To: Sam Lee who wrote (152 ) 9/21/1998 1:56:00 PM From: Robert Floyd Respond to of 320
I think this release provides a more complete picture of what they are trying to do with ARONEX: ARONEX PHARMACEUTICALS ANNOUNCES EXPANDED CLINICAL DEVELOPMENT PROGRAM FOR ATRAGENr -- ATRAGENr being evaluated in non-Hodgkin's lymphoma -- -------------------------------------------------------------------------------- The Woodlands, Texas, July 21, 1998 -- Aronex Pharmaceuticals, Inc. (Nasdaq National Market: ARNX), a biopharmaceutical company focused on proprietary medicines to treat cancer and infectious diseases, announced today an expanded clinical development program for ATRAGENr, its proprietary liposomal formulation of all-trans retinoic acid (ATRA) for the treatment of hematologic malignancies and solid tumors. The Company has begun to evaluate ATRAGEN in a Phase II clinical trial in patients diagnosed with non-Hodgkin's lymphoma. In addition, enrollment has been completed for the ATRAGEN pivotal Phase II clinical trials in acute promyelocytic leukemia. The Company anticipates a year-end 1998 filing of a New Drug Application (an "NDA") for this indication. In commenting on the expanded ATRAGEN clinical development program, Geoffrey F. Cox, Ph.D., Chairman and CEO of Aronex Pharmaceuticals, said, "We are very pleased that we have completed enrollment of our pivotal Phase II clinical trial as planned. The Company believes ATRAGEN could have potential in a number of further cancer indications. Like oral ATRA, clinical trials indicate that ATRAGEN acts by inducing tumor cells to differentiate into mature cells that do not proliferate abnormally. Unlike oral ATRA, ATRAGEN's liposomal formulation sustains higher blood levels over long periods of time thus extending the potential effectiveness of the drug. The Company believes that ATRAGEN could be a complementary treatment to conventional chemotherapy. A positive clinical impact in one or all of the identified additional indications would have a substantial impact on the market potential for ATRAGEN and will help to define the product's potential future role." The Company has initiated a multi-center Phase II study of ATRAGEN in patients with relapsed or refractory non-Hodgkin's lymphoma. This study will evaluate the ability of ATRAGEN to induce a response in this population as well as establish the optimal dose. According to the American Cancer Society, there are more than 55,000 cases of non-Hodgkin's lymphoma diagnosed every year. Worldwide, this could be translated into approximately 100,000 cases. This clinical indication was chosen based on the in vitro work of Richard Ford, M.D. Ph.D. of the University of Texas, M.D. Anderson Cancer Center. In the October 1997 issue of Cell Growth & Differentiation, Dr. Ford showed that ATRAGEN is substantially more potent than free ATRA in inhibiting the growth of B-cell non-Hodgkin's lymphomas taken from patients. Other retinoids have shown only modest inhibition of cell growth and only at considerably higher concentrations. In addition, ATRAGEN induced a high level of apoptosis (programmed cell death). The Company's expanded ATRAGEN clinical trial program is expected eventually to encompass the evaluation of ATRAGEN in a number of other hematologic malignancies and solid tumors. 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 advanced clinical development, two of which are in an advanced stage, as well as a pipeline of additional products. Any statements which are not historical facts, including statements regarding the Company's clinical development programs and the expected timing of clinical trials and NDA filings, 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 results of financing efforts, the ability to complete transactions and other risks identified in the Company's Securities and Exchange Commission filings.