Just found this, sounds good to me. Been holding ARNX since Jul of 96.
Thursday March 27 3:04 PM EDT
Aronex and Genzyme Announce Atragen(TM) Developments
Positive Preliminary Data Reported for Acute Promyelocytic Leukemia and Kaposi's Sarcoma
THE WOODLANDS, Texas and CAMBRIDGE, Mass., March 27 /PRNewswire/ -- Aronex Pharmaceuticals, Inc. (Nasdaq/NNM: ARNX) and Genzyme General (Nasdaq/NNM: GENZ) today announced positive preliminary clinical trial results for Atragen(TM) in acute promyelocytic leukemia ("APL") and Kaposi's sarcoma ("KS"). The companies also announced that they have amended their agreement relating to Atragen(TM).
Preliminary safety data from an ongoing Phase II trial in APL indicate that Atragen(TM) was well tolerated, and reflected results obtained in the Phase I maximum tolerated dose trial. One hundred percent of first relapse patients (10 out of 10) have achieved a complete remission with Atragen(TM) monotherapy.
"At the end of 1997, we expect to file a New Drug Application (NDA) for the APL indication," said James M. Chubb, Ph.D., President of Aronex. "We further envision supplementing this initial NDA filing with additional data in Kaposi's sarcoma and other indications to broaden the labeling claim."
The companies also announced preliminary data from a Phase II/III trial of Atragen(TM) in AIDS patients with Kaposi's sarcoma. As reported previously, the Phase I human study demonstrated that Atragen(TM) can be safely delivered at high doses exceeding 120 mg/m2, which are maintained in the bloodstream for extended periods. Preliminary results from the Phase II/III trial indicate that the drug was generally well tolerated, with headache and dry skin being the primary reported adverse events. In this study, two dose regimens of Atragen(TM) were evaluated: once weekly versus thrice weekly dosing. In addition, dose levels ranging from 60 mg/m2 to 120 mg/m2 were evaluated. A total of 82 patients have been treated to date. A subset group of 13 Kaposi's sarcoma patients treated at a dose of 120 mg/m2 three times a week were evaluated using the AIDS Clinical Trials Group (ACTG) response criteria. In this evaluable subset of patients classified by investigators: 8 percent achieved a clinical complete response, 46 percent had a partial response or stable disease, and 46 percent showed progressive disease.
Aronex and Genzyme also announced that they have amended their agreement relating to the development of Atragen(TM). Under the revised agreement, Genzyme's rights will be converted to an option to commercialize Atragen(TM). If Genzyme exercises its option, Aronex will receive cash payments of $5.0 million, $2.0 million of which have already been paid. Aronex will also receive royalties on sales and equal co-promotion rights in the United States. If Genzyme does not exercise its option, Aronex will reacquire worldwide rights by paying Genzyme $2.0 million in cash and capped royalty payments on product sales.
"This revised agreement provides Aronex with complete control over the development of Atragen(TM) and greater potential return on its investment, while allowing Genzyme to continue to participate in the commercialization of the product," said Dr. Chubb.
Henri A. Termeer, Genzyme's Chairman and Chief Executive Officer said, "The changes implemented in the Atragen(TM) agreement enhance our flexibility to pursue our internal molecular oncology program while retaining an option to assist in commercializing Atragen(TM)."
Genzyme Corp., a biotechnology and health care products company, focuses on developing innovative products and services for major unmet medical needs.Genzyme General develops and markets pharmaceuticals, genetic diagnostic services, and diagnostic, surgical, and specialty therapeutic products. Its drug discovery unit uses combinatorial chemistry and high-throughput screening to develop small molecule therapeutics for the treatment of cancer, infectious diseases, and autoimmune/inflammatory diseases.
Aronex Pharmaceuticals, Inc. is a leading biopharmaceutical company engaged in the identification and development of proprietary innovative medicines to treat cancer and life-threatening infectious diseases. Aronex currently has four products (Nyotran(TM), Atragen(TM), Annamycin and Zintevir(TM)) in various stages of ongoing clinical development and a number of products in preclinical development.
Any statements which 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 and the outcome of governmental proceedings, 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. SOURCE Aronex Pharmaceuticals, Inc. |
