New released today. Stock uo 1/2 to 9
THE WOODLANDS, Texas, Nov. 21 /PRNewswire/ -- Aronex Pharmaceuticals, Inc.
(Nasdaq/NNM: ARNX) today reported interim results from a Phase II/III multiple center study of Nyotran(TM), its liposomal formulation of the antifungal drug nystatin. Nyotran(TM) was evaluated in patients with proven candidemia, a life-threatening systemic fungal infection carried in the blood. In this study, 74 percent of the evaluable patients treated with Nyotran(TM) responded to therapy, remaining free of infection six weeks post treatment. In addition, the drug was well tolerated. Nyotran(TM), the Company's lead product, is also currently undergoing Phase III trials comparing it directly to the standard therapy for systemic fungal infections.
In the Phase II/III trial, Nyotran(TM) was administered to 33 seriously ill, hospitalized patients at a dose of 2 mg/kg daily for a median of 13 days (minimum 5, maximum 28). A clinical and microbiological cure was observed at six weeks post treatment in 74 percent of the evaluable patients treated. In addition, Nyotran(TM) was well tolerated. The investigators assessed no reports of drug-related fever and chills, which are often associated with
other therapies for systemic fungal infections. Another common side effect for these therapies is an elevation in serum creatinine levels, an indicator of potential kidney function impairment. To date, only six percent of the patients in the Phase II/III trial have experienced a doubling of serum creatinine.
"These results suggest that Nyotran(TM) may be an effective and safe alternative to currently available systemic antifungal therapies, said James M. Chubb, Ph.D., president of Aronex. Double-blind, comparative Phase III trials of Nyotran(TM) are ongoing in the United States and in Europe. We expect to complete the U.S. Phase III trial in late 1997 and file an NDA soon thereafter."
Nyotran(TM) is a lipid-based, intravenous formulation of nystatin, an established, widely used topical antifungal agent. The product is being developed for the treatment of serious systemic fungal infections which occur in hospitalized patients with suppressed immune systems due to cancer chemotherapy, other immunosuppressive therapies and AIDS. Over 200,000 individuals worldwide are believed to develop systemic fungal infections annually.
Aronex Pharmaceuticals, Inc. is a leading biopharmaceutical company engaged in the discovery and development of proprietary innovative medicines to treat cancer and life-threatening infectious diseases. Aronex currently has four products (Nyotran(TM), Atragen(TM) (TretinoinLF), 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.
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