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GLG News by Oncologists (US)

Analysis of: Curis Announces Genentech's Initiation of Hedgehog Antagonist Phase II Clinical Trial In Metastatic Colorectal Cancer (www.pipelinereview.com)
GDC-0449 is an oral agent that will be added to "standard" therapy in metastatic colorectal carcinoma (CRC) and evaluating progression free survival as the primary objective.
Analysis of: Proteolix Initiates Phase 2 Clinical Trial of Carfilzomib in Patients with Relapsed Solid Tumors (www.pipelinereview.com)
The data from this phase Ib study will allow Proteolix to proceed with a phase II study of their novel proteasome inhibitor Carfilzomib in patients with advanced solid tumors.  Phase II studies are already underway investigating its activity in myeloma, the tumor type shown to be sensitive...
Analysis of: AmpliMed Corporation Announces Start of Randomized Phase 2 Trial of Amplimexon in Pancreatic Cancer (www.pipelinereview.com)
An interesting randomized phase II trial of Gemzar (the current standard with Tarceva) vs imexon + Gemzar. BUT shouldn't it be compared to Gemzar/ Tarceva??
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: DOR BioPharma Initiates Non-Human Primate Efficacy Studies of RiVaxTM, Its Vaccine Against Ricin Toxin (www.pipelinereview.com)
Ricin is an extraordinarily potent toxin that is fatal because of its ability to inhibit protein synthesis and rapidly cause multisystem failure.  Because ricin can be prepared from castro beans, it has the potential to be used in terrorist attacks.  The present vaccine has the potential to...
Michael Grossbard, MD, Professor of Clinical Medicine
Columbia University College of Physicians and Surgeons
Analysis of: Data suggests promising overall survival and progression-free survival with Vargatef(TM) (BIBF 1120) (www.pipelinereview.com)
Vargatef is a novel angiokinase inhibitor that blocks VEGF, PDGR and FGF receptors.  The current phase II study in patients with non small cell lung cancer shows that this oral agent can be given safely.  It is far too early to draw conclusions regarding efficacy.
Analysis of: AstraZeneca Files Marketing Application in Europe for EGFR Inhibitor Gefitinib (IRESSA(TM)) in Locally Advanced Pre-Treated Non-Small Cell Lung Cancer (www.pipelinereview.com)
Approval will be base on the phase III INTEREST trial that showed in NSCLC that Iressa was "non-inferior" to standard chemotherapy after platinum therapy failure first line. Iressa was better tolerated and had an improved quality of life.
Analysis of: Micromet Enrolls First Patient in Phase 1 Clinical Trial with MT110, the First BiTE Antibody for Treatment of Solid Tumors (www.pipelinereview.com)
Micromet's Bite antibodies strategy garners the patient's T-cells to attack tumor cells. This technology showed proof of principle i hematological malignancies , and now a Phase I clinical trial has commenced for solid tumors. The rationale is intriguing, but immunotherapy has been elusive in solid...
Analysis of: Genentech and Biogen Idec Announce Top-Line Results From Phase II/III Clinical Study of Rituxan in Systemic Lupus Erythematosus (www.pipelinereview.com)
This large study did not show any benefit for Rituxan in a general lupus population. But, patients with nephritis - a common kidney complication - were specifically excluded from this study and are specifically being studied with Rituxan in the LUNAR study, which will yield results in early...
Analysis of: New Study Ties Genes To Leukemia Treatment (online.wsj.com)
Gene mutation analysis can help refine therapy in acute leukemia and impact on results!!
Analysis of: Cytheris Announces New Phase I Study of Interleukin-7 As Immunotherapy In Treatment of Bone Marrow or Peripheral Blood Stem Cell Transplant Patients (www.pipelinereview.com)
IL-7 is important for B and T cell development.  But both cells require multiple cytokines, in the correct chronological order and appropriate amounts, for optimum results.

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