Circadian's VGX-100 neutralises VEGF-C and inhibits tumour growth in mouse models of human cancers

• Data demonstrates efficacy of VGX-100 with other therapeutic agents in mouse models of lung, ovarian and prostate cancers.
• VGX-100 improves the efficacy of Avastin® in a lung cancer model and further inhibits tumour growth when combined with Avastin® plus docetaxel in mouse models of human lung and ovarian cancer. Data expand on previous anti-cancer effects seen with VGX-100 in prostate, pancreatic and brain cancers (glioblastoma).
• In addition to the effect on primary tumour growth, VGX-100 significantly reduces the metastatic spread of prostate cancer in a mouse model.  
• IND Filing for VGX-100 in oncology applications on track for filing Q3 2011

Circadian Technologies Limited (ASX.CIR) today released data at the American Association for Cancer Research (AACR) annual conference in Orlando, Florida (U.S.A.) demonstrating that its lead anti-cancer therapeutic, VGX-100, significantly inhibits tumour growth and spread in a variety of different mouse models of human cancer.  These data indicate that, if clinically validated, VGX-100 has the potential to be a useful new treatment for some types of cancer.

VGX-100 is a fully human monoclonal antibody targeting the VEGF-C growth factor.  VGX-100 inhibits the development of blood vessels that are required for tumour growth.  Additionally, VGX-100 may inhibit cancer spread (metastasis) by suppressing the development of both blood and lymphatic vessels.

Highlights of the data are as follows:

• Addition of VGX-100 to bevacizumab (Avastin®) + docetaxel therapy reduces tumour burden in prostate, ovarian and lung cancer models.
• In an orthotopic mouse model of human prostate cancer (a model where tumours are inoculated directly into the prostate) single-agent VGX-100 significantly inhibited primary tumour growth by 59% compared to a control antibody.
• In the same orthotopic model of human prostate cancer single agent VGX-100 significantly reduced the incidence of metastasis (tumour spread) to local lymph nodes by 55%.

The poster entitled "The novel therapeutic monoclonal antibody VGX-100 neutralises VEGF-C and inhibits tumour growth and metastasis in subcutaneous and orthotopic models of human cancer" and a more detailed description and data figures are contained in the Appendix that follows.

"This data further demonstrates that blocking the VEGF-C pathway by VGX-100 can inhibit tumour growth in mouse models of cancer.  Moreover, our data indicates that VGX-100 can act either by itself or in combination with approved drugs to slow the growth of several different tumour types including prostate, ovarian, lung, pancreatic, and glioblastoma. The observed effects on inhibiting the effects of metastatic spread in the prostate cancer model are especially exciting," commented Dr. Megan Baldwin, Head of Preclinical Research and Development and senior author.

Robert Klupacs, CEO of Circadian stated that, "This data, in addition to the data we have previously released publically, continues to build the strong case for clinical evaluation of VGX-100 and its possible future use as a new cancer treatment option. We are very excited by the prospect of commencing clinical development later this year."

Circadian controls exclusive worldwide rights to an extensive intellectual property portfolio enabling it to commercially develop antibodies targeting VEGF-C.  

Circadian intends to file an Investigational New Drug (IND) application with the US FDA in the third quarter of 2011 in order to begin human clinical trials of VGX-100.  This is subject to successfully completing the VGX-100 animal safety/toxicology studies which evaluate whether
VGX-100 is safe to be studied in humans.