Beacon NewsFlashes – September 27, 2010

Amgen Recalls Anemia Drugs Epogen And Procrit – On Friday, Amgen recalled certain lots of Epogen and Procrit (epoetin alfa), which are used to treat anemia (low red blood cell counts). Procrit is manufactured by Amgen but sold by Johnson & Johnson. The recalled lots may contain barely visible glass flakes that could cause blood clots, swelling of veins, and immune reactions. There have not yet been any reports of negative side effects directly tied to the glass flakes, which result over time from an interaction between the drug and the glass container. To prevent this problem, Amgen will reduce the shelf life of Epogen from 36 months to 12 months for single-dose vials and 15 months for multi-dose vials. Additionally, the company will begin using glass vials that do not interact with the drug during the shelf life of the product. For more information or the specific lot numbers, please see the Amgen website.
Biotest Pharmaceuticals Initiates Phase 1/2 Trial Of BT-062 For Multiple Myeloma – Biotest Pharmaceuticals has started recruiting patients with relapsed or refractory multiple myeloma for a Phase 1/2 clinical trial of BT-062. This initial trial will focus on determining BT-062’s safety, anti-tumor activity, and dosage limits. BT-062 is a toxic drug bound to an antibody that helps deliver the treatment to cancer cells. For more information, please see the clinical trial description and the Biotest website.
Cylene Initiates Phase 1 Trial of CX-4945 For Multiple Myeloma – Cylene Pharmaceuticals has started recruiting patients with relapsed or refractory multiple myeloma for a Phase 1 clinical trial of CX-4945. The Phase 1 study is designed to test CX-4945’s safety, tolerability, and dosage limits. CX-4945 is an oral CK2 inhibitor, a class of drugs that causes cell death in cancerous cells. A separate Phase 1 trial will also be conducted to determine the use of CX-4945 for the treatment of solid tumors. For more information, please see the Cylene press release and the clinical trial description.
Minnesota Cancer Researchers Receive $26 Million To Study Stem Cell Therapies – Dr. Philip McGlave and Dr. Jeffrey Miller, researchers at the University of Minnesota’s Masonic Cancer Center, will receive $26 million from the National Institutes of Health to continue their study of stem cell therapies used to treat blood and bone cancers, among other disorders. Dr. McGlave’s research will focus on improving stem cell transplants and cell-based treatments, while Dr. Miller will continue research on the immune system to reduce the rate of relapse of leukemia after stem cell transplantation. They will also collaborate with blood and bone marrow experts at cancer centers throughout the country. For more information, please see the University of Minnesota press release.
Signal Genetics And Array BioPharma Partner To Advance Personalized Medicine In Multiple Myeloma – Signal Genetics, a predictive genetic testing company focused on oncology, recently announced the company will work with Array BioPharma to identify patients for treatment using genetic markers. Signal Genetics’ genomic testing instrument, MyPRS, will be used to provide Array BioPharma with genetic information during clinical trials for its multiple myeloma drug candidate, ARRY-520 (filanesib). This collaboration may lead to the development of personalized treatment options for myeloma patients based on genetic markers. For more information, please see the Signal Genetics press release (pdf) and the Array BioPharma website.
Related Articles:
- U.S. FDA Okays First Clinical Trial Of An Allogeneic CAR T-Cell Therapy For Multiple Myeloma
- Nelfinavir-Velcade Combination Very Active In Advanced, Velcade-Resistant Multiple Myeloma
- Once-Weekly High-Dose Kyprolis Yields Deeper Responses And Longer Remissions Than Twice-Weekly Kyprolis (ASCO & EHA 2018)
- FDA Approves Once-Weekly Dosing And Revised Safety Information For Kyprolis
- ECT-001 Granted Regenerative Medicine Advanced Therapy (RMAT) Designation By U.S. FDA