The most straightforward application of our alphavaccine vector technology is in the development of prophylactic vaccines for the prevention of infectious disease. The Company has vigorously pursued the development of several prophylactic vaccines for important human diseases during the past twelve years, either alone or in collaboration with corporate partners, academic institutions, and government agencies. In addition to our licensed CMV alphavaccine, AVX has developed alphavaccines for HIV-1, HSV-2,, RSV, seasonal and pandemic influenza viruses, gastrointestinal cancers, breast cancer, Marburg and Ebola viruses, and Smallpox.
One of our more recent bio-defence applications may be reviewed in a publication that discusses the results of using our technology in challenge studies of non-human primates against the Ebola virus. This publication may be viewed at
Therapeutic vaccines, used to treat chronic or recurrent diseases, offer an additional attractive opportunity for the application of our alphavaccine technology. Vaccines that treat existing diseases by enabling the immune system to control or clear the responsible pathogen are an emerging and competitive alternative to drug therapy. Examples of such diseases would include HSV, HPV, and HCV.
There is mounting evidence to suggest that if the body's natural immune response can be sufficiently stimulated, it can recognize and kill cancer cells. We are using alphavaccines to express tumor-specific antigens to maximize such anti-tumor immune responses. The technology has shown exciting promise in animal models of breast, melanoma, cervical, and prostate cancer. Our technology is currently being evaluated in phase I/II trials for colon/gastrointestinal cancers, breast cancer and in pre-clinical trials for prostate cancer.
Data from clinical trials in CEA-induced cancers is now available and analysis of survival has been completed. A trend toward extended survival has been seen. Immunological data, and related findings, in breast cancer trials where Her2 is over-expressed, are currently being analyzed - pursuant to the completed enrollment of both cohorts of patients. Analysis of a second clinical trial in GI tumors will await the enrollment of the final patient scheduled for later in 2016.
On account of its potent immunogenicity, applicability to a wide variety of pathogens, and potential for rapid deployment, the alphavaccine system is ideally suited to address threats from bioterror agents.
Over the last decade, AVX was awarded four multi-million dollar biodefense grants, further validating the utility of the alphavaccine vector technology in this arena. We have worked in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to assess the performance of these vaccine candidates in animal studies in high-containment laboratories. In the face of a credible threat, emergency stockpiles of such vaccines could be manufactured for government-directed use. Products based on these candidates can be approved for widespread use based on human safety and the animal rule.