In order to bring this first therapeutic closer to patients, the company needs to first produce cGMP grade RGD-AAVP-TNF, complete an IND filing for the FDA, and initiate a clinical trial. The company is now completing necessary toxicity studies and manufacturing, and targets to complete IND-enabling work in 2017. During this time, the Company will request a pre-IND meeting with the FDA to discuss the development plan and ensure all pre-IND requirements are met. In mid-2017, AAVP will focus on raising another round of capital to fund its Phase I dose escalating clinical trial, which should conclude in 2018. This study will be a standard safety and toxicity study, but will also capture important efficacy data. Efficacy in this case is defined by the ability to selectively deliver the target gene to the tissue of interest and exclusively express the gene at that site. Additional endpoints are to demonstrate lack of toxicity and lack of the generation of a blocking immune response. Tumor response will be assessed as a secondary endpoint. All of the company’s early data from animal studies including the veterinary trial supports the anticipation that the in-human study will be successful. In order to accomplish its goals, AAVP has retained a strong management team, and continues to identify partners to assist the company in moving the platform forward. The company has also assembled a team of investigators that are experienced in clinical trial design and implementation.