[ peripheral interest, perhaps ]
Tuesday March 28, 7:00 am Eastern Time
Company Press Release
SOURCE: Aronex Pharmaceuticals, Inc.
Aronex Pharmaceuticals Initiates Phase II Clinical Trial
for Annamycin as A Treatment for Breast Cancer
THE WOODLANDS, Texas, March 28 /PRNewswire/ -- Aronex Pharmaceuticals, Inc. (Nasdaq: ARNX - news) announced
today the initiation of a Phase II clinical trial evaluating the use of Annamycin in refractory breast cancer patients, who
overexpress P-glycoprotein (PGP) in the tumor cell. It is now widely accepted that PGP acts as one of the principal
mechanisms to transport drugs out of the tumor cells, rendering the drugs ineffective. Once resistance develops, it often extends
to other chemotherapeutic agents, resulting in multidrug-resistant tumors. Annamycin is a novel liposomal anthracycline designed
to treat a broad range of cancers, including those that exhibit multidrug resistance, a limitation seen in a majority of cancer
patients. This trial is being funded by the United States Department of Defense and is being conducted by researchers at the
New York University School of Medicine, Kaplan Comprehensive Cancer Center.
Roman Perez-Soler, M.D., Associate Director of Clinical Oncology at the Kaplan Comprehensive Cancer Center, said,
``There are a number of products in clinical development designed to evade PGP; however, these products must be used in
combination with chemotherapy. Unlike these, Annamycin is a chemotherapeutic agent whose chemical structure has been
specifically designed to evade PGP giving the drug the opportunity to stay within the tumor cell. It is this contrast to
conventional chemotherapeutic agents that makes Annamycin such an interesting drug candidate. We are encouraged by the
favorable safety profile demonstrated in earlier clinical trials, especially in the area of cardiotoxicity and mucositis, a painful
inflammation of the lining of the mouth. We will now begin to accrue patients into this newly- designed breast cancer trial to
evaluate the efficacy of Annamycin in the treatment of breast cancer patients, some of whom are genetically predisposed to
resisting common cytotoxic agents.'
The Phase II clinical trial is an open label trial designed to evaluate the safety and efficacy of Annamycin as a treatment for
breast cancer. Patients who have failed prior therapy will be screened for multidrug resistance by expression of PGP in tumor
tissue, if available, and by a Sestamibi scan. Sestamibi is retained by tumors that do not express PGP. An effort will be made to
enroll patients who have evidence of multidrug- resistant tumors; however, this will not be mandatory for enrollment.
Annamycin is a chemical entity belonging to a class of widely prescribed anticancer agents known as anthracyclines. In addition
to multidrug resistance, Annamycin was designed to address the problem of cardiotoxicity. Cardiotoxicity resulting from the
administration of anthracyclines is usually cumulative and dose limiting. Some patients are required to discontinue their
anthracycline therapy due to this severe adverse event even though they may be responding well to their treatment.
Annamycin is also being evaluated in a Phase I/II clinical trial evaluating its potential use as a treatment in patients with
refractory or relapsed leukemia.
Aronex Pharmaceuticals, Inc. is a biopharmaceutical company that develops and commercializes proprietary innovative
medicines to treat cancer and infectious diseases. Aronex Pharmaceuticals currently has four products in clinical development,
two of which (ATRAGEN© and Nyotran©) are in an advanced stage. For more information about Aronex Pharmaceuticals,
please visit the Company's web site at aronex-pharm.com.
Aronex Pharmaceuticals Safe Harbor Statement
Any statements that are not historical facts, including statements regarding the Company's clinical development programs and
the expected time of clinical trials and NDA filings, contained in this release are forward-looking statements that involve risks
and uncertainties, including but not limited to the Company's early stage of development, clinical trial results, the uncertainty of
regulatory approvals in the U.S., history of operating losses, future capital needs and uncertainty of additional funding,
governmental regulation, intellectual property rights, limited sales and marketing experience, competition and technological
change, and other risks identified in the Company's Annual Report on Form 10-K for the year ended December 31, 1998, as
filed with the Securities and Exchange Commission.
SOURCE: Aronex Pharmaceuticals, Inc. |
