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ApoImmune Awarded Phase II SBIR Grant for Continued Development of Novel Cervical Cancer Vaccine
July 31, 2008 (Louisville, KY) - ApoImmune, Inc. today announced that it has been selected to receive a 2-year Phase II Small Business Innovation Research (SBIR) grant of $1.64 million for the ongoing development of ApoVax104-HPV, a novel therapeutic vaccine for cervical cancer and human papillomavirus infection (HPV). HPV is the virus that causes cervical cancer in women. This award is the eighth National Institutes of Health (NIH) SBIR/STTR and the first Phase II grant received by the company.
The two-year Phase II SBIR grant, awarded by National Institute of Allergy and Infectious Disease (NIAID), will fund work to finalize the pre-clinical testing that will support submission of an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) for approval to initiate human clinical trials. Human clinical trials will be initiated to establish the product's safety and efficacy. In preclinical studies, the vaccine has proven to be much more effective and less toxic than other vaccine components currently being tested in late stage clinical trials by large pharmaceutical companies.
"ApoImmune is pleased to receive this prominent peer-reviewed award in the current highly competitive environment," said Steven T. Downey, President and CEO of ApoImmune, Inc. "Through this award, the NIH acknowledges the innovative nature of ApoImmune's technology as well as the strong commercial potential of our ApoVax104 vaccine technology. Our ongoing plans for ApoVax104-HPV seek to establish its safety and efficacy as a therapeutic vaccine for cervical cancer."
The grant follows the successful completion of the Phase I SBIR project, which established the initial efficacy studies of the vaccine in mice.
About ApoImmune, Inc.
ApoImmune Inc. is a Louisville, Kentucky-based biotechnology company developing novel immunotherapies, which are treatments based on the concept of regulating the immune system to fight disease. The Company's lead immunotherapy is based on the ProtEx technology's ability to teach the immune system to recognize foreign pathogens as harmful and specifically target those harmful cells for destruction. ApoImmune is also developing ProtEx to suppress the immune system in certain cases, which improves current organ and tissue transplant therapies by protecting the transplant from being attacked by the recipient's immune system when transplanted into the body. An added benefit of the ProtEx immune system suppression technology is that it also reduces the need for powerful immunosuppressive drugs with highly toxic effects that are required after transplantation.
For more information, visit www.apoimmune.com.
Certain statements made throughout this press release that are not historical facts contain forward-looking statements regarding the Company's future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements.
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