The Liposome Company Inc. on Wednesday reported favorable resultsfrom trials for their antifungal drug amphotericin B Lipid Complex(ABLC).The Princeton, N.J. company briefed analysts on its clinicaldevelopment program Tuesday, and gave them a preview of data thatwill be presented Oct. 7 at the Interscience Conference onAntimicrobial Agents and Chemotherapy conference in Orlando, Fla.The company said that an abstract to be presented shows 69 percent of183 patients (who were treated on a compassionate use basis)responded to treatment with ABLC. The patients had failed treatmentwith conventional amphotericin and/or other systemic antifungal drugs.Investigators also reported a statistically significant improvement inkidney function in patients who had suffered nephrotoxicity, inducedby prior administration of free amphotericin B.Separately, ABLC is in Phase III trials in the U.S. for patients withaspergillosis refractory to standard therapy, and as a comparative test todetermine the effectiveness of ABLC vs. amphotericin B in treatingfungal infections in patients receiving cancer chemotherapy or bonemarrow transplants.The company said ABLC, which incorporates amphotericin B in a lipidcomplex, may reduce the toxicity of conventional amphotericin B aswell as allowing for larger doses.Liposome Company has filed for marketing approvals in eightEuropean countries, and told analysts it could gain approval in some ofthe markets by early 1995. The company told analysts it plans to file anew drug application in the U.S. in the fourth quarter of 1995.Brooks Boveroux, vice president, finance and chief financial officer forthe company, told BioWorld that "we are continuing to accumulatepositive clinical data on ABLC. Our cash resources continue to bestrong [$97 million in cash as of June 30, and burning $11 million perquarter], allowing us to continue to aggressively develop our products."At this point we have no partners for ABLC, but we are looking on aselected country-by-country basis to enter into co-promotion or other,similar types of agreements," Boveroux said. "In the U.S. our currentintention is to develop and market the product ourselves."He said the company also is planning to seek marketing approvals inanother 10 countries. "Data we are using for our submissions arecoming from a number of different sources," said Boveroux, whowould not elaborate. But the company said it has treated more than1,000 patients with ABLC in clinical trials and emergency-useprotocols in the U.S. and Europe.The company revealed to analysts, for the first time, its detailed marketresearch study on ABLC, according to D. Larry Smith of Hambrecht &Quist Inc., who said the analysis showed the market where the productwould compete is $500 million, $200 million of which is in the U.S.The company said it expects Phase III trials of another drug TLC D-99(liposomal doxorubicin) to begin by the end of the year. Smith said thecompany disclosed for the first time that it conducted a 60-patient trialcomparing the cardiotoxicity of D-99 to doxorubicin. n
-- Jim Shrine
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