Printer Friendly
The Free Library
14,574,058 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

ImmunoGen, Inc. Announces Presentation at ASH of Encouraging Findings with HuN901-DM1 for the Treatment of Multiple Myeloma.


The Company Also Announces Progress with AVE9633 for Acute Myeloid Leukemia myeloid leukemia
n.
See myelogenous leukemia.
 

CAMBRIDGE, Mass. -- ImmunoGen, Inc. (Nasdaq: IMGN) announced the presentation today of encouraging initial findings from a Phase I study evaluating the Company's huN901-DM1 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 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
 at the annual meeting of the American Society of Hematology (ASH) in Orlando, FL. These initial findings show evidence of anticancer activity among the patients receiving the higher of the two huN901-DM1 dose levels evaluated to date. ImmunoGen also announced progress with the TAP compound, AVE9633, which is in development by sanofi-aventis for the treatment of acute myeloid leukemia (AML AML - A Manufacturing Language ). The Company's TAP technology uses tumor-targeting antibodies to deliver a potent cell-killing agent specifically to cancer cells cells once believed to be peculiar to cancers, but now know to be epithelial cells differing in no respect from those found elsewhere in the body, and distinguished only by peculiarity of location and grouping.

See also: Cancer
.

HuN901-DM1 Clinical Findings Reported at ASH

The findings to date from this ongoing trial are being presented today (poster #3574) by Asher Chanan-Khan, MD, of the Roswell Park Cancer Institute The Roswell Park Cancer Institute is a cancer research and treatment center located in Buffalo, New York. Founded in 1898 by Dr. Roswell Park, it was the first dedicated medical facility for cancer treatment and research in the United States.  in Buffalo, NY. This Phase I study is designed to evaluate huN901-DM1 for the treatment of relapsed multiple myeloma. To qualify for enrollment, patients must have relapsed or relapsed/refractory multiple myeloma that expresses the CD56-antigen targeted by huN901-DM1; approximately 70% of multiple myeloma cases express this antigen. All of the patients enrolled to date received four or more chemotherapeutic regimens prior to entering the study. HuN901-DM1 is the only anticancer agent administered during this trial.

In this study, huN901-DM1 is administered weekly for two consecutive weeks in a three-week cycle. A primary objective of the trial is to determine the maximum tolerated dose (MTD MTD Mounted
MTD Maximum Tolerated Dose
MTD Memory Technology Device
MTD Month To-Date
MTD Methadone (drug screening)
MTD motion to dismiss (legal)
MtD Mountain Dew
MTD Memory Technology Driver
) of huN901-DM1 in multiple myeloma patients with this dosing schedule. To establish the MTD, sequential new cohorts of patients receive increasing doses of huN901-DM1 until dose-limiting toxicity is encountered.

Two huN901-DM1 dose levels had been evaluated at the time of the ASH meeting: 40 mg/m2/day and 60 mg/m2/day. The MTD has not yet been defined and patient enrollment continues.

Evidence of antitumor an·ti·tu·mor   also an·ti·tu·mor·al
adj.
Counteracting or preventing the formation of malignant tumors; anticancer.

Adj. 1.
 activity was reported among the small group of patients receiving the higher of the two dose levels evaluated to date. One of the three patients receiving the 60 mg/m2/day dose had a minimal objective response by European Bone Marrow Transplant bone marrow transplant: see bone marrow.  (EBMT EBMT European group for Blood and Marrow Transplantation
EBMT Example-Based Machine Translation
) criteria. This patient had a 39% reduction in her serum M component, a disappearance of her urine M component, and no evidence of disease progression in her skeleton or bone marrow. She had previously been treated with thalidomide thalidomide (thəlĭd`əmĭd'), sleep-inducing drug found to produce skeletal defects in developing fetuses. The drug was marketed in Europe, especially in West Germany and Britain, from 1957 to 1961, and was thought to be so safe that , lenalidomide, multiple chemotherapy regimens, and radiation therapy. To date, this patient has received 12 cycles of treatment with huN901-DM1 (24 doses over 36 weeks). Another of the three patients receiving 60 mg/m2/day remained on treatment for five cycles, and the most recently enrolled patient has had stable disease for at least two cycles and continues to receive huN901-DM1.

Robert J. Fram, MD, Vice President, Clinical Development, commented, "These findings, while preliminary, are very encouraging. HuN901-DM1 has been well tolerated and a patient who failed multiple prior therapies had an objective response at the higher of the two doses evaluated to date."

HuN901-DM1 is designed to target and kill CD56-expressing cancer cells. The compound comprises the CD56-targeting antibody, huN901, and the potent cell-killing agent, DM1. Its antibody component serves to target the compound specifically to the cancer cells and its DM1 component functions to kill the cancer cells. Targeting of huN901-DM1 to the myeloma myeloma /my·elo·ma/ (mi?e-lo´mah) a tumor composed of cells of the type normally found in the bone marrow.

giant cell myeloma  see under tumor (1).
 cells in the marrow was confirmed in this study using immunohistochemistry. There have been no reports of clinically significant myelosuppression with huN901-DM1 either in this study or in the two studies underway that evaluate the compound 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.  and other CD56-expressing solid tumors.

Clinical Progress with AVE9633

Findings were published in an abstract (abstract #4548) to the ASH meeting on a second TAP compound, AVE9633, in development for the treatment of a hematological malignancy. This compound comprises the CD33-targeting antibody, huMy9-6, and the potent cell-killing agent, DM4, and is in Phase I clinical testing for the treatment of AML. AVE9633 was developed by ImmunoGen and licensed to sanofi-aventis, which is responsible for the clinical development of the compound.

The findings are from the first Phase I trial initiated with AVE9633. In this trial, the compound was dosed once per three weeks to provide information on the safety and pharmacokinetics of single administrations of AVE9633. The compound was found to be well tolerated: doses up to 260 mg/m2 were administered without dose-limiting toxicity.

The favorable tolerability profile of AVE9633 demonstrated in this first trial enables the compound to be evaluated in additional Phase I studies with a more frequent dosing schedule better suited to the highly proliferative nature of AML. A study evaluating AVE9633 when dosed weekly for two consecutive weeks in a four-week cycle is underway in Europe. While data from the European Phase I study have not yet been reported, to date they are encouraging.

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. Five anticancer compounds are in clinical testing through ImmunoGen and the Company's collaborators - huN901-DM1 and huC242-DM4, which are wholly owned by ImmunoGen, AVE9633 and AVE1642, in development by sanofi-aventis, and trastuzumab-DM1, in development by Genentech. Amgen (formerly Abgenix), Biogen Idec, Biotest AG, Boehringer Ingelheim, Centocor, Genentech, Millennium Pharmaceuticals, Inc., and sanofi-aventis have licensed the right to develop and/or test TAP compounds to specific targets; ImmunoGen also has a broader collaboration with sanofi-aventis.

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, 2006 and other reports filed with the Securities and Exchange Commission.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Dec 11, 2006
Words:1003
Previous Article:Hewitt Survey Shows Holiday Bonuses Continue to Decline in Popularity as Companies Turn to Pay-for-Performance Plans to Reward Employees.
Next Article:Covalent Technologies Adds Terracotta Clustering Capabilities to Enterprise Ready Server(TM).
Topics:



Related Articles
ImmunoGen, Inc. Announces Clinical and Preclinical Findings with TAP Compounds to be Presented at the AACR-NCI-EORTC International Conference on...
ImmunoGen, Inc. Announces Presentation of HuN901-DM1 Clinical Data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer...
Callisto Anti-Cancer Drug Atiprimod Chosen for Second High-Profile Oral Presentation at American Society of Hematology Meeting; Newly Released...
ImmunoGen, Inc. Announces Genentech Has Taken Fourth License to Use ImmunoGen's TAP Technology to Develop Novel Anticancer Therapeutics.
Callisto Cites New Research Data on Cancer Drug Atiprimod in Presentations at American Society of Hematology Meeting; Company Announces Plan for Next...
ImmunoGen, Inc. Grants Biotest AG Rights to Use ImmunoGen TAP Technology to Develop Novel Anticancer Therapeutics; ImmunoGen Has Opt-In Rights on...
ImmunoGen, Inc. Announces Presentation of HuC242-DM4 Clinical Data at EORTC-NCI-AACR Conference.
ImmunoGen Announces Initiation of Clinical Testing of AVE1642 Anticancer Compound in Collaboration with sanofi-aventis.
ImmunoGen, Inc. Announces Presentation of HuN901-DM1 Clinical Data At EORTC-NCI-AACR Conference Showing Compound is Well Tolerated and Demonstrates...
ImmunoGen, Inc. Announces Clinical Data Reported at ASCO.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles