* 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
MELBOURNE, Australia | April 6, 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.
About Circadian Technologies Limited
Circadian (ASX:CIR.ax – News) is a biologics drug developer focusing on cancer therapies. It controls exclusive worldwide rights to a significant intellectual property portfolio around Vascular Endothelial Growth Factor (VEGF) C and D. The applications for the VEGF technology, which functions in regulating blood and lymphatic vessel growth, are substantial and broad. Circadian’s internal product development programs are focussed on novel anti-cancer therapeutics for large unmet needs. Circadian has also licensed rights to some parts of its intellectual property portfolio for the development of other products to ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, including the antibody-based drug IMC-3C5 targeting VEGFR-3.
About Circadian’s pipeline of treatments for cancer
The clinical and outstanding commercial success of Avastin®, an antibody that blocks the activity of VEGF-A, clinically validated anti-angiogenic drugs as an effective means of inhibiting solid tumour growth. By blocking the interaction of VEGF-A with its receptors, primarily VEGFR-2, the multi-billion dollar cancer therapeutic slows tumour growth by inhibiting blood vessel recruitment into the tumour, effectively starving tumours of essential nutrients and oxygen required for growth. Avastin®, which is sold by Genentech, now part of Roche, had U.S. sales in 2009 of US$5.7 billion and worldwide sales in excess of US$8.6 billion. Avastin® is approved by the US FDA in the following indications: metastatic colorectal cancer, non-squamous-cell lung cancer, metastatic breast cancer, glioblastoma, metastatic renal cell carcinoma.
The VEGF-C inhibitor, VGX-100, a key therapeutic in Circadian’s portfolio, block this alternative stimulator for VEGFR-2. As such, it has the potential to block blood vessel growth in tumours resistant to anti-VEGF-A therapy and, when used in combination with drugs like Avastin®, may completely shut down angiogenesis (the growth of blood vessels) mediated by VEGFR-2, resulting in greater clinical efficacy.
VEGF-C along with the molecule VEGF-D. are also the only known proteins to bind and activate VEGFR-3 which drives lymphatic vessel and tumour-associated blood vessel growth. Inhibitors of VEGF-C thus have therapeutic potential to inhibit not only primary tumour growth through their anti-angiogenic activities, but to also inhibit tumour spread or metastasis via the lymphatic vessels – a mechanism of tumour dissemination that is often the deadliest aspect of many tumour types and a mechanism that is not effectively blocked by anti-VEGF-A or anti-VEGFR-2 therapeutics.
Inherent risks of Investment in Biotechnology Companies
There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialisation and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Circadian are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Thus investment in companies specialising in drug development must be regarded as highly speculative. Circadian strongly recommends that professional investment advice be sought prior to such investments.
SOURCE: Circadian
Post Views: 29
* 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
MELBOURNE, Australia | April 6, 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.
About Circadian Technologies Limited
Circadian (ASX:CIR.ax – News) is a biologics drug developer focusing on cancer therapies. It controls exclusive worldwide rights to a significant intellectual property portfolio around Vascular Endothelial Growth Factor (VEGF) C and D. The applications for the VEGF technology, which functions in regulating blood and lymphatic vessel growth, are substantial and broad. Circadian’s internal product development programs are focussed on novel anti-cancer therapeutics for large unmet needs. Circadian has also licensed rights to some parts of its intellectual property portfolio for the development of other products to ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company, including the antibody-based drug IMC-3C5 targeting VEGFR-3.
About Circadian’s pipeline of treatments for cancer
The clinical and outstanding commercial success of Avastin®, an antibody that blocks the activity of VEGF-A, clinically validated anti-angiogenic drugs as an effective means of inhibiting solid tumour growth. By blocking the interaction of VEGF-A with its receptors, primarily VEGFR-2, the multi-billion dollar cancer therapeutic slows tumour growth by inhibiting blood vessel recruitment into the tumour, effectively starving tumours of essential nutrients and oxygen required for growth. Avastin®, which is sold by Genentech, now part of Roche, had U.S. sales in 2009 of US$5.7 billion and worldwide sales in excess of US$8.6 billion. Avastin® is approved by the US FDA in the following indications: metastatic colorectal cancer, non-squamous-cell lung cancer, metastatic breast cancer, glioblastoma, metastatic renal cell carcinoma.
The VEGF-C inhibitor, VGX-100, a key therapeutic in Circadian’s portfolio, block this alternative stimulator for VEGFR-2. As such, it has the potential to block blood vessel growth in tumours resistant to anti-VEGF-A therapy and, when used in combination with drugs like Avastin®, may completely shut down angiogenesis (the growth of blood vessels) mediated by VEGFR-2, resulting in greater clinical efficacy.
VEGF-C along with the molecule VEGF-D. are also the only known proteins to bind and activate VEGFR-3 which drives lymphatic vessel and tumour-associated blood vessel growth. Inhibitors of VEGF-C thus have therapeutic potential to inhibit not only primary tumour growth through their anti-angiogenic activities, but to also inhibit tumour spread or metastasis via the lymphatic vessels – a mechanism of tumour dissemination that is often the deadliest aspect of many tumour types and a mechanism that is not effectively blocked by anti-VEGF-A or anti-VEGFR-2 therapeutics.
Inherent risks of Investment in Biotechnology Companies
There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialisation and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Circadian are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Thus investment in companies specialising in drug development must be regarded as highly speculative. Circadian strongly recommends that professional investment advice be sought prior to such investments.
SOURCE: Circadian
Post Views: 29
