Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
Reuters NewMedia, Inc.; Thursday September 10, 1998
Lodenosine is a reverse transcriptase inhibitor that is reported to have an encouraging resistance profile, meaning laboratory tests have shown that the drug kills viral strains that have shown resistance to other available HIV drugs.
The company plans to begin its multicenter Phase II trial of lodenosine in combination with stavudine, whose brand name is Zerit, and indinavir sulfate, whose brand name is Crixivanr, in previously untreated HIV patients.
To expedite this 48-week study, U.S. Bioscience has contracted with the firm PPD Pharmaco, which has experience in HIV/AIDS therapeutics.
U.S. Bioscience said it is working with the National Cancer Institute under a cooperative research and development agreement.
The institute is conducting Phase I/II dose escalation trials in adults and pediatrics. Data from 25 adult patients participating in the Phase I dose escalation trial of 12 weeks of single agent lodenosine was presented this year at the World AIDS Conference in Geneva in June.
Results indicated that the drug had good oral bioavailability and was well tolerated. In eight patients tested at the two highest dose levels, 1.6 mg/kg and 3.2 mg/kg administered twice a day, results showed a median decrease in viral load of -0.42 log10 copies/ml by the sixth week.
Some 19 of the 25 patients in this study had previously received more than six months of multiple anti-retroviral therapies.
"Laboratory studies of resistance, combined with the results of this trial, suggest that lodenosine has relatively little cross-resistance with other commercially available anti-HIV drugs," said Dr. Robert Yarchoan of the National Cancer Institute in a statement.
Earlier this year, the National Cancer Institute amended the protocol to assess the efficacy of a more convenient, once daily dose of lodenosine in combination with stavudine and nelfinavir, known also as Viracept.
"The emerging profile of lodenosine suggests that it has the opportunity to be an important treatment for patients with AIDS," said C. Boyd Clarke, chief executive of U.S. Bioscience, in a statement. "We look forward to initiating trials and accelerating the development of this anti-HIV therapy."
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