REDWOOD CITY, Calif., Nov. 7 /PRNewswire-FirstCall/ -- Maxygen, Inc. 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 www.maxygen.com . 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 www.maxygen.com . 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.
CONTACT: Linda Chrisman of Maxygen, Inc., +1-650-298-5351, or fax,+1-650-364-2715
Web site: http://www.maxygen.com/
