Aronex Pharmaceuticals Reports Phase II Data on Nyotran(R) in Patients With Invasive Aspergillus Infections.
THE WOODLANDS, Texas, Sept. 19 /PRNewswire/ --
Aronex Pharmaceuticals, Inc. (Nasdaq: ARNX), announced the presentation of clinical, preclinical and pharmacokinetic data for the investigational new drug Nyotran(R) in four different sessions at the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting held in Toronto, Ontario, Canada. Nyotran(R) is Aronex Pharmaceuticals' proprietary liposomal formulation of nystatin under development for the treatment of systemic fungal infections. The Company anticipates submission of a New Drug Application (NDA) for Nyotran(R) with the United States Food and Drug Administration in 2001.
Anthony H. Williams, M.D., Vice President of Medical Affairs at Aronex Pharmaceuticals, said, "We are very pleased to be able to report such a broad range of data at this year's ICAAC meeting. All of these studies are most valuable and assist us in obtaining a much better understanding of Nyotran(R). They are an important part of our extensive preclinical and clinical development programs for this product."
1. Phase II Clinical Trial in Refractory or Intolerant Patients with
In a completed Phase II clinical trial of Nyotran(R) conducted by investigators from the European Organization for Research and Treatment of Cancer (EORTC), 24 patients with definite or probable invasive Aspergillus were treated with Nyotran(R) at 4 mg/kg/day. These patients were either intolerant to (3 out of 24) or had failed treatment with conventional and/or liposomal amphotericin B (21 out of 24). The investigators found that Nyotran(R) was well tolerated with objective responses observed in 6 out of 19 fully evaluable patients. Mycological response was seen in 5 of the 19 patients. Seven out of 16 evaluable patients who were refractory to amphotericin B were alive on day 30 after treatment with Nyotran(R) ended.
In addition to the clinical data, preclinical and pharmacokinetic data were presented at the meeting in three separate sessions:
2. Comparative Urinary Pharmacokinetics and Drug Disposition of
Multilamellar Liposomal Nystatin and Amphotericin B
In a study conducted by researchers at the National Cancer Institute, the urinary pharmacokinetics and disposition of Nyotran(R) (2, 4 or 6 mg/kg) and amphotericin B (1 mg/kg) were investigated in normal rabbits. The doses used in this study are similar to those used in human clinical trials. The researchers reported striking differences in the disposition of the two compounds: at 24 hours, independent of the dosage, less than 0.5% of the Nyotran(R) dose was recovered from the liver, spleen, kidneys and lung; whereas, with amphotericin B, 25% of the dose was found in the liver.
3. Efficacy of Nyotran(R) in the Treatment of Disseminated Candidiasis in
Neutropenic Guinea Pig Model
Researchers from two centers in Cleveland, Ohio compared the efficacy of Nyotran(R) (3 mg/kg intravenously) with amphotericin B (0.75 mg/kg intrapleurally) using a neutropenic guinea pig model of candidiasis. The data indicated that although amphotericin B treatment prolonged animal survival relative to untreated controls, all animals succumbed to infection within the treatment period; however, Nyotran(R) treatment significantly reduced animal death relative to untreated controls. Further, amphotericin B was not as efficacious as Nyotran(R) in clearing the Candida albicans fungi from the kidneys.
4. Differential In Vitro Antifungal Activity of Nystatin Peak 1 and Peak 2
Using four Candida species, researchers from the University of Texas Medical School investigated the in vitro antifungal activity of amphotericin B, nystatin and the two distinguishable chromatographic peaks (Peak 1 and Peak 2) that develop when nystatin is used in vivo. The data from the analysis indicated that Peak 1 is the principal active component of nystatin.
To view the abstracts and presentations, please visit the 40th anniversary ICAAC website at www.asmusa.org/mtgsrc/40icaac.htm.
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(R) and Nyotran(R)) are in an advanced stage. For more information about Aronex Pharmaceuticals, please visit the Company's web site at http://www.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 regulatory 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, 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 first amendment to its Annual Report on Form 10-K/A for the year ended December 31, 1999, as filed with the Securities and Exchange Commission.