Maxygen, Inc.
(Nasdaq: MAXY) announced today that Roche has initiated a Phase Ia clinical
trial in New Zealand to evaluate the safety, tolerability, pharmacokinetic
and pharmacodynamic profile of Maxy-alpha, a next-generation interferon
alpha for the treatment of hepatitis C virus infection.
The Phase Ia clinical trial is a double-blind, dose-escalation,
controlled study of a single sub-cutaneous administration of Maxy-alpha in
healthy volunteers with both placebo and PEGASYS(R) (peginterferon alfa-2a
(40KD)) control groups. Maxy-alpha, also known as R7025, Roche's internal
designation for the molecule, is a novel PEGylated interferon alpha variant
created through the use of Maxygen's proprietary MolecularBreeding(TM)
directed molecular evolution technologies. Maxy-alpha has been designed to
have more anti-viral activity against the hepatitis C virus and be more
effective in stimulating immune responses to help combat the infection.
Preclinical data comparing Maxy-alpha to PEGASYS(R) demonstrated that
Maxy-alpha has increased anti-viral and immune stimulatory activity
compared to PEGASYS(R). Roche and Maxygen worked together to PEGylate
Maxy-alpha to ensure comparable pharmacokinetics and dosing convenience to
Roche's currently marketed PEGylated interferon alpha, PEGASYS(R).
Maxygen will receive a $2 million dollar milestone payment for the
commencement of the Phase Ia trial.
"Maxy-alpha is the first 'shuffled' protein to enter clinical
development," said Russell Howard, Chief Executive Officer of Maxygen.
"This demonstrates how Maxygen's proprietary technologies can be used to
specifically enhance desired properties of potential protein drugs. We
designed this molecule to have greater potency over the currently marketed
interferon alpha drugs in the hopes of addressing the large percentage of
patients that are not effectively served by current therapies. We are
hopeful that the forthcoming clinical trials of Maxy-alpha will demonstrate
a significant improvement in the treatment of hepatitis C virus infection.
Roche is an ideal partner for Maxygen's next-generation interferon alpha
and we are encouraged by their enthusiasm and commitment to the program."
About Hepatitis C
Hepatitis C virus infection causes chronic inflammation in the liver.
In a majority of patients, hepatitis C virus infection can persist for
decades and eventually lead to cirrhosis, liver failure and liver cancer.
Hepatitis C virus infection represents a significant medical problem
worldwide. Currently, there is no vaccine available to prevent hepatitis C
virus infections. The standard treatment for hepatitis C virus infections
is a combination of PEGylated interferon and ribavirin, a small molecule.
About Alpha Interferon
Alpha interferon is a natural protein that is produced by many cell
types, including T-cells and B-cells, macrophages, fibroblasts, endothelial
cells, osteoblasts and others, and is an important component of the
anti-viral response, stimulating both macrophages and natural killer (NK)
cells.
Market Opportunity
Based on currently available market data, worldwide sales of drugs for
the treatment of hepatitis C virus infections, including PEGylated
interferon alpha and ribavirin, were approximately $2.75 billion in 2005.
Sales of drugs to treat hepatitis C virus infections are expected to grow
due to improved market penetration through improvements in therapies,
increased awareness and improved diagnosis rates.
About Maxygen
Maxygen, Inc., headquartered in Redwood City, California, is committed
to the discovery, development and commercialization of improved
next-generation protein pharmaceuticals for the treatment of disease and
serious medical conditions. For additional information on Maxygen,
including access to Maxygen's SEC filings, please visit Maxygen's website
at maxygen. Maxygen and the Maxygen logo are trademarks of
Maxygen, Inc.
Forward-Looking Statements
This news release contains forward-looking statements about our
research and business prospects, including those relating to: the ability
or intent of Roche to successfully conduct and complete clinical trials of
Maxy-alpha and, if successful, to commercialize Maxy-alpha; the ability or
intent of Roche to otherwise perform its obligations under its
collaboration agreement with us for the Maxy-alpha program, our ability to
perform our obligations under the collaboration agreement and to
effectively manage our relationship with Roche; the potential safety,
tolerability, pharmacokinetic and pharmacodynamic profile of Maxy-alpha;
the expected safety, tolerability, pharmacokinetic and pharmacodynamic
profile of Maxy-alpha compared to other interferon alpha products; whether
Maxygen's therapeutic products will exhibit improved properties in humans
as compared to currently marketed drugs; and the potential market
opportunity for sales of alpha interferon products and other drugs to treat
hepatitis C virus infections. Such statements involve risks and
uncertainties that may cause results to differ materially from those set
forth in these statements. Among other things these risks and uncertainties
include, but are not limited to: changing research and business priorities
of Maxygen and/or Roche; the inherent uncertainties of pharmaceutical drug
development; the uncertain timing of therapeutic drug development;
competitors producing superior products; and our ability to establish and
maintain our research and commercialization collaborations and
manufacturing arrangements. These and other risk factors are more fully
discussed in our Form 10-K for the year ended December 31, 2005, including
under the caption "Risk Factors," and in our other periodic SEC reports,
all of which are available from Maxygen at maxygen. Maxygen
disclaims any obligation to update or revise any forward-looking statement
contained in this release as a result of new information or future events
or developments.
Maxygen, Inc.
maxygen
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