Next-generation G-CSF for the Treatment of Neutropenia

Maxygen focuses on developing improved versions of protein therapeutics. Our MAXY-G34 product candidate was designed to be an improved next-generation granulocyte colony stimulating factor, or G-CSF, for the treatment of neutropenia. G-CSF is a natural protein that works by stimulating the body’s bone marrow to produce more white blood cells.  

Neutropenia is a severe decrease in neutrophil cell counts in the blood. Neutrophils are a specific type of blood cell that plays an important role in the defense against bacterial infections.  Neutropenia is a common side effect of chemotherapeutic treatments for many forms of cancer, including breast cancer, lung cancer, lymphomas and leukemias. Neutropenic patients contract bacterial infections more easily and often, some of which can be life threatening. Further, and most importantly, chemotherapy treatment for neutropenic patients may be reduced or delayed, which can result in cancer progression.

MAXY-G34 may help the body make white blood cells more quickly than the products currently approved for the treatment of neutropenia, Neupogen® and Neulasta®, which could make it an attractive alternative for both doctors and patients. In multiple pre-clinical animal models, we have generated data that suggest that our MAXY-G34 product candidate reduces the duration of neutropenia by clinically relevant periods (approximately 25% shorter duration of neutropenia) when compared to the currently marketed products. This may help protect patients from chemotherapy and radiation therapy-related infections, shorten the duration of hospital stays and help keep patients on schedule for their cancer treatments.

Market Opportunity
Neupogen®, a first-generation G-CSF product, and Neulasta®, a second-generation G-CSF product, currently dominate the market to treat chemotherapy and radiation-induced neutropenia. Worldwide sales of G-CSF products were approximately $3.9 billion in 2006.

Development Status
In the third quarter of 2006, we initiated a Phase I clinical trial in the United States for our lead MAXY-G34 product candidate in healthy male and female volunteers.  The results of the Phase I clinical trial showed that MAXY-G34 was safe and well tolerated throughout the study, at all doses, which ranged from 5 to 150 mcg/kg of MAXY-G34. All doses tested in this Phase I trial increased the neutrophil levels as compared to the placebo controls. In subject follow-up 30 days after the administration of MAXY-G34, no antibodies were detected in any clinical trial participants.  As expected based on the results of pre-clinical animal studies, MAXY-G34 demonstrated a prolonged half-life compared to Neulasta.

In June 2007, we initiated a Phase IIa clinical trial of MAXY-G34 in cancer patients.  This trial, which will be conducted at multiple centers in Eastern Europe, is the first trial of MAXY-G34 in patients. Approximately 30 patients with Stage I-III breast cancer will undergo TAC (docetaxel, adriamycin and cyclophosphamide) chemotherapy followed by next-day administration of either MAXY-G34 or Neulasta® (control population). The trial is designed as a multiple ascending dose study, with planned doses at 10, 30, 60, or 100 mcg/kg of MAXY-G34 compared to 6mg of Neulasta®. Both MAXY-G34 and Neulasta will be administered as a single subcutaneous injection once per chemotherapy cycle.The primary objective of the Phase IIa trial is to identify one or more doses of MAXY-G34 that effectively treat chemotherapy-induced neutropenia.

We currently retain all rights to our MAXY-G34 product candidates. 

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