Tag: Clinical Data

Company News: Micromet Presents Promising New Data on Anti-Cancer BiTE® Antibody Blinatumomab

Micromet has presented promising new data from two clinical trials with its lead BiTE® antibody, blinatumomab, at the 53rd American Society of Hematology (ASH) Annual Meeting in San Diego, CA. Blinatumomab is the first of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells. The compound is being developed for the treatment of leukemia and B cell lymhoma.

The data show that Micromet’s blinatumomab more than doubled the complete remission rate produced by current standard therapies used to treat adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).

In a phase 2 single-arm dose-ranging trial, 68% of evaluable patients (17/25) across all tested doses and schedules achieved a complete response (CR) or complete response with partial hematologic recovery (CRh*) following treatment with blinatumomab.  Of the 12 evaluable patients who received the selected dose and schedule 75% (9 of 12) achieved a CR or CRh*.  Notably, all responders also achieved a molecular response, or in other words, had no evidence of remaining leukemic cells detectable in the blood or bone marrow.

A first interim analysis of the time impact of blinatumomab treatment was conducted for the initial 18 patients enrolled to the trial. The median survival had not been reached, with a median follow-up period of 9.7 months. With combination chemotherapy, median survival typically ranges from 3 – 6 months1-5.  12 of the initial 18 patients had a CR or CRh* with a median duration of response of 7.1 months. Based on the results of this study, the Company initiated a global phase 2 study in this patient population in November 2011.

 

Moreover, new findings from a phase 1 trial presented at the meeting demonstrate Micromet’s blinatumomab induces durable responses in patients with extensively pre-treated diffuse large B cell lymphoma (DLBCL).

Data focused on a cohort of 13 patients with DLBCL, of which 11 received the target dose and were evaluable for response. Of these 11 patients, 6 (55%) achieved an objective response following treatment with blinatumomab. 4 of 11 patients (38%) achieved a complete response. Patients were treated with a single course of blinatumomab induction therapy for up to eight weeks. As of October 2011, 5 of 6 patients had ongoing responses for up to 16.6 months. The median duration of response had not been reached with a median observation time of 7.1 months.

All patients enrolled in this study had received prior rituximab-containing regimens. Most had received three or more prior lines of therapy, including 8 of 13 patients with prior autologous stem cell transplant.

Food for Thought: Weekly Wrap-Up

Hearts can heal themselves, at least in newborn mice, reports  Sindya N. Bhando in the New York Times. She features a research group that is now trying to identify the genes regulating the process. If the researchers could restart the genetic network in adult animals, science would be a step closer to a better heart disease therapy.

Matthew Herper in Forbes deals with the success of Vertex’s cystic fibrosis drug VX-770 in its 161 patients STRIVE clinical trial. While it works only in a small subset of patients carrying a particular mutation, in this group it improved the patients’ ability to exhale by about 17%. Robert Langreth, also in Forbes, introduces biotech investor Randal J. Kirk who made more than $2 billion from his biotech investments, among others, by selling New River Pharmaceuticals to Shire. Right now, he is about selling his anti-depressant play Clinical Data to Forest Laboratories. Kirk prefers to buy unknown companies at a very low price and stays until a drug gets to the market. His latest interest focuses on synthetic biology, and he runs and finances the 180-person company  Intrexon, founded in 1998 by biologist Thomas Reed. Intrexon claims to command a library of 70,000 DNA pieces that can be used to control gene expression. This enables it, as an example, to induce and regulate in vivo protein expression through dosing of a small molecule activator. Applications range from medical to agricultural and industrial biotechnology and protein production.

Kate McAlpine in New Scientist explains how a technology that manipulates light so that it can deliver sharp images through opaque materials might someday be useful to treat cancer. Like opaque material, human skin scatters light in both time and space, however with the new technology it may be possible to exactly target and destroy cancer cells by laser light without harming surrounding healthy tissue.

Joachim Müller-Jung in Frankfurter Allgemeine Zeitung (FAZ) reports on a new technology to improve hygiene in clinics. Developed by the Max Planck Institute for Extraterrestrial Physics it generates cold plasma gas that is able to kill bacteria even in skin pores within three to five seconds. The technology already is being used in food processing and for treating chronic wounds. The device is about the size of a hand dryer already used in public lavatories. A license to the technology is still available.

Susanne Kutter in Die Wirtschaftswoche reports on a new test to diagnose a myocardial infarction on the spot. It is based on the enzyme glycogen-phosphorylase BB which is released into the blood stream as soon as the heart muscle is suffering from oxygen deprivation. A common competitor test on the market is based on a molecule released only after disintegration of heart muscles cells and tissue, i.e. hours after the incident. The Diacordon test is marketed by Diagenics.

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