ARONEX PHARMACEUTICALS ANNOUNCES EXPANDED CLINICAL DEVELOPMENT PROGRAM FOR
Annamycin
- Annamycin Being Evaluated in Leukemia -
THE WOODLANDS, Texas, April 26 /PRNewswire/ -- Aronex Pharmaceuticals, Inc. (Nasdaq: ARNX) announced today the initiation of a Phase I/II clinical trial evaluating the use of Annamycin in patients with refractory or relapsed leukemia. Annamycin is a novel liposomal anthracycline designed to treat a broad range of cancers, including those that exhibit multiple drug resistance.
"This expansion complements our strategy to evaluate the efficacy of Annamycin in a variety of solid tumors, leukemias and lymphomas," said Geoffrey F. Cox, Ph.D., Chairman and CEO of Aronex Pharmaceuticals. "Leukemia is our second indication under evaluation for Annamycin. We expect this to be an important step to further strengthen our clinical program and promote the detection of Annamycin's best developmental pathway."
Annamycin is a chemical entity belonging to a class of widely prescribed anticancer agents known as anthracyclines. Annamycin was designed to overcome two major limitations seen in anthracyclines that are currently on the market: cardiotoxicity and multiple drug resistance. 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. In addition, activity against tumors that are refractory to other agents is a potential advantage of Annamycin. Cancer cells often develop a resistance to anthracyclines, rendering the drugs ineffective. Once resistance develops, it often extends to other chemotherapeutic agents, resulting in multiple-drug-resistant tumors.
The Phase I/II clinical trial has been designed to document the antitumor activity and define the maximum tolerated dose of Annamycin in patients with refractory or relapsed acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL) or blast crisis of chronic myelogenous leukemia (CML). According to the American Cancer Society, for 1999 the incidence of these three indications is estimated to be approximately 86,100 new cases annually in the United States, with more than 43,900 patients dying each year. Despite the fact that 80% to 90% of patients achieve a complete remission following intensive induction with chemotherapy, more than 50% of the patients relapse, often because of the recurrence of disease associated with clinical drug resistance. It is now widely accepted that the P-glycoprotein pump acts as one of the principal mechanisms to transport drugs out of the tumor cells, including most types of anticancer drugs. Annamycin was specifically designed to avoid the P-glycoprotein pump giving the drug the opportunity to stay within the cell.
The Company presented promising preclinical data for Annamycin at the recent American Association of Cancer Research annual meeting. The data presented stated that results of a study comparing Annamycin to doxorubicin, a commonly-used anthracycline, reflected Annamycin's ability to circumvent multiple drug-resistant transporters including P-glycoprotein, MRP1 and MRP2.
Aronex Pharmaceuticals, Inc. is a biopharmaceutical company that develops and commercializes proprietary innovative medicines to treat cancer and infectious diseases. Aronex Pharmaceuticals currently has five products in clinical development, two of which (ATRAGEN(R) and NYOTRAN(R)) are in an advanced stage, as well as a pipeline of additional products. In late 1998, the Company filed a New Drug Application for ATRAGEN (an injectable form of all-trans retinoic acid or tretinoin) for the treatment of patients with acute promyelocytic leukemia for whom therapy with tretinoin is necessary but for whom an intravenous administration is required. In 1998, the Company licensed NYOTRAN, its novel antifungal agent, to Abbott Laboratories, providing them with exclusive worldwide rights to market and sell this product.
Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including but not limited to those relating to product demand, pricing, market acceptance, the effect of economic conditions, intellectual property rights and litigation, clinical trials, governmental regulation, competitive products, risks in product and technology development, the ability to raise additional capital when needed and on acceptable terms, and other risks identified in the Company's Securities and Exchange Commission filings. SOURCE Aronex Pharmaceuticals, Inc.
-0- 04/26/99 /CONTACT: Connie Stout, Associate Director, Corporate Communications of Aronex Pharmaceuticals, Inc., 281-367-1666; or Theresa McNeeley or Karen Drake, both of Feinstein Kean Partners Inc., 508-490-0954, for Aronex Pharmaceuticals, Inc./
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