Prevacus to Begin Phase 1 Clinical Studies of PRV-002 for the Treatment of Concussion
TALLAHASSEE, Fla., Feb. 09, 2017 (GLOBE NEWSWIRE) — Prevacus, Inc., a leading biopharmaceutical company focused on developing treatments for concussion aka mild Traumatic Brain Injury (mTBI) and other neurological disorders; today announced plans to initiate Phase 1 clinical studies of a novel treatment for concussion in humans. The Company expects to initiate its Phase 1 trial during the first half of 2017.
“I am excited with the progress we’ve made in advancing PRV-002, our novel treatment for mTBI,” said Dr. Jake VanLandingham, CEO of Prevacus. “Concussion presents a significant, unmet medical need, and our PRV-002 compound has the potential to reduce the adverse effects associated with mTBI in athletes, military personnel, and civilian patients while improving the quality of life thereby, saving the U.S. Healthcare system significant costs.”
These clinical studies will examine the potential of Prevacus’ proprietary compound PRV-002 for concussion treatment in humans. In pre-clinical animal studies, the compound performed positively in all measured areas, including memory score, sensory-motor function, anxiety, cerebral edema, cell death and cellular regeneration. PRV-002 is administered nasally providing for a 4-fold higher exposure to the injured brain while simultaneously reducing potential adverse effects on other regions of the body. Furthermore, the compound appears to be over 380-fold safe in toxicology and safety studies in three separate species.
Prevacus, Inc. is a biopharmaceutical company developing drug candidates with the potential to advance treatment in the fields of traumatic brain injury and other neurological disorders. The Company’s first development candidate (PRV-002) represents a breakthrough strategy for treating concussion working at the molecular level to simultaneously reduce inflammation, swelling, ischemic injury and oxidative stress.
A concussion is a type of traumatic brain injury caused by a significant force to the head or upper body causing the brain to shake inside the skull. The injury is defined as a concussion when it causes a change in mental status such as amnesia, disorientation, mental fogginess, confusion, nausea/vomiting, blurred vision, headache, balance deficits or loss of consciousness. There are 21 symptoms demonstrated to be associated with concussion. Loss of consciousness does not indicate injury severity. Because no two concussions are exactly alike, effects and recovery are sometimes difficult to assess. Therefore the condition requires a compound that can work to reduce multiple pathological issues.
PRV-002 is a fully synthetic non-naturally occurring neurosteroid administered through the nasal cavity. PRV-002 carries with it equivalent, if not superior, neuroprotective effects compared to related neurosteroids. Animal models of concussion demonstrated that PRV-002 reduces the behavioral pathology associated with brain injury symptoms such as memory impairment, anxiety, and motor/sensory performance. Additionally, PRV-002 is lipophilic and can easily cross the blood-brain barrier to rapidly eliminate swelling, oxidative stress and inflammation in the brain while restoring proper blood flow.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, future financial results, including operating expenses and cash position, pursuit of strategic options and pursuit of research and clinical development programs. Risks that contribute to the uncertain nature of the forward-looking statements include: we expect to incur losses for the foreseeable future and will need additional funds to finance our operations; our operating results fluctuate significantly; our estimates regarding our ability to initiate and/or complete our clinical trials and the timing and expense of these trials may not be accurate; enrollment in our clinical trials may be delayed; our clinical trials may not demonstrate the efficacy and safety of our product candidates; we may not be able to manufacture our product candidates on a commercial scale in a timely or cost-efficient manner; our estimates regarding expenses and capital requirements may not be accurate; regulatory developments in the United States and foreign countries may adversely affect our operations or prospects; we must obtain and maintain intellectual property protection for our product candidates; the loss of key scientific or management personnel could adversely affect our operations. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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