Next-generation G-CSF for the Treatment of Neutropenia

MAXY-G34 is a novel, pegylated granulocyte-colony stimulating factor (G-CSF) that has been developed to treat chemotherapy-induced neutropenia.  G-CSF is a natural protein that stimulates the body’s bone marrow to produce neutrophils, a specific type of white blood cell that plays an important role in the defense against bacterial infections.

Neutropenia is a severe decrease in neutrophil cell counts in the blood.  Chemotherapy-induced neutropenia (CIN) is a common side effect of myelosuppressive chemotherapeutic treatments for many forms of cancer, including breast cancer, lung cancer, lymphomas and leukemias.  Neutropenic patients are at increased risk of contracting bacterial infections, some of which can be life threatening.  Further, neutropenic patients may require reduced or delayed chemotherapy treatment, which can result in cancer progression.

In December 2008, we completed a Phase IIa clinical trial for our MAXY-G34 product candidate for the treatment of chemotherapy-induced neutropenia in breast cancer patients. As we previously announced, we plan to continue to delay both Phase III manufacturing activities and a Phase IIb clinical trial of our MAXY-G34 program for chemotherapy-induced neutropenia until we identify a partner who can share these significant future costs. To date, we have not identified a suitable partner for this program for chemotherapy-induced neutropenia.

In May 2009, we entered into an option and license agreement with Cangene pursuant to which we have granted Cangene options to obtain certain licenses to intellectual property rights associated with our MAXY-G34 program to fulfill potential future government contracts related to the development, manufacture and procurement of MAXY-G34 for the treatment or prevention of neutropenia associated with acute radiation syndrome. We have received an option fee of $500,000 and are eligible to receive an option exercise fee, as well as additional license fees based on a percentage of net contract revenue received by Cangene, to the extent that Cangene is awarded one or more applicable government contracts and exercises an option for a license.

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