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Micromet's Blinatumomab Produces High Single-Agent Activity in Patients with Relapsed ALL

10-06-2011. Data to be presented tomorrow at the 16th Annual Meeting of the European Hematology Association (EHA) in London, UK, show that Micromet's blinatumomab produced a high complete remission rate in adult patients with acute lymphoblastic leukemia (ALL) who had relapsed following treatment with standard therapy.1 Blinatumomab is the most advanced of a new class of agents called BiTE(R) antibodies, designed to harness the body's T cells to kill cancer cells.
Interim results from this phase 2 single-arm trial showed that 75% of patients (9 of 12) achieved a complete remission (CR) or CR with partial recovery of blood counts (CRh*) following treatment with blinatumomab. All nine responding patients achieved a complete molecular response, or had no evidence of leukemic cells in their bone marrow, a key prognostic factor for patient survival. Notably, four patients with genetic abnormalities typically associated with poorer outcomes all achieved a CR or CRh*. "Relapsed/refractory acute lymphoblastic leukemia is a difficult to treat disease that has seen no meaningful improvement in decades," said Professor Max Topp, Department of Internal Medicine II, University of Wuerzburg and the chair of the study. "To date blinatumomab has shown an impressive and unprecedented level of efficacy in a patient population with limited therapeutic options."
The most common clinical adverse events were fever, peripheral edema and fatigue. Treatment of two of the twelve patients was interrupted due to fully reversible and manageable CNS events. In one patient, cytokine release syndrome was observed, which was mitigated in subsequent patients through dose modification and pre-treatment with concomitant medication. No additional cytokine release syndrome was observed. "These results are particularly striking relative to the fact that the majority of enrolled patients had characteristics typically associated with a dismal outlook," said Professor Topp.
Current treatment for Philadelphia negative relapsed/refractory ALL consists of combinations of toxic chemotherapy drugs that in the majority of cases fail to drive the disease into remission. In more than 30 years, no new drug has been approved for use in this setting, leaving physicians with few options to improve long-term patient outcomes other than variations in the dose and schedule of old drugs with limited efficacy. With current approaches, complete remission rates range from 17-45%.2-6 Standard chemotherapy is associated with a mortality rate of up to 23%.7 The average five-year survival rate for adult ALL patients after first relapse is 7%.5

Study design
This study is designed to evaluate the efficacy, safety and tolerability of blinatumomab in up to 25 adult patients with B-precursor ALL who relapsed after at least induction and consolidation treatment or who have refractory disease. Patients receive blinatumomab as a continuous infusion for 28 days followed by a treatment free interval of two weeks. Patients who achieve a CR/CRh* within the first two treatment cycles can receive consolidation with either three additional cycles of blinatumomab or allogeneic HSCT. The primary endpoint of the study is the rate of CR/CRh*. Secondary endpoints include molecular response rate, duration of response and overall survival. Enrollment in this study is currently on-going.

References:
1. Topp, M.S. et. al. Haematologica. 2011; abstract no. 844
2. Kantarjian H, et al. Cancer. 2010;116:5568-5574.
3. Advani AS, et al. Br J Haematol. 2010;151(5):430.
4. Oriol A, et al. Haematologica. 2010;98(4):589-596.
5. Fielding A, et al. Blood. 2007;109(3):944-950.
6. O'Brien S, et al. Cancer. 2008;113:3186-3191.
7. Bassan R, et al. J Clin Oncol. 2011;29(5):532-543.

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More accolade for Steven Ley - A Pioneer in Organic Chemistry

29 October 2009. Prof. Steven Ley, Head of the Department at Cambridge University received another prestigious science award, the Heinrich-Wieland-Prize sponsored by Boehringer Ingelheim. This is his third award after the Royal Society of Chemistry’s Perkin Prize for Organic Chemistry and the Tetrahedron Prize for Creativity in Organic Chemistry from Elsevier. A spokesperson of Boehringer Ingelheim said at the occasion that with awarding the Heinrich Wieland Prize Boehringer Ingelheim aims to foster research on lipids and other biologically active substances in the areas of chemistry, biochemistry, physiology as well as clinical medicine. Since 1964 60 scientists have received the prize including Nobel laureates 1985 Michael Brown and Joseph Goldstein.

Prof. Steven Ley Lab (C) University of Cambridge 2009

Steven Victor Ley was born in 1945. He obtained his PhD in Chemistry at Loughborough University in 1972. Thereafter he performed post-doctoral research at Ohio State University and Imperial College where he became later Head of Department. In 1992 he was nominated BP (1702) Professor of Organic Chemistry at the University of Cambridge.
Prof. Ley is a pioneer in green chemistry and an expert in the synthesis of natural products. In is Cambridge Laboratory named after Thomas Whiffen he follows the tradition of the reputed alkaloid chemist and entrepreneur. Here Ley achieved total synthesis of more than 120 natural compounds, such as Bengazole A and B, a new class of lipophilic molecules with antifungal activity (c.p.: http://leygroup.ch.cam.ac.uk/natprodpapers.html). He is the inventor of Tetra-n-butylammonium Per-ruthenate TPAP reagent), which is a widely used catalytic oxidant. His research on synthesis of biologically active substances having an acetylene skeleton in the molecule, or an organic functional material has led up to catalysts applicable for manufacture of polymer materials, liquid crystals or optical materials. Ley’s scientific work then is of equal interest to the chemicals, pharmaceutical, agro and electronic industries with major companies such as AstraZeneca, BASF, Daihatsu, GlaxoSmithKline, Novartis, Roche, or Wyeth.

With more specific regard to pharma intermediates and drugs more recent achievements are on elucidating the regulation of the ERK/MAP kinase signalling pathway by Tumor Progression Locus-2 (TPL-2) important for modulating inflammatory response. It is leading up to powerful inhibitors which are currently under development. Another recent examples are the synthesis of the C‑reactive protein inhibitor compound designed by Mark Pepys, Royal Free Hospital (UK) as well as development of small molecule ligands to treat transthyretin amyloidosis with Pepys and Vittorio Bellotti, Università degli Studi di Pavia (IT). “Both projects are at the top level of scientific originality, and have been recognised as such by both major scientific prizes and grant awards, and of great potential medical significance” Mark Pepys comments on the collaboration with his colleague Steve Ley. Amyloidosis is a disease caused by extracellular deposition of insoluble abnormal fibrils. It predominantly affects the heart, but also eyes and kidney. It is rare in Caucasians, but medical epidemiologist estimate that it some 1.3 million Afro Americans are carriers of this disease. The development of a combined small molecule-antibody to treat amyloidosis is currently commercialised in Pentraxin Therapeutics Ltd. for GSK. Several other companies are developing Prof. Ley’s research into products such as Chiroscience (UCB Celltech) at Slough. A second area of interest towards major efforts are dedicated is development of enabling technologies for organic synthesis in the so-called Innovative Technology Centre at Cambridge. This is resulting in a number of industrially attractive methods in microfluidic flow chemistry or instruments like microwave reactors for automated syntheses. While supporting technology transfer throughout his career he is not actively taking major roles in these firms.

Prof. Steven Ley (C) University of Cambridge 2009 Prof. Steven V. Ley holds the oldest continuously occupied chair of chemistry in Britain.

Stem Cell Insights Collection 2010

Issues and Evaluation from Pharma Leaders

How does the pharma industry view application of stem cell technologies? Where are R&D efforts needed, and where does academic research not fulfill expectations? What is the role of suppliers in the field?

Read fresh answers from the leaders, provided exclusively to readers of B2Bioworld. Published only here, and all in one.

(C) Boehringer Ingelheim (C) Wolf G Kroner 2009 (C) Hoffmann-La Roche 2009

We are obliged to more and more move away from animal models
- Prof. Andreas Barner, Boehringer Ingelheim

Preparing for Another Level of Innovation
- Dr Mark Fishman, Novartis

Clear away complete confusion of terms
- Dr Bernhard Kirschbaum, Merck Serono

Stem Cells: a discovery tool and a potential therapeutic modality
- Dr Jonathan Knowles, Hoffmann-La Roche

It really started last year…
- Dr Ruth McKernan, Pfizer Regenerative Medicine

Stem Cells and Vaccines Production
- Dr Majid Mehtali, Vivalis

Doing our business a little bit differently than the others in the industry
- Dr Mads Krogsgaard, Novo Nordisk

Triggering Regenerative Functions with Transplanted Cells and Small Molecules
- Dr Kurt Stoeckli, Biological Sciences/Discovery Sanofi-Aventis

Stem Cell Research in GlaxoSmithKline and Beyond
- Dr Patrick Vallance, GlaxoSmithKline Drug Discovery

Stem Cells – Failings and Deliveries
- Hugh Ilyine, Consultant & Guest Editor

Patenting Stem Cells
- Dr. Sebastian Tegethoff, 24IP

Drug Testing with Embryonic Stem Cells – Towards Standards For Assays
– Dr David C Hay, University of Edinburgh, MRC Centre for Regenerative Medicine

L’Oréal avance dans les cellules souches
- Report by Hélène Guyot (with summary in English)

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REALATED ARTICLES

Micromet's Blinatumomab Produces High Single-Agent Activity in Patients with Relapsed ALL

More accolade for Steven Ley - A Pioneer in Organic Chemistry

Stem Cell Insights Collection 2010

Issues and Evaluation from Pharma Leaders

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