novel anti-HIV treatment
Yale has granted Oncolys BioPharma Inc. of Tokyo the global exclusive right for clinical and business development of a novel compound for the treatment of HIV.
A patent application has been submitted by Yale for 2',3'-Didehydro-3'-Deoxy-4'-Ethynylthymidine, or Ed4T, a compound with a new and potentially effective anti-HIV clinical treatment.
Ed4T is a thymidine analogue that blocks HIV-1 reverse transcriptase, the enzyme that is essential for viral replication. The compound was discovered and developed jointly by Professor Masanori Baba of Kagoshima University and Professor Hiromichi Tanaka of Showa University in Japan, and Yung-Chi Cheng, the Henry Bronson Professor of Pharmacology at Yale's School of Medicine.
"This license agreement was possible because Yale has shown keen appreciation of our corporate philosophy -- pharmaceutical development creating timely remedies for maximum patient relief," says Yasuo Urata, president and chief executive officer of Oncolys BioPharma. "We will give this project our concentrated effort so that patients worldwide can have the benefit of Ed4T as soon as possible." Pre-clinical studies have already begun and Oncolys BioPharma will accelerate the studies with a target of initiating Phase I/II clinical trials in 2008.
An estimated 20 million people worldwide have died from AIDS, and 40.3 million are infected with the virus. In 2004, a reported 1,000 patients in Japan were infected, and the number is soaring.
Since 1985, when AZT was introduced into clinical practice, 18 products have been approved and commercialized worldwide as anti-HIV-1 treatment. The drugs are in four categories, according to their various modes of action and chemical structures. Of the available drugs, seven are nucleoside-analogue reverse transcriptase inhibitors (NRTIs), three are non NRTIs (NNRTI), seven are protease inhibitors, and one is a fusion inhibitor.
The current standard treatment for AIDS is highly active anti-retroviral therapy (HAART), a combination regimen including drugs with different modes of action. HAART has two standard regimens: either treatment with two NRTIs plus one or two Protease Inhibitor(s), or treatment with two NRTIs plus one NNRTI.
However, during long-term treatment with anti-HIV-1 drugs, patients can develop a resistant strain of the virus, and require a new drug to counter the mutation.
Pharmacological studies have demonstrated that Ed4T has more potent anti-HIV activity than the existing NRTI and is active against those viruses that are resistant to the existing NRTI and NNRTI drugs. Further, Ed4T does not affect DNA synthesis in mitochondria, a toxic side effect of some nucleotide analogues. These findings suggested that Ed4T might offer unique therapeutic advantages over existing anti-HIV drugs.
-- By Janet Rettig Emanuel
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