot tolerate thalidomide. Janssen-Cilag, a subsidiary of Johnson & Johnson that markets Velcade in Europe, appealed the draft guidance; however, NICE continues to consider thalidomide more cost effective. The final NICE decision is expected in July. For information, please see a related Bloomberg article.

MD Anderson Cancer Center Announces Start Of Phase 1 Trial With CEP-18770 In Myeloma – The MD Anderson Cancer Center announced last week that it will be starting a Phase 1 trial to test the efficacy and safety of CEP-18770 in combination with Revlimid (lenalidomide) and dexamethasone (Decadron) in relapsed or refractory multiple myeloma patients. CEP-18770 is a boronic acid-based proteasome inhibitor, like Velcade, that is being developed by the biopharmaceutical company Cephalon. It suppresses tumor growth by inhibiting the enzymes that break down important proteins in cancerous cells. Animal studies showed that CEP-18770 demonstrated superior activity to Velcade, and it caused fewer side effects during treatment. For more information, please see the clinical trial description.

Immune System Therapeutics Expands Phase 2 Trial For MDX-1097 In Myeloma – The Australian bio-therapeutic company Immune System Therapeutics announced last week that it will be expanding the ongoing Phase 2 clinical trial of its investigational drug MDX-1097 to include up to 27 myeloma patients. MDX-1097 is an antibody that binds to certain proteins on the surface of myeloma cells, triggering the immune system to kill the cancer cells. Immune System Therapeutics decided to extend the trial after it received a positive review for the efficacy and safety of the first six patients enrolled in the study from an independent data monitoring committee. For information, please see the Immune System Therapeutics press release.

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