| Amgen Announces Interim Results Of Aranesp(R) ''PREPARE'' Study In ...
Amgen, Inc. (NASDAQ: AMGN) announced that it had received interim results from the independent investigator-sponsored "PREPARE" study, an open-label, randomized, multicenter Phase 3 study of Aranesp(R) (darbepoetin alfa) in 733 neoadjuvant breast cancer patients receiving dose-dense, dose-intense preoperative chemotherapy compared to a standard preoperative chemotherapy regimen.
Initiated in 2002, the PREPARE study was developed, conducted and analyzed by the independent German Gynecological Oncology Study Group (AGO) and the German Breast Group. It was designed to evaluate the effects of preoperative chemotherapy using a sequential dose-dense and dose-intensified regimen of epirubicin, paclitaxel, and CMF compared to preoperative sequential administration of epirubicin and cyclophosphamide followed by paclitaxel in patients with breast cancer, with respect to event-free and overall survival, with or without Aranesp to prevent anemia and to potentially augment the therapeutic effects of the chemotherapy regimens.
Researchers advance stem cell gene therapy
Under this protocol, MGMT, a drug-resistance gene, is added into purified hematopoietic stem cells to protect these cells from the damage of chemotherapy regimens. In one of 24 presentations by Ireland Cancer Center researchers at the annual American Society of Hematology meeting, Stanton Gerson, MD, and colleagues presented that eight patients were enrolled on the trial and six were infused with their own stem cells which were engineered to carry the MGMT gene. In three patients, stem cells carrying the gene were identified in their blood or bone marrow. In one patient, stem cells carrying the gene were detected up to 28 weeks after their administration. This significant finding has never been reported before with this gene and drug combination. ??This study is the first to show the success of treatment with evidence that stem cells now carry the new gene,?? says Dr.
EntreMed Commences Phase 2 Study With MKC-1 In Pancreatic Cancer
EntreMed, Inc. (Nasdaq: ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, announced that it has commenced a multi-center Phase 2 clinical trial with MKC-1 in patients with advanced pancreatic cancer. The primary objectives of this study will be to determine the antitumor activity of orally-administered MKC-1 in unresectable or metastatic pancreatic cancer patients who have failed at least one prior chemotherapy regimen. The study will also assess the safety, tolerability and overall median survival time of pancreatic cancer patients treated with MKC-1. Massachusetts General Hospital Cancer Center is the lead institution for the study and Eunice Kwak, M.D., Ph.D., Assistant in Medicine, Tucker Gosnell Center for Gastrointestinal Cancers, will serve as the principal investigator.
Three Chemo Drugs Better Than Two for Advanced Head/Neck Cancers
WEDNESDAY, Oct. 24 (HealthDay News) -- The addition of the chemotherapy drug, docetaxel, to the standard two-drug regimen used for head and neck cancers improved the efficacy of the treatment while reducing the toxicity, two new studies report. .
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