Anti-HIV Drug Invented by Emory University Scientists Continues Development
Through Pharmaceutical Collaboration
ATLANTA — Incyte Corporation and Pharmasset, Ltd., have announced a
licensing collaboration to continue development and commercialization
of an anti-HIV drug invented by scientists at Emory University. The
antiretroviral drug Reverset™, also known as RVT, D-D4FC or DPC-817
is currently in Phase IIa clinical trials and is targeted to HIV patients
who have developed resistance to common antiretroviral drugs.
Reverset was invented by Emory University scientists Raymond F. Schinazi,
PhD and Dennis Liotta, PhD. It originally was licensed in 1998 to Pharmasset,
a company partially co-founded by Emory University scientists to discover,
develop, and commercialize novel antiviral and anticancer drugs. As
part of the collaborative agreement between the companies, Incyte is
sub-licensing certain of the rights originally licensed by Emory to
Reverset is an oral, once-a-day nucleoside analog that inhibits HIV-1
and HIV-2 by targeting the reverse transcriptase, which is part of the
cellular machinery that allows the virus to copy itself. In preclinical
studies Reverset inhibited the replication of wild type and mutant strains
of HIV that commonly arise after patients are treated with the antiretroviral
drugs zidovudine (ZDV) and lamivudine (3TC). The preclinical studies
also showed that Reverset does not produce a common toxicity associated
with certain anti-HIV drugs that can lead to serious and sometimes life-threatening
bone marrow suppression.
Following approval by the FDA as an Investigational New Drug (IND) Reverset
was tested in Phase I safety studies in 56 HIV-positive male volunteers.
It was well tolerated, with mild effects that occurred no more frequently
than with placebo. Pharmasset is currently conducting a dose-escalating
Phase II clinical trial of Reverset in HIV patients who have not been
treated with other anti-HIV drugs. A second Phase II trial, testing
Reverset in combination with other antiretroviral drugs in patients
already undergoing drug therapy, is expected to begin early in 2004.
"We are extremely proud of the continued success of our Emory scientists
in discovering innovative new drugs to treat HIV," said Frank Stout,
Emory vice president for research. We are optimistic that this collaboration
between Incyte and Pharmasset will further accelerate the development
and availability to patients of this new therapy."
According to Dr. Schinazi, "We are very pleased that the basic science
conducted at Emory University resulted in a highly potent drug, Reverset,
that is the cornerstone technology of this collaboration and license
agreement. The Pharmasset-Incyte deal will accelerate the clinical development
of this nucleoside towards a U.S. FDA New Drug Application (NDA) filing
and eventual commercialization. Scientifically, Reverset has the potential
to become the best drug in its class and that scenario would result
in a win-win situation for Emory, Pharmasset, Incyte and the individuals
infected with HIV."
Emory University is a world leader in AIDS research, addressing the
epidemic through the development of widely used anti-HIV drugs and promising
HIV vaccine candidates, renowned research in prevention and behavioral
sciences, and clinical trials within highly regarded treatment facilities.
The Emory Center for AIDS Research (CFAR) is a designated NIH research