Circadian Technologies (ASX: CIR) managing director, Robert Klupacs, has outlined in the preliminary final report the company's strategy to commercially develop the extensive intellectual property (NYSE:IP) platform.
This platform includes VEGF-C, VEGF-D and VEGFR-3 as therapeutic and diagnostic products in cancer and eye disease.
In the operations report, Klupacs highlighted the significant milestones achieved by the company during financial year 2011, which included:
- Completion of IND enabling studies for VGX-100 in the oncology setting. We plan to commence Phase I studies before the end of 2011;
- Our first therapeutic product candidate (IMC-3C5, a human antibody to VEGFR-3) being developed by our licensee ImClone Systems Inc entered into Phase I clinical trials;
- Our first clinical diagnostic product, a VEGF-D diagnostic test to diagnose patients with the debilitating lung disease – lymphangioleiomyomatosis (LAM), was launched in the USA through our partner Cincinnati Children’s Hospital Medical Centre;
- We successfully resolved the arbitration proceedings with Ark Therapeutics Limited relating to that company’s ongoing development of VEGF-D gene therapy products and which will result in improved licencing terms to us in the future;
- We achieved the grant of very important patents in the USA and Europe covering the use of any of our lead therapeutic product candidates or similar products of third parties, to treat cancer or eye disease which extended patent coverage to September 2023, as well as additional patents in the USA covering VEGF-D diagnostics;
- We considerably strengthened our dominant IP position in respect of VEGF-D and VEGF-D antibodies through the receipt of a worldwide exclusive licence to VEGF-D IP owned by the largest biotechnology company in Japan - Chugai Pharmaceutical Co;
- In collaboration with the Schepens Eye Research Institute at Harvard University, identified that the VEGF-C/VEGFR-3 pathway is a major mediator of inflammatory disease in the cornea and that VGX-100 could become a major new therapeutic in the treatment of front-o f- the eye diseases;
- We outlined in detail our clinical development strategy and projected timelines to develop VGX-100 in combination with existing standard of care chemotherapy regimens in patients with glioblastoma (brain cancers) and colorectal cancers; and
- Announced our strategy to develop VGX-100 as an agent to treat various corneal (front of the eye) diseases.
Advancing the Circadian product pipeline
Klupacs added that the company's short term goal is to file an IND with the FDA and subsequently commence Phase I clinical trials in cancer patients in the December quarter of 2011.
Circadian is continuing to undertake additional studies to evaluate VGX-100 in a range of different tumour types in rodent cancer models.
In regards to front of the eye disease - the company have an ongoing collaboration with scientists at the Schepens Eye Research Institute at Harvard University evaluating VGX-100 in a range of corneal disease models.
The Schepens scientists have previously identified the key role of the VEGFC/D/VEGFR-3 axis in mediating corneal inflammation and avascularity.
The year ahead
Circadian are targeting the following key events for the next 12 months, including:
- IND filing in respect of the VGX-100 with the US FDA and subsequent commencement of clinical trials;
- Generation of additional data in animal models on corneal diseases to support development of VGX-100 in corneal disease settings;
- Launch of CUP diagnostic test by Healthscope;
- Development of additional clinical diagnostic tests for the measurement of VEGF-C, VEGF-D and/or VEGFR-3 in patient tissue as diagnostic assays in oncology; and
- Continued expansion of the marketing of our VEGF-D based diagnostic test for LAM, outside of the USA.