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CLTR 27.125 -2.937
Wednesday April 5, 7:02 am Eastern Time
Company Press Release
Coulter Pharmaceutical Announces Preferential Tumor Activation and Tumor Inhibition With Prodrug CPI-0004
SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--April 5, 2000-- Coulter Pharmaceutical (Nasdaq:CLTR - news) today announced promising data from preclinical studies of its CPI-0004 tumor activated prodrug (TAP), a prodrug version of the anticancer agent, doxorubicin.
The data supported preferential activation of a doxorubicin prodrug within the tumor environment leading to increased anti-tumor activity and reduced toxicity to normal tissues. In addition, tumor inhibition was more pronounced and more durable in breast and colon tumor models treated with CPI-0004 compared to doxorubicin alone.
The data were presented in two poster presentations at the 91st Annual Meeting of the American Association for Cancer Research by Andre Trouet, M.D., Ph.D., professor of Cellular Pharmacology and head of Cell Biology at Universite Catholique de Louvain in Belgium, and consultant to Coulter Pharmaceutical, Inc.
The preclinical results showed that the prodrug CPI-0004 was more effective than doxorubicin in inhibiting tumor growth, as well as being four- to sixteen-fold better tolerated. In an aggressive colon tumor model known to be resistant to doxorubicin, CPI-0004 produced a 65 percent reduction in tumor volume compared to doxorubicin treatment.
In a second colon cancer model which is doxorubicin-sensitive, tumor volume remained stable even after withdrawal of CPI-0004 treatment while regrowth was observed immediately in groups treated with doxorubicin. In a breast cancer model, CPI-0004 showed significantly better anti-tumor activity than doxorubicin.
``Through these preclinical data, we believe we have further established proof-of-principle of our tumor activated prodrug technology,' said Michael F. Bigham. ``The activation mechanism in our TAP technology has made a more potent, less toxic version of the powerful anticancer agent doxorubicin. We intend to complete our preclinical and scale up work on CPI-0004 by the end of this year with the goal of beginning human clinical trials next year.'
Greater drug tolerance was observed with CPI-0004 which permitted 3 to 16 fold higher doses of doxorubicin. These more potent dose levels with CPI-0004 are believed to be possible due to preferential activation of doxorubicin at the tumor site.
Coulter is developing tumor activated pro-drugs to enhance the specificity of chemotherapeutic agents for tumor cells. TAP prodrugs are designed to remain stable in circulation until being activated preferentially at the tumor site by enzymes secreted by the tumor. As a result, relatively larger quantities of cytotoxic agents are expected to reach and enter malignant cells compared to normal cells.
This could permit a significant increase in maximum tolerated dosages, potentially overcoming drug resistance in some cancer cells. The lead product candidate, CPI-0004 is a prodrug version of doxorubicin and represents proof-of principle of a new platform technology.
Doxorubicin is an off-patent chemotherapeutic drug which currently is used in the treatment of a number of solid tumor cancers, including breast, prostate and ovarian cancers. The prodrug technology is protected by a recently granted U.S. patent.
Coulter Pharmaceutical, Inc. is engaged in the development of novel drugs and therapies for the treatment of cancer and autoimmune diseases. The company currently is developing a family of therapeutics based upon two drug development programs: therapeutic antibodies and targeted oncologics.
The company's most advanced product candidate is Bexxar(TM), a monoclonal antibody conjugated to a radioisotope. The company's therapeutic antibodies program also includes an interferon receptor antagonist. Initial efforts in the targeted oncologics program are based on tumor activated prodrug (TAP) and tumor-specific targeting (TST) technologies. For more company information, visit Coulter Pharmaceutical's web site at coulterpharm.com.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements for Coulter Pharmaceutical, Inc. that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of Bexxar(TM) or the company's other product candidates and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission (SEC). In particular, see ``Risk Factors' in the company's filed Form 10-K for the year ended December 31, 1999.
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Contact:
Coulter Pharmaceutical, Inc.
Sylvia Wheeler, 650/553-2000 |
