ImmunoGen, Inc. Initiates Clinical Testing of HuN901-DM1 for Treatment of Multiple Myeloma; Study Expands HuN901-DM1 Clinical Development Program.CAMBRIDGE, Mass. -- ImmunoGen, Inc. (Nasdaq: IMGN) today announced the initiation of clinical testing with its Tumor-Activated Prodrug prodrug /pro·drug/ (-drug) a compound that, on administration, must undergo chemical conversion by metabolic processes before becoming an active pharmacological agent; a precursor of a drug. (TAP) compound, huN901-DM1, for the treatment of multiple myeloma multiple myeloma A malignant proliferation of abnormal plasma cells that populate the marrow-containing bones of the body. The affected plasma cells produce myeloma protein, a monoclonal antibody that replaces normal antibodies in the blood, thereby increasing susceptibility . This study expands the huN901-DM1 clinical program - the compound also is in two clinical trials for the treatment of small-cell lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. . The huN901-DM1 multiple myeloma study is being conducted at the Jerome Lipper Center for Multiple Myeloma of the Dana-Farber Cancer Institute in Boston, MA. Robert Schlossman, MD, is the Principal Investigator Noun 1. principal investigator - the scientist in charge of an experiment or research project PI scientist - a person with advanced knowledge of one or more sciences . Co-investigators in the study include Kenneth Anderson Ken or Kenneth Anderson may refer to:
In 1980 when the Phillies won the World Series, Richardson was awarded a World Series Ring alongside the players. , MD, and Nikhil Munshi Munshi is a degree in South Asia, that is given after passing a certain course of basic reading, writing, and math etc. The advanced degree was Munshi Fazil or Munshi Fadhil. Munshi is also a title that a graduate of Munshi course is allowed to attach to his name. , MD, of the Jerome Lipper Center. Additional clinical centers are expected to be added. The primary objective of this Phase I study is to evaluate the safety of huN901-DM1 in patients with relapsed or refractory multiple myeloma, and to identify the maximum tolerated dose of the compound in this patient population. The study also will evaluate the anticancer activity of huN901-DM1 in multiple myeloma. The first dose level to be evaluated in this study will be close to the maximum tolerated dose that was established with the compound as part of the small-cell lung cancer clinical program. Patients will receive huN901-DM1 - as monotherapy - once weekly for two consecutive weeks every three weeks. To qualify for enrollment in this study, patients need to have received at least one prior treatment for their multiple myeloma. Patients also need to have multiple myeloma that expresses the CD56 antigen targeted by huN901-DM1. Previous research conducted at the Dana-Farber Cancer Institute confirms that most cases of multiple myeloma express CD56. In the same preclinical research, conducted in the laboratory of Dr. Munshi, huN901-DM1 was found to selectively target and kill CD56-expressing multiple myeloma cells. The compound was found to have substantial activity even when the multiple myeloma cells were in the presence of bone marrow stromal cells (BMSCs). There is evidence that multiple myeloma cells adhering to BMSCs are able to resist being killed by standard chemotherapeutic agents. Dr. Schlossman commented, "HuN901-DM1 is a targeted approach to the treatment of multiple myeloma, in contrast to the currently approved agents for this malignancy. The findings from the preclinical multiple myeloma studies are encouraging, and we look forward to assessing this compound clinically." HuN901-DM1 is in development by ImmunoGen for the treatment of cancers that express the CD56 protein targeted by the compound. CD56-expressing malignancies include multiple myeloma, small-cell lung cancer, and other cancers of neuroendocrine neuroendocrine /neu·ro·en·do·crine/ (-en´do-krin) pertaining to neural and endocrine influence, and particularly to the interaction between the nervous and endocrine systems. neu·ro·en·do·crine adj. origin. HuN901-DM1 comprises the anti-CD56 antibody, huN901, and the potent cell-killing agent, DM1. The huN901 antibody is used to target the compound specifically to CD56-expressing cancer cells and the DM1 serves to kill these cells. About ImmunoGen, Inc. ImmunoGen, Inc. develops targeted anticancer biopharmaceuticals. The Company's proprietary TAP technology uses tumor-targeting antibodies to deliver a potent, cell-killing agent specifically to cancer cells. ImmunoGen is advancing its wholly-owned TAP compounds, huN901-DM1 and huC242-DM4. Centocor (a wholly-owned subsidiary of Johnson & Johnson), Biogen Idec, Genentech, the sanofi-aventis Group, Millennium Pharmaceuticals, Inc., Boehringer Ingelheim, and Abgenix have licensed the right to develop or test TAP compounds to specific targets; ImmunoGen also has a broader collaboration with the sanofi-aventis Group. This press release includes forward-looking statements. For these statements, ImmunoGen claims the protection of the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. for forward-looking statements provided by the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. It should be noted that there are risks and uncertainties related to the Company's development of its own products, as well as to the development of products by our collaborators. A review of these risks can be found in ImmunoGen's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the fiscal year ended June 30, 2005 and other reports filed with the Securities and Exchange Commission. |
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