Pipeline for Better Management of Neurodegeneration

F-18 Flornaptitril

CereMark Pharma has an exclusive license to F-18 Flornaptitril (fka, F-18 FDDNP) which is a new and investigational radiopharmaceutical that is used in conjunction with Positron Emission Tomography (PET). 

PET Imaging

PET is a routinely available, non-invasive type of nuclear medicine imaging that utilizes the special nuclear properties of positron-emitting radionuclides to obtain precise images of organ systems and pathology patients. 

Investigational Research

Investigational research with F-18 Flornaptitril (fka, F-18 FDDNP) in humans, and collaborative of tissue samples taken at autopsy in a subject who underwent PET imaging with F-18 Flornaptitril showed that F-18 Flornaptitril is taken up by the two principal pathological proteins  – tau and beta amyloid plaque – that are implicated to occur in forms of neurodegenerative diseases, including Alzheimer’s disease and Chronic Traumatic Encephalopathy (CTE) that has been associated with traumatic brain injuries.  Investigational New Drug (IND) studies with F-18 Flornaptitril have been performed in subjects with Alzheimer’s Disease (AD), and suspected CTE, including both concussive and percussive brain injuries (see figure).

Pipeline

Collaboration on New Neurotherapeutics

CereMark Pharma is pleased to be affiliated with ProPhos NeuroScience, LLC, an early-stage research company that is developing innovative compounds as potential neurotherapeutics that block initial injury effects at the brain cellular level to prevent the damaging neurological cascade which can occur following brain trauma impacts or that happen in the course of neurodegenerative diseases. By targeting the primary source of initial brain injury, we anticipate blocking the brain’s pathological processes to prevent or limit the progressive form of neurodegeneration leading to the dementia syndromes including CTE and diseases that follow this form of neurotoxicity. ProPhos NeuroScience researchers have identified both in laboratory models and well as human CTE brains, a common pathway which is promising as a targetable mechanism to intervene earlier before irreversible neurological damage can occur or progress and worsen.

PET images of subject brains obtained with F-18 Flornaptitril (fka, FDDNP)

Examples of FDDNP-PET DVR transaxial, coronal, and sagittal images of a cognitively healthy individual, Alzheimer’s disease patient, football player, and a military subject. The Alzheimer’s disease patient shows higher DVR signals in parietal, temporal and frontal regions compared to the healthy individual, who may have neuropathology deposition given the age of the subject (80 years). The football player and military subject show higher amygdala, midbrain, and other subcortical binding compared with the healthy individual and Alzheimer’s disease patient. The healthy individual showed some mild cortical binding typical of other healthy individuals age 70 and older (or darker shades in greyscale). Warmer colors (or darker shades in greyscale) indicate higher FDDNP binding.
Reprinted from J Alzheimers Dis 65(1), Chen ST, et al., “FDDNP-PET Tau Brain Protein Binding Patterns in Military Personnel with Suspected Chronic Traumatic Encephalopathy”, 79-88, Copyright (2018), with permission from IOS Press.

F-18 Flornaptitril (fka, F-18 FDDNP) is a new investigational radiopharmaceutical that is used in conjunction with Positron Emission Tomography (PET) and has been safely tested in research trials involving several hundreds of subjects.  CereMark Pharma plans to conduct the pivotal Phase 3 clinical trial of F-18 Flornaptitril shortly. 

We are focused now on developing high precision imaging solutions and neurotherapeutics with our collaborating affiliate ProPhos NeuroScience.