Targeted Docetaxel-Nanocolloid for the Treatment of Ovarian Cancer

靶向多西紫杉醇纳米胶体治疗卵巢癌

• 批准号: 8442130
• 负责人: Timothy P Coleman
• 金额: $ 28.83万
• 依托单位: NEMUCORE MEDICAL INNOVATIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-26 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8442130
• 关键词: Address; Adult; Advanced Development; Adverse effects; Affect; Affinity; Aftercare; Antineoplastic Agents; Binding; Biodistribution; Blood; Blood Vessels; CA-125 Antigen; Cancer Diagnostics; Cancer Model; Cancer Patient; Cessation of life; Characteristics; Cisplatin; Clinic; Clinical; Clinical Trials; Collaborations; Combined Modality Therapy; Companions; Dana-Farber Cancer Institute; Data; Development; Diagnosis; Diagnostic; Disease; Disease remission; Dose; Drug Kinetics; Drug toxicity; Effectiveness; Encapsulated; Exposure to; FDA approved; Face; Fox Chase Cancer Center; Generations; Goals; Grant; Growth; In Vitro; Integrins; Laboratories; Ligands; Louisiana; Malignant Female Reproductive System Neoplasm; Malignant Neoplasms; Malignant neoplasm of ovary; Marketing; Medical; Medicine; Methods; Mission; Modeling; Mus; NCI-Designated Cancer Center; NIH Program Announcements; Nanotechnology; Neoplasm Metastasis; Newly Diagnosed; Organ; Paclitaxel; Patient Selection; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase; Physicians; Platinum; Play; Primary Neoplasm; Process; Property; Proteins; Quality of life; RGD (sequence); Recurrence; Refractory; Refractory Disease; Relapse; Research; Research Personnel; Research Proposals; Residual Tumors; Resistance; Role; Safety; Serum; Site; Small Business Innovation Research Grant; Solubility; Solutions; Specificity; Staging; System; Taxane Compound; Technology; Testing; Therapeutic; Therapeutic Agents; Time; Tissues; Toxic effect; Toxicology; Tumor Cell Invasion; United States National Institutes of Health; Universities; Vascularization; Work; advanced disease; angiogenesis; base; cancer cell; cancer therapy; chemotherapeutic agent; clinical practice; cohort; combat; controlled release; conventional therapy; cytotoxic; cytotoxicity; design; docetaxel; drug standard; experience; improved; in vivo; innovation; intraperitoneal; intravenous administration; manufacturing process; nanocolloid; nanomedicine; nanosized; neovasculature; novel; ovarian neoplasm; palliation; patient population; phase 2 study; pre-clinical; preclinical study; prevent; programs; response; selective expression; taxane; tumor; tumor progression

DESCRIPTION (provided by applicant): PROJECT SUMMARY This proposal is a Phase 1 proposal in response to The National Institute of Health Small Business Innovation Research (SBIR) Program call for proposals for the Cancer Diagnostics and Therapeutic Agents Enabled By Nanotechnology (SBIR [U43/U44]) [Program Announcement Number: PA-10-286]. Nemucore Medical Innovation, Inc.'s (NMI) goal for this Phase 1 SBIR proposal is to fully determine the controlled release, targeting, cytotoxicity, pharmacokinetics, and efficacy profile for a novel integrins v3 and v5 targeted docetaxel (DTX) encased in a nanocolloid created with a proprietary layer-by-layer manufacturing process, designated NMI-700, for treatment of integrin expressing ovarian cancers. NMI's long- term goal is to couple NMI-700 with a companion diagnostic utilizing AutoGenomic's INFINITI" platform to screen for integrin expressing ovarian tumors in order to stratify patients into a cohort who would most benefit from this unique treatment. Part of the challenge with standard chemotherapeutic agents is the retention and distribution of the agent, which can be solved with the use of the NMI's long circulating nanocolloid technology developed for encapsulating poorly soluble drugs, such as DTX. Integrin targeting is highly applicable for ovarian cancer because most of ovarian cancers differentially express integrins compared to other adult tissues. Therefore design of NMI-700 incorporates a number of key attributes, which respond to physical limitations of DTX by mitigating solubility issues and to clinical observations that limiting systemic exposure that reduces drug toxicity, clearance, and inactivation through targeting and controlled release of sequestered DTX. For newly diagnosed ovarian cancer patients, a majority of whom rapidly progress to a chemoresistant state, NMI's nanomedicine offers a solution that is urgently needed for treating patients with refractory disease, which is generally incurable, and the goal of further treatment changes from one of cure to one of palliation. It is anticipated that the pre-clinical studies will advance to subsequent clinical trials where patients will be segregated into potential responders using the companion INFINITI" diagnostic. By the end of the grant period NMI should have much of the data needed to proceed to the next stage of preclinical development and to further the advancement of this unique integrin-targeted/DTX nanomedicine into the clinic. NMI anticipates that development of NMI-700 product will provide the following benefits: ¿ Provide a new highly cytotoxic treatment for tumors of a patient population in desperate need for a clinical solution. ¿ Advance the development of nanomedicine, a key compliment to the promise of personalized medicine. ¿ Commercialize a new method of manufacture for solubilizing poorly soluble drugs.

描述（由应用程序提供）：项目摘要本提案是对国家卫生研究所小型企业创新研究（SBIR）计划的一项第1阶段提案，呼吁纳米技术启用癌症诊断和治疗剂的建议（SBIR [sbir [u43/u44]）[程序宣布编号：PA-10-0-286]。 Nemucore Medical Innovation, Inc.'s (NMI) goal for this Phase 1 SBIR proposal is to fully determine the controlled release, targeting, cytotoxicity, pharmacokinetics, and effectiveness profile for a novel integrins v3 and v5 targeted docetaxel (DTX) encased in a nanocolloid created with a proprietary layer-by-layer manufacturing process, designated NMI-700, for treatment of integrin表达卵巢癌。 NMI的长期目标是将NMI-700与伴侣诊断使用自生构的Infiniti”平台，以筛选表达卵巢肿瘤的整合素的平台，以使患者分类为一个同类群体，该群体将从这种独特的治疗中受益。与标准化学疗法的挑战的一部分是与标准化学疗法一起使用的nmi comprient the nmi nmi，可以在nmi中求解。封装固体药物（例如DTX）。整联蛋白的靶标高度适用于卵巢癌通过针对新诊断的卵巢癌患者的靶向和受控释放，大多数人迅速发展到化学抗性状态，NMI的纳米医学提供了一种迫切需要治疗难治性疾病的患者的解决方案 进一步的治疗从一种治疗中变为一种抑制。预计，临床前研究将发展为随后的临床试验，在这些试验中，患者将使用Infiniti“诊断性诊断”将患者隔离为潜在的响应者。到赠款期结束时，NMI应该拥有许多需要进行下一阶段的数据，以促进临床上的临时性开发，并进一步将这种独特的整合性/dtx nani-dtx nani-nanimi-nanmi-nanmi-nmi-nmi-nmi-nmi-nmi-nmi-nmi-Ini-nmi-Ini-nmi-Inmi-Inmi-Inmi-Inmi-Inm-Inmi-Inmi-Inm-Inm-Inmi-Inm-Inmi-Inm-Inmi-Inm-Inmi-Inmi-Inmii则进行。产品将提供以下好处：为迫切需要临床解决方案的患者人群的肿瘤提供新的高度细胞毒性治疗方法。