Articles tagged with: MDX-1097
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This year’s Congress of the European Hematology Association (EHA) is currently being held in Stockholm. It started earlier this week and will run through Sunday, June 16.
A substantial amount of myeloma-related research will be presented during the EHA meeting during both oral presentations and poster presentations.
This article summarizes some of the important myeloma-related findings that are expected to be presented during poster sessions today and tomorrow. A previous article covered the key findings that will be presented during oral presentations.
The studies covered in this article are primarily ones …
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MDX-1097 Receives Orphan Drug Status For Multiple Myeloma – The Australian bio-therapeutic company Immune System Therapeutics announced last week that it has received orphan drug designation from the United States Food and Drug Administration (FDA) for its investigational drug MDX-1097. 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. The FDA uses the orphan drug designation to promote the development of new treatments for rare diseases that affect fewer than 200,000 individuals in the United States. The orphan drug status provides the developer of the drug with several benefits, including funding for clinical trials and marketing exclusivity for up to seven years. For more information, please see the Immune System Therapeutics press release.
MD Anderson Cancer Center Announces Start Of Phase 1 Trial With Carfilzomib Plus Panobinostat In Myeloma – The MD Anderson Cancer Center announced last week that it will be starting a Phase 1 trial in early August to determine the highest tolerable dose levels of carfilzomib in combination with panobinostat (Farydak) in relapsed and refractory multiple myeloma patients. The safety of the combination treatment will also be assessed. Carfilzomib, which belongs to the same class of drugs as Velcade (bortezomib), is a new drug from Onyx Pharmaceuticals that is currently being investigated as a potential treatment for multiple myeloma. Panobinostat is an oral experimental cancer drug that is being developed by Novartis. For more information, please see the clinical trial description.
Music Against Myeloma – On Wednesday, July 13, several bands will play at Greenhouse in Manhattan to raise awareness and funds for multiple myeloma. The event starts at 8 p.m. and will feature live bands, drink specials, cupcakes, and more. All proceeds will go to the International Myeloma Foundation. For more information and tickets, please see the Music Against Myeloma website.
For a more detailed listing of myeloma-related events, please check the Myeloma Beacon Events Calendar.
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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.