Five Eleven Pharma Inc. — Department of Health and Human Services SBIR Phase I: 102

Description

Abstract Five Eleven Pharma is developing a novel radiotracer Ga P to facilitate Positron Emission Tomography PET detection of bone cancer Our Phase I feasibility and dosimetry clinical trial in metastatic prostate cancer patients IND was well received by the FDA who provided guidance on an expanded effort at this early phase to determine near optimum dose regimen and imaging parameters P has funded this clinical study through its own resources Using this company funded trial data this Phase I SBIR application will specifically support the imaging analytical data assessment required to answer the FDA s question to allow the company to move into Phase II III clinical trials next year This project supports an innovative new bone imaging agent Ga P that utilizes a well known ligand HBED in conjunction with the leading bone targeting agent bisphosphonate to specifically target cancerous bone lesions This novel radiotracer should allow for the broader adoption of highly targeted low radiation short lived Ga imaging agents for bone cancer The early detection of cancer and metastatic disease is paramount to improving cancer outcomes and Ga imaging agents such as Ga P have a number of clear advantages such as short half life decay by positron emission and generator based radionuclide production that will support a broader adoption and use of these PET enhancing radiotracers To support the FDA s request Aim will determine the optimal radiopharmaceutical dose and scan time to preserve diagnostic accuracy while minimizing patient exposure We will sub sample the list mode PET data from our metastatic prostate cancer study to simulate injected dose scan time after injection and scan duration We will use data acquired from patients following a MBq mCi dose using a list mode acquisition on a Philips Ingenuity PET CT scanner and then sub sample the data to emulate lower dose injections using published bootstrapping methods to create replicates for each dose we wish to evaluate we plan to generate replicates corresponding to and MBq and mCi in addition to the data set at MBq mCi injection We will use Time of Flight TOF reconstruction methods as this leads to improved detectability and more accurate recovery of lesion uptake with lower variability We expect to determine the dependence of lesion VOI bias and precision to decreasing injected dose which will allow us to determine the optimized injected dose scan time and scan duration that optimizes diagnostic acccuracy lesion detection while minimizing patient radiation exposure In Aim we will evaluate all Phase I clinical data including drug pharmacokinetics safety radiation dosimetry and other pertinent information to create a report of clinical findings in preparation for meeting with the FDA to plan additional studies Successful completion of these aims will provide a clear path forward for future studies needed to obtain NDA approval Page of Narrative Short lived Ga based radiopharmaceuticals represent a major advancement in cancer patient care using PET imaging Five Eleven Pharma is developing a novel Ga bone imaging agent to provide more effective detection of bone lesions in metastatic prostate cancer patients This novel drug should provide higher resolution images of earlier stage bone metastases with potentially less patient radiation exposure that could lead to earlier treatments and improved interventions Page of