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GLG News by Oncologists Specializing in Hematologic Malignancies in the U.S.

Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: Hana Biosciences Initiates Marqibo Phase 2 Clinical Trial in Metastatic Malignant Uveal Melanoma (www.pipelinereview.com)
Uveal melanoma is an uncommon disease but is devastating when it metastasizes.  The most common site of metastases is the liver and response rates to conventional chemotherapy agents are poor.   This trial is designed specifically to assess the activity of Marqibo in patients with metastatic...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: Avastin receives positive opinion in Europe for first-line treatment of patients with advanced kidney cancer (www.pipelinereview.com)
Avastin now has been approved in Europe for the treatment of metastatic renal cell carcinoma.  Avastin + Interferon nearly doubles the PFS vs Interferon alone.  Approval in Europe (and similar FDA approval) will be critical to the marketing of this expensive agent.  However, these data...
Brian Abbott, MD, Medical Director of Hematology
Brian Abbott, MD, Medical Director of Hematology
Big Sky Oncology
Analysis of: Vidaza vs Dacgoen for MDS (www.newratings.com)
There is no reason to believe Dacogen is inferior to Vidaza. In some studies, Dacogen seems to produce a deeper quality of response, and may also prove more beneficial in AML.
Brian Abbott, MD, Medical Director of Hematology
Brian Abbott, MD, Medical Director of Hematology
Big Sky Oncology
Analysis of: Phase II study of lenalidomide in transfusion-dependent, low- and intermediate-1-risk myelodysplastic syndromes with karyotypes other than deletion 5q (bloodjournal.hematologylibrary.org)
Revlimid benefits are often over-stated in non-5Q minus MDS. The cost is a hurdle for many patients with poor prescription plans. Vidaza and Dacogen seem superior in my experience for higher risk patients.
Analysis of: Amgen Spends Big Protesting Curbs On Anemia Drugs (online.wsj.com)
Amgen and to a lesser degree JNJ are lobbying cancer patients to fight Medicare's restriction on their ESA products Aranesp, Epogen and Procrit. The Medicare rule and FDA warnings are fair since using ESA's to increase hemoglobin levels. 12 grams/dl was associated with incraesed mortality, tumor progression,...
Analysis of: Major Phase 3 Trial Shows Zevalin(R) Extends Progression-Free Survival in one of the most common types of Lymphoma (www.pipelinereview.com)
Bayer's Zevalin showed efficacy as single dose in first line consolidation treatment of patients with follicular lymphoma. These impressive results will have little impact on Zevalin's use since this radio-labeled antibody had to be administered in specialized nuclear medicine setting which is not available...
Analysis of: Avax initiates Phase III registration trial for metastasis vaccine (www.therapeuticsdaily.com)
Avax's M-Vax vaccine will be tested in a randomized Phase III trial , together with other immunomodualtors, in 387 patients with metastatic melanoma. The study is well designed with specific end points and good sample size. Earliest efficacy data would be in late 2009. This vaccine has a good potentail...
Analysis of: IDM Pharma Announces Updated Phase 2 UVIDEM(R) Results Showing Durable Disease Control and Tolerability in Advanced Melanoma Patients (www.pipelinereview.com)
IDM's dendritic cell-based vaccine produced 30 %" clinical benefit" in a phase II trial of 33 patients with"low volume"  metastatic melanoma with long duration of responses ( 7.2 to 29.7 months) These are impressive results even in this " favorably selected" patient poulation. Other therapies being...
Analysis of: Micromet's BiTE(R) Antibodies Reveal Unique Mode of Action (www.pipelinereview.com)
Micromet's antibodies activate cytotoxic T-cells to help cancer cell killing. Only 1 antibody has had any , yet early clinical trials/ Mechanism is rational; there is potential role in hematological malignancies, but meaningful clinical results are many years away.
Analysis of: Data Show SuperGen's Multi-Targeted Tyrosine Kinase Inhibitor Demonstrates Pre-clinical Activity in Glioblastoma Multiforme (www.bio-medicine.org)
Supergen's MP470, an oral multi-kinase inhibitor has activity against GBM cell lines and xenograft models. Temodar remians the only FDA approved agent for this highly fatal disaese. Avastin, Traceva, Cloretazine, CPT-11, several cancer vaccine, are all in cliical trials, but no real winner has yet emerged....

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