Myriad Genetics Submits IND on Vivecon
Novel Mechanism of Action, Active Against Drug-Resistant HIV
Salt Lake City, UT, December 04, 2007—Myriad Genetics, Inc. (NASDAQ:
MYGN) announced today that it has
submitted an Investigational New Drug (IND) application to the United
States Food and Drug Administration to begin human clinical trials
with its drug candidate,
Vivecon™ (MPC-9055), for the treatment of AIDS.
Vivecon is a novel, small-molecule drug candidate that Myriad has
designed to be taken orally and to inhibit viral maturation. The drug
candidate inhibited viral particles from reaching maturity, so they
were incapable of infecting other cells, by targeting the capsid-SP1
cleavage site in the HIV Gag protein. One of the last steps in viral
maturation is the enzymatic cleavage of capsid from SP1 by the viral
protease. Vivecon is believed to inhibit this cleavage step by
binding with the capsid-SP1 junction in Gag, leading to inhibition in
development of the viral core. It does not inhibit HIV protease
itself.
Vivecon is the first Myriad
anti-viral drug candidate, among several
in development, to advance into human clinical trials. Myriad's
anti-viral drug discovery program began with the discovery of the
interaction between the HIV Gag protein and the human host protein,
TSG101, in the viral budding/maturation pathway of HIV. This research
was published in the October 5, 2001 issue of the scientific journal CELL, where it was featured
as the cover article. Myriad scientists
have made subsequent discoveries regarding the biology of HIV viral
particle maturation, viral fusion with host cells and intra-cellular
events in the life cycle of HIV which has enabled Myriad to identify
additional novel targets which may inhibit HIV infection.
This work resulted in the development of Vivecon, which Myriad
believes is a unique viral maturation inhibitor, and MPI-451936, a
novel, orally-available, small molecule fusion inhibitor against HIV
virus. MPI-451936 targets viral Gp41 protein and uniquely inhibits
fusion of HIV virus that utilizes the CXCR4 co-receptor, instead of
the more common CCR5 co-receptor.
Vivecon has been tested extensively for anti-viral activity and
safety with both in-vitro and in-vivo models, in preclinical studies.
It demonstrated anti-viral activity of less than 10 nanomolar IC50
against the HIV virus, with at least a 1,000-fold therapeutic safety
index. Vivecon was also shown to be active against viral strains that
are resistant to the currently marketed anti-HIV drugs, including
nucleoside reverse transcriptase inhibitors such as AZT™,
non-nucleoside reverse transcriptase inhibitors such as Efavirenz™
and protease inhibitors such as Ritonavir™. Vivecon has also shown
a well-tolerated safety profile in a variety of preclinical studies.
"We are very pleased to begin human clinical trials with this
exciting new drug candidate for the treatment of AIDS," said Adrian
Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. "Vivecon is
an important addition to our pipeline of drug candidates in
development to treat some of the most serious, costly and devastating
diseases of our time. It is also the first in a series of compounds
that we hope to develop for the treatment of viral diseases."
The current clinical development plan for Vivecon is designed to
expedite the drug candidate through the clinical development path. The
first Phase 1 trial is intended to assess the pharmacokinetics,
absorption and tolerability of the compound. This trial is formatted
as a single ascending dose in healthy volunteers. Assuming successful
completion of Phase 1, the plan calls for the rapid initiation of a
Phase 2a multiple ascending dose trial in HIV-infected individuals to
evaluate safety, pharmacokinetics and Vivecon's ability to inhibit
viral replication. Myriad believes this should permit Vivecon to skip
the more conventional Phase 2 clinical trial and potentially move
more quickly into Phase 3 studies.
According to the U.S. Centers for Disease Control and Prevention
(CDC), there are approximately 1.1 million persons in the United
States living with HIV/AIDS. In 2005, the estimated number of new
diagnoses of AIDS in the United States and dependent areas was 41,897
per year. The estimated number of deaths in 2005 of persons with AIDS
in the United States and dependent areas was 17,011.
According to the United Nations UNAIDS program, over 33 million
people throughout the world are living with HIV/AIDS, and over 22
million people have died from the disease. Some 2.5 million people
were newly infected with the virus in 2007, or 6,800 new infections
every day.
While the widespread availability of antiretroviral and other drugs
in North America has helped the number of AIDS-related deaths there to
remain relatively low, the challenge has become managing these
patients, due to the increase in viral resistance to the current
classes of drugs. There is a strong need for drugs that can stop the
resistant virus from spreading.
About Myriad
Myriad Genetics, Inc. is a biotechnology company focused on the
development and marketing of novel therapeutic and molecular
diagnostic products. Myriad's news and other information are
available on the Company's Web site at www.myriad.com.
Flurizan, Azixa and Vivecon are trademarks of Myriad Genetics, Inc.
in the United States and other countries.
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements include statements relating to the
potential for Vivecon to be taken orally and to inhibit viral
maturation, Myriad's discovery of additional novel targets which may
inhibit HIV infection, Myriad's pipeline of drug candidates in
development to treat some of the most serious, costly and devastating
diseases of our time, Myriad's plans to develop a series of compounds
for the treatment of viral diseases, and Myriad's current clinical
development plans for Vivecon, including the potential to move more
quickly through the typical development path and into Phase 3
studies. These risks and uncertainties include, but are not limited
to, our inability to further identify, develop and achieve commercial
success for new products and technologies; our ability to discover
drugs that are safer and more efficacious than our competitors; our
ability to develop molecular diagnostic products that help assess
which patients are subject to greater risk of developing diseases and
who would therefore benefit from new preventive therapies; the
possibility of delays in the research and development necessary to
select drug development candidates and delays in clinical trials; the
risk that clinical trials may not result in marketable products; the
risk that we may be unable to successfully finance and secure
regulatory approval of and market our drug candidates, or that
clinical trials will be completed on the timelines we have estimated;
uncertainties about our ability to obtain new corporate
collaborations and acquire new technologies on satisfactory terms, if
at all; the development of competing products and services; our
ability to protect our proprietary technologies; patent-infringement
claims; risks of new, changing and competitive technologies and
regulations in the United States and internationally; and other
factors discussed under the heading "Risk Factors" contained in Item
1A in our Annual Report on Form 10-K for the year ended June 30,
2007, which has been filed with the Securities and Exchange
Commission, as well as any updates to those risk factors filed from
time to time in our Quarterly Reports on Form 10-Q or Current Reports
on Form 8-K. All information in this press release is as of the date
of the release, and Myriad undertakes no duty to update this
information unless required by law.
Contact: William A. Hockett
Exec.VP, Corporate Communications
(801) 584-3600
Email: Email Contact
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