This phase Il application is part of a program to commercialize a folate targeted diagnostic imaging agent. Endocyte has developed and is conducting clinical trials with a folate targeted Indium-I Il agent (111In- DTPA-folate). The objective of this Phase Il SBlR grant is to complete pre-clinical development, file an IND, and conduct a phase I/II clinical trial with a folate targeted technetium diagnostic agent (99mTc-EC14). A 99mTc based folate-targeted system has many advantages over an Indium based agent including improved image quality, lower cost, and reduced radiation exposure.
The specific aims for this study are as follows: 1. To perform pre-clinical pharmacology studies aimed at determining 99mTc-EC14's biodistribution, pharmacokinetic, and serum protein binding properties; and metabolic fate; 2. To conduct an """"""""Expanded Acute Toxicity Study"""""""" in two animal species; 3. To generate 99mTc-EC14 radiopharmaceutical kits manufactured and packaged in accordance with cGMP requirements for use in human clinical trials; 4. To prepare and submit an IND application to the FDA to obtain approval for the initiation of a Phase I/II human clinical trial. 5. To conduct a Phase I/II clinical study in ovarian cancer patients to evaluate the safety and efficacy of the 99mTc-ECI4 product for imaging primary and metastatic ovarian carcinomas.
The proposed project is aimed at developing a Tc99m-folate imaging agent to be used in diagnoses of malignant tumors expressing the folate receptor. This product will significantly impact clinical management of an estimated 300,000 folate receptor positive cancer patients by providing a safe, affordable, and accurate method to distinguish between malignant and benign masses, locate metastatic sites, check for recurrence, and identity cancers for folate targeted therapy.
