To: Rich1 who wrote (63314 ) 9/27/1999 9:07:00 AM From: kendall harmon Respond to of 120523
ARNX--the pr newswire version THE WOODLANDS, Texas, Sept. 27 /PRNewswire/ -- Aronex Pharmaceuticals, Inc. (Nasdaq: ARNX - news), announced a late breaker presentation of Phase III data at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting held in San Francisco, California, demonstrating that NYOTRAN® and amphotericin B were equivalent in treating presumed fungal infections as defined by the protocol, and NYOTRAN had less renal toxicity compared with amphotericin B. In addition to the Phase III data, the Company presented in vitro data of NYOTRAN at a separate session. NYOTRAN is Aronex Pharmaceutical's proprietary liposomal formulation of nystatin under development for the treatment of systemic fungal infections. The Company's goal is to submit a New Drug Application (NDA) with the United States Food and Drug Administration by the end of the year. Anthony H. Williams, M.D., Vice President of Medical Affairs at Aronex Pharmaceuticals, said, ''We are pleased to be able to report that data from the Phase III study demonstrate a favorable profile for NYOTRAN compared to amphotericin B in the treatment of patients with presumed fungal infection. The results indicate efficacy with less renal toxicity, a common side effect with current therapies. This study is an important part of an extensive clinical development program that is also evaluating NYOTRAN in a broad range of confirmed fungal infections.'' In the completed Phase III clinical trial of NYOTRAN as reported in the ICAAC presentation, 538 neutropenic patients who had failed previous antibacterial therapy were enrolled at clinical sites in the United States and Europe. In the modified intent-to-treat population, 65 NYOTRAN patients (36%) were successes compared to 66 amphotericin B patients (39%). Amphotericin B patients experienced significantly more renal adverse events and hypokalemia. They also had a significantly greater frequency of metabolic and nutritional disorders compared with NYOTRAN patients. In Vitro Interaction Study with NYOTRAN and Conventional Antifungals, Antibiotics, Antivirals, and Immunosupressive Drugs Against Common Fungal Pathogens Investigators from the Center for Medical Mycology at Case Western Reserve University in Cleveland, Ohio presented data from an in vitro study designed to evaluate the susceptibility effects of using NYOTRAN in combination with conventional antifungals and antibiotics. Three isolates each of Candida albicans, Candida glabrata, Candida krusei, Cryptococcus neoformans and Aspergillus fumigatus were tested. The data showed that NYOTRAN in combination with amphotericin B was active against two out of three isolates and additive against one out of three Candida glabrata isolates. NYOTRAN was additive in combination with itraconazole or flucytosine against three Candida krusei isolates, and was additive in combination with amphotericin B against two out of three Aspergillus fumigatus isolates. There were sporadic additive results with other fungi, but the remainder of the results showed indifferent interactions. In 1998, the Company licensed NYOTRAN to Abbott Laboratories providing them with exclusive worldwide rights to market and sell this product. The Company will have the opportunity to co-promote NYOTRAN within the United States and Canada for a period of at least two years. Abbott Laboratories will be responsible for registration of NYOTRAN in other countries outside the United States. To date, the Company has received $14.7 million in payments under this license agreement, and $3.0 million related to a stock purchase agreement.biz.yahoo.com