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Biotech / Medical : Micromet Inc (MITI) -- Ignore unavailable to you. Want to Upgrade?

To: dr.praveen who wrote (35)	6/19/2006 3:53:12 AM
From: dr.praveen	Read Replies (2) \| Respond to of 196

Preliminary Clinical Data of MT103 (MEDI-538), a CD19-specific BiTE(R), Indicate Biological and Clinical Activity in Non-Hodgkin Lymphoma Monday June 19, 2:57 am ET MÃœNCHEN, GERMANY--(MARKET WIRE)--Jun 19, 2006 -- Carlsbad, CA, - June 19, 2006 - Micromet, Inc. (NasdaqNM:MITI - News) today announced preliminary data from an ongoing phase 1 trial on MT103 (also known as MEDI-538) investigating the safety and tolerability of a continuous infusion of MT103 over a 4- to 8-week period at escalating dose levels in patients with relapsed, indolent Non-Hodgkin Lymphoma (NHL). The data were presented at the 11th Congress of the European Hematology Association. So far, 19 patients with a median number of four previous lines of therapy have been included. In the first three cohorts (0.5 up to 5 mg/m2/24 h), no dose limiting toxicities have been observed. Evaluation of dose level 4 (15 mg/m2/24h) is currently ongoing. Pharmacodynamic effects have been observed at 5 and 15 mg/m2/24 h with complete depletion of malignant B cells as well as significant T cell expansion in the majority of patients. Three out of five patients receiving 15 mg/m2/24 h MT103 for at least two weeks showed clinical responses assessed by central radiology. One patient had a complete tumor response and 2 patients showed partial tumor responses according to standardized Cheson criteria. The most common adverse events of grade 3 or higher were lymphopenia (63 percent), leukopenia (47 percent), neutropenia and enzyme abnormality (both 16 percent). "These preliminary clinical data are encouraging. In particular, the observation of confirmed clinical responses after single-agent treatment with very low doses of MT103/MEDI-538 in this late-stage patient population shows the therapeutic potential of the BiTE® platform," commented Dirk Reitsma, M.D., Vice President of Clinical Oncology at MedImmune, Inc. "The results underline the potential of cytotoxic T cells, when targeted by MT103/MEDI-538, to induce clinical responses in a human cancer." MT103 is a recombinant single-chain bispecific antibody derivative out of Micromet's BiTE® platform targeting the CD19 antigen, which is uniquely expressed on B cells. The BiTE® molecule is being co-developed by Micromet and MedImmune, Inc. for the treatment of B cell-derived lymphomas and leukemias. "It is intriguing to observe that the preclinical data of MT103 now translate into clinically relevant results. MT103 shows clinical activity at a serum level that is 100,000 lower than that used in the clinic with the monoclonal antibody Rituxan®/Mabthera®, a standard therapy for NHL," commented Dr. Ralf Bargou, the principal investigator of the trial from the University of Wuerzburg, Germany. The activation of T cells against tumor cells by BiTE® represents a new therapeutic approach to cancer therapy with potential benefits for patients, in particular for those who are resistant or have become refractory to existing treatments. "The preliminary results provide first clinical validation for MT103 as the most advanced of the novel class of BiTE® therapeutics," added Dr. Carsten Reinhardt, Senior Vice President, Clinical Development of Micromet, Inc. "We will now further explore MT103 dose and regimen in order to optimize the benefit for NHL patients and we are looking forward to also exploring the potential of other BiTE® molecules for the treatment of solid tumors." Under a separate agreement, Micromet and MedImmune currently collaborate on two new product candidates based on the BiTEâ platform. About MT103 (MEDI-538) MT103, which is being co-developed with MedImmune, Inc. as MEDI-538, is a BiTE® molecule being advanced with the intent to treat certain types of B-cell lymphomas. In February 2006, the U.S. Food and Drug Administration (FDA) approved an orphan drug designation for MT103/MEDI-538 for the treatment of indolent B cell lymphoma, excluding chronic lymphocytic leukemia and Non-Hodgkin Lymphoma with central nervous system involvement. MT103/MEDI-538 also received orphan drug designation from the EMEA for the treatment of mantle cell lymphoma and chronic lymphatic lymphoma. BiTE® molecules are part of a novel class of antibody derivatives that may have the potential to selectively direct and activate an individual's own immune system to act against cancer cells. This action is believed to occur as a result of the molecule's stimulation of T cells (a very potent type of white blood cell) to target and destroy cancer cells that over-express a specific antigen. MT103/MEDI-538 specifically targets the CD19 antigen, which is present on B-cells but not on other types of blood cells or healthy tissues.