Vote for CereNovo on the Duke Start-Up Challenge Facebook Page.
is a North Carolina based start up that is developing a biologic to treat the
neurological damage caused by traumatic brain injury and stroke. CereNovo
is currently seeking $1.5 MM to proceed with
preclinical IND-enabling studies. CereNovo intends to
use the $50,000 prize money, in conjunction with other non-dilutive capital
to incorporate, license, and continue preclinical studies. To further explain our value proposition we have created a short 5-minute video.
Every 40 seconds, someone in the United States has a stroke. This number adds up to 795,000 strokes a year. The statistics for traumatic brain injury (TBI) are similar with 1.5 million
TBIs occurring each year in the United States; of this number, 275,000 TBI
patients are hospitalized and 43% suffer long-term cognitive, motor, and emotional changes. The
total direct medical cost, including both acute and long-term care, of TBI and
stroke is approximately $89 billion per year. After the initial insult to the
brain (trauma/bleeding/infarct), it is vital for a patient’s survival and recovery
to prevent further brain deterioration (secondary damage). However, the major
problem with treating stroke and TBI is that current treatment is merely
palliative and focuses on stabilizing the patient’s intracranial
pressure, cerebral blood flow, and oxygen supply. No treatment today effectively addresses the secondary neurological damage
caused by the body’s immune response after a brain-injuring event. The lack of an FDA approved drug to effectively treat TBI and stroke shows a
clear unmet need for these patients.
CereNovo, a North Carolina based start up, addresses this need by creating a proprietary neuro-protective biologic called CN-1. It reduces neuronal degeneration and death by shielding the brain from the secondary damage derived from inflammation after a stroke/TBI event. CN-1 achieves its therapeutic effect by mimicking apoE, a protein found in the brain that reduces inflammation after brain injury. Animal studies have revealed that CN-1 not only diminishes neural degeneration and death, but also improves recovery of motor and cognitive functions. Clinicians surveyed on CN-1’s potential used words like “fascinating”, “exciting” and “important” to express their interest in the CN-1 biologic.
CN-1 is targeting two global market segments: TBI and stroke. The estimated annual TBI market exceeds $500 million both in the United States and Europe. The global TBI therapeutics market was worth $1.54 billion in 2010, growing at an estimated 3.8% for seven years, and is expected to reach $2 billion by 2017. The global market for stroke was valued at approximately $3.0 billion in 2008. It is forecast to grow at a CAGR of 3.4% and projected to reach $3.6 billion by 2015.
For the next 2-4 years, CereNovo will be performing preclinical testing such as: 1) toxicology and PK/PD studies, 2) a primate dose escalation and/or Phase 0 human micro-dosing efficacy study, and 3) manufacturability and formulation testing. After preclinical testing is completed, an IND application will be submitted to the FDA and Phase I-III human clinical trials will begin, running for approximately 6 years. Upon completion, a Biologic License Application (BLA) will be submitted to the FDA for approval.
Vote for CereNovo on the Duke Start-Up Challenge Facebook Page! And be sure to join us for the Grand Finale on April 20th at 7:30pm ET in Geneen Auditorium at the Fuqua School of Business, or live on Duke's Ustream Channel. RSVP for the event on Facebook