SBIR Phase I: Green Nanotechnology for Medicine: Scaling up the Synthesis of Novel Poly(ethylene glycol) Based Dendrimers for Targeted Drug Delivery Applications

这一小型企业创新研究第一阶段项目旨在展示一种新型多价治疗(治疗和诊断的组合)试剂中试规模生产的可行性，该试剂能够通过单个纳米大分子控制多个靶向配体的呈现，用于化疗应用。这家提议的公司成立于2011年，目标是基于阿克伦大学(UA)开发的技术开发和营销一系列生物医学产品。这项拟议研究的关键成果将是一种新型的聚乙二醇基树枝状大分子，它是在无溶剂条件下通过酶催化的“绿色”工艺生产的。具体地说，将在两加仑的中试规模上生产一种在外冠具有8个官能团的聚乙二醇基树状大分子，可用于靶向、成像/诊断和治疗药物的结合，供提议团队进行全面表征。最初的目标市场包括研究人员、研究性化学品供应商，以及为靶向药物输送开发新产品而进行研究的公司和组织。这个项目的更广泛的影响/商业潜力是巨大的。根据美国国家癌症研究所的数据，被诊断患有癌症的美国人将增长到1820万人。这项技术的一个具体好处与其对乳腺癌治疗的潜在影响有关。乳腺癌是白人和非裔美国女性最常被诊断出的癌症。每八名美国女性中就有一名罹患乳腺癌，美国每三分钟就有一名女性被诊断出患有乳腺癌。通过化疗系统治疗癌症有许多副作用，需要延长患者护理时间。有针对性的癌症治疗和诊断将产生重大影响，将对患者及其家人的破坏性副作用降至最低。根据对研究人员的销售，我们估计近期(3-5年)的市场潜力在100-150万美元左右。从长远来看，随着这项技术嵌入到特定的产品中，市场规模可能会达到数亿美元。最后，无溶剂的“绿色”技术将对环境产生积极影响。

This Small Business Innovation Research Phase I project is aimed at the demonstration of the feasibility of pilot scale production of a novel multivalent theranostic (combination of therapeutic and diagnostic) agent, capable of controlled presentation of multiple targeting ligands by a single nanosized macromolecule for chemotherapeutic applications. The proposing company was founded in 2011 with the objective of developing and marketing a range of biomedical products, based on technologies developed at the University of Akron (UA). The key outcome of the proposed research will be a novel poly(ethylene glycol) (PEG)-based dendrimer, produced by a "green" process using enzyme catalysis under solventless conditions. Specifically, a PEG-based dendrimer with 8 functional groups in the outer corona, available for the conjugation of targeting, imaging/diagnostic and therapeutic agents, will be produced at the two-gallon pilot scale for full characterization by the proposing team. The initial targeted market segment consists of researchers, research chemical suppliers, and companies and organizations doing research to develop new products for targeted drug delivery. The broader impact/commercial potential of this project is significant. Based on data from the National Cancer Institute, the number of Americans who are diagnosed with cancer will grow to 18.2 million. One specific benefit of this technology relates to its potential effects on breast cancer treatment. Breast cancer is the most frequently diagnosed cancer in both white and African-American women. One in eight American women develops breast cancer, and every three minutes a woman in the United States is diagnosed with breast cancer. Systemic treatment of cancer by chemotherapy has many side effects, requiring extended patient care. Targeted cancer treatment and diagnosis will have a major impact by minimizing the devastating side effects on the patient and his/her family. In the near term (3-5 years) we estimate a market potential on the order of $1-1.5 million, based on sales to researchers. In the longer term, the market size can potentially be in the hundreds of millions as the technology becomes embedded in specific products. Finally, the solventless "green" technology will have a positive effect on the environment.