Health & Fitness
Health and Fitness
Health and Fitness
Tue, October 12, 2010
Mon, October 11, 2010
Micromet Announces FDA Acceptance of Investigational New Drug Application for BiTE Antibody MT111/MEDI-565
BETHESDA, Md.--([ BUSINESS WIRE ])--Micromet, Inc. (NASDAQ: MITI) today announced that its licensee for MT111, MedImmune, plans to initiate a Phase 1 trial in patients with advanced gastrointestinal cancers based on an investigational new drug (IND) application recently accepted by the U.S. Food and Drug Administration (FDA). MT111, also known as MEDI-565, is a BiTE® antibody designed to direct a patient's T cells, the bodya™s most potent killer cells, against cancer cells that express carcinoembryonic antigen (CEA). CEA is a protein found on the surface of a number of gastrointestinal cancers, including colorectal, esophageal and gastric.
"We are looking forward to learning more about the potential of this compound to improve the lives of patients with advanced gastrointestinal cancers."
MedImmune is advancing the development of MT111/MEDI-565 under a collaboration agreement signed with Micromet in June 2003. Under the terms of the agreement, development and commercialization of MT111/MEDI-565 will be led by MedImmune in the U.S. and outside of Europe, and by Micromet in Europe. MedImmunea™s submission of an IND for MT111/MEDI-565 triggered a milestone payment to Micromet. MedImmune anticipates initiating the Phase I trial in the first half of 2011.
aWe are pleased to advance the development of this innovative oncology drug candidate,a said Bahija Jallal, Ph.D., executive vice president of research and development at MedImmune. aWe are looking forward to learning more about the potential of this compound to improve the lives of patients with advanced gastrointestinal cancers.a
Preclinical studies have demonstrated potent activity of MT111/MEDI-565 against human cancer cell lines and inhibition of tumor growth in animal models.
aWe are very pleased with the progress achieved under our collaboration with MedImmune and are excited to see the third BiTE antibody enter the clinic," said Christian Itin, Ph.D., Micrometa™s President and Chief Executive Officer.
About BiTE Antibodies
BiTE® antibodies are designed to direct the body's cytotoxic, or cell-destroying, T cells against tumor cells, and represent a new therapeutic approach to cancer therapy. Typically, antibodies cannot engage T cells because T cells lack the appropriate receptors for binding antibodies. BiTE antibodies have been shown to bind T cells to tumor cells, ultimately inducing a self-destruction process in the tumor cells referred to as apoptosis, or programmed cell death. In the presence of BiTE antibodies, T cells have been demonstrated to serially eliminate tumor cells, which explains the activity of BiTE antibodies at very low concentrations. Through the killing process, T cells start to proliferate, which leads to an increased number of T cells at the site of attack.
About Micromet, Inc.
Micromet, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative antibody-based therapies for the treatment of cancer. Its product development pipeline includes novel antibodies generated with its proprietary BiTE® technology, as well as conventional monoclonal antibodies. The Companya™s lead product candidate blinatumomab (MT103) is currently the subject of a pivotal trial in patients with minimal residual disease positive acute lymphoblastic leukemia. Micromet has collaborations with a number of leading pharmaceutical and biotechnology companies, including Bayer Schering Pharma, Boehringer Ingelheim, MedImmune, Merck Serono, Nycomed and sanofi-aventis. Additional information can be found at [ www.micromet.com ].
About MedImmune
MedImmune, the worldwide biologics unit for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,500 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmunea™s website at [ http://www.medimmune.com/ ].
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein that do not describe historical facts are forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. These forward-looking statements include statements regarding the development and commercialization of MT111, including the timeline for the initiation of the phase 1 clinical trial. You are urged to consider statements that include the words aadvance,a aaimed,a "will," alook forward,a aenter,a amay,a adesigned,a adirect,a or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that MT111 does not demonstrate safety and/or efficacy in future clinical trials, difficulty in enrolling patients in clinical trials, delays in development and testing, including the risk that we will not obtain approval to market MT111, and the risks associated with reliance on outside financing to meet capital requirements. These factors and others are more fully discussed in Micromet's Annual Report on Form 10-K for the fiscal year ended December 31, 2009, filed with the SEC on March 5, 2010, Micromet's Quarterly Report on Form 10-Q for the quarter ended June 30, 2010, filed with the SEC on August 6, 2010, as well as other filings by the Company with the SEC. Micromet cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Micromet also disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
